Pub Ctzn Hlth Rsrch v. FDA

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued May 11, 1999 Decided August 6, 1999

No. 98-5161

Public Citizen Health Research Group,
Appellee

v.

Food & Drug Administration,
Appellant in 98-5161

Schering Corporation,
Appellant in 98-5162

Consolidated with
98-5162

Appeals from the United States District Court
for the District of Columbia
(No. 94cv00018)

Marina Utgoff Braswell, Assistant U.S. Attorney, argued
the cause for appellant Food & Drug Administration. With

her on the briefs were Wilma A. Lewis, U.S. Attorney, and
R. Craig Lawrence, Assistant U.S. Attorney.

Bruce N. Kuhlik argued the cause and filed the briefs for
appellant Schering Corporation.

Amanda Frost argued the cause for appellee. With her on
the brief was Brian Wolfman. Lucinda A. Sikes entered an
appearance.

Marjorie E. Powell was on the brief for amicus curiae
Pharmaceutical Research and Manufacturers of America.

Before: Ginsburg, Henderson, and Garland, Circuit
Judges.

Opinion for the Court filed by Circuit Judge Ginsburg.

Opinion concurring in the result filed by Circuit Judge
Garland.

Ginsburg, Circuit Judge: Pursuant to the Freedom of
Information Act, the Public Citizen Health Research Group
asked the Food and Drug Administration for documents
relating to drug applications that had been abandoned for
health or safety reasons. The FDA denied this request and
Public Citizen sued the agency in district court, where Scher-
ing Corporation, which had submitted five investigational new
drug applications (INDs) of the sort requested by Public
Citizen, intervened as a defendant. The FDA and Schering
claimed that certain of the documents in those five INDs
contained confidential commercial information and therefore
could be withheld under Exemption 4 of the FOIA, 5 U.S.C.
s 552(b)(4). Public Citizen argued that the documents could
not be withheld under that exemption and that in any event
disclosure was required under 21 U.S.C. s 355(l), which it
asserted sets a standard for nondisclosure higher than that in
Exemption 4 of the FOIA.

The district court ordered the release of all the disputed
documents on the ground that, although some could be with-
held under Exemption 4, the FDA had not met the higher

standard of s 355(l). We affirm the judgment of the district
court in part, albeit on a different ground, reverse it in part,
and remand the case for further proceedings consistent with
this opinion.

I. Background

Before marketing a new drug in the United States a
manufacturer must obtain the approval of the FDA contin-
gent upon clinical (i.e., human) tests showing that the drug is
safe and effective. See 21 U.S.C. s 355(a), (d). Before a
company may begin clinical testing, however, it must first
submit an IND describing the drug, the results of laboratory
and pre-clinical (i.e., animal) testing, and the proposed clinical
testing. See id. s 355(i). An applicant may begin the pro-
posed clinical testing 30 days after submitting its IND; the
FDA, however, may place the testing on hold at any time.
See 21 C.F.R. ss 312.40(b), 312.42. During clinical testing
the company must update its IND with safety reports, annual
reports on the progress of the testing, any amendments to
the testing protocols, and other information. See id.
ss 312.30-312.33. After clinical testing, the company must
file a new drug application (NDA), which must include infor-
mation about the results of both pre-clinical and clinical
testing; information previously submitted in the IND may be
incorporated by reference into the NDA. See 21 U.S.C.
s 355(b); 21 C.F.R. s 314.50.

This case began when Public Citizen filed a FOIA request
with the FDA for "[a]ll documents concerning pre-clinical and
clinical studies for all prescription drugs which had a discon-
tinuance of the clinical trials because of death or serious
injury of patients or because of safety concerns from preclini-
cal studies ... between January 1, 1990 and [July 12, 1993]."
When the agency denied the request Public Citizen filed suit
in the district court seeking release of the documents.

The FDA moved to dismiss, arguing that although a search
of its database identified 230 INDs for which the agency had
received safety reports and which were either withdrawn,
terminated, or placed on hold by the FDA, it could not

without an unduly burdensome manual search of each file
determine which of these were discontinued "because of"
health or safety concerns. The district court denied the
motion to dismiss, and the agency then determined that 14 of
the 230 INDs were responsive to the FOIA request; of those,
only portions of the five filed by Schering are at issue in this
appeal.

