Abigail Alliance for Better Access to Developmental Drugs & Washington Legal Foundation v. Von Eschenbach

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United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued October 21, 2005 Decided May 2, 2006

No. 04-5350

ABIGAIL ALLIANCE FOR BETTER ACCESS TO
DEVELOPMENTAL DRUGS AND
WASHINGTON LEGAL FOUNDATION,
APPELLANTS

v.

ANDREW C. VON ESCHENBACH, M.D.,
IN HIS OFFICIAL CAPACITY AS ACTING COMMISSIONER,
FOOD AND DRUG ADMINISTRATION AND
MICHAEL O. LEAVITT,
IN HIS OFFICIAL CAPACITY AS SECRETARY,
U.S. DEPT. OF HEALTH AND HUMAN SERVICES,
APPELLEES

Appeal from the United States District Court
for the District of Columbia
(No. 03cv01601)

James S. Ballenger argued the cause for appellants. With
him on the briefs were Daniel J. Popeo and David Price.
 2

Richard A. Samp entered an appearance.

Rhonda C. Fields, Assistant U.S. Attorney, argued the cause
for appellee. With her on the brief were Kenneth L. Wainstein,
U.S. Attorney, Michael J. Ryan, Assistant U.S. Attorney, Eric
M. Blumberg, Deputy Chief Counsel, U.S. Department of Health
and Human Services, and Karen E. Schifter, Associate Chief
Counsel. R. Craig Lawrence, Assistant U.S. Attorney, entered
an appearance.

Before: GINSBURG, Chief Judge, and ROGERS and GRIFFITH,
Circuit Judges.

Opinion for the Court filed by Circuit Judge ROGERS.

Dissenting opinion filed by Circuit Judge GRIFFITH.

ROGERS, Circuit Judge: The Abigail Alliance for Better
Access to Developmental Drugs (“the Alliance”) seeks to enjoin
the Food and Drug Administration (“FDA”) from continuing to
enforce a policy barring the sale of new drugs that the FDA has
determined, after Phase I trials on human beings, are sufficiently
safe for expanded human testing (hereafter “post-Phase I
investigational new drugs”). More specifically, the Alliance
seeks access to potentially life-saving post-Phase I
investigational new drugs on behalf of mentally competent,
terminally ill adult patients who have no alternative government-
approved treatment options (hereafter “terminally ill patients”).
The Alliance contends that the FDA’s policy violates the
substantive due process rights to privacy, liberty, and life of its
terminally ill members. The complaint presents the question of
whether the Due Process Clause protects the right of terminally
ill patients to decide, without FDA interference, whether to
assume the risks of using potentially life-saving investigational
new drugs that the FDA has yet to approve for commercial
 3

marketing but that the FDA has determined, after Phase I
clinical human trials, are safe enough for further testing on a
substantial number of human beings.

Upon applying the Supreme Court’s test for addressing
substantive due process claims set forth in Washington v.
Glucksberg, 521 U.S. 702, 710 (1997), we hold that the district
court erred in dismissing the Alliance’s complaint pursuant to
Federal Rule of Civil Procedure 12(b)(6) for failure to state a
claim. First, the right at issue, carefully described, is the right
of a mentally competent, terminally ill adult patient to access
potentially life-saving post-Phase I investigational new drugs,
upon a doctor’s advice, even where that medication carries risks
for the patient. Second, we find, upon examining “our Nation’s
history, legal traditions, and practices,” Glucksberg, 521 U.S. at
710, that the government has not blocked access to new drugs
throughout the greater part of our Nation’s history. Only in
recent years has the government injected itself into consideration
of the effectiveness of new drugs. Third, Supreme Court
precedent on liberty indicates that the right claimed by the
Alliance can be inferred from the Court’s conclusion in Cruzan
v. Director, Missouri Department of Health, 497 U.S. 261, 278
(1990), that an individual has a due process right to refuse life-
sustaining medical treatment, id. at 279. Here, the claim
implicates a similar right — the right to access potentially life-
sustaining medication where there are no alternative
government-approved treatment options. In both instances, the
key is the patient’s right to make the decision about her life free
from government interference.

Because the question remains whether the FDA’s
challenged policy has violated that right, we reverse the
dismissal of the Alliance’s complaint and remand the case to the
district court to determine whether the FDA’s policy “is
narrowly tailored to serve a compelling [governmental]
 4

interest.” Glucksberg, 521 U.S. at 721 (quoting Reno v. Flores,
506 U.S. 292, 302 (1993)).

In Part I, we set forth the background to this appeal. In Part
II, we examine Supreme Court precedent indicating how
substantive due process rights are to be discerned. So guided,
we consider, in Part III, whether the Alliance’s claimed right
warrants protection under the Due Process Clause.

I.

A.
The Food, Drug, and Cosmetic Act (“FDCA”), Pub. L. No.
75-717, §§ 1-902, 52 Stat. 1040 (1938) (codified as amended at
21 U.S.C. § 301 et seq. (2000)), prohibits drug manufacturers
from introducing any “new drug” into interstate commerce until
manufacturers have applied for, and received, FDA approval.
21 U.S.C. § 355(a). A “new drug” is any substance covered by
the FDCA not “generally recognized, among experts . . . as safe
and effective for use under the conditions prescribed . . . in the
labeling.” 21 U.S.C. § 321(p)(1); see also United States v. 50
Boxes More or Less, 909 F.2d 24 (1st Cir. 1990). Before a new
drug is eligible for full approval and marketing, the Secretary of
the U.S. Department of Health and Human Services must find
“substantial evidence that the drug will have the effect it
purports or is represented to have.” 21 U.S.C. § 355(d).
Exempted from this general ban are new drugs “intended solely
for investigational use by experts . . . .” Id. § 355(i)(1).

