12‐2106(L)
NRDC v. US FDA
UNITED STATES COURT OF APPEALS
FOR THE SECOND CIRCUIT
August Term, 2012
(Argued: February 8, 2013 Decided: July 24, 2014)
Docket Nos. 12‐2106‐cv(L), 12‐3607‐cv(CON)
NATURAL RESOURCES DEFENSE COUNCIL, INC., CENTER FOR SCIENCE IN THE PUBLIC
INTEREST, FOOD ANIMAL CONCERNS TRUST, PUBLIC CITIZEN, INC., UNION OF
CONCERNED SCIENTISTS, INC.,
Plaintiffs‐Appellees,
— v. —
UNITED STATES FOOD AND DRUG ADMINISTRATION, MARGARET HAMBURG, in her
official capacity as Commissioner, United States Food and Drug Administration,
CENTER FOR VETERINARY MEDICINE, BERNADETTE DUNHAM, in her official capacity
as Director, Center for Veterinary Medicine, UNITED STATES DEPARTMENT OF
HEALTH AND HUMAN SERVICES, KATHLEEN SEBELIUS, in her official capacity as
Secretary, United States Department of Health and Human Services,
Defendants‐Appellants.
1
B e f o r e:
KATZMANN, Chief Judge, LYNCH, Circuit Judge, and FORREST, District Judge.*
__________________
On appeal from entry of summary judgment in the United States District
Court for the Southern District of New York (Theodore H. Katz and James C.
Francis IV, Magistrate Judges), defendants challenge the district court’s conclusion
that the United States Food and Drug Administration (“FDA”) is required by 21
U.S.C. § 360b(e)(1) to proceed with hearings to determine whether to withdraw
approval for the use of penicillin and tetracyclines in animal feed and that the
FDA’s decision denying two citizen petitions urging it to hold such hearings was
arbitrary or capricious within the meaning of 5 U.S.C. § 706(2).
REVERSED.
Chief Judge Katzmann dissents in a separate opinion.
JENNIFER A. SORENSON (Mitchell S. Bernard, Avinash Kar, on the
brief), Natural Resources Defense Council, New York, New
York, for Plaintiffs‐Appellees.
*
The Honorable Katherine B. Forrest, of the United States District Court
for the Southern District of New York, sitting by designation.
2
ELLEN LONDON (Amy A. Barcelo, Benjamin H. Torrance, Assistant
United States Attorneys, David J. Horowitz, Deputy General
Counsel, Elizabeth H. Dickinson, Chief Counsel, Food and
Drug Division, Eric M. Blumberg, Deputy Chief Counsel,
Litigation, Thomas J. Cosgrove, Associate Chief Counsel,
Department of Health and Human Services, on the brief), for
Preet Bharara, United States Attorney for the Southern District
of New York, New York, New York, for Defendants‐
Appellants.
GERARD E. LYNCH, Circuit Judge:
For nearly seventy years, antibiotics have provided dramatic medical
advances in the treatment of bacterial infections.1 For nearly as long, scientists
have been concerned about the problem of antibiotic resistance. Through
repeated exposure to antibiotics, some strains of bacteria develop resistance or
immunity to particular antibiotics. Such resistance presents a serious threat to
1
The first major antibiotic, penicillin, was discovered in 1928 by the
Scottish scientist Alexander Fleming. Its precise chemical structure was first
described in 1945 by the American scientist Dorothy Hodgkin, and a method for
its mass production was developed that same year. Despite the importance of
her discovery, Hodgkin was not among the scientists awarded the 1945 Nobel
Prize in Chemistry for the production of therapeutic penicillin. Hodgkin later
received that prize in 1964 for her discovery of the structure of vitamin B12. See
Joachim Pietzsch, The Nobel Prize in Chemistry 1964: Dorothy Crowfoot
Hodgkin, Nobelprize.org, available at http://www.nobelprize.org/nobel_prizes/
chemistry/laureates/1964/perspectives.html (last visited July 29, 2013).
3
human health. Infections in humans caused by antibiotic‐resistant bacteria result,
on average, in longer hospital stays, worse side effects of treatment, and a greater
likelihood of death. In an effort to forestall the development of antibiotic‐
resistant strains of bacteria, doctors exercise restraint in prescribing antibiotics
and are careful to direct patients to use antibiotics only as prescribed.
However, for each dose of antibiotics given to humans for medical
purposes, four doses are given to livestock for non‐medical reasons to encourage
faster, healthier growth. In 2009, 28.8 million pounds of antibiotics were
administered to animals raised for food, most of it through animal feed.
Unfortunately, research shows that bacteria that develop resistance to antibiotics
used in animal feed can transfer to human beings and pose a risk to human
health. For that reason, various public‐interest organizations have sought to
force the Food and Drug Administration (“FDA”) to prohibit the use of certain
antibiotics in animal feed. This case arises from one such effort.2
In this lawsuit, the plaintiff organizations contend that the FDA is required
by 21 U.S.C. § 360b(e)(1) to proceed with hearings to determine whether to
2
For another case arising from an effort to force the FDA to limit
nontherapeutic uses of antibacterial agents in a different context, see Natural Res.
Def. Council v. FDA, 710 F.3d 71 (2d Cir. 2013).
4
withdraw approval for the use of penicillin and tetracyclines in animal feed, and
that the FDA’s denial of two citizen petitions demanding such hearings was
arbitrary or capricious within the meaning of 5 U.S.C. § 706(2). The district court
accepted plaintiffs’ contention. Because we conclude that plaintiffs and the
district court are incorrect, we reverse the judgment of the district court.
BACKGROUND
I. FDA Regulation of Animal Feed Antibiotics
The FDA has statutory authority to regulate new animal drugs3 introduced
into interstate commerce. See 21 U.S.C. § 360b(a)(1). New animal drugs are
prohibited unless specifically approved by the FDA following a new animal drug
application (“NADA”) made by a sponsor, which is usually the drug
manufacturer that produced the drug.4 Because antibiotics can be used in animal
feed to produce bigger animals that grow faster on less food, many drug
manufacturers have sought approval to sell antibiotics for use in animal feed.
3
The term “new animal drug” is defined in 21 U.S.C. § 321(v); see note 11,
infra, for the text of that section.
4
Generic‐drug applications receive a slightly different label, “abbreviated
NADA.”
5
In 1951, the FDA approved the first use of antibiotics as ingredients in
animal feed to encourage animal growth. Two years later, it approved the first
use of antibiotics as drugs in animal feed. But by the late 1960s, the FDA
“became concerned about the safety to man and animals of subtherapeutic
antibiotic use” both as a general matter and specifically in the context of animal
feed.5 See Tetracycline (Chlortetracycline and Oxytetracycline)‐Containing
Premixes: Opportunity for Hearing, 42 Fed. Reg. 56264, 56266 (Oct. 21, 1977)
(“Tetracycline NOOH”). Thus began the decades‐long investigation of the
danger posed by such use, and the concern about human safety has persisted
ever since.
In 1970, prompted by a report published by the United Kingdom’s Joint
Committee on the Use of Antibiotics in Animal Husbandry and Veterinary
Medicine, the FDA instituted a Task Force to study the problem. In 1972, the
Task Force published its report, concluding that: (1) the use of antibiotics in
“subtherapeutic amounts” favors the selection of antibiotic‐resistant bacteria; (2)
5
“Subtherapeutic” uses are those that seek “increased rate of [weight]
gain, disease prevention[,] etc.,” as opposed to uses to treat illnesses or other
pathological conditions. 21 C.F.R. § 558.15(a). Other sources prefer the term
“nontherapeutic,” for the same meaning.
6
animals treated with such doses of antibiotics can serve as hosts for resistant
bacteria, which can then be transferred to humans; (3) the prevalence of resistant
bacteria had increased; and (4) resistant bacteria had been found in meat and
meat products intended for human consumption. The Task Force’s report
proposed withdrawing approval for all then‐approved subtherapeutic uses of
antibiotics unless the manufacturers of the drugs submitted evidence regarding
the safety and effectiveness of the drugs as used in animal feed.
In 1977, after receiving the requested information from the drug
manufacturers and the recommendation of the Animal Feeds Subcommittee of
the National Advisory Food and Drug Committee, the FDA’s Bureau of
Veterinary Medicine (“CVM”)6 issued notices of opportunity for hearing
(“NOOHs”) with respect to both penicillin and tetracyclines, another family of
antibiotics. Penicillin‐Containing Premixes: Opportunity for Hearing, 42 Fed.
Reg. 43772 (Aug. 30, 1977) (“Penicillin NOOH”); Tetracycline NOOH, 42 Fed.
Reg. 56264 (Oct. 21, 1977). The notices detailed the history of subtherapeutic
6
The Bureau of Veterinary Medicine is now known as the Center for
Veterinary Medicine. In the interest of simplicity, we use the abbreviation CVM
to refer to that subdivision of the FDA regardless of its official title at any given
time.
7
antibiotic drug use and the scientific data on the safety and effectiveness of such
use, and concluded that the drug manufacturers had “failed to resolve the basic
safety questions that underlie the subtherapeutic use of [antibiotics] in animal
feed.” The Penicillin NOOH went on to state that the Director of the CVM had
conclude[d], on the basis of new information before him
with respect to these drug products, evaluated together
with the evidence available to him when they were
originally approved, that the drug products are not
shown to be safe under the conditions of use prescribed,
recommended, or suggested in their labeling. The
evidence, in fact, indicate[d] that such penicillin use
may be unsafe, particularly if the higher or therapeutic
levels of penicillin should be used as substitutes for the
levels currently used subtherapeutically.
42 Fed. Reg. at 43792. The Tetracycline NOOH stated that the use of such drugs
was safe only for a list of specific and strictly limited uses. 42 Fed. Reg. at 56287.
Less than a year after the NOOHs were issued, congressional
appropriations committees set aside funds so that the National Academies of
Sciences (“NAS”) could conduct further research on the safety and effectiveness
of antibiotics in animal feed. The report issued by the House Appropriations
Committee included thinly veiled suggestions that the FDA not go forward with
the hearing process until the research was completed. See H.R. Rep. No. 95‐1290,
8
at 99 (1978). The NAS report, which was largely inconclusive but found that
“subtherapeutic use of antimicrobials does increase the prevalence of resistance
among the E. coli and Salmonella of treated animals,” also recommended that
additional studies be conducted. National Academy of Sciences, The Effects on
Human Health of Subtherapeutic Use of Antimicrobials in Animal Feed xiv
(1980), http://www.nap.edu/catalog.php?record_id=21.
Two years later, the House committee reiterated its desire to see further
evidence before approving the hearing process. A year after that, the Senate
Committee on Appropriations noted that the additional studies recommended by
the NAS had not yet been conducted and concluded that the “FDA will be
expected to continue to hold in abeyance any implementation of its proposal
pending the final results of the above research and evidentiary hearings.” S. Rep.
No. 97‐248, at 79 (1981).
In 1981, several industry groups petitioned the FDA to withdraw the 1977
NOOHs. They also sought approval for new uses of antibiotics. On February 1,
1983, the FDA formally denied the petitions. Penicillin and Tetracycline
(Chlortetracycline and Oxytetracycline) in Animal Feeds; Denial of Petitions, 48
Fed. Reg. 4544, 4556 (Feb. 1, 1983). The published notice accompanying the
9
denials stated that “the Director [of the CVM] does not have any less concern at
present about the safety issues that prompted adoption of [the NOOHs]. The
Director has not changed his earlier conclusion that the available scientific
information warrants the proposed actions.” Id. at 4555. In conclusion, the FDA
stated that
[t]he notices of opportunity for hearing represent the
Director’s formal position that use of the drugs is not
shown to be safe. Therefore, the Director has concluded
that he does not wish to withdraw the notices of
opportunity for hearing. Instead, the Director wishes to
place the notices in abeyance pending completion of the
studies mandated by Congress.
The Commissioner [of the FDA] has reviewed the
Director’s decision and concurs with it.
That notice was signed by the Commissioner of the FDA.
Meanwhile, several additional studies were either commissioned by
various government agencies or conducted by independent multinational
organizations. In 1984, the FDA contracted with the Seattle‐King County Health
Department to conduct yet another study. That study sought to determine how
easily antibiotic‐resistant bacteria could travel from food animals to humans. It
concluded that such transmission was likely. In 1987, the FDA asked the Institute
10
of Medicine (“IOM”) to conduct a review of the risks to human health from
subtherapeutic uses of antibiotics in animal feed. IOM found “a considerable
body of indirect evidence implicating both subtherapeutic and therapeutic use of
antimicrobials as a potential human health hazard,” although it could not
establish a definitive direct link. In 1997, the World Health Organization held a
meeting of experts to develop a report on the question. The WHO report
recommended ceasing subtherapeutic use in animals of any antibiotic that is
prescribed for use in humans to combat bacterial infections. Many other reports
were also compiled and described in the FDA’s draft Guidance for Industry #209,
issued on June 28, 2010.
The FDA never held the hearings it proposed in the 1977 NOOHs. On
March 9, 1999, a group of public‐interest organizations petitioned the FDA,
pursuant to § 512(e) of the Food, Drug, and Cosmetic Act (“FDCA”), to withdraw
regulatory approval for the subtherapeutic use in animal feed of a specified list of
antibiotics, which included penicillin and tetracyclines. On April 7, 2005, an
overlapping but distinct group of public‐interest organizations petitioned the
FDA a second time with the same request. Both petitions received preliminary
11
responses, but the FDA issued no final response until after the instant lawsuit
was filed.
In the meantime, the FDA issued a series of guidance documents to
industry groups, in an effort to implement a voluntary program for gradually
reducing the subtherapeutic use of antibiotics in animal feed. The primary
mechanism for this hoped‐for reduction was an agreement to limit the use of
certain antibiotics to therapeutic uses authorized by veterinary prescription. The
FDA’s October 23, 2003 Guidance for Industry #152 detailed the FDA’s
conclusions about the dangers posed by subtherapeutic use of antibiotics in
animal feed. Guidance 152, by its terms, applied primarily to applications for
regulatory approval for new uses of antibiotic drugs. On June 28, 2010, FDA
released draft Guidance for Industry #209, which set out its plan to avoid all uses
of antibiotics that were not “judicious.” A disclaimer on Guidance 209 specifies
that “[i]t does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. You can use an alternative approach if the
approach satisfies the requirements of the applicable statutes and regulations.”
12
At the time this lawsuit was filed, the FDA had issued no final response to
the citizen petitions and none of the Guidances discussed above had been
finalized.
II. The Instant Lawsuits
Plaintiffs, a group of advocacy organizations,7 filed this lawsuit in the
United States District Court for the Southern District of New York on May 25,
2011. They pled two distinct claims. First, they claimed that 21 U.S.C.
§ 360b(e)(1) compelled the FDA to hold the hearing proposed by the 1977
NOOHs and, if appropriate, withdraw approval for the antibiotic uses the
NOOHs listed.8 Second, they claimed that the FDA had unreasonably delayed by
failing to respond finally to the 1999 and 2005 citizen petitions, and asked the
7
The plaintiffs are the Natural Resources Defense Council, Inc., the Center
for Science in the Public Interest, the Food Animal Concerns Trust, Public Citizen,
Inc., and the Union of Concerned Scientists, Inc.
8
Plaintiffs also pled claims pursuant to § 706(1) of the Administrative
Procedure Act (“APA”), which generally authorizes courts presented with
challenges to agency inaction to “compel agency action unlawfully withheld or
unreasonably delayed.” 5 U.S.C. § 706(1). Because the essence of plaintiffs’ APA
claim is that the FDCA requires the FDA to hold the hearings described in the
1977 NOOHs, the question posed by § 706 is identical to that posed by the text of
§ 360b(e) itself.
13
court to order prompt responses. On July 7, 2011, they filed an amended
complaint, which clarified their basis for standing to sue.
On October 6, 2011, after the FDA answered the amended complaint,
plaintiffs moved for summary judgment.9 A month later, the FDA issued final
responses denying the 1999 and 2005 citizen petitions, effectively mooting the
plaintiffs’ second claim. Essentially, the FDA took the position that an alternative
strategy for combatting the ill effects of subtherapeutic use of antibiotics in
animal feed would be more efficient than pursuing an effort to withdraw
approval for any such uses. By way of explaining its decision, the FDA stated
that proceedings to withdraw drug approvals are very costly and lengthy. The
FDA also stated that any new proceedings would require a new NOOH
incorporating new scientific findings on the relationship between human health
and subtherapeutic uses of antibiotics in animal feed. Moreover, the FDA
argued, it could not grant the petitions because the withdrawal process had to
proceed on a drug‐by‐drug basis. Accordingly, the FDA had decided to pursue
an alternative but complementary course of voluntary measures. Shortly
thereafter, the FDA formally withdrew the 1977 NOOHs. Withdrawal of Notices
9
The parties did not conduct discovery.