On cross-motions for summary judgment, the district court
first held that the disputed documents in the five INDs could
be withheld under Exemption 4, because they contain "com-
mercial or financial information obtained from a person [that
is] privileged or confidential." 5 U.S.C. s 552(b)(4). Scher-
ing's affidavits demonstrated to the court that disclosure
would "cause substantial harm to [its] competitive position."
National Parks & Conservation Ass'n v. Morton ("National
Parks I"), 498 F.2d 765, 770 (D.C. Cir. 1974). The district
court then held that under 21 U.S.C. s 355(l)(1) the FDA
must nonetheless disclose the same documents absent "ex-
traordinary circumstances." Finding no such circumstances
here, the court granted summary judgment for Public Citizen
and ordered the agency to release the disputed documents.
Both the FDA and Schering appealed to this court.

II. Analysis

The FDA and Schering argue that the agency may under
s 355(l) withhold any data pertaining to the safety and effec-
tiveness of an abandoned drug that it may withhold under
Exemption 4 of the FOIA--in other words, that the standards
in the two statutes are the same. Public Citizen contends
that s 355(l) imposes a more stringent standard for nondis-
closure than that in Exemption 4. We need not resolve this
dispute over the relationship between the two statutes, how-
ever, because we hold that s 355(l) does not apply to INDs.
Viewing the documents solely through the lens of Exemption
4, we conclude that the FDA has justified withholding at least
some information in four of the five INDs.

A. Section 355(l)

Section 355(l) requires the FDA, upon request, to disclose
"[s]afety and effectiveness data and information which has

been submitted in an application under subsection (b) [of
s 355] for a drug" that subsequently was abandoned by its
sponsor, "unless extraordinary circumstances are shown." 21
U.S.C. s 355(l)(1). No one disputes that an "application
under subsection (b)" is an NDA. Schering argues that
s 355(l), therefore, simply does not apply to information in an
IND, which is submitted under subsection (i), not subsection
(b). That is indeed the plain meaning of the provision, and
we cannot understand how "submitted in an application under
subsection (b)" could include anything other than information
submitted in an NDA. Public Citizen's arguments to the
contrary are not convincing.

First, Public Citizen contends that the agency applies
s 355(l) to the disclosure of material submitted in an IND
and that we should accord "substantial weight" to the FDA's
view of its regulatory structure. As Schering notes, however,
the FDA has never promulgated a regulation--nor are we
apprised of any FDA decision or other document--so inter-
preting s 355(l). More important, it is apparent that the
Congress has spoken to "the precise question at issue" here,
Chevron U.S.A. Inc. v. NRDC, 467 U.S. 837, 842-43 & n.9
(1984): s 355(l) by its terms applies only to "safety and
effectiveness data and information" submitted in an NDA.
Therefore, even if the agency had interpreted the phrase
"subsection (b)" in s 355 to include information submitted in
an IND, we could not defer to that interpretation.

Second, Public Citizen argues that to read s 355(l) as
applying only to NDAs is erroneous because "the IND and
NDA are not two distinct stages" in the drug approval
process. In support of this view, Public Citizen points out
that the FDA stores information related to the approval of a
drug in its IND file even after an NDA is submitted. The
fact remains, however, that NDAs and INDs are the subject
of separate subsections of s 355 and the Congress referred
only to one of them in s 355(l). We cannot help but conclude,
therefore, that the statute treats the submission of an NDA
as a discrete event in the drug approval process, regardless
how the FDA maintains its files.

 Third, Public Citizen contends that a plain meaning ap-
proach to s 355(l) leads to an illogical result: data and
information submitted in an IND which later, rather than
being resubmitted in an NDA, are incorporated by reference
into the NDA would not be "submitted in an application
under subsection (b)," that is, an NDA. The FDA and
Schering offer a more sensible view, however: to incorporate
IND materials by reference into an NDA is indeed to submit
those materials as part of the NDA. By the same token, once
those materials are incorporated by reference into an NDA,
their disclosure is subject to the standard in s 355(l) even if
the FDA keeps them in an IND file.

Finally, Public Citizen argues that "[i]t makes no sense to
assume Congress enacted a statute mandating disclosure of
safety and effectiveness data only when the sponsor had filed
an NDA ..., but not when the sponsor had abandoned the
drug earlier in the process." In this regard Public Citizen
points out that the FDA accords the same treatment to such
data regardless whether they were submitted in an NDA or
an IND. Specifically, the FDA by regulation (21 C.F.R.
s 312.130(b)) provides that disclosure of information in an
IND "will be handled in accordance with" the regulation
governing disclosure of information in an NDA (21 C.F.R.
s 314.430(f)).