The FDCA directs the Secretary to promulgate regulations
for testing new drugs. Id. Pursuant to this authority, the FDA
has promulgated regulations that require three phases of
government testing on humans before investigational new drugs
can receive FDA approval and enter the commercial
marketplace. In Phase I, new drugs are tested on 20 to 80
 5

human subjects to determine “the side effects associated with
increasing doses, and, if possible, to gain early evidence on
effectiveness.” 21 C.F.R. § 312.21(a). It takes approximately
one year to conduct Phase I testing.1 FDA counsel
acknowledged at oral argument that drugs that survive this phase
have been deemed “sufficiently safe for substantial human
testing, but [are] not yet proven to be safe and effective to the
satisfaction of the FDA [to be commercially marketed].” Oral
Argument Tape of Oct. 21, 2005 at 15:57-15:59. Phase II
involves targeted, controlled clinical studies of up to several
hundred human subjects “to evaluate the effectiveness of the
[Phase I investigational new] drug . . . and to determine the
common short-term side effects and risks associated with the
drug.” 21 C.F.R. § 312.21(b). Phase III expanded trials, which
can include several thousand human subjects, are “performed
after preliminary evidence suggesting effectiveness of the drug
has been obtained, and are intended to gather the additional
information about effectiveness and safety that is needed to
evaluate the overall benefit-risk relationship of the drug . . . .”
Id. § 312.21(c). With narrow exceptions, FDA regulations
require informed consent to be obtained from clinical trial
participants. Id. §§ 50.1-50.27.

B.
On January 16, 2003, the Alliance submitted a proposal to
the FDA for new regulations to render post-Phase I
investigational new drugs available to terminally ill patients who
were not admitted to the FDA’s clinical trials. The FDA
rejected the proposal by letter dated April 25, 2003, outlining the
FDA’s policy. On June 11, 2003, Alliance filed a Citizen
Petition, pursuant to 21 C.F.R. § 10.30, challenging the FDA’s

1
See Alison R. McCabe, A Precarious Balancing Act—The
Role of the FDA as Protector of Public Health and Industry Wealth,
36 SUFFOLK U. L. REV. 787, 790 n.26 (2003).
 6

policy barring the sale of investigational new drugs that have
successfully completed Phase I trials to terminally ill patients
not selected for clinical trials. The FDA acknowledged receipt
of the Citizen Petition but otherwise did not respond within 180
days, thereby entitling the Alliance to seek judicial review of the
challenged policy. See id. § 10.30(e)(2).

The Alliance filed suit against the FDA Commissioner and
the Secretary of the Department of Health and Human Services,
seeking to enjoin the FDA from enforcing the policy barring the
sale of post-Phase I investigational new drugs to terminally ill
patients not in Phase II clinical trials. Noting that the FDA has
administrative discretion to define several stages for human
testing of new drugs after animal testing has been conducted, the
complaint alleges that it takes, on average, just under seven
years for investigational new drugs to complete the three phases
of clinical human trials and receive FDA approval for
commercial marketing and thus become eligible for purchase by
persons not in FDA clinical trials. Compl. ¶ 12.2 The complaint
also alleges that non-commercial options provide relief only to
a very small number of terminally ill patients as spaces in
clinical trials are “very limited . . . in relation to the need.”
Compl. ¶ 15. The Alliance asserts that clinical human trials are
limited in number and by type of patient who qualifies. Further,
the FDA’s “compassionate use” programs, which permit drug
companies voluntarily to provide new drugs at cost during the
pre-approval period, are available only to “a fraction of those in
desperate need.” Id. Although the FDA may permit “treatment
use” of unapproved new drugs, see 21 C.F.R. § 312.34 (1999),
and has allowed access for limited groups of persons with

2
See also Christopher P. Adams & Van V. Brantner, New
Drug Development: Estimating Entry from Human Clinical Trials 9
( J u l y 7 , 2 0 0 3 ) , a v a i l a b l e a t
http://www.ftc.gov/be/workpapers/wp262.pdf.
 7

AIDS,3 the FDA has refused as a general matter to allow
terminally ill patients to have access to investigational new
drugs that have successfully completed Phase I trials.
Consequently, the complaint alleges, the effect of the FDA
policy, as illustrated by the examples of the deaths of four
terminally ill patients, has been to deny terminally ill patients
the choice to use post-Phase I investigational new drugs despite
the patients’ willingness “to assume risks if their physicians
advise them that a treatment may save or prolong their lives and
if they have no other viable options.” Compl. ¶¶ 16, 18. Prior
to discovery, the FDA moved to dismiss the complaint, and,
alternatively, for summary judgment. The Alliance responded
by filing an opposition and its own motion for summary
judgment.

The district court dismissed the complaint pursuant to Rule
12(b)(6) for failure to state a claim. The court rejected the
Alliance’s argument that it sought no “new” right but only
recognition and enforcement of the right to life that is explicitly
guaranteed by the Due Process Clause, observing that no court
decision has “extended the Due Process Clause to cover a
terminally ill patient’s right to receive medical treatment.”
Mem. Op. of Aug. 30, 2004, at 18 (emphasis deleted). Although
acknowledging “the Nation’s longstanding legal tradition . . . to
attempt to preserve life,” id., the district court stated that in
Glucksberg, the Supreme Court had distinguished some
“personal” decisions from others, 521 U.S. at 727, and that the
Alliance could not “possibl[y] claim that the specific right
claimed has a long-standing tradition.” Mem. Op. at 18. The
district court also rejected the Alliance’s argument that the
Supreme Court’s recognition in Cruzan of the right to choose

3
See Michael D. Greenberg, AIDS, Experimental Drug
Approval, and the FDA New Drug Screening Process, 3 N.Y.U. J.
LEGIS. & PUB. POL’Y 295, 315-20 (1999-2000).
 8

death by refusing medical treatment implied a complementary
right to choose life by obtaining potentially life-saving
medication. In the district court’s view, the Alliance sought
recognition of “an entirely different sort of right [from that
recognized in Cruzan] — not freedom from government
imposition, but an affirmative right of access to medical
treatment.” Id. at 19. In the absence of due process protection
for terminally ill patients seeking access to potentially life
saving post-Phase I drugs, the district court concluded that the
challenged FDA policy is rationally related to a legitimate
governmental interest.