14
of Opportunity for a Hearing: Penicillin and Tetracycline Used in Animal Feed,
76 Fed. Reg. 79697 (Dec. 22, 2011).
In light of these actions, the plaintiffs withdrew their claim to compel
action on their petition, which had been mooted by the FDA’s denial, and, on
February 1, 2012, filed a supplemental complaint alleging that the denial of their
petitions was arbitrary and capricious. The parties then filed renewed cross‐
motions for summary judgment. The district court ruled separately on the two
remaining claims. In a March 22, 2012 order, the district court (Theodore H.
Katz, Magistrate Judge) granted plaintiffs’ motion for summary judgment on the
NOOH claim.10 Natural Res. Def. Council, Inc. v. FDA (“NRDC I”), 884 F. Supp.
2d 127 (S.D.N.Y. 2012). The district court ruled that 21 U.S.C. § 360b(e) required
the FDA to hold a hearing once it had made a finding that a particular drug use
was not safe. It further ruled that the 1977 NOOH constituted or contained such
a finding, and that withdrawal of the 1977 NOOH did not effect a withdrawal of
that finding. It therefore ordered FDA to institute withdrawal proceedings for
the uses discussed in the 1977 NOOH and, unless the manufacturers could rebut
the finding, withdraw approval for those drug uses.
10
The parties had consented to trial before a magistrate judge.
15
In a June 1, 2012 order, the district court (Theodore H. Katz, Magistrate
Judge) granted plaintiffs’ motion for summary judgment as to the claims that the
denial of the citizen petitions was arbitrary and capricious. Natural Res. Def.
Council, Inc. v. FDA (“NRDC II”), 872 F. Supp. 2d 318 (S.D.N.Y. 2012).
According to the district court, the reasons stated in the withdrawal were
insufficient to meet even the very limited review authorized by the arbitrary‐and‐
capricious standard. As to the FDA’s claim that withdrawal proceedings are
costly and lengthy, the district court ruled that the statute was clear and that
these concerns were not relevant. In making this point, the district court relied
primarily on Massachusetts v. EPA, 549 U.S. 497 (2007). NRDC II, 872 F. Supp. at
333‐34, 337‐38. As to the FDA’s claim that it was pursuing alternative voluntary
measures to regulate the use of antibiotics, the district court again concluded that
the statute was clear and that voluntary measures – effective or not – could not be
substituted for the mandatory measures required by the text of the statute.
The government timely appealed both of the district court’s judgments.
DISCUSSION
We review a district court’s decisions on motions for summary judgment
de novo. Chandok v. Klessig, 632 F.3d 803, 812 (2d Cir. 2011). Summary
16
judgment is appropriate if there is no genuine dispute as to any material fact and
the movant is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(a). Here,
the facts of the case are undisputed, and the questions posed are purely legal.
I. The Required Hearings Claim
A. The Statutory Text
The principal question presented by this appeal is whether 21 U.S.C.
§ 360b(e)(1) requires the FDA to proceed with withdrawal hearings for certain
previously approved subtherapeutic uses of antibiotics in animal feed because
the FDA has made a finding that those uses are not shown to be safe for humans.
The text of § 360b(e)(1) clearly requires withdrawal of approval once such a
finding has been made; it does not equally clearly specify when the agency
makes such a finding, and in particular whether the type of finding that
mandates withdrawal of approval is a conclusion based on internal agency
deliberations that precedes (and then requires) the holding of a hearing, or a
finding that represents the conclusion reached as the result of such a hearing.
17
21 U.S.C. § 360b(e)(1) addresses the FDA’s power to withdraw approval for
“new animal drug[s].”11 The text of the statute states that
(1) The Secretary[12] shall, after due notice and
opportunity for hearing to the applicant, issue an order
withdrawing approval of an application filed pursuant
to subsection (b) of this section with respect to any new
animal drug if the Secretary finds . . .
(B) that new evidence not contained in such
application or not available to the Secretary
until after such application was approved,
or tests by new methods, or tests by
methods not deemed reasonably applicable
when such application was approved,
evaluated together with the evidence
available to the Secretary when the
application was approved, shows that such
drug is not shown to be safe for use under
the conditions of use upon the basis of
which the application was approved . . . ;
Id.
11
“New animal drug” is elsewhere defined, subject to limited exceptions,
as “any drug intended for use for animals other than man, including any drug
intended for use in animal feed but not including such animal feed, . . . the
composition of which is such that such drug is not generally recognized, among
experts qualified by scientific training and experience to evaluate the safety and
effectiveness of animal drugs, as safe and effective for use under the conditions
prescribed, recommended, or suggested in the labeling thereof.” 21 U.S.C.
§ 321(v) (2008).
12
Although the statute refers to the Secretary of Health and Human
Services, the Secretary has delegated her duties under the FDCA to the
Commissioner of the Food and Drug Administration.
18
The parties dispute the circumstances under which the mandatory
language “shall . . . issue an order withdrawing approval” comes into play. In
particular, they dispute what it means for the Secretary to make a finding, and
when that finding occurs. The text makes clear that an order withdrawing
approval must be issued (and so far as relevant here may only be issued) upon
the occurrence of two conditions precedent – a finding and a hearing. The
parties, in effect, dispute the required and anticipated sequence of those
conditions.
The government reads the statute as requiring the sequence: hearing,
finding, order. In effect, it reads the provision to say, “If, after notice and a
hearing, the secretary finds that a drug is not shown to be safe for use,” she is
required to withdraw approval of the drug. In this interpretation, the
withdrawal process begins with a notice from the FDA to a drug sponsor of its
concerns about an drug, and offering the opportunity for a hearing regarding the
safety of the animal drug. If, at the conclusion of the hearing, upon consideration
of the evidence presented, the secretary finds that the drug is indeed not shown
to be safe for use, she must then issue an order withdrawing approval of the
drug. That order of events depends upon the conclusion that a finding that an
19
animal drug is not shown to be safe can be made only after the drug’s sponsor’s
due process rights – notice and an opportunity to be heard – have been respected.
Therefore, the mandatory “shall” applies only to the action – withdrawal of
approval – that the Secretary must take if the hearing results in a finding adverse
to the drug. On the government’s reading, the mandatory “shall” does not apply
to the holding of the hearing itself, which the government argues is a
discretionary action that the agency may undertake, or not, in its discretion,
based on its judgment about whether the scientific evidence and sound public
policy warrant instituting proceedings to withdraw approval.
By contrast, plaintiffs favor the sequence: finding, hearing, finding, order.
In effect, they read the statute to say, “If the secretary finds a drug is not shown
to be safe for use, she shall provide notice to the applicant, hold a hearing, issue a
second finding, and then withdraw approval.” In their interpretation, the initial
finding that the drug is not shown to be safe is based on the agency’s internal
investigations of the scientific evidence, and comes before any hearing is held. On
plaintiffs’ reading, once the agency reaches the conclusion that the drug is not
shown to be safe, the mandatory language of the statute becomes applicable – the
agency must issue an order of withdrawal, though it must hold a hearing first.
20
The mandatory “shall” thus in effect governs not only the remedy that must
follow a formal conclusion after a hearing, but also the process itself; after
reaching its initial conclusion that the drug is not shown to be safe, the agency is
required to institute proceedings and effectuate them through a hearing, after
which (if the evidence present at the hearing sustains the finding) she must issue
an order of withdrawal.
As plaintiffs admit, their construction necessarily contemplates two
findings that a drug is not shown to be safe for use: one (based on internal
deliberations) that triggers the (mandatory) hearing, and another (after the
sponsor has been given notice and an opportunity to be heard, and based on the
evidence presented at that hearing) that supports the issuance of an order of
withdrawal.13 Plaintiffs argue that the initial finding made by the agency is
subject to rebuttal by the sponsor at the mandated hearing; in the absence of such
13
The hearing would have an Alice‐in‐Wonderland quality (sentence first,
trial afterward) unless it were understood that the Secretary may only ultimately
withdraw approval if the evidence presented at the hearing warrants a finding
that the drug is not shown to be safe. There would be no purpose to a hearing if
the agency’s initial internal conclusion of itself mandated withdrawal, regardless
of the outcome of the hearing.
21
rebuttal, the original finding “ripens” and requires issuance of an order of
withdrawal.
The text of § 360b(e)(1) itself does not unambiguously express either of
these sequences. The syntax makes at least two things clear. First, because the
mandatory verb “shall” is linked to “issue an order withdrawing approval” of an
NADA if the requisite finding is made, the statute is clear that the withdrawal of
the approval is mandatory if the preconditions set in the statute are met. Second,
the statute is clear that two such conditions must be met before the requirement
that the Secretary “shall” withdraw her approval is triggered: a temporal
condition (the withdrawal order may only be issued “after due notice and
opportunity for hearing”), and a factual condition (withdrawal is required only
“if the Secretary finds . . . that such drug is not shown to be safe for use”).
The syntax is not similarly clear as to the temporal relationship between
the hearing and the finding, because the phrase “after due notice and
opportunity for hearing” is inserted somewhat awkwardly between “shall” and
“issue.” Different placement of the notice and hearing language could have
decisively directed one or the other of the competing interpretations. Had
Congress written, “If the Secretary finds [that the drug is not shown to be safe for
22
use], she shall conduct a hearing on due notice to the applicant, and shall
withdraw approval if the evidence at the hearing supports the finding,” the
plaintiffs would clearly be correct: after making a “finding,” the Secretary would
be required to withdraw approval of the drug, but only after a notice and hearing
process. In contrast, if Congress had written, “The Secretary shall withdraw
approval [of an NADA] if she finds, after due notice and opportunity for hearing
to the applicant [that the drug is not shown to be safe],” the FDA’s interpretation
would clearly be correct. Unfortunately, it wrote neither, adopting a syntactically
awkward variation that leaves the intended sequence ambiguous.
Although the grammar of the sentence as it is actually written does not
absolutely compel either reading, we believe that the government’s interpretation
is far more plausible, both as a matter of language and as a matter of
conventional legal practice.14 As noted above, the plaintiffs’ reading requires not
14
In his thoughtful dissenting opinion, Judge Katzmann correctly notes
that “[W]e begin . . . any exercise of statutory construction with the text of the
provision in question, and move, as need be, to the structure and purpose of the
Act in which it occurs.” (Dissenting opinion, post, at 5, quoting N.Y. State
Conference of Blue Cross & Blue Shield Plans v. Travelers Ins. Co., 514 U.S. 645,
655 (1995)). This principle guides our analysis, and confirms our respectful
disagreement with Judge Katzmann’s conclusion regarding the interpretation of
the statute.
Insofar as the dissent’s analysis refers to the purpose of the statute, it
23
one but two findings, in a sentence that only refers to one. Congress expressly
provided that withdrawal of approval is required (indeed, such withdrawal is
authorized) only after a hearing is held and a finding is made. The hearing
process is thus a critical precondition of the withdrawal order, and as plaintiffs
concede, the entire purpose of the hearing is to determine whether the evidence
does indeed show that the drug is not shown to be safe for use. The hearing thus
eventuates in withdrawal of approval only if the Secretary concludes, based on
hinges on the unquestioned goal of Congress to protect human health. But this is
largely a red herring. As Judge Katzmann acknowledges (Dissenting opinion,
post, at 6‐7), that goal does not require us to interpret any ambiguity in the
statute in the manner that we think is most conducive to protecting the public
health; the statute reflects in its language particular judgments about how that
goal should be pursued and when it must yield to or be balanced with other
concerns. Our views regarding how the FDA can best serve its mission of
protecting human health through the use of drugs to treat animals or the analytic
import of other prospectively ambiguous Congressional statutes must defer to
the most reasonable reading of the text before us. Section 360b(e)(1) is most
“naturally read” (Dissenting opinion, post, at 20) in the manner that makes best
sense of the statutory language itself. That in turn compels us to conclude that
where a statute explicitly considers only a single finding and directs that any
such finding mandates the agency to take decisive action, the statute only
involves a single finding by that agency.
Insofar as the dissent addresses the statutory structure, it primarily relies
on a perceived parallel between the procedures for initial approval of a drug and
withdrawal of that approval. But this attempted parallel ignores the fact that a
withdrawal procedure occurs after a drug has already been found safe – a
difference that amply justifies a different process.
24
the evidence of “experience and scientific data” presented at the hearing, that the
drug is not shown to be safe. Yet according to the plaintiffs’ reading, the statute
makes no explicit reference to any such finding at the culmination of the hearing
– in plaintiffs’ view, the only finding that Congress expressly requires, and the
one that the grammatical construction of the sentence makes prerequisite to the
withdrawal of approval, is the finding that the Secretary makes before the hearing
even takes place.15
Similarly, while the plaintiffs’ reading would make the initial internal
administrative finding of a lack of showing of safety the trigger for a mandatory
hearing, the statute does not grammatically link the only “finding” referred to in
the statute to a mandatory hearing, but rather to a mandatory withdrawal of
15
Put another way, plaintiffs’ interpretation is internally inconsistent. On
the one hand, it relies on the literal language of the statute to insist that upon the
“finding” of lack of showing of safety – by which plaintiffs mean the preliminary
internal conclusion of the agency that leads to the issuance of an NOOH –
withdrawal of approval is mandatory, but on the other they acknowledge that
that preliminary “finding” does not and cannot in fact mandate withdrawal of
approval, because it leads only to a hearing that may or may not result in a
finding that the drug is not shown to be safe. Plaintiffs insist that the “finding”
or preliminary assessment of the agency mandates that the agency hold a
hearing, but the finding referred to in § 360b(e)(1) requires that the Secretary issue
an order withdrawing approval of the drug. Only a finding that is made after notice
and an opportunity for a hearing can have this effect.
25
approval. Moreover, the statute does not require withdrawal of approval based
solely upon an internal, pre‐hearing finding – withdrawal of approval must
await the conclusion of the hearing, at which further findings would have to be
made. At that point, the withdrawal is no longer the mandatory consequence of
the initial finding – if the hearing demonstrated the safety of the drug,
withdrawal of approval would not be required, or even permitted. It is, instead,
the consequence of the further finding at the end of the hearing, based on the
evidence presented there. According to plaintiffs, Congress meant to mandate
that upon making the “finding” referred to in § 3609(e)(1)(A), the Secretary is
required to hold a hearing, and yet Congress provided that upon making such a
finding the Secretary “shall issue” not a notice of opportunity for a hearing, but a
withdrawal of approval of the drug. In short, it would be singularly odd for
Congress to have chosen the language that it did to describe the process that even
the plaintiffs concede it intended.
The government’s preferred reading yields no such difficulties. While it is
true that the statute would read more smoothly, and would more clearly express
the government’s position, if the phrase “after due notice and an opportunity for
hearing” were placed after “finds,” rather than between “shall” and “issue,”
26
nothing in the statutory language needs to be twisted to yield the government’s
interpretation. Although the placement of the notice and hearing provision is
awkward (on either side’s interpretation), even as placed, it is entirely consonant
with the government’s reading. There is nothing syntactically difficult or odd
about providing that the Secretary shall withdraw her approval of a drug, after a
notice and hearing process, if a finding is made (after such process) that the drug
is not shown to be safe.
B. Context
The parties call our attention to various aspects of the larger statutory
context that might cast further light on the meaning of this particular provision.
The cited portions of the statute, however, do not provide much help in clarifying
the meaning of the provision in question, and certainly do not provide sufficient
instruction to overcome the reading derived from the language of the debated
text itself.
As the parties note, different language within the same statutory
subsection provides for emergency withdrawal of approval for animal drugs “if
the Secretary . . . finds” that the drugs pose an “imminent hazard to the health of
man or of the animals.” 21 U.S.C. § 360b(e)(1) (last paragraph). In such a case,
27
the Secretary – but not any delegate – may immediately and without a hearing
suspend approval for the drug in question. That provision can be used to
support either side. On the one hand, plaintiffs argue that its language supports
the notion that the Secretary can make “findings” by an internal administrative
process, without notice or a hearing. On the other hand, the government argues
that the special exception permitting emergency interim relief to prevent
“imminent hazards,” and the reservation of authority to make such emergency
findings to the Secretary, serves to underscore the general and otherwise‐
applicable rule that findings that induce final agency actions adverse to
applicants must be made after notice and hearing, and must represent the final
conclusion of the agency, rather than an interim judgment delegable to lower‐
ranking officials. Neither of these inferences from the emergency suspension
provision can be dismissed as implausible, but neither persuasively illuminates
the process anticipated by the language in question in this case.