Nonetheless, when the Congress enacted s 355(l) it did not
mandate disclosure of information in an IND. Moreover,
Schering offers a perfectly sensible explanation why the
Congress did not do so. The Drug Price Competition and
Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98
Stat. 1585, of which s 355(l) was a part, established an
abbreviated process through which a company could obtain
approval to market the generic equivalent of a drug that the
FDA had previously approved on the basis of an NDA. See
Mova Pharm. Corp. v. Shalala, 140 F.3d 1060, 1063-65 (D.C.
Cir. 1998) (describing abbreviated new drug application pro-
cess). The statute, Schering continues, does "not deal with
INDs at all, and Congress had no reason in this legislative
context to extend [s 355(l)] to them." Even if, as Public
Citizen contends, it would be more wise not to treat informa-

tion submitted in an IND differently from information sub-
mitted in an NDA, a matter about which we express no
opinion, the Congress may, of course, approach matters one
step at a time. See FCC v. Beach Communications, Inc., 508
U.S. 307, 316 (1993)

In view of the above analysis, we hold that s 355(l) does
not apply to data and information submitted solely in an IND;
such information may be withheld if the agency carries its
burden under Exemption 4 of the FOIA. Schering did not
file an NDA for four of the five INDs at issue in this case
(which four we consider in Part II.B.1), but concedes that it
filed two NDAs relating to the drug at issue in IND No.
18113. We need not determine the import of Schering's
concession, however, for we conclude (in Part II.B.2) that
documents in that IND cannot be withheld under the alleged-
ly more lenient standard in Exemption 4.

B. Exemption 4

Exemption 4 of the FOIA permits an agency to withhold
"commercial or financial information [that was] obtained from
a person [and is] privileged or confidential." 5 U.S.C.
s 552(b)(4). Information that a person is required to submit
to the Government is considered confidential only if its disclo-
sure is likely either "(1) to impair the Government's ability to
obtain necessary information in the future; or (2) to cause
substantial harm to the competitive position of the person
from whom the information was obtained." National Parks
I, 498 F.2d at 770. In the present case the FDA and
Schering invoke only the latter standard. Meanwhile, Public
Citizen claims disclosure would prevent other drug companies
"from repeating Schering's mistakes, thereby avoiding risk to
human health," and relies upon dicta in several district court
opinions in arguing that under Exemption 4 the court should
gauge whether the competitive harm done to the sponsor of
an IND by the public disclosure of confidential information
"is outweighed by the strong public interest in safeguarding
the health of human trial participants."* See Public Citizen

__________
* Our concurring colleague is of the opinion that Public Citizen
has failed to create a genuine issue of material fact as to whether

Health Research Group v. FDA, 964 F. Supp. 413, 415
(D.D.C. 1997); see also Teich v. FDA, 751 F. Supp. 243, 253
(D.D.C. 1990); AT&T Info. Sys., Inc. v. General Servs. Ad-
min., 627 F.Supp. 1396, 1403 (D.D.C. 1986).

We reject Public Citizen's proposal because a consequen-
tialist approach to the public interest in disclosure is inconsis-
tent with the "[b]alanc[e of] private and public interests" the
__________
disclosure is necessary to safeguard participants in clinical trials,
and therefore that it has not done enough to prevent summary
judgment from being entered against it, even if its view of the law
were correct. See Concur. at 2 & n.1. The record, however, makes
clear that Public Citizen has more than met its burden of raising a
dispute over this fact. The affidavit it submitted to the district
court states:

Defendants' arguments of substantial competitive harm are
disturbing from a public health standpoint because the data we
seek involve experimental drugs that were determined to pose
such serious health or safety risks that clinical testing of the
drug was stopped. ...[B]ecause the safety and effectiveness
data for this experimental drug is being withheld, we cannot
determine whether the FDA adequately protected human sub-
jects in these clinical trials. Defendants will not be competi-
tively harmed from the release of [this information] because
tests that reveal the hazards of a drug are simply not the type
of studies that competitors would want to copy. On the other
hand, the public will benefit significantly from their release.
Indeed, if these studies are kept secret, other drug companies
may unknowingly conduct similarly hazardous studies, poten-
tially placing many patients needlessly at risk.

Similarly, Public Citizen's affiant states: "disclosure ... serves the
public interest in two independent ways. First, it allows the public
to scrutinize FDA's decisions concerning human testing of investi-
gational drugs.... Second, disclosure of safety and effectiveness
data decreases the likelihood that other drug companies will repli-
cate potentially hazardous human testing."

That the FDA claims it has another, more direct, way to prevent
exposure of human beings to this risk, see Op. at 11, merely joins
the dispute on the factual question; it does not resolve it. See
Niagara Mohawk Power Corp. v. DOE, 169 F.3d 16, 18-19 (D.C.
Cir. 1999).