The Alliance appeals, and our review is de novo.4 See
Cicippio-Puleo v. Islamic Republic of Iran, 353 F.3d 1024,
1031-32 (D.C. Cir. 2004). We treat the dismissal of the
complaint as occurring pursuant to Rule 12(b)(6),
notwithstanding the district court’s consideration of the FDA’s
April 23, 2003 letter because the letter’s conclusion was alleged
in the complaint and the FDA does not dispute its contents. See
Gryl ex rel. Shire Pharms. Group PLC v. Shire Pharms. Group
PLC, 298 F.3d 136, 140 (2d Cir. 2002); Pryor v. Nat’l
Collegiate Athletic Ass’n, 288 F.3d 548, 560 (3d Cir. 2002)
(citing 62 Fed. Proc. L. Ed. § 62:508). Cf. Settles v. United
States Parole Comm’n, 429 F.3d 1098, 1107 (D.C. Cir. 2005).

A court should not dismiss a complaint pursuant to Rule
12(b)(6) for failure to state a claim “unless it appears beyond
doubt that the plaintiff can prove no set of facts in support of his
claim which would entitle him to relief.” Conley v. Gibson, 355
U.S. 41, 45-46 (1957); Warren v. District of Columbia, 353 F.3d
36, 37 (D.C. Cir. 2004). In determining the sufficiency of the

4
The Washington Legal Foundation is also a named
appellant, but conceded at oral argument that it lacked Article III
standing.
 9

complaint, this court reviews questions of law de novo while
treating the complaint’s factual allegations as true and granting
the plaintiff the benefit of all reasonable inferences from the
facts alleged. See Conley, 351 U.S. at 45-46; Sparrow v. United
Air Lines, Inc., 216 F.3d 1111, 1114 (D.C. Cir. 2000).

II.

The Due Process Clause of the Fifth Amendment to the
United States Constitution provides that “[n]o person shall be .
. . deprived of life, liberty, or property, without due process of
law.” U.S. CONST. AMEND. V. The Supreme Court has held
that the Clause “guarantees more than fair process” and accords
substantive protection to the rights it guarantees. See Troxel v.
Granville, 530 U.S. 57, 65 (2000) (plurality opinion);
Glucksberg, 521 U.S. at 719; Flores, 507 U.S. at 301-02.
Substantive due process claims can present difficulties for
courts. See Michael H. v. Gerald D., 491 U.S. 110, 121 (1989)
(plurality opinion); Moore v. City of East Cleveland, 431 U.S.
494, 502 (1977). In a case of first impression where
fundamental rights may be at stake, determining the limits of the
government’s authority over an individual’s freedom to make
certain personal decisions unavoidably entails a careful and
possibly arduous assessment of that personal decision’s
objective characteristics in order to determine whether it
warrants protection under the Due Process Clause. Cf. Roberts
v. U.S. Jaycees, 468 U.S. 609, 620 (1984). Nonetheless, the
district court appears to have viewed its role as unduly
constrained. Pointing to an advisory cautioning in Dronenburg
v. Zech, 741 F.2d 1388, 1396 (D.C. Cir. 1984), that lower courts
“should [not] freely create new constitutional rights” without
“guidance from the Constitution or . . . from articulated Supreme
Court principle,” the district court focused on the absence of
binding precedent recognizing the substantive due process right
claimed by the Alliance. Since Dronenberg, the Supreme Court
 10

has provided guideposts to enable a court to assess the merits of
the Alliance’s claim.5

Although the Supreme Court has never explicitly said so,
and we need not decide the matter here, it appears the Supreme
Court has employed two distinct approaches when faced with a
claim to a fundamental right. In some cases, the Court has
discerned the existence of fundamental rights by probing what
“personal dignity and autonomy” demand. See Planned
Parenthood of Southeastern Pa. v. Casey, 505 U.S. 833, 851
(1992) (citations omitted). In other cases, the Court has derived
fundamental rights by reference to the Nation’s history and legal
tradition, see, e.g., Glucksberg, 521 U.S. 702.6 The line of cases
beginning with Griswold v. Connecticut, 381 U.S. 479 (1965),
and continuing through Eisenstadt v. Baird, 405 U.S. 438
(1972), Roe v. Wade, 410 U.S. 113 (1973), and Casey, 505 U.S.
833, follow the first approach with their heavy reliance on the
concepts of individual rights to autonomy and self-
determination, and in their unwillingness to countenance state
intrusion into certain protected domains such as the bedroom,
the clinic, and the womb. This approach is succinctly captured
by Casey’s characterization of substantive due process rights as
those that involve “the most intimate and personal choices a
person may make in a lifetime, choices central to personal
dignity and autonomy.” Casey, 505 U.S. at 851.

The other approach for determining whether a claimed right

5
The dissent, to the extent it presupposes the only liberties
protected by the Constitution are those that have been explicitly
recognized by the Supreme Court, see Dissent at 13 & n.3, is in error.
6
See Robert C. Post, The Supreme Court, 2002
Term—Foreword: Fashioning the Legal Constitution: Culture,
Courts, and Law, 117 HARV. L. REV. 4, 89 (2003).
 11

warrants substantive due process protection, which appears to be
more restrictive,7 has two “features.” See Glucksberg, 521 U.S.
at 720. Under Glucksberg, courts must inquire whether the
fundamental right asserted is “objectively, ‘deeply rooted in this
Nation’s history and tradition,’” id. at 721 (quoting Moore, 431
U.S. at 503; Snyder v. Massachusetts, 291 U.S. 97 (1934)),8 and