The district court also relied on a distinction between § 360b(e)(1) and the
preceding subsection of the statute, § 360b(d)(1), to support its conclusion that
findings could precede hearings for purposes of § 360b(e)(1). Section 360b(d)(1) –
which lists the permissible grounds on which the Secretary may initially deny an
28
application for approval of a new animal drug – clearly states that findings of fact
must occur after a hearing, by placing the “after due notice [and] hearing”
language immediately after the verb “finds.”16 That difference in language, the
district court concluded, suggests that Congress intended different schemes
under the two subsections. The government challenges that reading, however,
arguing that § 360b(d) is expressly connected to the language of the preceding
§ 360b(c)(1), which in turn explicitly contemplates that some findings may be
made without a hearing.17 In that context, it makes sense that Congress would
use more sharply contrasting language to distinguish the findings made under
subsection (d) from those required in subsection (c). By contrast, under
§ 360b(e)(1), no order withdrawing approval may issue before a hearing unless
the drug represents an “imminent hazard.” In the government’s reading, the
16
21 U.S.C. § 360b(d)(1) states: “If the Secretary finds, after due notice to
the applicant in accordance with subsection (c) of this section and giving him an
opportunity for a hearing, in accordance with said subsection, that [one of nine
specified conditions is satisfied,] he shall issue an order refusing to approve the
application. If, after such notice and opportunity for hearing, the Secretary finds
that [those conditions are not met], he shall issue an order approving the
application.”
17
Specifically, the Secretary is authorized to approve an application for a
new animal drug if she “finds that none of the grounds for denying approval
specified in [§ 360b(d)] applies.” 21 U.S.C. § 360b(c)(1).
29
difference in language between subsections (d) and (e) reflects the differing
procedures for approval of a new drug and for the withdrawal of approval of a
previously approved drug, rather than any intention to limit agency discretion to
institute, pursue, or abandon procedures to withdraw drug approvals.
Again, we find both parties’ inferences from the language of § 360b(d)
reasonable. But neither is sufficiently compelling either to strongly corroborate
or to seriously undermine our reading of the text. As noted above, it is
unquestionably clear from the text that the mandate to order withdrawal only
applies after the agency has held a hearing. Indeed, it is clear from the text that
an order withdrawing approval may not be entered (except in the emergency
circumstances referred to in § 360b(e)(1)) without providing notice and a hearing
to the drug’s sponsor. It seems to us that, when a statute provides that an agency
must take some action after a hearing “if it finds” something to be true, the more
persuasive reading is that the finding referred to is the fruit of the required
hearing.
C. The Relevant Regulations
30
Both parties argue that various regulations implementing the statute
support their respective interpretations. For the reasons set forth below, we do
not find these arguments especially helpful.
The government argues that the FDA’s interpretation of the statute is
entitled to deference. We generally give deference to an agency’s interpretation
of statutes that the agency administers. See Chevron U.S.A., Inc. v. Natural Res.
Def. Council, Inc., 467 U.S. 837, 844‐45 (1984). The Supreme Court has held that
the FDA is entitled to deference when it interprets Title 21 of the United States
Code, FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 132 (2000),
because the FDA, as designee of the Department of Health and Human Services,
is the agency tasked with administering the FDCA. We will therefore defer to the
FDA’s interpretation if Congress has not directly spoken to the precise question
at issue and the agency can point to an official interpretation that sets forth a
permissible construction of the statute.
However, before we defer to an agency’s interpretation of a statute, we
must identify an agency document setting forth that interpretation. The level of
deference to an agency’s interpretation of its own statute depends on the nature
of the document setting forth the interpretation. Regulations promulgated after a
31
period of notice and comment are typically granted the relatively strong form of
deference described by Chevron. See United States v. Mead Corp., 533 U.S. 218,
228‐30 (2001). We give substantially less deference to post hoc interpretations
offered only for purposes of litigation, particularly when those interpretations
represent a “departure from prior norms.” See Am. Fed’n of State, County, &
Mun. Emps. v. Am. Int’l Grp., Inc., 462 F.3d 121, 129 (2d Cir. 2006), quoting
Atchison, Topeka & Santa Fe Ry. Co. v. Wichita Bd. of Trade, 412 U.S. 800, 808
(1973). The government urges us to apply Chevron deference to the FDA’s
interpretation of the statute as embodied in its notice and comment regulations.
The government, however, overlooks a basic predicate of administrative
deference. In order to merit deference on a given issue, a particular regulation
must shed light one way or the other on the issue. The government points to
three regulations to support its position, but none of them help decide the
question before us: whether the findings referred to in § 360b(e) precede
hearings, or follow them. The government concedes that the regulations it cites
do not explicitly undertake to interpret the statutory provision at issue and
answer the question before us, but nevertheless argues that the regulations
presuppose an answer to that question.
32
First, the government relies on 21 C.F.R. § 5.84, which authorizes the
Director of CVM, as the Secretary’s delegate, to issue NOOHs on the latter’s
behalf.18 Specifically, the regulation provides that the Director may issue NOOHs
or, if the sponsor has waived the right to a hearing, the Director may issue an
order of withdrawal. But that regulation fails to give any indication about what,
if any, conditions might require a hearing. The government argues that, because
§ 5.84 represents a partial delegation of the Secretary’s duties under § 360b(e)(1)
only for purposes of issuing NOOHs, it does not authorize the Director to make
“findings,” and that therefore the issuance of an NOOH is never preceded by a
finding as defined in the statute. But the regulation merely states that “[t]he
Director and Deputy Director [of the CVM] are authorized to issue [NOOHs] . . .
and to issue notices of withdrawal of approval when opportunity for hearing has
18
21 C.F.R. § 5.84 has been formally withdrawn in an amendment of the
regulations governing the FDA organizational structure, promulgated by a rule
that is “editorial in nature.” Revision of Organization and Conforming Changes
to Regulations, 77 Fed. Reg. 15961‐02 (Mar. 19, 2012) (codified at 21 C.F.R.
Chapter I). The substance of the delegation from the Secretary to the CVM
contained within 21 C.F.R. § 5.84 is now authorized by FDA Staff Manual Guides,
Volume II – Delegation of Authority, SMG § 1410.503 (Feb. 24, 2011). As the
modification to the regulations was editorial rather than substantive, the
language of the delegation remains the same, and both parties implicitly agree
that § 5.84 remains in effect, we address the regulation here.
33
been waived.” 21 C.F.R. § 5.84(a)(1)‐(2). It is thus equally plausible to read § 5.84
as delegating to the Director of CVM19 the responsibility for making any findings
that might trigger the mandatory issuance of NOOHs and any resulting actions.
The government next points to 21 C.F.R. § 514.200(c), which sets out the
possible responses a sponsor may make to an NOOH, and describes the requisite
showing a sponsor must make to secure an actual hearing as opposed to a
decision on the papers. It argues that that regulation precludes plaintiffs’ reading
because any pre‐hearing findings are necessarily preliminary. Specifically, the
regulation requires a sponsor seeking a hearing to
giv[e] the reason why the application should not be
refused or should not be withdrawn, together with a
well‐organized and full‐factual analysis of the clinical
and other investigational data he is prepared to prove in
support of his opposition to the Commissioner’s
proposal. A request for a hearing may not rest upon
19
As the district court noted, the Commissioner of the FDA ratified the
judgment reflected in the 1977 NOOHs by concurring – in a policy statement
published in the Federal Register – with the Director’s 1983 decision not to
rescind those NOOHs. Penicillin and Tetracycline (Chlortetracycline and
Oxytetracycline) in Animal Feeds; Denial of Petitions, 48 Fed. Reg. 4554, 4556
(Feb. 1, 1983) (“The Commissioner has reviewed the Director’s decision and
concurs with it. In addition, for the reasons discussed above, the Commissioner
has decided that he will not withdraw the advance notice of hearing or the
proposal to restrict therapeutic approvals to prescription use, but will hold them
in abeyance.”).
34
mere allegations or denials, but must set forth specific
facts showing there is a genuine and substantial issue of
fact that requires a hearing. When it clearly appears
from the data in the application and from the reasons
and a factual analysis in the request for the hearing that
no genuine and substantial issue of fact precludes the
refusal to approve the application or the withdrawal of
approval of the application (for example, no adequate
and well‐controlled clinical investigations to support
the claims of effectiveness have been identified), the
Commissioner will enter an order on this data, stating
his findings and conclusions.
21 C.F.R. § 514.200(c) (emphasis added). The government argues that, because a
decision to grant a hearing represents only the Commissioner’s determination
that there may be a “genuine and substantial issue of fact preclud[ing] . . . the
withdrawal of approval of the application,” it cannot represent a conclusive
finding triggering a mandatory duty. By contrast, the plaintiffs argue, and the
district court agreed, that not only does § 514.200(c) fail to support the position
that findings may take place only after a hearing, but it also explicitly
contemplates findings even in the absence of a hearing. If the sponsor’s written
response to a NOOH is insufficient, the Commissioner is to enter an order of
withdrawal based on, among other things, the data in the initial application.
The regulation, it seems to us, simply provides a mechanism for a kind of
“summary judgment” proceeding that might obviate an evidentiary hearing. If
35
the applicant requests a hearing, the decision to withdraw approval of the drug
must be based either on formal “findings” derived from the evidence adduced at
a hearing or, where that the request for a hearing does not raise a genuine issue
of disputed fact, on a summary judgment–like conclusion. To that extent, the
regulation is consistent with the government’s basic contention that “findings”
normally result from an adjudicative process, and are made after that process is
instituted. It does not, however, directly address – let alone lead us to
conclusively reject – plaintiffs’ contention that the entire proceeding is triggered
by an agency “finding.” We therefore conclude that this regulation does not
embody an unambiguous interpretation of § 360b(e)(1) to which we must defer in
this case.
Finally, the government urges us to take account of 21 C.F.R.
§ 10.55(b)(2)(i), which provides for the separation of investigative and
adjudicative responsibilities within the FDA in the event of a hearing.
Specifically, that regulation provides that, from the time of the announcement of
a formal hearing, CVM will be “responsible for all investigative functions” and
for presenting the FDA’s case before the adjudicator. According to the
government, this separation of functions “reflects FDA’s understanding that
36
throughout the withdrawal process, CVM does not speak on behalf of” the FDA.
Because CVM cannot speak on behalf of the Commissioner once hearing
proceedings have been instituted, the government argues that any “finding” by
CVM cannot trigger a mandatory duty on the part of the Commissioner. That
argument has one major flaw: the finding that plaintiffs argue triggered the
FDA’s duty to proceed with the hearing necessarily preceded the period of
separation of administrative functions. Because functions are separated only
upon publication of an NOOH, anything that precedes or is included in the
NOOH might have represented an action by the Commissioner through her
delegate, the Director of CVM.
We are therefore unable to identify a regulation promulgated by FDA
pursuant to its notice and comment rulemaking authority that clearly reflects a
definitive interpretation of § 360b(e)(1). While the regulations relied upon by the
FDA do not expressly adopt or unambiguously require any particular
interpretation of the contested language to which we must accord Chevron
deference, they still provide some guidance. As we discuss below, we believe
that the regulations relied upon by the FDA reflect a conventional understanding
of the administrative process that is consistent with the interpretation of
37
§ 360b(e)(1) advanced by the government. We cannot conclude, however, that
any of those regulations directly speak to the specific question of statutory
interpretation before us, or reflect a clear adoption by the agency of any position
on that question.
Plaintiffs, for their part, also seek support in FDA regulations. They argue
that the regulation most on point is 21 C.F.R. § 514.115(b)(3)(ii), which details the
procedures for withdrawal of approval of an NADA. That regulation provides:
“The Commissioner shall notify in writing the person holding an application
approved pursuant to section 512(c) of the act and afford an opportunity for a
hearing on a proposal to withdraw approval of such application if he finds” that
one of the conditions described in § 360b is met. 21 C.F.R. § 514.115(b)(3)
(emphasis added). That regulation unquestionably lends plausibility to
plaintiffs’ reading of the statute because it clearly contemplates that the
Commissioner must make some sort of finding before the issuance of an NOOH.
Indeed it was largely on the basis of § 514.115(b)(3)(ii) that the district court
interpreted the statute to require the FDA to proceed with the hearing.
The government, however, argues that this regulation is inapposite
because “identical words need not have identical meanings when used in
38
different contexts” and the FDA’s use of “finds” in the regulation refers only to a
preliminary finding. While the government’s argument is hardly compelling, the
regulation can indeed be read as it proposes. Moreover, that the FDA regulation
refers to a finding made by the Commissioner before instituting a hearing does
not mean that the regulation is intended to set forth the agency’s definitive
interpretation, or indeed any interpretation at all, of the statutory language whose
meaning the parties here dispute. In other words, plaintiffs’ reliance on
§ 514.114(b)(3)(ii) suffers from the same flaw as the FDA’s reliance on the
regulations that it cites. All of the cited regulations are drafted to define
administrative procedures, and not to interpret the mandate set forth by
Congress in § 360b(e)(1). The use of certain language in those regulations or the
nature of the procedures that they create may lend some support to the position
of one side or the other, but the regulations simply cannot be said to answer the
question before us.
In short, we are not required to defer to an agency’s interpretation of a
statute when its regulations do not directly address the question before the Court,
and when the language of one regulation appears to be in tension with the
agency’s interpretation of the statute advanced for purposes of litigation. We
39
therefore conclude that Chevron deference does not provide an answer to the
question before us.
D. Background Legal Concepts
We take some comfort from the fact that our interpretation of the statutory
text is consistent with ordinary understandings of administrative and judicial
litigation processes. In interpreting a statute, courts generally presume that
Congress acts “against the background of our traditional legal concepts.” United
States v. U.S. Gypsum Co., 438 U.S. 422, 437 (1978). See also United States v.
Pacheco, 225 F.3d 148, 157 (2d Cir. 2000). Of course, Congress may depart from
such traditions; it may use words in ways that are unconventional, or adopt
innovative procedures. But when a statute does not provide clear direction, it is
more likely that Congress was adopting, rather than departing from, established
assumptions about how our legal or administrative system works. We will not
lightly assume a less conventional meaning absent a clear indication that such a
meaning was intended. In our view, the interpretation advanced by the
government is more in accordance with such conventions.
First, the government’s interpretation is more consistent with our usual
understanding of an administrative “finding.” An agency “finding” typically
40
represents an official determination, reflecting a final, deliberative decision
issuing at the conclusion of a process, and taking a fixed form embodied in an
identifiable document. Judicial or administrative findings most commonly are
adopted not as a prerequisite but as a consequence of a hearing or other official
proceeding. For example, Black’s Law Dictionary defines the verb “find” as “To
determine a fact in dispute by verdict or decision,” Black’s Law Dictionary 707 (9th
ed. 2009) (emphasis added), and the noun “finding of fact” as “A determination
by a judge, jury, or administrative agency of a fact supported by the evidence in
the record, usu. presented at the trial or hearing,” id. at 708 (emphasis added). Thus
a “finding” traditionally occurs after adversarial parties are given notice of a
hearing and an opportunity to be heard there, at least if hearings are
contemplated as part of the administrative scheme.
Other areas of the law define “findings” to mean written conclusions
issued only at the completion of an administrative process. For example, for
purposes of judicial review of agency adjudication under the Social Security Act,
we have held that the term “findings” refers to the agency’s on‐the‐record
determinations at a hearing, and that the agency has an affirmative duty to
develop the record during the hearing to facilitate judicial review. See Pratts v.
41
Chater, 94 F.3d 34, 37 (2d Cir. 1996); see also 42 U.S.C. § 405(g). Similarly, albeit
in a context that does not necessarily contemplate hearings, Federal Rule of
Evidence 803(8)(A)(iii), which provides an exception to the hearsay rule for
written public records and reports, permits admission into evidence “findings
from a legally authorized investigation,” and the Supreme Court has interpreted
the rule as requiring a “conclusion . . . based on a factual investigation.” Beech
Aircraft Corp. v. Rainey, 488 U.S. 153, 170 (1988) (emphasis added). In these
instances, “findings” are written and issue only at the conclusion of the entire
process.