Congress struck in Exemption 4. Critical Mass Energy
Project v. NRC, 975 F.2d 871, 872 (D.C. Cir. 1992) (in banc);
see also FBI v. Abramson, 456 U.S. 615, 621 (1982) (although
FOIA implements policy of broad disclosure, the Congress
also realized "that legitimate governmental and private inter-
ests could be harmed by release of certain types of informa-
tion and provided nine specific exemptions under which dis-
closure could be refused"); see also National Parks I, 498
F.2d at 770 (legislative history of FOIA "firmly supports the
inference that [Exemption 4] is intended for the benefit of
persons who supply information"). That balance is accurately
reflected in the test of confidentiality set forth in National
Parks I, which was "known to and acquiesced in by Con-
gress" when it enacted 5 U.S.C. s 552b(c)(4), an exemption to
the Government in the Sunshine Act that is identical to
Exemption 4 of the FOIA. CNA Fin. Corp. v. Donovan, 830
F.2d 1132, 1153 n.146 (D.C. Cir. 1987) (describing legislative
history of s 552b(c)(4)).

In other words, the Congress has already determined the
relevant public interest: if through disclosure "the public
would learn something directly about the workings of the
Government," then the information should be disclosed unless
it comes within a specific exemption. National Ass'n of
Retired Fed. Employees v. Horner, 879 F.2d 873, 879 (D.C.
Cir. 1989) (emphasis in original). Indeed, Public Citizen's
main reason for seeking this information is to "review wheth-
er the FDA is adequately safeguarding the health of people
who participate in drug trials"; the information sought, in
other words, would reveal "what the[ ] government is up to."
DOJ v. Reporters Comm. for Freedom of Press, 489 U.S. 749,
773 (1989). It is not open to Public Citizen, however, to
bolster the case for disclosure by claiming an additional public
benefit in that, if the information is disclosed, then other drug
companies will not conduct risky clinical trials of the drugs
that Schering has abandoned. That is not related to "what
the[ ] government is up to" and the Court has clearly stated
that "whether disclosure of a ... document ... is warranted
must turn on the nature of the requested document and its
relationship to the basic purpose of the Freedom of Informa-

tion Act to open agency action to the light of public scrutiny
... rather than on the particular purpose for which the
document is being requested." Id. at 772. In other words,
the public interest side of the balance is not a function of the
identity of the requester, see id. at 771, or of any potential
negative consequences disclosure may have for the public,
Washington Post Co. v. HHS, 865 F.2d 320, 327-28 (D.C. Cir.
1989), nor likewise of any collateral benefits of disclosure.

In litigation seeking the release of information under the
FOIA, "the agency has the burden of showing that requested
information comes within a FOIA exemption." Niagara Mo-
hawk Power Corp. v. DOE, 169 F.3d 16, 18 (D.C. Cir. 1999).
Even when the requester files a motion for summary judg-
ment, the Government "ultimately [has] the onus of proving
that the [documents] are exempt from disclosure." National
Ass'n of Gov't Employees v. Campbell, 593 F.2d 1023, 1027
(D.C. Cir. 1978). The burden upon the requester is merely
"to establish the absence of material factual issues before a
summary disposition of the case could permissibly occur."
Id. Accordingly, in order to obtain a summary judgment
Public Citizen need not demonstrate that Schering would
suffer no competitive harm from the release of this informa-
tion; rather, its task is to show that there is no dispute about
an issue of fact material to the FDA's burden of demonstrat-
ing that Schering would suffer substantial competitive harm
from the disclosure of its INDs. See National Parks I, 498
F.2d at 770.

1. IND Nos. 35757, 34465, 31911, and 30647

For the reasons stated in the opinion of the district court,
997 F. Supp. at 63-64, we agree with the FDA and Schering
that under Exemption 4 the agency may withhold information
in the four INDs listed above. Release of that information
would cause substantial harm to Schering's competitive posi-
tion.

With respect to the first three INDs, Public Citizen con-
tends that releasing health and safety information would only
"save Schering's competitors the time Schering spent devel-
oping and testing a dangerous drug, and thus save human

trial participants from being exposed to a dangerous drug."
According to Public Citizen, that "cannot be considered the
type of 'competitive harm' justifying withholding of the docu-
ments under Exemption 4."

Having already rejected Public Citizen's argument that any
collateral benefit from the disclosure of information--that is,
any benefit beyond learning "what the[ ] government is up
to"--must be weighed against the competitive harm that
would result from disclosure, we do not consider Public
Citizen's assertion that disclosure would in fact prevent the
exposure of human beings to a health risk. In any event, as
both the FDA and Schering point out, were a competitor to
submit an IND involving a risk known to the FDA because of
its experiences with Schering's INDs, the agency could and
presumably would refuse to permit that company to begin
clinical testing.