7
Post, supra note 6, at 91-93; Laurence H. Tribe, Lawrence
v. Texas: The “Fundamental Right” That Dare Not Speak its Name,
117 HARV. L. REV. 1893, 1921-23 (2004).
8
The Supreme Court’s mention in Lawrence v. Texas, 539
U.S. 558, 592 (2003), of the “emerging awareness” regarding the
liberty to engage in homosexual conduct does not limit the swath of
time to be surveyed in a Glucksberg analysis of history and tradition.
The reference to “laws and tradition in the past half century” appears
in support of the Court’s decision to depart from stare decisis and
overrule Bowers v. Hardwick, 478 U.S. 186 (1986). Discrediting
Bowers’s “sweeping references” to history thus had a purpose in
addition to that addressed by the Glucksberg analysis: it is intended to
show that not only had the Court in Bowers misread history but that
it also had ignored modern trends giving protection to conduct that
had long avoided criminal proscription in the states. See Lawrence,
539 U.S. at 568. Reading Lawrence as narrowing the Glucksberg
historical inquiry to the last half century would gut the purpose of the
Glucksberg test, which is to prevent the creation of substantive due
process rights by forcing courts to accord due process protection only
to those rights with a strong foundation in tradition. Other circuits
have either treated the Glucksberg analysis as controlling after
Lawrence, see Fields v. Palmdale School Dist., 427 F.3d 1197 (9th
Cir. 2005); Fields v. Legacy Health System, 413 F.3d 943 (9th Cir.
2005); Doe v. City of Lafayette, Ind., 377 F.3d 757, 768 (7th Cir.
2004), or viewed Lawrence as not, properly speaking, a substantive
due process decision, see Lofton v. Sec’y of Dep’t of Children and
Family Servs., 358 F.3d 804, 815-16 (11th Cir. 2004); Muth v. Frank,
412 F.3d 808, 818 (7th Cir. 2005). No court has regarded Lawrence
as cabining Glucksberg.
 12

“implicit in the concept of ordered liberty, such that neither
liberty nor justice would exist if [it] were sacrificed,”
Glucksberg, 521 U.S. at 721 (quoting Palko v. Connecticut, 302
U.S. 319, 325-26 (1937)) (internal quotation marks omitted).
Additionally, in order to ensure that courts do not multiply rights
without principled boundaries, courts must provide a “careful
description of the fundamental liberty interest.” Id. at 721-23.
If a court concludes that the claimed right is a fundamental right
entitled to protection under the Due Process Clause, then the
burden shifts to the government to show that its encroachment
upon the right “is narrowly tailored to serve a compelling
[governmental] interest.” Id. at 721 (quoting Flores, 507 U.S.
at 302).

Because we conclude, upon applying the seemingly more
restrictive analysis of Glucksberg, that the claimed right
warrants protection under the Due Process Clause, we need not
decide whether the line of cases construing the concept of
“personal dignity and autonomy” would also lend protection to
the claimed right.

III.

The question presented by the Alliance’s complaint is
whether the Due Process Clause protects the right of terminally
ill patients to make an informed decision that may prolong life,
specifically by use of potentially life-saving new drugs that the
FDA has yet to approve for commercial marketing but that the
FDA has determined, after Phase I clinical human trials, are safe
enough for further testing on a substantial number of human
beings. The Due Process Clause, as Glucksberg makes clear,
protects those liberties “deeply rooted in this Nation’s history
and tradition.” 521 U.S. at 721 (citation omitted). The Supreme
Court has variously referred to these rights as principles “so
rooted in the traditions and conscience of our people as to be
 13

ranked as fundamental,” Snyder, 291 U.S. at 105, and as
immunities “implicit in the concept of ordered liberty,” Palko,
302 U.S. at 325. Thus, a court’s examination of our Nation’s
history and tradition cannot be based on so specific a description
of the claimed right as would undercut the interests protected by
the Due Process Clause.

A.
One feature of the Glucksberg analysis requires courts to
compose a “careful description” of the asserted fundamental
liberty interest before extending due process protection to it.
521 U.S. at 721. The Supreme Court has not settled on how
precisely formulated the right must be. Two Justices have
interpreted the “careful description” requirement as indicating
that courts should identify fundamental rights at the “most
specific level at which a relevant tradition protecting, or denying
protection to, the asserted right can be identified.” Michael H.,
491 U.S. at 127 n.6 (1989) (Scalia, J., with Rehnquist, C.J.,
concurring). Two other Justices have indicated that asserted
rights not expressed at “‘the most specific level’ [of generality]
available” can nonetheless be recognized. Id. at 132 (O’Connor
and Kennedy, JJ., concurring). The “careful description”
requirement was first invoked by the Court in Flores, 507 U.S.
at 302 (1993), which relied on Collins v. City of Harker Heights,
503 U.S. 115, 125 (1992), where the notion of careful
description was expressed as a pleading requirement. Since
Glucksberg, the Court has applied this requirement once without
elaboration. See Chavez v. Martinez, 538 U.S. 760, 775-76
(2003).

In Hutchins v. District of Columbia, 188 F.3d 531 (D.C. Cir.
1999), the en banc court applied the careful description
requirement in its substantive due process analysis. The court
viewed the careful description requirement as a means of
constraining the inadvertent creation of rights that could fall
 14

within the scope of loosely worded descriptions and thus
threaten the separation of powers. See id. at 542-45. Despite
reaching different conclusions about the appropriate level of
generality in describing the claimed right, compare id. at 538
(citing Michael H., 491 U.S. at 127 n.6) (Scalia, J., with
Rehnquist, C.J., concurring), with id. at 555-57 (Rogers, J.,
dissenting) (citing Moore, 431 U.S. at 502-03), the court
concluded that the animating principle underlying the careful
description requirement is that courts should proceed with care
in examining substantive due process claims. See id. at 538.

The Alliance’s complaint contains the careful description
we seek, allowing this court to consider whether the challenged
FDA policy impinges upon one or more of the interests
protected by the Due Process Clause. The FDA characterizes
the Alliance’s claimed right as a broadly stated prerogative to
access post-Phase I investigational new drugs and to receive
treatment, but the Alliance has defined the right more narrowly.
The Alliance claims neither an unfettered right of access to all
new or investigational new drugs nor a right to receive treatment
from the government or at government expense. The Alliance’s
claim also does not challenge the Controlled Substances Act, 21
U.S.C. §§ 801 et seq., or the government’s authority to regulate
substances deemed harmful to public health, safety, and welfare.
Rather, the Alliance contends that the fundamental due process
rights to privacy, liberty, and life include the right of terminally
ill patients, acting on a doctor’s advice, to obtain potentially life-
saving medication when no alternative treatment approved by
the government is available. Recognizing that the effectiveness
and side effects of the investigational new drugs may still be in
question after the Phase I trials have been completed, the
Alliance asks only that the decision to assume these known or
unknown risks be left to the terminally ill patient and not to the
FDA. This description of the claimed right conforms to the
demands of even the narrowest interpretation of the Glucksberg
 15