We do not suggest that the term cannot be, or indeed is not, sometimes
used in a different sense. As plaintiffs point out, even in this very regulatory
scheme, the FDA uses the word “find” in a context that clearly refers to a
preliminary finding that does not share the characteristics discussed above. See 21
C.F.R. § 514.115(b)(3)(ii), discussed above. Similarly, the emergency suspension
proceedings in § 360b(e)(1) itself refer to findings that are made by the Secretary
without a hearing, though, notably in that context, the finding is the basis for an
action that has an immediate legal effect on the rights of a drug sponsor, rather
than being the basis of a decision to institute a process that may eventually lead
42
to such an effect. Nevertheless, where the context does not clearly indicate to the
contrary, typical usage suggests that an administrative finding reflects the
agency’s final decision issued at the conclusion of a process, rather than a
preliminary assessment that contemplates further proceedings before final action
is taken.20
Second, the function of the finding contemplated by § 360b(e)(1), and the
mandate that Congress attached to the making of such a finding, is consistent
with this more natural meaning. As plaintiffs themselves emphasize, a finding
by the Commissioner that a drug is not shown to be safe requires the FDA to
“issue an order withdrawing approval” of the drug. 21 U.S.C. § 360b(e)(1). The
FDA is not accorded discretion to adopt a different remedy. The consequences of
such a withdrawal are significant for society and for the sponsor or manufacturer
20
Looking beyond the specific context of the Federal Food, Drug, and
Cosmetic Act, Judge Katzmann cites a number of statutes in which Congress has
used language similar to that at issue here. (Dissenting opinion, post, at 19‐20).
Significantly, however, he cites no judicial interpretation of this language that
supports plaintiffs’ readings (or, for that matter, that supports ours). The fact
that Congress has created similar ambiguities in other contexts tells us nothing
about how to resolve the ambiguity. Similarly, we are unpersuaded by the
dissent’s suggestion that the Supreme Court offhandedly endorsed plaintiffs’
view of § 360(b)(1)(B) in Brown & Williamson (Dissenting opinion, post, at 13).
In the cited passage, 529 U.S. at 134, the Court simply repeats, in a slightly
condensed form, the ambiguous language of the statute itself.
43
of the drug. It is logical to assume that Congress would mandate withdrawal of
approval of a drug when it has been determined that the drug has not been
shown to be safe by a formal decision of the agency, after a careful hearing at
which evidence both for and against the safety of the drug has been presented.
In contrast, it would seem peculiar for Congress (absent an emergency of the sort
authorizing unilateral agency action provided for in the last paragraph of
§ 360b(e)(1)) to mandate such a strong remedy based not on a final decision by
the agency head after a full deliberative process, but on a preliminary conclusion
reached by lower‐level officials before those affected have had an opportunity to
be heard.
And of course, as plaintiffs in effect concede, Congress clearly has not done
so. While the language of the statute dictates that withdrawal of approval is the
necessary consequence of a finding that an animal drug is not shown to be safe,
the statute requires notice to the sponsor and an opportunity for a hearing before
a final order of withdrawal may issue, and plaintiffs agree that such an order
may issue only if the hearing results in a finding by the Secretary that the drug is
not shown to be safe. Under the literal words of the statute, as well as in
accordance with common sense, the agency must issue an order withdrawing
44
approval when it finds that the drug is not shown to be safe – something that, as
a matter of statutory command and due process, may only occur after the
hearing.
Third, the administrative process contemplated by the government’s
interpretation of the statute accords with our traditional expectations of
governmental enforcement of legal rules. The traditional model of
administrative or judicial enforcement features an investigation by executive or
administrative personnel, followed by the issuance of a case‐initiating document
that sets forth the conclusions or charges reached by the prosecuting authority,
followed by a hearing. That process culminates in a final adjudication that is
reached by the agency and embodied in a formal decision, and imposes whatever
remedies or penalties are applicable. In civil and criminal actions, the initial
conclusions of the administrative agency or executive officer that lead to the
filing of a lawsuit and an adjudication by a court are not thought of as “findings”
and do not mandate final action; a remedy (discretionary or mandatory) is
contingent on the ultimate finding of the court.
The same is typically true of administrative processes. Commonly, an
agency seeking to take action adverse to the interests of an affected party brings a
45
charge that leads to a hearing process; only after the hearing does the final
agency action result in formal findings and a resultant order.21 The government’s
interpretation of the statute – and the regulations it has issued that implement it –
is essentially consistent with this model. The plaintiffs’ interpretation departs
from it, by insisting that a preliminary conclusion sufficient to trigger a full‐dress
hearing should be treated as an agency “finding” that mandates action.
Fourth, interpreting the statute to mandate action upon a “finding” that is
not the result of the required hearing presents the problem of identifying when
and how such a finding has been made. Under the plaintiffs’ interpretation, the
“finding” that would trigger these mandatory consequences is not, as in the
normal understanding of an agency finding, a formal decision embodied in
documentary form. The most plausible place to look for a formal finding that
precedes and therefore could trigger a hearing under the plaintiffs’ interpretation
is in the NOOHs issued by the CVM in 1977 which set forth the scientific
21
To take only one example of this familiar process, when the Securities
and Exchange Commission seeks to impose a cease‐and‐desist order against a
corporation for violating Section 21C of the Securities Exchange Act of 1934, the
Commission’s staff issues a notice of a hearing prior to the issuance of such an
order. It is the final decision of the Commission, not the charges contained in the
notice, that constitute the “findings” of the agency, lead to the issuance of the
order, and trigger judicial review.
46
conclusions of the Director regarding the safety issues affecting animal antibiotics
and initiate the process by which the agency can withdraw approval of their
subtherapeutic use.
But if the NOOHs contain or embody the findings on which plaintiffs rely,
plaintiffs are confronted with the problem that those NOOHs have been
withdrawn. Nothing in the statute or regulations explicitly restricts the FDA’s
ability to withdraw an NOOH after it has issued. Thus, at this moment, there is
no operative document that contains any formal finding, final or preliminary,
that any use of animal antibiotics pose health threats to humans. Accordingly,
the plaintiffs must, and do, argue that the withdrawal of the NOOHs does not
effectively withdraw the finding that was documented in them. They reason that
“findings” need not be reflected in any one document but rather comprise the
FDA’s considered collective judgment about the science underlying antibiotic
resistance and its effects on human safety. To withdraw the findings, plaintiffs
argue, the FDA must publicly recant its earlier position on the safety of the use of
antibiotics in animal feed. According to plaintiffs, the agency’s continued
insistence, up to and including in briefing and oral argument on this appeal, that
such use of antibiotics does pose risks for humans actually “reaffirmed” the
47
findings first announced in the 1977 NOOHs. In short, the “finding” that
subtherapeutic uses of antibiotics in animal feed is not shown to be safe resides
not in any formal legal conclusion but in the scientific judgment of the relevant
FDA officials, current and past, that such uses may be dangerous. By the
plaintiffs’ argument, once the Secretary reaches a conclusion that a drug use is
not shown to be safe, she is required to act on that opinion.
The withdrawal of the NOOHs, however, simply makes more stark a
problem inherent in the plaintiffs’ argument. The underlying logic of the
plaintiffs’ position is that the finding of the Secretary that triggers a hearing must
precede even the NOOH itself, for it is this finding that triggers the obligation of
the FDA to hold a hearing that, assuming that it results in yet another finding
adverse to the drug, is the precursor to a mandatory order withholding approval
of the drug. In other words, once the Secretary reaches a certain conclusion, an
NOOH must issue, and a hearing must commence.
That interpretation is problematic. Administrative findings, whether or
not preceded by adversarial evidentiary hearings, are ordinarily clothed in the
garb of decision, and reflect a formal determination. The fact that plaintiffs argue
that the findings originated with the 1977 NOOHs underscores that conclusion,
48
since the NOOHs have the level of formality we typically expect findings to have.
But if the NOOHs embody (or contain) the requisite findings, and revocation of
the NOOHs does not suffice to withdraw them, where do the findings exist? In
the thoughts and beliefs of the Secretary or Commissioner? Scattered across
various agency documents reflecting such thoughts?
That is not merely a formal or metaphysical point, but an intensely
practical one. By the language of the statute, once a finding is made, agency
action is mandatory, and in default of that action, the courts may compel the
agency to act. Under the government’s interpretation of the statute, the mandate
that the courts are to enforce is straightforward. If, after holding a hearing and
reviewing the evidence presented, the agency formally finds that a particular use
of an animal drug has not been shown to be safe for humans, but fails to
withdraw approval of the use of that drug and instead adopts some other
approach for dealing with the prospective danger, the courts must enforce the
congressional mandate and require the Secretary to withdraw approval.22
22
Moreover, upon the issuance of findings for or against the
demonstration of the safety of the drug at the conclusion of a hearing, judicial
review of whether the findings are adequately supported by the record will be
available.
49
Under the plaintiffs’ interpretation, in contrast, the courts must first
determine whether an entirely subjective and unexpressed finding has been
made during internal agency deliberations. On the facts of this case, plaintiffs
would have us seek such a finding in the now‐withdrawn 1977 NOOH, and
would have us conclude that the finding continues to exist based on various
statements of FDA representatives in public and before the Congress, in
litigation, and in the actions taken by the FDA to encourage voluntary reductions
in animal antibiotic use. That is itself sufficiently problematic, but in principle
plaintiffs’ position would permit lawsuits contending that the Secretary or her
delegates have actually made findings that remain entirely unexpressed in any
formal document, because they have formed opinions based on internal agency
deliberations or on a review of scientific studies.23
23
The dissent disavows any reliance on the subjective views of FDA
officials (Dissenting opinion, post, at 24‐25), but then falls back on essentially the
same argument about what the agency really believes by arguing that the now‐
withdrawn NOOHs were merely the “medium” for the “message” they
contained: the prior internal agency conclusions that penicillin and tetracycline
had not after all been shown to be safe (Dissenting opinion, post, at 25‐26). The
dissent concludes that withdrawal of the formal document on which it relies as a
basis for judicial review is insufficient unless the agency has actually changed its
mind, and deduces from a variety of sources that it has not.
50
Fifth, the traditional model of enforcement action described above
contemplates considerable discretion on the part of an agency to decide, for
prudential reasons, whether to initiate action or not, and whether to desist from
proceeding before a final conclusion is reached. Such discretion is a typical and
often necessary feature of the administrative process. Agencies have many
responsibilities, and limited resources. Deciding whether and when to deploy
those resources in an arduous, contested adversarial process is an important and
difficult responsibility. It is rare that agencies lack discretion to choose their own
enforcement priorities. Indeed, the Supreme Court has long applied a
presumption against judicial review of agency decisions declining to proceed
with enforcement actions because such decisions are, for purposes of the
Administrative Procedure Act (“APA”), “committed to agency discretion.”
Heckler v. Chaney, 470 U.S. 821, 832‐33 (1985), quoting 5 U.S.C. § 701(a)(2).
Plaintiffs’ interpretation of § 360b(e)(1) would deny that discretion to the
FDA. Were the “finding” that requires the withdrawal of approval located not in
the final decision of the Commissioner at the conclusion of a hearing at which all
relevant evidence is publicly presented, but in a determination by the head of the
CVM, based on an internal consideration of studies conducted by the agency or
51
in the academic literature, that the scientific evidence warrants initiating a
hearing so that the Commissioner might eventually reach such a final decision,
the agency would be required to take irrevocable action whenever the CVM
forms such an opinion that a drug is not shown to be safe, regardless of whether
the FDA believes that proceeding further is worth the diversion of resources from
other agency priorities. Ordinarily, administrative discretion is at its zenith when
an agency decides whether to initiate enforcement proceedings. The
government’s position is consistent with this longstanding discretion; the
plaintiffs’ position is not.
In canvassing these various principles and practices, we do not suggest
that they are mandatory and inescapable presumptions about administrative law.
Administrative procedure is flexible, and different approaches may be
appropriate in different contexts. We have pointed to what we believe are the
more common understandings or expectations about agency findings, orderly
procedure, administrative discretion, and judicial review. We are confident that
numerous exceptions and counter‐examples exist. More importantly, it is
beyond doubt that Congress has the power to alter these assumptions, in any
particular case or in general, by adopting legislation that imposes contrary
52
mandates on administrative agencies.24 Moreover, given the preeminent
importance of health and safety in the usage of powerful bioactive substances
such as human and animal drugs, it would hardly be surprising for Congress to
impose limits on traditional agency discretion or to mandate actions protective of
human safety. But the issue here is not whether Congress can impose the sort of
mandate plaintiffs would find in the statute – of course it can – but whether
Congress has done so.
E. Summary
Our survey of the text, the context, the regulations, and the background
legal principles leave us firmly persuaded that Congress has not required the
FDA to hold hearings whenever FDA officials have scientific concerns about the
safety of animal drug usage, that the FDA retains the discretion to institute or
24
Such was the situation in the recently decided Cook v. FDA, 733 F.3d 1
(D.C. Cir. 2013). There, the D.C. Circuit found the FDA failed to enforce a statute
that included a clear Congressional mandate for the FDA to take action in
particular circumstances. The FDA argued that because enforcement is a matter
of agency discretion, the decision to not enforce the statute was not subject to
judicial review. Id. at 5. The court found the relevant statute to be
“unambiguously binding” on the FDA in mandating that particular actions be
taken. Id. at 7 (citation omitted). Thus, the case addressed an instance of explicit
legislative instruction stripping an agency of discretion. Such clear legislative
instruction is noticeably absent here.
53
terminate proceedings to withdraw approval of animal drugs by issuing or
withdrawing NOOHs, and that the statutory mandate contained in § 360b(e)(1)
applies to limit the FDA’s remedial discretion by requiring withdrawal of
approval of animal drugs or particular uses of such drugs only when the FDA
has made a final determination, after notice and hearing, that the drug could
pose a threat to human health and safety.
That conclusion begins, as it must, with the text of the statute. Although
the text is not unambiguously clear, we believe that the FDA put forth the more
natural reading. The statute requires the FDA to withdraw approval of an
animal drug only “after due notice and opportunity for hearing” has been
afforded, and then only “if the Secretary finds” that the drug is not shown to be
safe. 21 U.S.C. § 360B(e)(1). That language most naturally refers to a finding that
is issued as a result of the hearing. That interpretation, moreover, avoids
injecting a second, unexpressed “finding” into the sequence of events mentioned
in the statute.
Although the regulations implementing the statute do not directly address
the question of interpretation posed by the plaintiffs, and contain at least some
language that arguably supports the plaintiffs’ reading of some terms in the
54
statute, the overall thrust of the regulations is consistent with the government’s
interpretation, and with what we regard as the more natural reading of the
statutory language. Moreover, the procedure set forth in those regulations, and
our reading of the text, are consistent with common assumptions about agency
procedure. Under that procedure, relevant experts within the agency (the staff of
the CVM) first assess the scientific issues regarding the risks and benefits of the
drug, and a high‐ranking agency official (the Director of the CVM) exercises
discretion to institute a proceeding that can lead to the revocation of approval of
the drug. Then (if the sponsor of the drug requests a hearing and raises genuine
issues of material fact about the preliminary conclusions set forth in the NOOH)
the staff proceeds to present evidence at a hearing featuring the separation of
functions between the “prosecuting” officials instituting the hearing and the
objective decisionmaker who will hear the evidence. At the conclusion of that
hearing, that decisionmaker issues findings that must be approved by a higher‐
ranking official, the Commissioner of the FDA. If the ultimate agency finding,
55
which is subject to judicial review, is that the drug is not shown to be safe, the
statute permits only one remedy – withdrawal of approval.25
Our interpretation of the statute is consistent with the regulations and with
conventional procedure. That alone does not make it correct; Congress
undoubtedly has the power to alter those conventions. We believe, however, that
if Congress intended to do so, and to mandate the commencement of the notice
and hearing process whenever the agency staff formed a scientific opinion
adverse to the drug, it would have stated those intentions explicitly. Far from
doing so, it has utilized language that is not only consistent with the traditional
administrative process, but that is more naturally read as adopting it.
II. The Citizen Petitions
Alternatively, plaintiffs argue that even if the FDA is not required to
proceed with hearings, its decision denying plaintiffs’ 1999 and 2005 citizen
petitions and withdrawing the 1977 NOOHs represented arbitrary or capricious
agency action in violation of the APA. See 5 U.S.C. § 706(2)(A). In particular,
25
Our reading thus emphatically recognizes the mandatory language of
the statute. Where the FDA would otherwise have considerable discretion to take
whatever action might be appropriate to protect the public safety in light of the
results of the hearing, Congress has specifically mandated in § 360b(e)(1) that
only one response is appropriate.