We turn therefore to Schering's evidence of competitive
harm from disclosure of these three INDs, all of which relate
to the same antifungal drug. According to the affidavit of its
Dr. George H. Miller, the Company "has just commenced
clinical testing on a successor [drug] which was designed
based on information learned during development of [the
drugs described in those INDs]." Further, Dr. Miller states
that "Schering's basic research revealed that the particular
type of fungal infection for which this product was designed
was not one that was relatively well-controlled by existing
products." He also states that "[t]he development and mar-
keting of new antifungal products is ... being actively en-
gaged in by a number of other drug companies," which could
make use of the information in the INDs in order to eliminate
much of the time and effort that would otherwise be required
to bring to market a product competitive with the product for
which Schering filed its most recent IND. This is clearly the
type of competitive harm envisioned in Exemption 4, as our
case law makes clear. See, e.g., National Parks & Conserva-
tion Ass'n v. Kleppe ("National Parks II"), 547 F.2d 673, 684
(D.C. Cir. 1976) ("Disclosure would provide competitors with
valuable insights into the operational strengths and weak-
nesses of a [company], while [its competitors] could continue

in the customary manner of 'playing their cards close to their
chest' "); cf. Webb v. HHS, 696 F.2d 101, 103 (D.C. Cir. 1982)
("If a manufacturer's competitor could obtain all the data in
the manufacturer's NDA, it could utilize them in its own NDA
without incurring the time, labor, risk, and expense involved
in developing them independently").

The fourth IND listed above concerned a drug "designed to
suppress allergic inflammations and subsequent symptoms of
asthma." Public Citizen concedes that Schering is now test-
ing compounds related to the abandoned drug. Nonetheless,
Public Citizen complains that the Company does not "explain
with any specificity how the pre-clinical and clinical studies on
the old compound would lead its competitors to the new
compounds that Schering has subsequently identified."

In the affidavit Schering filed to support withholding the
documents in this IND, Dr. Francis Cuss recounts that the
Company initially believed the drug was a "leukotrine inhibi-
tor," but that its "scientists observed certain unanticipated
effects during toxicity and clinical testing .... suggest[ing]
that the drug may have achieved its anti-inflammatory effects
through a [different] mechanism." Therefore, states the affi-
ant, the "toxicity and clinical data together could direct a
competitor of Schering .... to pursue the the same avenues
of research and development" that Schering has pursued
since abandoning this IND. We think this explanation suffi-
ciently specific to support Schering's argument that disclo-
sure of information in this IND would cause it substantial
competitive harm.

Accordingly, we reverse that portion of the district court's
order requiring the agency to release the documents in these
four INDs. See Critical Mass, 975 F.2d at 880.

2. IND No. 18113

We turn now to the documents in the fifth IND, which
involved "one of four isomers making up a prescription medi-
cine currently marketed by Schering and indicated for use in
controlling blood pressure in cases of severe hypertension."
We find that Schering's affidavit professing the extent of

competitive injury it would suffer from disclosure of the
information in this IND is not sufficient to support its motion
for summary judgment; indeed, it fails to raise a dispute as
to any material issue of fact. Summary judgment for Public
Citizen is therefore indicated.

The affidavit of Schering's Dr. Ronald J. Garutti contains
only conclusory assertions that disclosure would cause sub-
stantial competitive harm. For example, the affiant states
that disclosure "would reveal substantial basic research" as
well as "disease models ... that have been developed by
Schering at a great expense," and that "[t]oxicology data ...
have significant value beyond the compound under investiga-
tion .... [and would be applicable] to any drug product any
of whose metabolites were identical or similar to those of
IND 18113 .... [and] other drugs [of] a similar chemical
type." Dr. Garutti attests that the clinical protocols also
"have applicability beyond the specific drug being tested" and
that disclosure "would have substantial commercial value to
any company attempting to develop cardiovascular therapies
generally." The arguments in Schering's brief are even more
general: disclosure would reveal its "assessment of regulato-
ry requirements and its experience with FDA in this area, as
well as [its] judgment as to what requirements will be neces-
sary in order to establish the drug's safety and effectiveness."

Although a party opposing a motion for summary judgment
is entitled to every favorable inference that may fairly be
drawn from its affidavits, see Greenberg v. FDA, 803 F.2d
1213, 1216 (D.C. Cir. 1986), such "[c]onclusory and general-
ized allegations of substantial competitive harm ... cannot
support an agency's decision to withhold requested docu-
ments." Public Citizen Health Research Group v. FDA, 704
F.2d 1280, 1291 (D.C. Cir. 1983). Accordingly, we hold that
the agency may not withhold the disputed documents in IND
No. 18113 under Exemption 4. We therefore affirm that
portion of the district court's order requiring the agency to
release them to Public Citizen, albeit for a different reason.