“careful description” requirement.9

9
In light of the dissenting opinion, it bears emphasizing that,
first, the court is presented with a constitutional challenge to a policy
adopted by the FDA pursuant to a statutory delegation of authority.
The dissent therefore can derive no support from its misplaced reliance
on cases raising statutory challenges, especially given that these cases
explicitly declined to address constitutional challenges. Compare
Dissent at 11-12, 19 (relying on United States v. Oakland Cannabis
Buyers’ Co-op., 532 U.S. 483 (2001) and Gonzales v. Raich, 125 S.Ct.
2195 (2005)), with Oakland Cannabis Buyers’ Co-op., 532 U.S. at 491
(“We need not decide, however, whether necessity can ever be a
defense when the federal statute does not expressly provide for it.”),
id. at 494 (“Nor do we consider the underlying constitutional
[substantive due process] issues today.”), and Gonzales, 125 S.Ct. at
2215 (“[W]e do not address the question whether judicial relief is
available to respondents” on their “substantive due process claim and
. . . [their] medical necessity defense.”). No more helpful are the other
cases cited, see Dissent at 19-20 & n.6, because in these cases either
no fundamental right was at issue, see Opinion at 28-29, or else the
fundamental right that was asserted was far broader in scope than the
right asserted here. Had these courts addressed the substantive due
process claim asserted by the Alliance, they no less than this court
could not ignore the Supreme Court’s substantive due process
precedents that discern fundamental liberty interests in long-standing
common law and constitutional protections. See Opinion at 19 n.12.

Second, contrary to the dissent’s argument, see Dissent at 21-
22, the court does not undertake scientific analysis in addressing the
Alliance’s claim to potentially life-saving medication. The science has
been decided by the FDA, as the Alliance acknowledges. The FDA
has determined, upon scientific analysis and evaluation, that certain
Phase I investigational new drugs are sufficiently safe for expanded
human testing in Phase II trials. The Alliance seeks only to piggyback
on the FDA’s scientific determination. Also, contrary to the dissent’s
claims, see Dissent at 11, 21-24, the court has engaged in no balancing
of interests and has not evaluated whether the FDA’s restrictions are
narrowly tailored. It remains for the district court on remand to
 16

B.
The other feature of the Glucksberg inquiry requires courts

determine in the first instance whether FDA restrictions on a
terminally ill patient’s right of access to potentially life-saving
medication that has cleared FDA Phase I trials are narrowly tailored
to serve a compelling governmental interest. See Opinion at 30. At
that time, the governmental interests will be identified by the FDA.
The dissent oscillates between ignoring that this issue remains to be
resolved, see Dissent at 9, and asserting that the issue is incapable of
resolution, see id. at 24. Performing strict scrutiny is not a task that
Article III courts have historically regarded as “impossible.” But see
Dissent at 24.

Third, the dissent suggests that the court paves the way for
medicinal use of marijuana. See Dissent at 14, 24. There is no
slippery slope from finding a right of access to potentially life-saving
investigational new drugs that have cleared FDA Phase I trials for
safety to finding a right of access to illegal narcotics. Marijuana is
listed as a Schedule I substance under the Controlled Substances Act.
A drug is included in Schedule I if it “has a high potential for abuse,”
“has no currently accepted medical use in treatment in the United
States,” and has “a lack of accepted safety for use . . . under medical
supervision.” 21 U.S.C. §§ 812(b)(1)(A)-(C). The investigational new
drugs that have cleared FDA Phase I trials do not possess these
attributes or the FDA would not be permitting their medical use in
treatment, under medical supervision, by Phase II trial participants.
Nothing in the court’s holding supports the dissent’s inference that
marijuana, or any other Schedule I substance, if tested, would qualify
for Phase I clearance and be potentially life-saving. By the same
token, the record does not imply that a right of access exists to
“federally-funded stem cell research and treatment.” Dissent at 24.
That issue is not before the court and the considerations that would be
relevant under Glucksberg are not obviously similar. See infra n.26.
 17

to determine whether there exists a long-standing tradition in our
Nation that would protect individual access to potentially life-
saving medication. Courts must focus on discerning those
constitutionally protected interests whose existence can be
inferred from the Due Process Clause and Supreme Court
precedent construing the Clause. See Cruzan, 497 U.S. at 278.
Although it is relevant to the substantive due process analysis
that the government has never proscribed the desired conduct,
this is not dispositive. The absence of regulation could be
attributable to a liberty interest that is deeply rooted in this
Nation’s history and tradition, and therefore characterized by a
history of liberty from governmental interference, but there may
be another explanation. For example, a lack of regulation might
indicate only that the technology of yesteryear did not warrant
it.

The FDA’s discussion of the merits of this question consists
of a single sentence: “[The] FDA has had statutory authority to
regulate drugs for almost a century, and that authority is now
firmly ingrained in our understanding of the appropriate role of
government.” Appellee’s Br. at 19.10 We offer the following
observations, mindful of the fact that the Alliance is
complaining only of obstacles to post-Phase I investigational
new drugs erected by the FDA and not obstacles that might be

10
The FDA argues in its brief that the Alliance never argued
in the district court that drugs were unregulated for most of our
Nation’s history, and thus cannot raise this argument for the first time
on appeal. In fact, the Alliance argued in district court that
Glucksberg supported its due process claim, see Pls.’ Cross-Mot. at 8-
9, and the district court relied on the Glucksberg analysis in dismissing
the complaint. As the FDA states in its brief, whether the Alliance has
asserted a fundamental right is a legal issue on which this court is fully
briefed. There is no reason why the analysis cannot proceed.
 18