56
plaintiffs argue that the FDA’s denials were based on factors not explicitly
mentioned by the statute, namely cost, time, and a preference for voluntary
compliance over adversary proceedings.
The FDA’s notice withdrawing the 1977 NOOHs sets out the reasons for
the action:
FDA is taking this action, and closing the corresponding
dockets, because: FDA is engaging in other ongoing
regulatory strategies developed since the publication of
the 1977 NOOHs with respect to addressing microbial
food safety issues; FDA would update the NOOHs to
reflect current data, information, and policies if, in the
future, it decides to move forward with withdrawal of
the approved uses of the new animal drugs described in
the NOOHs; and FDA would need to prioritize any
withdrawal proceedings (for example, take into account
which withdrawal(s) would likely have the most
significant impact on the public health) if, in the future,
it decides to seek withdrawal of the approved uses of
any new animal drug or class of drugs.
Withdrawal of Notices of Opportunity for a Hearing: Penicillin and Tetracycline
Used in Animal Feed, 76 Fed. Reg. 79697, 79697 (Dec. 22, 2011). The letters in
which the FDA finally denied of the citizen petitions further elaborate on the
decision to withdraw the NOOHS and deny the petitions, stating “reviewing
safety information for antimicrobial drugs approved before 2003, and pursuing
withdrawal proceedings in some cases, would take many years and would
57
impose significant resource demands on the [FDA].” J. A. at 622; J. A. at 627. In
the letters the FDA describes its plan to “work[] cooperatively” with the animal
pharmaceutical industry to “ensur[e] the judicious use of medically important
antimicrobial drugs in food‐producing animals.” Id.
In arguing that such denial is arbitrary or capricious, plaintiffs claim that
the FDA ignored the reams of scientific data presented in the petitions and that
the reasons given by the FDA are illegitimate because they are orthogonal to
what plaintiffs persuaded the district court is the governing criterion described in
the statute: “whether the drugs at issue pose a threat to human health.” See
NRDC II, 872 F. Supp. 2d at 338.
Plaintiffs argue that this case is best analogized to Massachusetts v. EPA,
549 U.S. 497 (2007), in which the Supreme Court invalidated the denial of a
petition seeking to require the Environmental Protection Agency (“EPA”) to
regulate greenhouse gases. But Massachusetts dealt with a much different
statutory provision, one which unambiguously compelled agency action. In that
case, a group of states, municipalities, and non‐profit organizations sought to
force the EPA to regulate four greenhouse gases as air pollutants under Section
202(a)(1) of the Clear Air Act, which provides that:
58
The [EPA] Administrator shall by regulation prescribe
. . . standards applicable to the emission of any air
pollutant from any class or classes of new motor
vehicles or new motor vehicle engines, which in his
judgment cause, or contribute to, air pollution which
may reasonably be anticipated to endanger public
health or welfare.
42 U.S.C. § 7521(a)(1) (emphasis added). The Supreme Court agreed with
the plaintiffs that the text of the Clean Air Act required the EPA to regulate
greenhouse gases. In reaching that conclusion, the Court understood the
“judgment” contemplated by the statute as limited to the scientific question
whether a particular pollutant contributed to air pollution. Put differently, the
Supreme Court read the Clean Air Act not to grant the EPA discretion to choose
to regulate only those pollutants that it deemed feasible or wise to regulate. As
the Court had it, “the use of the word ‘judgment’ is not a roving license to ignore
the statutory text.” Massachusetts, 549 U.S. at 533. Once the EPA determined
that carbon dioxide contributed to air pollution, the Court concluded, the statute
required it to regulate the emission of that gas.
Massachusetts v. EPA is therefore fully distinguishable from the present
case. The Clean Air Act limited the EPA Administrator’s “judgment” to the
scientific question of whether the pollutant in question causes dangerous air
59
pollution; nothing in § 360b(e)(1) limits the considerations that the FDA may take
into account in deciding whether to initiate the hearing process by issuing an
NOOH. Moreover, unlike the Clean Air Act, which explicitly and
unambiguously requires the regulation of pollutants (“The Administrator shall by
regulation prescribe . . . standards”), as explained above, § 360b(e)(1) does not
mandate that the FDA take any action until and unless certain findings are made
after a hearing.26 In short, the Clean Air Act provision at issue in Massachusetts
v. EPA unambiguously required the EPA to undertake action to create emission
standards (leaving it to the EPA’s expertise to determine the substance of the
standards) whenever it forms a scientific judgment that a particular pollutant
contributes to dangerous air pollution, while the provision of the FDCA at issue
in this case requires the FDA to take a specific remedial step when, after a
26
Plaintiffs’ reliance on Brown & Williamson is also misplaced. In that
case, the Supreme Court held that the FDA lacked statutory authority to regulate
the sale of tobacco products. 529 U.S. at 125‐26. In the course of its analysis, the
Court noted that if it had statutory jurisdiction to regulate tobacco products, FDA
would have been required by its organic statute to remove them from the market
altogether. Id. at 135‐36. There was no question in that case, however, that FDA
had made “findings” about the safety of tobacco before issuing a final rule
governing youth access to tobacco products. The Supreme Court did not address
whether, if tobacco fell within its jurisdiction, the FDA would have been required
to initiate, or forbidden from abandoning, a course of hearings that might or
might not have resulted in such findings.
60
hearing, it has made certain findings, without imposing any absolute
requirement that the agency investigate the need for withdrawing approval of
animal drugs under any particular circumstance.
The present case is therefore more analogous to New York Public Interest
Research Group v. Whitman, 321 F.3d 316 (2d Cir. 2003), in which we interpreted
section 502(i) of the Clean Air Act, 42 U.S.C. § 7661a(i)(1). That provision
required the Administrator of the EPA to give notice and, if appropriate, impose
the relevant sanctions, “[w]henever the Administrator makes a determination that
a permitting authority is not adequately administering and enforcing a program .
. . in accordance with the requirements of this subchapter.” Id. (emphasis added)
We held that the use of the word “determination” “grants discretion.” Whitman,
321 F.3d at 330. Rejecting the view that the EPA was required to issue a notice of
deficiency whenever it found defects in a state permitting program, we noted
that “Congress could have fashioned a regime under which, for example, an
interested party could initiate the process leading to a determination of whether
‘a permitting authority is adequately administering and enforcing a program,’”
but that by referring to a “determination” on the part of the agency, Congress left
61
it to the discretion of the EPA Administrator whether and when to initiate
enforcement proceedings. Id. at 331, quoting 42 U.S.C. 7661a(i)(1).27
For the reasons set forth above, we conclude that the decision whether to
institute or terminate a hearing process that may lead to a finding requiring
withdrawal of approval for an animal drug is a discretionary determination left
to the prudent choice of the FDA.28
On that basis, it is relatively easy for us to accept the FDA’s determination
that its preferred program of voluntary compliance offers greater prospect for
immediate and significant reductions in animal antibiotic use than the pursuit of
27
As further evidence of the absence of a statutory mandate, we noted the
lack of any time statutory time limits on the agency’s action, 321 F.3d at 331 n.8, a
factor also applicable here.
28
We respectfully disagree with Judge Katzmann’s assertion (Dissenting
opinion, post, at 32) that because we find Whitman to offer a helpful analogy to
determine whether the FDA abused its discretion, we are implicitly equating a
withdrawal action to an enforcement action. Whitman provides guidance in that
the relevant statutory language in that case (“Whenever the Administrator makes
a determination,” 321 F.3d at 330, quoting 42 U.S.C. § 7661(a)(i)(1)) left the
mandatory agency action conditional upon a discretionary agency finding, much
like the statutory provision at issue here (action is required only “if the Secretary
finds” that certain conditions adhere). The relevant parallel in these cases is one
of analogical statutory construction that leaves action dependent upon agency
discretion, a construction distinguishable from the unequivocal imperative in the
statute at issue in Massachusetts v. EPA. Whether a withdrawal action is an
enforcement action is not relevant to our conclusion.
62
a potentially contentious withdrawal hearing. That is the sort of prudential
judgment better suited to expert administrators than to federal judges. We are
bolstered in this conclusion by the nature of the problem confronted by the FDA.
Nothing in the NOOHs suggests that penicillin and tetracycline, when
administered to animals, are inherently dangerous to human health; such
antibiotics are widely, effectively, and beneficially used in human medical care.
And while we are hesitant, for the reasons set forth above, to ascribe scientific
conclusions to the FDA based on our reading of a melange of different studies,
regulatory documents, and litigation positions, it appears clear that while the
agency regards the indiscriminate and extensive use of such drugs in animal feed
as threatening, it does not necessarily believe that the administration of
antibiotics to animals in their feed is inherently dangerous to human health.
Under these circumstances, we cannot conclude that it is arbitrary or
capricious for the FDA to pursue polices intended to reduce the use of animal
feed containing antibiotics through a variety of steps short of withdrawing
approval for the use of antibiotics in feed via a protracted administrative process
and likely litigation. As it was neither arbitrary nor capricious for the FDA to
63
deny the petitions for the reasons it did, the district court’s decision to the
contrary was error.
In letters recently submitted to the Court by the government, the
government notes that the FDA is “encouraged” by the “overwhelmingly
cooperative” reaction of the animal feed industry to the guidelines for voluntary
compliance that the agency has issued in lieu of proceeding with the process
initiated in 1977 with the issuance of the Penicillin and Tetracycline NOOHs,
Gov’t Letter dated March 27, 2014, and asserts that the high level of cooperation
by drug manufacturers “demonstrate[s] that the cooperative approach . . . has
been effective in enabling FDA to achieve its goals of phasing out the use of
medically important antimicrobial drugs for food‐production purposes,” Gov’t
Letter Dated July 1, 2014. In light of the discussion above, it should be obvious
that we express no opinion on the effectiveness of the FDA’s approach to what it
agrees is a significant regulatory concern about the overuse of antibiotics in
animal feed, and that in determining the issues in this case, we place no weight
on the agency’s informal assurances that its program is successful. It is not for us
to determine whether the agency has been prudent or imprudent, wise or foolish,
effective or ineffective in its approach to this problem. Whether the agency’s long
64
inaction in the face of the dangers highlighted in the 1977 NOOH’s represented
politically‐inspired foot‐dragging or wise caution in developing a cost‐effective
approach, it was for the agency, and not the courts, to determine how best to
proceed.
CONCLUSION
For the foregoing reasons, the decisions of the district court are
REVERSED, and the case is remanded to the district court with instructions to
deny the plaintiffs’ motion for summary judgment, grant the defendants’ motion
for summary judgment, and dismiss the action.
65
KATZMANN, Chief Judge, dissenting:
In 1977, nearly four decades ago, the Food and Drug Administration
(“FDA”) formally declared that the subtherapeutic use of penicillin and
tetracyclines in animal feed “ha[s] not been shown to be safe.” Penicillin‐
Containing Premixes; Opportunity for Hearing, 42 Fed. Reg. 43,772, 43,772 (Aug.
30, 1977) [hereinafter Penicillin NOOH]; Tetracycline (Chlortetracycline and
Oxytetracycline)‐Containing Premixes; Opportunity for Hearing, 42 Fed. Reg.
56,264, 56,264 (Oct. 21, 1977) [hereinafter Tetracycline NOOH]. It has never
abandoned that position. Indeed, the FDA has consistently reaffirmed that using
low doses of antibiotics on healthy livestock to promote growth could accelerate
the development of antibiotic‐resistant bacteria, causing “a mounting public
health problem of global significance.” FDA, Guidance for Industry #209: The
Judicious Use of Medically Important Antimicrobial Drugs in Food‐Producing
Animals 4 (April 13, 2012). The FDA has nevertheless refused to move forward
with the statutorily‐prescribed process for withdrawing approval from the
subtherapeutic use of penicillin and tetracyclines. It has also refused to begin the
1
process of withdrawing approval from the subtherapeutic use of other medically
important antibiotics on animals.
The majority begins by recognizing that antibiotic resistance presents a
serious global health problem, and that the indiscriminate use of antibiotics on
animals contributes to that problem. Its ruling nevertheless seems to accept the
view that Congress gave the FDA discretion to do virtually nothing about that
problem for over 30 years—and then, when it finally decided to act, to adopt a
different regulatory strategy than Congress expressly provided. More precisely, it
permits the FDA to renounce the statutory withdrawal procedure in favor of its
own “voluntary compliance” strategy, which consists of asking animal drug
sponsors to voluntarily relabel their products in order to prevent them from
being used to promote animal growth. See FDA, Guidance for Industry # 213:
New Animal Drugs and New Animal Drug Combination Products Administered
in or on Medicated Feed or Drinking Water of Food‐Producing Animals
(December 2013).
I cannot agree with the majority’s conclusions. In light of the statutory
structure and its purposes, I am convinced that 21 U.S.C. § 360b(e)(1) requires the
2
FDA to continue the proposed withdrawal proceedings for the subtherapeutic
use of penicillin and tetracyclines in animal feed. I am likewise convinced that the
agency’s decision to deny the citizen petitions was arbitrary and capricious under
Massachusetts v. EPA, 549 U.S. 497 (2007), because it failed to address the statutory
question of whether the animal drug uses at issue were shown to be safe.
Today’s decision allows the FDA to openly declare that a particular animal
drug is unsafe, but then refuse to withdraw approval of that drug. It also gives
the agency discretion to effectively ignore a public petition asking it to withdraw
approval from an unsafe drug. I do not believe the statutory scheme can be read
to permit those results, and I must therefore respectfully dissent.
I. The Required Hearings Claim
A. Text
Like the majority, I begin with the text of the statute:
The Secretary shall, after due notice and opportunity for hearing to
the applicant, issue an order withdrawing approval of an application
. . . with respect to any new animal drug if the Secretary finds—
. . .
(B) that new evidence . . . shows that such drug is not shown to be
safe for use under the conditions of use upon the basis of
which the application was approved . . . .
3
21 U.S.C. § 360b(e)(1).
I agree with the majority that the bare text of this statute is ambiguous, and
that both plaintiffs and the FDA have presented plausible readings. In plaintiffs’
view, “if the Secretary finds . . . that new evidence . . . shows that [a] drug is not
shown to be safe” then “[t]he Secretary shall, after due notice and opportunity for
a hearing to the applicant, issue an order withdrawing approval of . . . [that]
drug.” Id. In that case, the FDA is statutorily required to institute withdrawal
proceedings whenever it makes a preliminary finding that a particular animal
drug has not been shown to be safe for its approved use. In the government’s
view, on the other hand, “if the Secretary finds,” “after due notice and an
opportunity for a hearing to the applicant,” “that new evidence . . . shows that
[any new animal] drug is not shown to be safe” then “[t]he Secretary shall . . .
issue an order withdrawing approval of . . . [such] drug.” Id. On that reading, the
FDA is never statutorily required to initiate or continue withdrawal proceedings
for a drug—no matter how terrifyingly unsafe that drug may be. Instead, the
FDA has complete discretion to decide when (and whether) to begin the process
of withdrawing approval for drugs that it has determined are not shown to be
4
safe; the only statutory requirement is that if the FDA chooses to hold a hearing,
and finds after that hearing that a drug has not been proven safe for its approved
use, then the FDA must withdraw its approval.
In an ideal world, Congress would have written a statute that clearly
selects between one of these two possible readings. But as the statutory language
is ambiguous, we must do our best to determine which of these two meanings
Congress intended to convey. To answer that question, I turn to the purpose and
structure of the statute as a whole.
B. Purpose and Structure
“[W]e begin . . . any exercise of statutory construction with the text of the
provision in question, and move on, as need be, to the structure and purpose of
the Act in which it occurs.” N.Y. State Conference of Blue Cross & Blue Shield Plans
v. Travelers Ins. Co., 514 U.S. 645, 655 (1995). The statute at issue here, 21 U.S.C.
§ 360b, is part of the Federal Food, Drug, and Cosmetic Act (“FDCA”), enacted in
1938 to protect American consumers from unsafe food, drugs, medical devices,
and cosmetics. See Federal Food, Drug, and Cosmetic Act, Pub. L. No. 75‐717, 52
Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301–399f).
5
“The FDCA statutory regime is designed primarily to protect the health
and safety of the public at large.” POM Wonderful LLC v. Coca‐Cola Co., 134 S. Ct.
2228, 2234 (2014); see also FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120,
133 (2000) (“Viewing the FDCA as a whole, it is evident that one of the Act’s core
objectives is to ensure that any product regulated by the FDA is ‘safe’ and
‘effective’ for its intended use. This essential purpose pervades the FDCA.”