C. Segregability

In view of our holding that the agency may, under Exemp-
tion 4, withhold information in four of the INDs, we turn to

Public Citizen's alternative request that we remand the case
for the district court to determine whether any non-exempt
portions of the documents that the agency may withhold can
be segregated and disclosed. Public Citizen contends that
the district court did not have occasion to make this determi-
nation because it required disclosure of all the records.
Schering responds that the district court did not do so
because Public Citizen never asked for, and therefore waived,
such relief, and that segregation would in any event be
"unreasonable" in this case.

From the record we see that Public Citizen did raise this
issue before the district court in its Reply in Support of its
Cross-Motion for Summary Judgment. In any event, on
remand it would be incumbent upon the district court on its
own initiative to address the issue of segregability. See
Trans-Pacific Policing Agreement v. United States Customs
Serv., 177 F.3d 1022, 1028 (D.C. Cir. 1999). One should
normally presume that a request for information under the
FOIA is a request for all or any, not for all or none, of the
information described. Cf. National Mining Ass'n v. Babbitt,
172 F.3d 906, 910 (D.C. Cir. 1999) (factual presumption is
reasonable when "the circumstances giving rise to the pre-
sumption ... make it more likely than not that the presumed
fact exists").

In view of the district court's disposition of this case, of
course, it had no need to address the issue of segregability
the first time around and we do not fault it for passing over
the issue then. We have now held, however, that information
in four of the five INDs at issue may be withheld. Because
"[t]he focus in the FOIA is information, not documents, and
an agency cannot justify withholding an entire document
simply by showing that it contains some exempt material," we
remand this case for the district court to determine whether
the documents the agency has withheld contain information
that can be segregated and disclosed. Schiller v. NLRB, 964
F.2d 1205, 1209-10 (D.C. Cir. 1992). In so doing, we express
no opinion upon Schering's claim that segregation is impracti-
cable in this case.

 III. Summary and Conclusion

For the foregoing reasons, we hold first that s 355(l)
applies only to information submitted in an NDA. In addi-
tion we hold that the FDA has not met its burden under
Exemption 4 with respect to, and therefore must disclose, the
information contained in IND No. 18113; and that the agency
has met its burden under Exemption 4 with respect to, and
therefore need not disclose, confidential information contained
in IND Nos. 35757, 34465, 31911, and 30647. As to the latter
four INDs, we remand the case for the district court to
determine in the first instance whether there is any non-
confidential information that can be segregated and disclosed.

So ordered.

 Garland, Circuit Judge, concurring in the result: Today
the court exercises appropriate discretion in declining to
decide whether section 355(l) and FOIA Exemption 4 are
congruent, because it is unnecessary to do so to resolve the
dispute before us. I believe the court errs, however, in not
exercising similar restraint with respect to an issue regarding
the meaning of Exemption 4 itself.

My colleagues hold that in determining whether a docu-
ment comes within Exemption 4, the court may not "gauge
whether the competitive harm" disclosure would cause to the
company that submitted the document "is outweighed by the
public interest in safeguarding" human health. Op. at 7-8.
This means that even if disclosure were the only way to
prevent the loss of human life, that would count for nothing
as against a showing by the company that disclosure would
cause substantial harm to its competitive position. See id. at
11 ("[W]e do not consider Public Citizen's assertion that
disclosure would in fact prevent the exposure of human
beings to a health risk."). This is an important issue, and the
kind that should be decided only after full briefing and
argument. See, e.g., Carducci v. Regan, 714 F.2d 171, 177
(D.C. Cir. 1983).

But we have not had that here. As the argument heading
of Public Citizen's brief makes clear, its core Exemption 4
argument was that the requested records "Do Not Constitute
Confidential Commercial Information." Public Citizen Br. at
31. In a single clause in a single sentence of that brief,
Public Citizen also said: "Any disadvantage to Schering is
minimal, and is outweighed by the strong public interest in
safeguarding the health of human trial participants." Id. at
34 (emphasis added). Schering replied in kind. In a single
clause in a single sentence of its reply brief (and without
citation), Schering said: "This enterprise [pharmaceutical re-
search] has well-served the public health through the discov-
ery and development of new medicines and should not, in
effect, be reorganized to suit Public Citizen's views through
an unprecedented and strained reading of exemption 4."
Schering Reply Br. at 6 (emphasis added). The italicized
phrases are the full extent of the argument we have heard on

this issue. The FDA did not mention the point at all; the
parties did not discuss it at oral argument; and the district
judge did not refer to it in his opinion.