erected by state consumer protection or other laws.11

A right of control over one’s body has deep roots in the
common law. The venerable commentator on the common law
William Blackstone wrote that the right to “personal security”
includes “a person’s legal and uninterrupted enjoyment of his
life, his limbs, his body, [and] his health,” as well as “the
preservation of a man’s health from such practices as may
prejudice or annoy it.” WILLIAM BLACKSTONE, 1
COMMENTARIES *125, *130. This right included the right to
self-defense and the right to self-preservation. “For whatever is
done by a man, to save either life or member, is looked upon as
done upon the highest necessity and compulsion.” Id. at *127.
As recognized throughout Anglo-American history and law,
when a person is faced with death, necessity often warrants
extraordinary measures not otherwise justified. Indeed the
principle holds even when that action impinges upon the rights
of others. See, e.g., Ploof v. Putnam, 81 Vt. 471, 475 (1908)
(“This doctrine of necessity applies with special force to the
preservation of human life. . . . One may sacrifice the personal
property of another to save his life or the lives of his fellows.”)
(internal citation omitted); Mouse’s Case, 77 Eng. Rep. 1341,
1342 (K.B. 1609) (deciding that it is lawful to throw overboard
property of another for safety of lives of passengers);
RESTATEMENT (FIRST) OF TORTS § 197 (1934); see generally
George C. Christie, The Defense of Necessity Considered from
the Legal and Moral Points of View, 48 DUKE L. J. 975 (1996).
But see The Queen v. Dudley and Stephens, 14 Q.B.D. 273
(1884) (holding that the defense of necessity did not justify

11
The FDCA does not regulate doctors in their practice of
medicine; they are licensed by the states. See Chaney v. Heckler, 718
F.2d 1174, 1179 (D.C. Cir. 1983), rev’d on other grounds, Heckler v.
Chaney, 470 U.S. 821 (1985). See also Gonzales v. Oregon, 126 S.
Ct. 904, 922-23 (2006).
 19

taking of innocent life). Barring a terminally ill patient from the
use of a potentially life-saving treatment impinges on this right
of self-preservation.

Such a bar also puts the FDA in the position of interfering
with efforts that could save a terminally ill patient’s life.
Although the common law imposes no general duty to rescue or
to preserve a life, it does create liability for interfering with such
efforts. Section 326 of the Restatement (First) of Torts, first
published in 1934, explained that

[o]ne who, without a privilege to do so, intentionally
prevents a third person from giving to another aid
necessary to his bodily security, is liable for bodily
harm caused to the other by the absence of aid which
he has prevented the third person from giving.

While infrequently invoked, this common law rule is of
venerable vintage. See id.; see also Soldano v. O’Daniels, 190
Cal. Rptr. 310, 313, 316-18 (Ct. App. 1983); Miller v. Arnal
Corp., 632 P.2d 987, 993 (Ariz. App. 1981).12

12
As the dissent notes, fundamental rights may “not [be]
simply deduced from abstract concepts of personal autonomy.”
Dissent at 10 (quoting Glucksberg, 521 U.S. at 725). Were it
impermissible to draw any inferences from a broader right to a
narrower right, however, nearly all of the Supreme Court’s substantive
due process case law would be out of bounds. See, e.g., Griswold, 381
U.S. at 484-86 (inferring specific right to use contraception from
general right to be free from intrusion into “sacred precincts of marital
bedrooms”); Roe, 410 U.S. 113 (identifying specific right to terminate
a pregnancy from broader right to privacy); Moore, 431 U.S. at 503
(extrapolating from broader constitutional protection for “the sanctity
of the family” to specific right to determine extended family living
arrangements). In any event, the court’s holding is not grounded in
the abstract notion of personal autonomy but rather in the specific
 20

In contrast to these ancient principles, regulation of access
to new drugs has a history in this country that is of recent origin.
Prior to 1906, there was essentially no drug regulation in the
United States.13 In that year Congress enacted the Pure Food
and Drug Act (“1906 Act”), Pub. L. No. 59-384, 34 Stat. 768
(repealed 1938), which prohibited misbranded and adulterated
foods or drugs from entering interstate commerce, 34 Stat. at
768, and prohibited false and misleading labeling, id. at 770.

right to act in order to save one’s own life.
13
See Charles J. Walsh & Alissa Pyrich, Rationalizing the
Regulation of Prescription Drugs and Medical Devices: Perspectives
on Private Certification and Tort Reform, 48 RUTGERS L. REV. 883,
890-91 (1996); Note, The Catch-22 for Persons with AIDS: To Have
or Not To Have Easy Access to Investigational Therapies and Early
Approval for New Drugs, 69 S. CAL. L. REV. 105, 109 (1995); see also
Gonzales v. Raich, 125 S. Ct. 2195, 2202-03 (2005). The FDA
Historian Wallace F. Janssen writes that prior to 1906 was the “heyday
of ‘patent medicines,’” a time when “[a]nyone, no matter how
ignorant or unqualified, could go into the drug manufacturing
business” and when “[m]edicines . . . were sold without restriction at
almost every crossroads store.” Wallace F. Janssen, Outline of the
History of U.S. Drug Regulation and Labeling, 36 FOOD DRUG COSM.
L. J. 420, 422 (1981) (“Outline of the History”). He further recounts
that in “colonial days, and long afterward, consumers . . . were their
own food and drug inspectors,” “there was a striking absence of
statutes dealing with drugs,” and, although there were food inspection
laws and standards for weights and measures, see id. at 423, 425,
“drug laws were virtually non-existent.” Janssen, America’s First
Food and Drug Laws, 30 FOOD DRUG COSM. L. J. 665, 669, 671
(1975). This suggests that in this country’s early history there were no
restrictions on a patient’s access to potentially life-saving medication,
regardless of whatever restrictions may have been placed on
physicians, pharmacists, apothecaries, poisons, or misbranded or
adulterated substances. See id. at 669-72; Janssen, Outline of the
History, at 426-28. But cf. Dissent at 15-17.
 21

For a small number of particularly dangerous drugs, the 1906
Act required the labels to identify the drug’s ingredients and
quantities. Id. The statute also authorized the Bureau of
Chemistry, a predecessor of the FDA, to seize nonconforming
goods and to recommend federal prosecution of those who
violated the 1906 Act. Id. at 769 § 4. The 1906 Act did not,
however, limit individual access to new drugs or regulate
therapeutic claims by drug manufacturers. Cf. United States v.
Johnson, 221 U.S. 488 (1911). It thus appears that a patient still
could obtain access to any new drug for medicinal use, even if
the drug had no therapeutic benefit, albeit subject to the controls
placed on narcotics in 1914 by the Harrison Narcotic Act. Act
of Dec. 17, 1914, 38 Stat. 785.14