(citations omitted)). The same purpose is reflected in the FDA’s mission, as
defined by Congress:
The Administration shall—
(1) promote the public health by promptly and efficiently
reviewing clinical research and taking appropriate action on
the marketing of regulated products in a timely manner;
(2) with respect to such products, protect the public health by
ensuring that—
. . .
(B) human and veterinary drugs are safe and effective . . . .
21 U.S.C. § 393(b). Of course, this broad statutory mandate to “promote the
public health” and “ensur[e] that human and veterinary drugs are safe and
effective” does not compel the agency to use any particular method to attain
those goals. After all, “no legislation pursues its purposes at all costs . . . and it
frustrates rather than effectuates legislative intent simplistically to assume that
6
whatever furthers the statute’s primary objective must be the law.” Rodriguez v.
United States, 480 U.S. 522, 525–26 (1987). But in construing § 360b, we must
surely keep in mind that the primary purpose of the FDCA (and of the FDA
itself) is to protect the public by prohibiting commerce in unsafe food and drugs.
The structure of § 360b reflects that primary purpose, ensuring that no
animal drug can be sold on the national market for a particular use unless the
FDA is convinced that drug has been shown to be safe for that use. Speaking in
broad outlines, § 360b(a) generally prevents any person from distributing a new
animal drug unless that drug has been approved by the FDA.1 Section 360b(b)
requires any person applying for approval of a new animal drug to submit (inter
alia) studies showing that drug is safe and effective, and § 360b(c) then requires
the FDA to determine whether there is any statutory reason not to approve the
1
To be more precise, § 360b(a) declares that a new animal drug “shall, with
respect to any particular use or intended use of such drug, be deemed unsafe” unless it
has been approved by the FDA or a special exception applies. Section 351(a)(5) then
declares that any new animal drug deemed unsafe under § 360b(a) shall be deemed
“adulterated,” and § 331(a) prohibits introducing any adulterated drug into interstate
commerce. Throughout the discussion below, I omit similarly tangential details of the
FDCA’s intricate statutory scheme.
7
new drug. Among the statutory grounds for disapproval, of course, is that the
drug has not been shown to be safe. 21 U.S.C. § 360b(d)(1)(B).
The statutorily‐defined process for approving a new animal drug is
marked by the strict limits it places on the FDA’s discretion. Within 180 days
after receiving an application, the FDA “shall either” enter an order of approval,
if it finds no reason to disapprove the application, or else give the applicant
notice of an opportunity for a hearing. Id. § 360b(c)(1)(A)–(B). If the applicant
requests a hearing, the FDA “shall” provide one within ninety days. Id.
§ 360b(c)(1). After the hearing, the FDA “shall” issue a final order within ninety
days. Id. If it finds that any of the statutory grounds for disapproval apply, it
“shall” refuse to approve the application; otherwise, it “shall” approve the
application. Id. § 360b(d)(1). At each step, the FDA is constrained to follow the
approval process laid out by the statute; and it is strictly forbidden at each stage
of the process from approving any drug that is not shown to be safe, or from
disapproving any drug without first giving its sponsor the opportunity for a
hearing. The initial approval provisions in § 360b(c)–(d) are thus designed to
8
ensure that the FDA fulfills its statutory role of keeping unsafe drugs off of the
market, while also providing due process to drug sponsors.
On plaintiffs’ interpretation, the withdrawal provision at § 360b(e)(1)(B)
fits comfortably within that statutory scheme. It requires the FDA to commence
withdrawal proceedings whenever the FDA preliminarily determines that an
approved animal drug is no longer shown to be safe for its approved use. The
FDA must then provide notice and an opportunity for the drug’s sponsor to be
heard; and if, after the hearing, it continues to find that the approved drug use is
no longer shown to be safe, it must withdraw its approval of that use. In other
words, plaintiffs’ interpretation reads the initial approval provisions and the
withdrawal provision in parallel: both require the FDA, if it thinks a drug is not
shown to be safe for a particular use, to provide a hearing and then (if still
unconvinced) to disapprove that drug for that use. Both parts of the statute thus
work together to make sure there are no unsafe drugs on the national market.
The initial approval provisions ensure that the FDA will keep new animal drugs
off the market unless they are shown to be safe, while the withdrawal provision
9
ensures that the FDA will withdraw approval from an existing drug if it is not
shown to be safe.
The FDA’s position, on the other hand, sets the approval provisions and
the withdrawal provision entirely at odds. The former provisions clearly indicate
that the FDA has no discretion to admit a new animal drug to the market if it
initially finds that drug is not shown to be safe for its proposed use; instead, the
agency must begin the rejection process by providing an opportunity for a
hearing. But according to the FDA, the withdrawal provision then gives the
agency complete discretion to leave an approved animal drug on the market even
if it later learns that drug is utterly unsafe. That interpretation cannot be
reconciled with the purpose of the FDCA, and it cannot be reconciled with the
mission of the FDA itself. I see no reason to believe that Congress carefully
cabined the FDA’s ability to admit new drugs to the market, but then sub silentio
left the agency entirely free to leave dangerous drugs on the market once
admitted. 2
2
The statute does contemplate certain grounds that would prevent a new drug
from being initially approved, but that would not require withdrawal of an approved
drug. Compare 21 U.S.C. § 360b(d)(1)(C) (barring approval of a new drug for which “the
methods used in, and the facilities and controls used for, the manufacture, processing,
10
The FDA argues that the formal withdrawal process contemplated by the
statute can be expensive and time‐consuming, and that its voluntary compliance
strategy will reach the same result more quickly and at lower cost. There is a
certain irony in the FDA’s argument that the formal withdrawal process is too
time‐consuming, given that the agency has now delayed even beginning that
process for thirty‐seven years. In any case, the minimum due process protections
provided by the statute—notice and an opportunity to be heard—are the same
for both the initial approval process and for the withdrawal process. If the FDA
preliminarily determines that a new animal drug is not shown to be safe, it must
provide the drug’s sponsor with the opportunity to be heard, even though the
resulting hearings may be long and expensive. See id. § 360b(c)–(d). The agency
has no discretion to deny those hearings. So too here: if the FDA preliminarily
determines that an approved animal drug is not shown to be safe, it must
provide the drug’s sponsor with the opportunity to be heard, and then (if still not
and packing of such drug are inadequate to preserve its identity, strength, quality, and
purity”), and id. § 360b(d)(1)(H) (barring approval where a new drug’s “labeling is false
or misleading in any particular”), with id. § 360b(e)(2)(B)–(C) (giving the Secretary
discretion to decide whether to withdraw approval from drugs under those conditions).
That is, where Congress wanted to give the FDA the discretion that the agency seeks
here, Congress expressly granted it.
11
convinced the drug is safe) must withdraw its approval. Id. § 360b(e)(1)(B).
Providing drug sponsors an opportunity to be heard may be tedious and costly,
but Congress has determined that the agency must use that process—both when
it finds a new animal drug is not shown to be safe, and when it finds an existing
animal drug is not shown to be safe.3 To the extent that statutory mandate
prevents the FDA from pursuing other regulatory strategies, “this is the
congressional design.” Massachusetts v. EPA, 549 U.S. 497, 533 (2007).
That same congressional design appears in 21 U.S.C. § 355, the FDCA
provision regulating the approval and withdrawal of approval for non‐animal
drugs. Sections 355 and 360b were once a single statutory section, see FDCA
§ 505, 52 Stat. at 1052–53, and the language of the latter was largely modeled on
the former. See H.R. Rep. No. 90‐875, at 5 (1967) (noting that the two sections
correspond); S. Rep. No. 90‐1308, at 5 (1968) (same). Both statutory sections apply
much the same process for the approval of drugs, using the same language to
prevent the FDA from approving new drugs unless they have been shown to be
3
The sole exception comes in § 360b(e)(1)’s “imminent hazard” provision, which
permits the Secretary of Health and Human Services to immediately suspend approval
of a particular animal drug use without a hearing if he finds that use presents an
imminent hazard to human or animal health.
12
safe. Compare 21 U.S.C. § 355(c)–(d) with id. § 360b(c)–(d). And both use the same
syntax in their respective withdrawal provisions, meaning that both share the
same textual ambiguity as to whether the FDA is required to hold a withdrawal
hearing once it makes a preliminary finding that a particular drug is not shown
to be safe.4
But the available evidence indicates that courts have uniformly construed
§ 355(e) to require the FDA to move forward with withdrawal proceedings if it
makes a preliminary finding that a drug is not shown to be safe. In dicta, the
Supreme Court characterized § 355(e) in language that almost exactly mirrors the
plaintiffs’ interpretation of § 360b(e)(1)(B): “If the FDA discovers after approval
that a drug is unsafe or ineffective, it ‘shall, after due notice and opportunity for
hearing to the applicant, withdraw approval of’ the drug.” Brown & Williamson,
529 U.S. at 134 (quoting 21 U.S.C. § 355(e)). The precise interpretation of § 355(e)
was not before the Court in that case; but its analysis assumed that once the FDA
determines a product under its jurisdiction is not shown to be safe, it is
4
For comparison, the first sentence of § 355(e) reads: “The Secretary shall, after
due notice and opportunity for hearing to the applicant, withdraw approval of an
application with respect to any drug under this section if the Secretary finds that [any of
the listed statutory grounds apply].” 21 U.S.C. § 355(e).
13
statutorily required to begin withdrawal proceedings.5 See id. at 135 (“[I]f tobacco
products were [covered] under the FDCA, the FDA would be required to remove
them from the market.”); see also American Public Health Ass’n v. Veneman, 349 F.
Supp. 1311, 1315–16 (D.D.C. 1972) (holding that the FDA must commence
withdrawal proceedings after announcing in the Federal Register that certain
drugs were not shown to be effective for their approved uses). Given the parallel
structure of the two statutes, § 360b(e)(1)(B) should be interpreted as § 355(e) has
been: to require the agency to commence withdrawal proceedings if it initially
finds that a drug has not been shown to be safe for its approved use.
C. The Relevant Regulations
Like the statute, the regulations implementing § 360b(e)(1)(B) show that the
agency’s duty to institute withdrawal proceedings is mandatory. In particular,
21 C.F.R. § 514.115(b) states: “The Commissioner shall notify in writing the
5
The majority indicates that Brown & Williamson is inapposite because the FDA
had already made “findings” showing that tobacco products were unsafe. But the
“findings” referred to in that case were the result of a notice‐and‐comment rulemaking
procedure, not the formal evidentiary hearing process envisioned by § 355(e) (or §
360b(e)(1)) and its accompanying regulations. Compare Brown & Williamson, 529 U.S. at
126–28, 134–35, with 21 C.F.R. § 10.50(c)(16)–(17). In other words, Brown & Williamson
clearly assumes that the agency can be bound in this context by a finding that does not
result from any formal evidentiary hearing.
14
person holding [an animal drug application] and afford an opportunity for a
hearing on a proposal to withdraw approval of such application if he finds . . .
that such drug is not shown to be safe . . . .” 21 C.F.R. § 514.115(b)(3)(ii). Unlike
the statute, the meaning of this regulation is entirely clear. If the FDA makes an
initial finding that a particular drug is not shown to be safe, it “shall” then
provide the drug’s sponsor with an opportunity to be heard. In sum, this
regulation imposes exactly the mandatory duty that plaintiffs see in the statute:
once the FDA makes a preliminary finding that a particular drug is not shown to
be safe, it must commence withdrawal proceedings.6
The majority asserts that § 514.115(b) does not represent an agency
interpretation of the statute, and so is not entitled to the deference we afford
6
The regulation is plainly mandatory. See Lopez v. Davis, 531 U.S. 230, 241 (2001)
(noting the use of the word “shall” to “impose discretionless obligations”). That alone
may well be enough to resolve this case, since “[w]here the rights of individuals are
affected, it is incumbent upon agencies to follow their own procedures.” Morton v. Ruiz,
415 U.S. 199, 235 (1974). I say “may well be enough” because some agency regulations
do not create judicially enforceable obligations. See Leslie v. Attorney General, 611 F.3d
171, 176 (3d Cir. 2010) (“[N]ot every promulgated regulation is of such a nature that a
violation should invalidate agency action.”). The parties have not thoroughly briefed
whether 21 C.F.R. § 514.115(b)(3)(ii) can, of its own force, require the FDA to carry out
withdrawal hearings. Because I think the statute provides sufficient grounds to reach
that result, I need not decide whether the regulation does as well.
15
under Chevron U.S.A., Inc. v. NRDC, 467 U.S. 837 (1984). I am not sure I agree. But
even if so, the regulation at least counsels strongly in favor of plaintiffs’
interpretation. It makes clear that the FDA expects the withdrawal procedure to
begin with an initial agency finding that a particular drug is not shown to be safe,
followed immediately by notice and an opportunity for a hearing.7 With or
without Chevron deference, I would still interpret the statute to accord with that
regulatory scheme.8
7
Other agency pronouncements confirm that the FDA has interpreted the
statutory finding described in § 360b(e)(1)(B) to be a preliminary finding that begins the
withdrawal process. See Guidance for Industry # 209, at 19 (“[I]nitiating action to
withdraw an approved new drug application . . . would require the agency to make the
showing required under [§ 360b(e)(1)].”); see also 21 C.F.R. § 514.80(a)(3) (“FDA reviews
the records and reports required in this section to facilitate a determination under
[§ 360b(e)] as to whether there may be grounds for suspending or withdrawing
approval . . . .”); Letter from Leslie Kux, Assistant Acting Commissioner for Policy,
FDA, to Sarah Klein, Center for Science in the Public Interest 2 (Nov. 7, 2011) (“If the
[agency] concludes that grounds exist to withdraw a new animal drug approval, . . .
FDA must provide the drug’s sponsor with notice and an opportunity for a formal
administrative hearing (‘NOOH’).”).
8
By contrast, I agree with the majority that none of the other regulations cited by
the FDA help our analysis, because none of them address the interpretive question
before us: whether the agency is required, after making an initial finding that a drug is
not shown to be safe, to commence withdrawal proceedings. I also reject the agency’s
bid for Auer deference to its argument that § 514.115(b) and the statute refer to different
findings, since “Auer deference is warranted only when the language of the regulation is
ambiguous.” Christensen v. Harris Cnty., 529 U.S. 576, 588 (2000).
16
D. Counterarguments
For the reasons described above, I believe 21 U.S.C. § 360b(e)(1)(B) compels
the FDA to initiate withdrawal proceedings once it makes a preliminary finding
that a drug is no longer shown to be safe. I now turn to the counterarguments
that the majority finds persuasive.
1. Text
The majority’s primary objection is that my interpretation of this provision
contravenes either basic principles of due process or else the statutory text. As I
construe the statutory text, “if the Secretary finds” that a drug is not shown to be
safe, “[t]he Secretary shall, after due notice and opportunity for a hearing to the
applicant, issue an order withdrawing approval of” the drug. 21 U.S.C.
§ 360b(e)(1). That reading grammatically links the agency’s pre‐hearing finding
to a mandatory withdrawal order. Taken literally, it would require the FDA to
withdraw approval from a drug whenever it made a pre‐hearing finding that
drug was not shown to be safe—making the hearing a pointless exercise. That
result would contravene basic principles of due process. See Hamdi v. Rumsfeld,
17
542 U.S. 507, 533 (2004) (plurality opinion) (noting that due process requires
notice and a meaningful opportunity to be heard).
There is an easy solution to this due process problem, however: to read the
statute “against the background of our traditional legal concepts,” United States v.
U.S. Gypsum Co., 438 U.S. 422, 437 (1978), as implicitly guaranteeing the drug
sponsor a meaningful opportunity to rebut the agency’s preliminary finding. On
that reading, the statute adopts the following procedure: When the FDA makes a
preliminary finding that a drug is not shown to be safe, it must offer the drug’s
sponsor a hearing. If after that hearing the FDA continues to find that the drug is
not shown to be safe, then it must issue an order withdrawing approval of the
drug. Alternatively, if after that hearing the FDA finds the drug’s sponsor has
presented persuasive evidence that the drug is safe, it will announce that finding
and end the withdrawal process. This procedure constrains the FDA to proceed
to a hearing if it makes a preliminary finding that a drug is not shown to be safe,
but also preserves the right of the drug’s sponsor to rebut that preliminary
finding by presenting evidence at the hearing.