Nor is this an issue we must decide in order to dispose of
this case. Even if a balancing of the public safety interest in
disclosure were an element of Exemption 4, and even if Public
Citizen had intended to raise the point, the conclusory asser-
tion the court cites is insufficient to prevent the entry of
summary judgment in favor of the FDA. As we have said
many times before, "[i]t is well settled that [c]onclusory
allegations unsupported by factual data will not create a
triable issue of fact." Exxon Corp. v. FTC, 663 F.2d 120,
126-27 (D.C. Cir. 1980) (internal quotation omitted); see
Alyeska Pipeline Serv. Co. v. EPA, 856 F.2d 309, 313-14
(D.C. Cir. 1988); Gardels v. CIA, 689 F.2d 1100, 1106 (D.C.
Cir. 1982); Military Audit Project v. Casey, 656 F.2d 724, 749
(D.C. Cir. 1981).1

Nor is this a case where the legal conclusion the court has
reached is indisputable. To the contrary, although no party
cited the relevant precedent on this point, we have twice held
that Exemption 4 requires a balancing of the interest in
nondisclosure "against the public interest in disclosure." See
Washington Post Co. v. HHS, 690 F.2d 252, 269 (D.C. Cir.

__________
1 The court notes that in addition to the single conclusory
statement in its brief, Public Citizen also mentioned the point in an
affidavit filed in district court. Op. at 8 n.*. But as my colleagues'
recitation of statements from the affidavit makes clear, that mention
is confined to a total of three sentences in that 12-page document.
See JA 312 (opining that "the public will benefit significantly from
their release" and that "if these studies are kept secret, other drug
companies may unknowingly conduct similarly hazardous studies,
potentially placing many patients needlessly at risk") (emphasis
added); id. at 309 (alleging that disclosure "decreases the likelihood
that other drug companies will replicate potentially hazardous hu-
man testing"). As the cases cited in the text above indicate, these
conclusory statements of affiant opinion are insufficient to defeat a
motion for summary judgment. See also 10B Wright, Miller &
Kane, Federal Practice & Procedure s 2738, at 346-56 (3d ed.
1998).

1982) (Washington Post I); Washington Post Co. v. HHS, 865
F.2d 320, 326-27 (D.C. Cir. 1989) (Washington Post II).
Washington Post I involved an analysis of Exemption 4 under
the "impairment" prong of the National Parks test for confi-
dential information.2 We held that "[t]his inquiry necessarily
involves a rough balancing of the extent of impairment and
the importance of the information against the public interest
in disclosure." Washington Post I, 690 F.2d at 269. Rather
than decide "the details of the balancing process," we re-
manded the case to the district court. Id. When the case
later returned to us, we concluded that the interest the
government asserted in nondisclosure--impairment of its
information-gathering ability--had not been appropriately re-
solved. We therefore remanded the case again, instructing
that "if the district court ultimately finds that disclosure will
impair the government's information-gathering, it will once
again be required to conduct the 'rough balancing of the
extent of impairment and the importance of the information
against the public interest in disclosure.' " Washington Post
II, 865 F.2d at 326-27 (quoting Washington Post I, 690 F.2d
at 269). And we made clear that "the only inquiry properly
before the district court was the question whether disclosure
of the financial information ... would be likely to impair the
government's ability to gather this information in the future,
and if so whether this risk outweighed the public's interest in
disclosure." Id. at 324-25 (emphasis added).3

__________
2 Under the test employed in National Parks & Conservation
Ass'n v. Morton, 498 F.2d 765, 770 (D.C. Cir. 1974), "commercial or
financial matter is 'confidential' for purposes of the exemption if
disclosure of the information is likely to have either of the following
effects: (1) to impair the Government's ability to obtain necessary
information in the future; or (2) to cause substantial harm to the
competitive position of the person from whom the information was
obtained." Nothing in the reasoning of Washington Post I sug-
gests that the public interest balancing it requires for prong (1) is
not also required for prong (2).