In 1938, Congress enacted the FDCA in response to the
deaths of more than one hundred people, many of them children,
from ingesting Elixir Sulfanilamide, which had been marketed
as an antibiotic. See Report of the Secretary of Agriculture on
Deaths Due to Elixir Sulfanilamide, S. Doc. No. 124, 75th
Cong., 2d Sess. 1, 1-3 (1937) (“1937 Report”).15 For the first
time, Congress required that drug manufacturers test, and the
FDA review, all new drugs for safety prior to their commercial
distribution. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified
as amended at 21 U.S.C. §§ 301 et seq.); 1937 Report at 1-3.
Under the 1938 Act, a new drug could be commercially

14
See generally James L. Zelenay, Jr., The Prescription Drug
User Fee Act: Is a Faster Food and Drug Administration Always a
Better Food and Drug Administration?, 60 FOOD & DRUG L.J. 261,
263-64 (2005); Steven R. Salbu, Regulation of Drug Treatments for
HIV and AIDS: A Contractarian Model of Access, 11 YALE J. ON REG.
401, 406-09 (1994); cf. State of Minnesota ex rel. Whipple v.
Martinson, 256 U.S. 41, 45 (1921).
15
See Salbu, supra note 14, at 407.
 22

marketed only after the manufacturer filed a New Drug
Application (“NDA”) with the FDA that set forth medical and
scientific information attesting to the drug’s safety. The 1938
Act did not, however, require drug manufacturers to receive
affirmative FDA approval before marketing the drug.16 Rather,
an NDA became automatically effective within a time frame set
by the FDA unless the FDA determined that the drug was unsafe
and barred its commercial distribution.17 It was not until 1951,
in the Durham-Humphrey Amendment, that Congress created
the category of prescription drugs, i.e., drugs that are unsafe for
self-medication but which can be used while under a doctor’s
supervision. See Act of Oct. 25, 1951, 65 Stat. 648 (1951)
(codified at 21 U.S.C. § 353(b)).

Only in 1962 did Congress require drug manufacturers to
provide empirical evidence of the effectiveness of a drug as
opposed to merely the drug’s safety.18 The Kefauver-Harris
Amendments, Pub. L. No. 87-781, 76 Stat. 780 (1960) (codified
in scattered sections of 21 U.S.C. §§ 301-81 (1982 & Supp. IV
1986)), were enacted in response to the rash of birth defects
discovered in babies whose mothers had taken Thalidomide to
ease morning sickness caused by pregnancy.19 The
Kefauver-Harris Amendments transformed drug regulation and
the approval process in several respects. First, the Amendments
required the FDA to review a new drug for both safety and
effectiveness and specified that to demonstrate effectiveness

16
See Zelenay, supra note 14, at 264-65.
17
Id.
18
See Greenberg, supra note 3, at 295, 300 & n.23.
19
See Salbu, supra note 14, at 408 n.41; see generally
HARVEY TEFF & COLIN R. MUNRO, THALIDOMIDE: THE LEGAL
AFTERMATH 1-10 (1976); Janssen, Outline of the History, at 438.
 23

manufacturers were required to submit data from “adequate and
well-controlled investigations.” 21 U.S.C. § 355(d). Second,
the Amendments authorized the FDA to approve human clinical
trials, regulate drug advertising, inspect drug-manufacturing
facilities, and promulgate good manufacturing practices. The
Amendments also required drug manufacturers to disclose to the
FDA any information they received regarding the adverse
consequences of approved drugs.20 This legislation set the
framework for the system of drug regulation currently in place.

Despite the increased federal scrutiny of new drugs,
important aspects of patient access to drugs are unregulated by
the government and appear always to have been unregulated.
“The FDA’s regulatory authority extends to manufacturers of
drugs but not to the physicians who dispense them.”21 Thus, a
doctor may prescribe a drug to a patient for a purpose other than
that for which the FDA has approved the use of the drug. Such
“off-label” use may occur even if the drug is not deemed safe or
effective for that use. Further, it appears that the FDA has never
prohibited either off-label prescription or off-label use of
drugs.22 In recent years, the FDA has been moving to permit
drug manufacturers to promote the use of their drugs for off-
label purposes in limited circumstances.23 See Food and Drug
Administration Modernization Act of 1997, Pub. L. No.

20
See Walsh & Pyrich, supra note 13, at 901; see also
Zelenay, supra note 14, at 266.
21
Steven R. Salbu, Off-Use, Prescription, and Marketing of
FDA-Approved Drugs: An Assessment of Legislative and Regulatory
Policy, 51 FLA. L. REV. 181, 189-92 (1999). See Chaney, 718 F.2d at
1180.
22
See Salbu, supra note 21, at 189-92.
23
See id. at 211.
 24

105-115, 111 Stat. 2296 (codified in scattered sections of 21
U.S.C. §§ 301-81).

For over half of our Nation’s history, then, until the
enactment of the 1906 Act, a person could obtain access to any
new drug without any government interference whatsoever.
Even after enactment of the FDCA in 1938, Congress imposed
no limitation on the commercial marketing of new drugs based
upon the drugs’ effectiveness. Rather, at that time, the FDA
could only interrupt the sale of new drugs based on its
determination that a new drug was unsafe. Government
regulation of drugs premised on concern over a new drug’s
efficacy, as opposed to its safety, is of recent origin. And even
today, a patient may use a drug for unapproved purposes even
where the drug may be unsafe or ineffective for the off-label
purpose. Despite the FDA’s claims to the contrary, therefore, it
cannot be said that government control of access to potentially
life-saving medication “is now firmly ingrained in our
understanding of the appropriate role of government,”
Appellee’s Br. at 19, so as to overturn the long-standing
tradition of the right of self-preservation.24

24
The court does not, as the dissent suggests, “infer[] a
constitutional right to be free from regulation” from “the lack of
federal regulation” in this area prior to the recent past. See Dissent at
14. Rather, the court infers the right from the Due Process Clause and
Supreme Court precedents construing the Due Process Clause. See
supra n. 12. The fundamental right to take action, even risky action,
free from government interference, in order to save one’s own life
undergirds the court’s decision. Our point is that the relatively short-
lived history of drug regulation, particularly as regards the
effectiveness of a new drug, is not, as the dissent suggests, sufficient
to establish that the government has acquired title to this right by
adverse possession. The same logic plainly would not serve to
establish a right to recreational drugs merely because, in the grand
sweep of the Nation’s history, these regulations are of relatively recent
 25