18
The majority recognizes that this interpretation would solve the due
process problem, but objects that it is not true to the statutory text. It observes
that the text of § 360b(e)(1) only refers to a single finding, while this
interpretation implies both a pre‐hearing finding and a post‐hearing finding. It
also observes that the statute literally requires the agency to issue a withdrawal
order if it makes the finding described in the statute. The majority infers that the
finding described in the statute must therefore be a post‐hearing finding, since (to
preserve due process) only a post‐hearing finding can absolutely require a
withdrawal order.
If Congress were always perfectly precise in its language, the majority’s
argument would have some force. In fact, however, Congress does draft statutes
that refer only to a single finding but that obviously imply both a pre‐hearing
and post‐hearing finding. To list a few:
If . . . the Administrator [of the Environmental Protection Agency
(“EPA”)] determines that [a person has violated a rule governing an
exemption], the Administrator shall . . . after providing written
notice to the person who holds such exemption and an opportunity
for a hearing, by order terminate such exemption . . . .
15 U.S.C. § 2603(c)(4)(B).
19
If the Secretary [of Education] determines that an accrediting agency
or association has failed to apply effectively the criteria in this
section, or is otherwise not in compliance with the requirements of
this section, the Secretary shall . . . after notice and opportunity for a
hearing, limit, suspend, or terminate the recognition of the agency or
association . . . .
20 U.S.C. § 1099b(l)(1).
[I]f the Secretary [of the Treasury] determines that any substantial
obligation under any agreement is not being fulfilled, he may, after
notice and opportunity for hearing to the person maintaining the
fund, treat the entire fund or any portion thereof as an amount
withdrawn from the fund in a nonqualified withdrawal.
26 U.S.C. § 7518(e)(2).
The Administrator [of the EPA] shall review approved plans from
time to time and if he determines that revision or corrections are
necessary . . . he shall, after notice and opportunity for public
hearing, withdraw his approval of such plan.
42 U.S.C. § 6947(a)(2).
Despite their literal text, none of these statutes (as far as I know) have been
interpreted to require or permit an agency to take action based solely on its pre‐
hearing finding. Instead, these statutes are naturally read in the same way that I
read § 360b(e)(1): as implying that the agency can only take final action after both
a pre‐hearing and a post‐hearing finding, even though the statutory text only
20
explicitly mentions one such finding. Given these examples, I see nothing
“singularly odd,” supra, at ___ (majority slip op. at 26), in believing that Congress
used the same shorthand in this statute that it did in those statutes—especially
since the agency regulations implementing this statute explicitly envision a pre‐
hearing finding as well as a post‐hearing finding. See 21 C.F.R. § 514.115(b).
2. Background Legal Concepts
The majority argues next that its interpretation is more consistent with our
ordinary understanding of administrative and judicial processes. In the
majority’s view, the normal administrative sequence runs “hearing, finding,
order,” and my interpretation violates that sequence by reading the statute to
refer to a pre‐hearing finding.
I concede that in many contexts, a “finding” is a post‐hearing
determination. But as the majority recognizes, see supra, at ___ (majority slip op.
at 42), the word “finding” can equally refer to a pre‐hearing determination—and
here, the agency’s own regulations clearly adopt that sense. Section 514.115(b)
explicitly states that the agency will only issue a notice of opportunity for a
hearing if it “finds” that one of the statutory grounds for withdrawal applies. 21
21
C.F.R. § 514.115(b); see also Sterling Drug, Inc. v. Weinberger, 384 F. Supp. 557, 588
(S.D.N.Y. 1974) (referring to the agency’s pre‐hearing determination under 21
U.S.C. § 355(e) that a drug was ineffective as a “finding”).
Nearby provisions of the statute also explicitly contemplate pre‐hearing
findings. When the FDA receives a new animal drug application, if it “finds that
none of the grounds for denying approval” in the statute apply, it must approve
the drug; if it finds otherwise, it must give notice of an opportunity for a hearing.
21 U.S.C. § 360b(c)(1). The FDA’s own brief describes that pre‐hearing
determination as a “finding.” Br. for Defendants‐Appellants at 25; see also id.
(noting that a hearing is required “[o]nly if FDA preliminarily ‘finds’ . . . a reason
for disapproval”). Likewise, under the imminent hazard provision—as the
majority notes—the Secretary first “finds that there is an imminent hazard” and
then “give[s] the applicant prompt notice of his action and afford[s] the applicant
the opportunity for an expedited hearing. 21 U.S.C. § 360b(e)(1); see supra, at ___
(majority slip op. at 42–43).
These examples point to a larger problem with the majority’s analysis:
namely, that it takes too limited a view of the normal administrative sequence.
22
Agency action often begins not with a hearing, but with a preliminary agency
finding that triggers notice and an opportunity for a hearing. After all, agencies
do not arbitrarily decide to initiate hearings; instead, they begin the hearing
process only when they find there is some reason to do so. As described above,
21 U.S.C. § 360b and 21 C.F.R. § 514.115(b) are not unique in explicitly
envisioning that a formal agency determination can occur before and lead to a
hearing. See 15 U.S.C. § 2603(c)(4)(B); 20 U.S.C. § 1099b(l)(1); 26 U.S.C.
§ 7518(e)(2); 42 U.S.C. § 6947(a)(2). And as the majority recognizes, administrative
enforcement proceedings often begin with the agency’s preliminary findings in
the form of “a case‐initiating document that sets forth the [agency’s] conclusions
or charges.” Supra, at ___ (majority slip op. at 45). In other words, the normal
administrative sequence in many cases is not simply “hearing, finding, order,”
but instead “preliminary finding, hearing, final finding, order.” In many cases,
the agency’s preliminary findings are not attached to any mandatory
consequences —especially not in the enforcement context, where agency
discretion is at its height. See Heckler v. Chaney, 470 U.S. 821 (1985). But if
Congress so chooses, it can require an agency to act on the basis of its preliminary
23
findings. Cf. id. at 834 (explaining that Congress can “withdr[a]w discretion from
the agency and provide[] guidelines for exercise of its enforcement power”). That
in no way contravenes our basic understanding of the administrative process.
The majority argues next that the statute cannot refer to a pre‐hearing
“finding” because it will be impossible to determine when the agency has made
that finding. In the majority’s view, if the pre‐hearing finding triggers the
withdrawal process, it must precede (and require) the issuance of an NOOH.
Therefore, the majority concludes, that pre‐hearing finding can only exist as an
intangible conclusion in the mind of the Secretary (or perhaps the collective mind
of the agency); and it is hard to believe that Congress would compel an agency to
act based on the internal beliefs of its officers or employees. Alternatively, the
majority argues that if the pre‐hearing finding is embodied in an NOOH itself,
then plaintiffs cannot compel the FDA to act because the FDA has withdrawn the
two NOOHs it issued.
The majority’s first argument attacks a straw man. No one contends that
the statute can require the FDA to act based on “an entirely subjective and
unexpressed finding . . . made during internal agency deliberations.” Supra, at
24
___ (majority slip op. at 50). Plaintiffs contend only that if the FDA does issue an
NOOH announcing that a drug is not shown to be safe, it must then move
forward with the withdrawal process.9 In other words, the statutory phrase “if
[the FDA] finds” does not mean “if the FDA subjectively believes”; it instead
means “if the FDA formally states a preliminary finding.” That interpretation in
no way requires courts to review the internal thoughts or beliefs of the
agency—only the agency’s official public statements about a particular drug. It
consequently raises none of the problematic reviewability issues that the majority
suggests. To the contrary, “the mandate that the courts are to enforce” under this
interpretation is just as “straightforward” as under the majority’s. Supra, at ___
(majority slip op. at 49).
Alternatively, the majority argues that the plaintiffs cannot compel agency
action based on the findings expressed in the 1977 NOOHs because those
NOOHs have now been withdrawn. That argument mistakes the medium for the
message. The findings that the FDA made in 1977 were that the use of penicillin
9
Because the FDA did issue two NOOHs in this case, we are not called on to
decide here whether the statute might require the FDA to commence withdrawal
proceedings if it used some other means to announce its position that a particular drug
had not been shown to be safe.
25
and tetracyclines had not been shown to be safe; the NOOHs were the medium
through which the FDA announced those findings. As described above, the
statute does not compel the FDA to take any action until it makes some formal
public announcement of its preliminary findings. But once the FDA announces its
findings, it cannot avoid withdrawal proceedings just by retracting the
announcement. Instead, it can only avoid withdrawal proceedings by retracting
the findings—that is, by announcing that those preliminary findings were
mistaken.
Here, the FDA has never retracted its preliminary findings. To the
contrary, the agency “has not issued a single statement since the issuance of the
1977 NOOHs that undermines [its] original findings.” NRDC v. FDA (“NRDC I”),
884 F. Supp. 2d 127, 150 (S.D.N.Y. 2012) (opinion below). And the FDA made
clear in the notices withdrawing the 1977 NOOHs that its action was based on its
choice to pursue a new regulatory approach, rather than on any doubt about its
findings that the subtherapeutic use of these drugs in animal feed was not shown
to be safe. Because the agency has never formally repudiated the preliminary
26
findings announced in the 1977 NOOHs, I would hold that it remains bound by
those findings under the statute.10
3. Agency Discretion
Finally, the majority argues that its interpretation is more consonant with
our tradition of agency discretion in the enforcement context. The FDA puts this
position more strongly, arguing that its decision to refrain from withdrawal
proceedings is entirely immune from judicial review under Heckler v. Chaney, 470
U.S. 821 (1985).
The Administrative Procedure Act (APA) embodies a “basic presumption
of judicial review.” Lincoln v. Vigil, 508 U.S. 182, 190 (1993) (quoting Abbott Labs.
v. Gardner, 387 U.S. 136, 140 (1967)); see 5 U.S.C. § 702 (“A person suffering legal
wrong because of agency action . . . is entitled to review thereof.”); Bowen v. Mich.
Academy of Family Physicians, 476 U.S. 667, 670 (1986) (noting “the strong
presumption that Congress intends judicial review of administrative action”).
Under 5 U.S.C. § 701(a)(2), however, judicial review is not available for “agency
action [that] is committed to agency discretion by law.” Id. This “very narrow
10
For the same reason, I would also hold that the withdrawal of the NOOHs did
not moot plaintiffs’ claim. See NRDC I, 884 F. Supp. 2d at 149–51.
27
exception” applies “in those rare instances where statutes are drawn in such
broad terms that in a given case there is no law to apply.” Citizens to Preserve
Overton Park, Inc. v. Volpe, 401 U.S. 402, 410 (1971) (internal quotation marks
omitted). In such circumstances, judicial review would be useless, because the
reviewing court “would have no meaningful standard against which to judge the
agency’s exercise of discretion.” Heckler, 470 U.S. at 830.
The Supreme Court has explained that § 701(a)(2) creates a presumption
against judicial review for “certain categories of administrative decisions that
courts traditionally have regarded as committed to agency discretion.” Vigil, 508
U.S. at 191 (internal quotation marks omitted). One such category of
administrative decisions are agency refusals to institute investigative or
enforcement proceedings. See Heckler, 470 U.S. at 830–31 (“[A]n agency’s decision
not to prosecute or enforce, whether through civil or criminal process, is a
decision generally committed to an agency’s absolute discretion.”). Although an
agency’s decision not to take enforcement action is presumptively unreviewable,
“the presumption may be rebutted where the substantive statute has provided
guidelines for the agency to follow in exercising its enforcement powers.” Id. at
28
832–33. If Congress specifies by statute the conditions under which an agency
must bring enforcement proceedings, then a court can review whether the agency
has followed Congressʹs directions. But if Congress merely authorizes the agency
to bring enforcement proceedings, without specifying when the agency is
required to do so, then the agencyʹs decision not to bring a particular
enforcement proceeding is unreviewable. See id. at 834–35, 838; see also Vigil, 508
U.S. at 193 (“Congress may always circumscribe agency discretion . . . by putting
restrictions in the operative statutes . . . .”). Heckler therefore “requires careful
examination of the statute on which the claim of agency illegality is based,” to
determine the extent to which Congress has placed judicially enforceable limits
on the agencyʹs discretion. Webster, 486 U.S. at 600.
As I discuss in more detail below, it is not clear whether the withdrawal
proceedings contemplated by § 360b(e)(1)(B) should be characterized as
enforcement proceedings under Heckler. I believe they should not. But even if
withdrawal proceedings were a form of enforcement, I would still conclude that
§ 360b(e)(1)(B) places judicially enforceable limits on the FDA’s discretion over
whether to commence those proceedings. In my view, the statute precisely
29
specifies when the FDA is required to commence withdrawal proceedings: when
the agency finds that a particular drug is not shown to be safe. Congress has thus
“indicated an intent to circumscribe agency . . . discretion, and has provided
meaningful standards for defining the limits of that discretion.” Heckler, 470 U.S.
at 834. Because the statute makes withdrawal proceedings mandatory under
particular circumstances, we have “law to apply” in determining whether the
agency has complied with the statutory command. See Citizens to Preserve Overton
Park, 401 U.S. at 410. I would therefore hold that even if Heckler’s presumption
against review applies, that presumption is overcome by the statutory text.
I recognize that Congress often affords great discretion to agencies in the
enforcement context, and rightly so. Enforcement decisions often require “a
complicated balancing of a number of factors which are peculiarly within [the
agency’s] expertise,” including the resources available to the agency, the
seriousness of the violation, the likelihood of a successful outcome, and many
others. Heckler, 470 U.S. at 831–32. Nevertheless, Congress also sometimes
decides to constrain agency discretion in order to ensure that its statutory
purposes are fully carried out. Cf. id. at 834–35. As the majority recognizes, there
30
are particularly good reasons to believe that Congress would cabin the FDA’s
discretion in this context: “[G]iven the preeminent importance of health and
safety in the usage of powerful bioactive substances such as human and animal
drugs, it would hardly be surprising for Congress to impose limits on traditional
agency discretion or to mandate actions protective of human safety.” Supra, at
___ (majority slip op. at 53). In my opinion, § 360b(e)(1)(B) does indeed constrain
the FDA’s discretion in order to protect the public from unsafe drugs. I would
therefore affirm the district court’s decision that the agency must proceed to a
hearing on whether to withdraw approval from the subtherapeutic use of
penicillin and tetracyclines in animal feed.
II. The Citizen Petitions
The second issue presented in this case is whether the FDA acted
arbitrarily and capriciously by denying the 1999 and 2005 citizen petitions. Those
petitions asked the FDA to initiate (and conclude) proceedings to withdraw
approval from the subtherapeutic use of medically important antibiotics on
animals. In effect, the petitions asked the FDA to make the same preliminary
finding for all medically important antibiotics that it had already made for
31
penicillin and tetracyclines, and then to move forward on withdrawal
proceedings regarding the subtherapeutic use of all of those antibiotics. The FDA
denied those petitions. In so doing, it did not address the plaintiffs’ scientific
evidence that the subtherapeutic use of medically important antibiotics on
animals was not shown to be safe; instead, the agency said only that it preferred
to employ a voluntary compliance strategy rather than formal withdrawal
proceedings.
The FDA argues that withdrawal proceedings are a form of enforcement
action, and so its refusal to initiate those proceedings is presumptively
unreviewable under Heckler. It further argues that nothing in the statute rebuts
that presumption, because the statute places no limit on the FDA’s discretion
over whether to find that a particular drug is not shown to be safe.
While the majority opinion does not explicitly consider whether
withdrawal proceedings should be characterized as a form of enforcement action,
it implicitly accepts the FDA’s view by analogizing this case to N.Y. Public Interest
Grp. v. Whitman, 321 F.3d 316 (2d Cir. 2003), which dealt with the EPA’s
“discretion to determine whether to engage its formal enforcement mechanism.”
32
Id. at 330. Whitman made clear that its logic was limited to the enforcement
context. Indeed, it relied on Heckler for the proposition that “an agency’s decision
not to invoke an enforcement mechanism provided by statute is not typically
subject to judicial review.” Id. at 331.
I agree with the FDA that if Heckler and Whitman governed this case, then
we could not disturb the agency’s decision to deny the citizen petitions. But
Heckler and Whitman do not govern here, because the withdrawal proceedings
contemplated by § 360b(e)(1)(B) are not a form of agency enforcement action.
Instead, this case falls squarely under the framework established by Massachusetts
v. EPA, 549 U.S. 497 (2007), which forbids an agency from relying on outside
factors in refusing to make a particular statutory determination.