3 See also Martin v. Lauer, 686 F.2d 24, 33 (D.C. Cir.1982) ("A
decision whether to release FOIA-exempt material ... requires a
considered balancing of the public's interest in disclosure of particu-

 None of the cases cited by the court holds that the public
safety interest in disclosure should not be weighed in apply-
ing FOIA Exemption 4. Certainly Reporters Committee does
not. See United States Dep't of Justice v. Reporters Comm.
for Freedom of the Press, 489 U.S. 749, 773 (1989). In that
case there was no question but that a balancing test was
required with respect to Exemption 7(C), id. at 776; the
question was what interests could be weighed in the balance.
The Supreme Court held that FOIA does not protect an
interest in "disclosure of information about private citizens
that is accumulated in various governmental files but that
reveals little or nothing about an agency's own conduct." Id.
at 773. But as my colleagues recognize, the Court also held
that an interest in "[o]fficial information that sheds light on
an agency's performance of its statutory duties falls squarely
within that statutory purpose" and may be weighed in the
balance. Id.

Unlike the information sought in Reporters Committee, the
information Public Citizen seeks may reveal much about "an
agency's performance of its statutory duties." All of the
records sought pertain to clinical trials that could not have
proceeded without FDA authorization, and that "were discon-

__________
lar material and the interests in nondisclosure acknowledged by the
statutory exemptions."). The Ninth Circuit has followed our ap-
proach, see GC Micro Corp. v. Defense Logistics Agency, 33 F.3d
1109, 1115 (9th Cir. 1994) ("We agree with the D.C. Circuit that, in
making our determination [of competitive harm under Exemption
4], we must balance the strong public interest in favor of disclosure
against the right of private businesses to protect sensitive informa-
tion."), as has our own district court, see Public Citizen Health
Research Group v. FDA, 964 F. Supp. 413, 415 (D.D.C. 1997) (citing
Teich v. FDA, 751 F. Supp. 243, 253 (D.D.C. 1990); AT&T Info.
Sys., Inc. v. General Servs. Admin., 627 F. Supp. 1396, 1403 (D.D.C.
1986)). See also 1 James T. O'Reilly, Federal Information Disclo-
sure s 14.12, at 14-44 (2d ed. 1990) ("In some cases the public need
for the information is factored by the court into its equation of
substantial competitive harm.... For example, public health and
safety factors may warrant more attention to the substantial harm
equation....").

tinued ... because of death or serious injury of patients."
FDA Br. at 2 (describing Public Citizen's FOIA request).
Disclosure assertedly will reveal "whether the FDA is ade-
quately analyzing data submitted in INDs before allowing
human testing to begin and whether safety problems uncov-
ered in clinical trials result in prompt cessation of those
trials." Public Citizen Br. at 5. That would certainly permit
the public to "learn something directly about the workings of
the Government." Op. at 9 (quoting National Ass'n of
Retired Fed. Empoyees v. Horner, 879 F.2d 873, 879 (D.C.
Cir. 1989)). Yet, in evaluating the government's Exemption 4
claims, the court makes no effort to determine how important
to the public interest learning such information would be,4 or
to weigh it against the injury Schering would suffer from
disclosure. Instead, the court ends its analysis upon finding
"that disclosure of information in this IND would cause
[Schering] substantial competitive harm." Id. at 12.

I cannot dispute my colleagues' conclusion that the briefs'
brief mention of this issue gives us the discretion to decide it.
But that is "not to say that affirmative exercise of the
discretion [is] wise." Fraternal Order of Police v. United
States, 173 F.3d 898, 903 (D.C. Cir. 1999), reconsidering
Fraternal Order of Police v. United States, 152 F.3d 998
(D.C. Cir. 1998). Deciding an issue in the absence of any
substantive briefing may later make us wish that we had

__________
4 One, but only one, of the elements of the public interest
asserted by Public Citizen is that disclosure would "save human
trial participants from being exposed to a dangerous drug" by
keeping other drug companies from replicating Schering's "hazard-
ous human testing." Op. at 10-11, 8 n.* (quoting Public Citizen).
As noted above, on the current record this is only a conclusory
allegation. But if in fact the FDA has not already protected human
trial participants directly by barring authorization for such replicat-
ed studies, disclosure of Schering's studies will reveal that fact (to
the drug companies, trial participants, their physicians, and other
knowledgeable members of the public). By thus revealing the
FDA's failure to "perform[ ] its statutory duties," Reporters Com-
mittee, 489 U.S. at 773, disclosure may enable the public to protect
itself.

waited. See id. ("In retrospect, it may well have been
imprudent to address the merits on so thin an argumentative
record."). For that reason, I would "decline to resolve this
issue on the basis of briefing which consisted of [not even]
three sentences in the ... brief and no discussion of the ...
relevant case law." Railway Labor Executives' Ass'n v.
United States R.R. Retirement Bd., 749 F.2d 856, 859 n.6
(D.C. Cir. 1984) (citing Carducci, 714 F.2d at 717); see
Washington Legal Clinic for the Homeless v. Barry, 107 F.3d
32, 39 (D.C. Cir. 1997).