A. Nature of Withdrawal Proceedings
The Supreme Court has never clearly defined what agency actions are
“enforcement” actions within the meaning of Heckler. The prototypical
enforcement action, of course, is an action taken by the agency to punish a past
violation of the law that the agency administers, or to enjoin an ongoing violation
of that law. See Heckler, 470 U.S. at 831 (discussing “an agency’s decision not to
33
prosecute or enforce, whether through civil or criminal process”); see also NRDC
II, 872 F. Supp. 2d at 333 (“[E]nforcement proceedings are traditionally
undertaken upon a finding that an entity has violated an existing regulation or
law.”). In this area, “an agency’s refusal to institute proceedings shares to some
extent the characteristics of the decision of a prosecutor not to indict,” Heckler, 470
U.S. at 832; the agency must weigh its resources and its priorities in determining
whether a particular violator should be pursued. Cf. Whitman, 321 F.3d at 332
(noting the impracticality of requiring the EPA to challenge every violation “no
matter how slight, isolated, or technical”). At the same time, Heckler indicates that
its concept of an “enforcement action” may extend somewhat beyond the
prototypical meaning of the term. In Heckler itself, the plaintiffs asked the FDA
not only “to recommend the prosecution” of those who used certain drugs for
lethal injection, but also (inter alia) “to affix warnings to the labels of [those]
drugs stating that they were unapproved and unsafe for human execution” and
“to send statements to the drug manufacturers and prison administrators stating
that the drugs should not be so used.” 470 U.S. at 824. The Court characterized all
34
of these requests as seeking “investigatory and enforcement actions,” id., even
though the latter two do not directly punish or enjoin any statutory violation.
As it is unclear what qualifies as an “enforcement action,” it is doubly
unclear whether the withdrawal proceedings contemplated by § 360b(e)(1)(B) fall
into that category. These withdrawal proceedings share some characteristics with
a traditional enforcement action; for instance, they envision an adversarial
process, in which the agency attacks the safety of a particular drug and its
sponsor defends it. See 21 U.S.C. § 360b(e)(1); 21 C.F.R. §§ 12.1–.159, 514.201
(describing hearing procedures). And like traditional enforcement actions, they
implicate the agency’s ability to manage its resources and set administrative
priorities. See Heckler, 470 U.S. at 834.
At the same time, withdrawal proceedings are also similar in many ways
to rulemaking proceedings, which we know fall outside the Heckler presumption.
See Massachusetts v. EPA, 549 U.S. at 527–28. First, the FDA “has chosen to utilize
withdrawal proceedings as the primary means of formally regulating approved
drugs,” the function normally served by notice‐and‐comment rulemaking. NRDC
II, 872 F. Supp. 2d at 333. Second, withdrawal proceedings (like approval
35
proceedings) establish a general standard of conduct; they apply to anyone
marketing a drug, not just the drug’s sponsor. Cf. A.L. Pharma, Inc. v. Shalala, 62
F.3d 1484, 1487 (D.C. Cir. 1995) (characterizing the approval of a new animal
drug as a “rule”). They also have only future effect; they can prevent regulated
entities from marketing a previously‐approved drug in the future, but they
cannot punish any past violation of the law. See Attorney General’s Manual on
the Administrative Procedure Act 14 (1947) [hereinafter Attorney General’s
Manual] (“Rule making is agency action which regulates the future conduct of
either groups of persons or a single person . . . . The object of the rule making
proceeding is the implementation or prescription of law or policy for the future,
rather than the evaluation of a respondent’s past conduct.”); see also
id. (contrasting rulemaking with adjudication, which normally involves “a
decision as to whether past conduct was unlawful, so that the proceeding is
characterized by an accusatory flavor and may result in disciplinary action”); 5
U.S.C. § 551(4) (defining a “rule” under the APA in part as an “agency statement
of general or particular applicability and future effect”). Because withdrawal of
approval has only future effect, the FDA must invoke a completely separate set of
36
enforcement procedures in order to enjoin or punish any person who markets a
drug from which approval has been withdrawn. See, e.g., 21 U.S.C.
§ 335b(b)(1)(A) (establishing procedures by which the Secretary may assess a civil
penalty); see also Cutler v. Hayes, 818 F.2d 879, 893 & n.116 (D.C. Cir. 1987)
(distinguishing the “enforceable statutory directive” to withdraw approval for
unsafe drugs under 21 U.S.C. § 355(e) from typical FDA enforcement actions).
Finally, although I “hesitate to place too much significance on the location of a
statute in the United States Code,” Jones v. R.R. Donnelley & Sons Co., 541 U.S. 369,
376 (2004), it is worth noting that the FDCA’s traditional enforcement
mechanisms fall in a different subchapter (titled “Prohibited Acts and Penalties”)
from the substantive regulatory section governing withdrawal proceedings. In
sum, withdrawal proceedings are in many ways “essentially legislative in
nature,” Attorney General’s Manual at 14, rather than essentially enforcement‐
oriented.
Though I recognize the decision is close, I would hold that withdrawal
proceedings under § 360b(e)(1)(B) are not enforcement actions within the
37
meaning of Heckler and Whitman.11 Given that these withdrawal proceedings
resemble rulemaking at least as much as they do enforcement, I think it better to
apply “the strong presumption that Congress intends judicial review of
administrative action,” Bowen, 476 U.S. at 670, rather than the “very narrow
exception” applicable for actions committed to agency discretion by law, Citizens
to Preserve Overton Park, 401 U.S. at 410. That strong presumption seems
particularly appropriate here, where there is every reason to believe that
Congress did not mean to give the FDA unlimited discretion to leave unsafe
drugs on the market for extended periods of time. Cf. Bowen, 476 U.S. at 670
(“[J]udicial review of a final agency action . . . will not be cut off unless there is
persuasive reason to believe that such was the purpose of Congress.” (quoting
Abbott Labs., 387 U.S. at 140)); A.L. Pharma, 62 F.3d at 1487, 1490–92 (reviewing the
FDA’s denial of a citizen petition asking it to withdraw approval of an approved
animal drug); cf. also supra, at ___ (majority slip op. at 53) (recognizing there is
good reason to believe Congress would limit the FDA’s discretion in this sphere
11
We are not called on to decide in this case whether withdrawal proceedings
initiated under the other subsections of 21 U.S.C. 360b(e) are likewise outside the scope
of Heckler and Whitman.
38
“given the preeminent importance of health and safety in the usage of powerful
bioactive substances”).
B. Arbitrary and Capricious Action
Given that the denial of the citizen petitions is subject to judicial review, I
think that Massachusetts v. EPA squarely requires us to hold that denial was
arbitrary and capricious. In Massachusetts v. EPA, the Court addressed a statute
with a discretionary determination that triggered a mandatory consequence:
The Administrator [of the EPA] shall by regulation prescribe . . .
standards applicable to the emission of any air pollutant from any
. . . new motor vehicles or new motor vehicle engines, which in his
judgment cause, or contribute to, air pollution which may
reasonably be anticipated to endanger public health or welfare.
42 U.S.C. § 7521(a)(1). As construed by the Court, that statute gives the
Administrator discretion to determine whether any particular air pollutant
causes or contributes to air pollution that might endanger public health or
welfare. But if the Administrator does judge that a particular air pollutant
endangers public health, then he must prescribe emission standards. See
Massachusetts v. EPA, 549 U.S. at 532–33.
39
A group of concerned organizations filed a citizen petition asking the EPA
to issue regulations governing greenhouse gas emissions from motor vehicles, on
the ground that those emissions endangered public health by causing global
warming. 549 U.S. at 510. The agency responded by refusing to decide whether
greenhouse gas emissions from motor vehicles endangered public health;
instead, it denied the citizen petition based on “a laundry list of reasons not to
regulate,” including its belief that regulating motor vehicle emissions would not
be an effective means of addressing global warming. Id. at 533.
The Court held that the EPA’s action was arbitrary and capricious, because
its reasons for denying the petition were “divorced from the statutory text.” Id. at
532. The statutory provision authorizing the agency to exercise its judgment was
“not a roving license to ignore statutory text,” but only “a direction to exercise
discretion within defined statutory limits.” Id. at 533. Since the discretionary
“judgment” contemplated by the statute asked only whether a particular air
pollutant endangered public health, the EPA could not rely on other
reasons—such as the cost or inefficiency of new regulations—in deciding
whether or not to regulate. Instead, the EPA could only avoid regulating
40
greenhouse gas emissions from motor vehicles if it found that “greenhouse gases
do not contribute to climate change,” or that “the scientific uncertainty is so
profound that it precludes [the agency] from making a reasoned judgment” on
that issue. Id. at 533–34. The agency’s discretion was thus limited to considering
the scientific question described in the statute, not any other factors the agency
might deem relevant. Cf. Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins.
Co., 463 U.S. 29, 43 (1983) (noting that an agency acts arbitrarily and capriciously
if it “has relied on factors which Congress has not intended it to consider”).
Like Massachusetts v. EPA, this case involves a statute that (as I interpret it)
follows a discretionary determination with a mandatory consequence. If the FDA
(in its discretion) determines that a particular drug is not shown to be safe, then it
shall commence (mandatory) withdrawal proceedings. See 21 U.S.C.
§ 360b(e)(1)(B). But just as in Massachusetts v. EPA, the agency’s discretion is
limited to making the determination required by the statute; it cannot refuse to
make that determination just because it would prefer a different regulatory
strategy than the statute specifies.
41
The FDA offers reasons for inaction that are eerily similar to those rejected
by the Court in Massachusetts v. EPA; it complains that withdrawal proceedings
“would take many years and would impose significant resource demands,” and
claims that its voluntary compliance approach will work just as well. Letter from
Leslie Kux, Assistant Acting Commissioner for Policy, FDA, to Sarah Klein,
Center for Science in the Public Interest 3–4 (Nov. 7, 2011). Again, there is some
irony in the FDA’s protestation that withdrawal proceedings could take many
years; the agency failed to respond to the citizen petitions for twelve and six
years, respectively, and its own voluntary compliance strategy contemplates a
three‐year “phase in.” See NRDC II, 872 F. Supp. 2d at 339; Guidance for Industry
# 213, at 9. But that is beside the point. Even if the agency’s reasons were
indisputably sound, they are not contemplated by the statute. Because the FDA
must “exercise [its] discretion within defined statutory limits,” Massachusetts v.
EPA, 549 U.S. at 533, it must respond to the citizen petition by evaluating the
statutory question of whether the drug uses at issue are shown to be safe.
The majority contends that Massachusetts v. EPA is distinguishable because
the statute in that case “unambiguously compelled agency action” and “limited
42
[the agency’s] ‘judgment’ to the scientific question.” Supra, at ___ (majority slip
op. at 58, 60). I respectfully believe that the first distinction is incorrect, and that
the second begs the question.
As for the first: The statute construed in Massachusetts v. EPA was just like
the statute at issue here—part discretionary (as to the agency’s “judgment”), and
part mandatory (as to the ensuing regulation). Indeed, the Court recognized in its
opinion that the EPA was not necessarily required to take any action beyond
adequately responding to the citizen petition. See 549 U.S. at 534–35 (“We need
not and do not reach the question whether on remand EPA must make an
endangerment finding, or whether policy concerns can inform EPA’s actions in
the event that it makes such a finding.”). I do not understand how that can be
read to “unambiguously compel[]” agency action.
As for the second: Nothing in the Clean Air Act explicitly “limited the
EPA’s Administrator’s ‘judgment’ to the scientific question,” supra, at ___
(majority slip op. at 60), any more than 21 U.S.C. § 360b(e)(1)(B) explicitly limits
the FDA’s judgment to the scientific question. See Massachusetts v. EPA, 549 U.S.
at 549–53 (Scalia, J., dissenting). Instead, the question presented in Massachusetts
43
v. EPA was whether the statute implicitly limited the agency’s judgment to the
scientific question, by specifying only that question for the agency’s
consideration. The Court held that it did: although the agency may have
“significant latitude as to the manner, timing, content, and coordination of its
regulations with other agencies, . . . its reasons for action or inaction must
conform to the authorizing statute.” Id. at 533 (majority opinion). Exactly the
same logic applies here: the FDA’s “reasons for action or inaction” must conform
to the authorizing statute, meaning that they must rest on the statutory question
of whether the drugs have been “shown to be safe,” 21 U.S.C. § 360b(e)(1)(B).
Like the EPA with air pollutants, the FDA cannot “choose to regulate only those
[drugs] that it deem[s] feasible or wise to regulate.” Supra, at ___ (majority slip
op. at 59).
The majority apparently believes that the FDA’s approach is permissible
because although the agency regards “the indiscriminate and extensive use of
[medically important antibiotics] in animal feed as threatening, it does not
necessarily believe that the administration of antibiotics to animals in their feed is
inherently dangerous to human health.” Supra, at ___ (majority slip op. at 63). I
44
see no reason why that should matter to our analysis. As the majority recognizes
at the opening of its opinion, antibiotic resistance “presents a serious threat to
human health,” and can result in “longer hospital stays, worse side effects of
treatment, and a greater likelihood of death.” Supra, at ___ (majority slip op. at
3–4). The FDA agrees. See J.A. 405 (reproducing statements from the FDA
website). The agency likewise agrees that the overuse of antibiotic drugs on
livestock can contribute to the development of antibiotic resistance. NRDC II, 872
F. Supp. 2d at 340. This problem, like global warming, is tied to the combined
effects of many small actions. Each individual animal dose of antibiotics may not
endanger human health; but that is no reason to think that Congress gave the
agency discretion to ignore the larger problem.
In any case, the 2005 citizen petition specifically asks the FDA to withdraw
approval from the indiscriminate “herdwide/flockwide” use of these antibiotics.
J.A. 262. If indeed the FDA regards such indiscriminate uses as threatening—or
more precisely, as “not shown to be safe,” 21 U.S.C. § 360b(e)(1)(B)—then it
should withdraw the relevant approvals. At the very least, it should be required
45
to squarely address the scientific issue of whether those uses have been shown to
be safe, which is the sole issue that the statute makes relevant.
Today as in 1977, drug manufacturers have “failed to resolve the basic
safety questions that underlie the subtherapeutic use of [antibiotics] in animal
feed.” Supra, at ___ (majority slip op. at 8) (alteration in original) (quoting
Penicillin NOOH, 42 Fed. Reg. at 43,792); see Tetracycline NOOH, 42 Fed. Reg. at
56,288. In not addressing those safety questions, the FDA has shirked its statutory
responsibilities. I would hold that action was arbitrary and capricious.
III. Conclusion
After thirty‐seven years of delay, the FDA has finally come up with a
strategy for confronting the dangers caused by the subtherapeutic use of
medically important antibiotics on animals. That strategy is to ask
pharmaceutical manufacturers to voluntarily relabel their drugs to prevent these
uses. See Guidance for Industry # 213. Meanwhile, the FDA continues to avoid
the withdrawal procedure contemplated by the statute, claiming that procedure
is too slow and too expensive. “One can only wonder what conceding the
46
absence of an effective regulatory mechanism signals to the industry which the
FDA is obliged to regulate.” NRDC II, 872 F. Supp. 2d at 339 n.23.
I agree with the majority that it is not our duty to judge the wisdom of the
FDA’s approach. But it is emphatically our duty to judge whether the FDA’s
actions conform with the dictates of Congress. For the reasons I have given, I am
convinced that they do not. As I interpret 21 U.S.C. § 360b(e)(1)(B), it requires the
FDA to pursue formal withdrawal proceedings whenever it makes a preliminary
finding that an animal drug is not shown to be safe for its approved use. And
under Massachusetts v. EPA, it also requires the agency to address that
preliminary question based on the scientific evidence available—not based on its
preference for a different regulatory strategy. Whatever the merits of the FDA’s
voluntary compliance strategy, the agency may not escape its statutory
responsibilities “simply by asserting that its preferred approach would be better
policy.” Engine Mfrs. Ass’n v. EPA, 88 F.3d 1075, 1089 (D.C. Cir. 1996).
To be clear, the statute does not restrain the agency from employing other
strategies in tandem with formal withdrawal proceedings. As the district court
below noted, nothing prevents the agency from simultaneously initiating
47
withdrawal proceedings and also seeking voluntary compliance. See NRDC II,
872 F. Supp. 2d at 340. But while the FDA is free to take any additional steps it
thinks are appropriate, it must at least carry out the minimum responsibilities
placed on it by the statute. If the FDA finds those statutory responsibilities are
unmanageable, then it should ask Congress—not us—to provide it with broader
discretion.
Because the majority decides otherwise, I respectfully dissent.
48
NRDC v. US FDA
Combined Opinion