C.
The Alliance’s claim also falls squarely within the realm of
rights the Supreme Court has held are “implicit in the concept of
ordered liberty.” Palko, 302 U.S. at 325. Specifically, the
claimed right is implied by the Court’s conclusion in Cruzan
that due process protects a person’s right to refuse life-
sustaining treatment. See Cruzan, 497 U.S. at 279. Writing for
the Court, Chief Justice Rehnquist noted in examining the
origins of the doctrine of informed consent that the Court had
observed early on that “[n]o right is held more sacred, or is more
carefully guarded, by the common law, than the right of every
individual to the possession and control of his own person, free
from all restraint or interference of others, unless by clear and
unquestionable authority of law.” Id. at 269 (quoting Union
Pacific R. Co. v. Botsford, 141 U.S. 250, 251 (1891)). The
Court reasoned that “[t]he logical corollary of the doctrine of
informed consent is that the patient generally possesses the right
not to consent, that is, to refuse treatment.” Id. at 270.
Confronting for the first time what it described as a “perplexing
question with unusually strong moral and ethical overtones,” id.
at 277, the Court turned to the language of the Fourteenth
Amendment and its precedent to determine whether “the United
States Constitution grants what is in common parlance referred
to as a ‘right to die,’” id. The Court reasoned that “[t]he
principle that a competent person has a constitutionally
protected liberty interest in refusing unwanted medical treatment
may be inferred from our prior decisions.” Id. Without
qualification, the Court stated: “It cannot be disputed that the
Due Process Clause protects an interest in life as well as an
interest in refusing life-sustaining medical treatment.” Id. at
281.

A similar analysis leads to the conclusion that the Due

vintage.
 26

Process Clause protects the liberty interest claimed by the
Alliance for its terminally ill members. See supra Part III.A.
The text of the Due Process Clause refers to protecting “liberty”
and “life.” Although there is no similarly clear textual basis for
a “right to die” or refusing life-sustaining medical treatment, the
Supreme Court in Cruzan recognized, in light of the common
law and constitutionally protected liberty interests based on the
inviolability of one’s body, that an individual has a due process
right to make an informed decision to engage in conduct, by
withdrawing treatment, that will cause one’s death.25 The
logical corollary is that an individual must also be free to decide
for herself whether to assume any known or unknown risks of
taking a medication that might prolong her life.

Like the right claimed in Cruzan, the right claimed by the
Alliance to be free of FDA imposition does not involve
treatment by the government or a government subsidy. Rather,
much as the guardians of the comatose patient in Cruzan did, the
Alliance seeks to have the government step aside by changing
its policy so the individual right of self-determination is not
violated. The Alliance claims that there is a protected right of
terminally ill patients to choose to use potentially life-saving
investigational new drugs that have successfully cleared Phase
I. If there is a protected liberty interest in self-determination
that includes a right to refuse life-sustaining treatment, even
though this will hasten death, then the same liberty interest must

25
It was only in the course of balancing an individual’s
liberty interest against the relevant government interests that the Court
indicated “the dramatic consequences involved in the refusal of [life-
sustaining] treatment would inform the inquiry as to whether the
deprivation of that interest is constitutionally permissible.” Cruzan,
497 U.S. at 279. The Court’s holding allowed the government to
protect the autonomous exercise of the right to refuse life-sustaining
treatment; it did not undermine the right.
 27

include the complementary right of access to potentially life-
sustaining medication, in light of the explicit protection
accorded “life.”26 Our reasoning is not unlike that of the
Supreme Court in Eisenstadt, 405 U.S. 438, where the Court
held that the right to be free from unwanted government
intrusion into the fundamental decision whether to have children
establishes a right of access to contraception.

Contrary to the FDA’s position, nothing in this court’s
precedent or that of the other circuit courts of appeal conflicts
with our analysis. Although the district court concluded, in
reliance upon our decision in Dronenberg, 741 F.2d at 1396, that
lower courts may not consider claims to new substantive due
process rights and principles not previously identified by the

26
The dissent fails to see how the court can reason from a
right to refuse life-saving treatment to a right of access to life-saving
treatment, see Dissent at 17-18, but the two go hand in hand. In either
instance — refusal or access — the key is the patient’s right to make
her own decision free from government interference. Moreover, the
right of access to investigational new drugs that have cleared Phase I
trials is different from and does not imply a general right to receive
life-saving treatment, as the dissent, Dissent at 24, and the district
court presumed. Nor does the court reach the question whether there
is such a right for that is not the Alliance’s claim.

Finally, the dissent mistakenly suggests the court offends the
“concept of ordered liberty” because the court’s decision is “contrary
to the expressed will of Congress and the Executive and to the
deference courts owe to the democratic branches on such controversial
matters.” Dissent at 22-23. Although the term “ordered liberty”
necessarily remains somewhat unclear, it cannot stand for a broad
principle of deference to the political branches whenever “unknown
questions of science” are involved. See id. Otherwise, it would
establish a zone in which the political branches would be free to
regulate persons unconstrained by the individual liberties preserved in
the Constitution.
 28

Supreme Court, see supra page 9, this court has addressed
substantive due process claims on a number of occasions. See,
e.g., N.Y. State Opthalmological Soc’y v. Bowen, 854 F.2d 1379
(D.C. Cir. 1988). Most pertinently, in Butera v. District of
Columbia, 235 F.3d 637 (D.C. Cir. 2001), the court confronted,
in the context of a qualified immunity defense, the claim of a
substantive due process right to life, personal security, and
bodily integrity. Butera involved a suit under 42 U.S.C. § 1983
brought by the mother of a man who was shot while working
undercover for the police department. The court in Butera did
not suggest that the advisory admonition in Dronenberg, 741
F.2d at 1396, precluded either the substantive due process
inquiry or the conclusion that a fundamental right was
implicated.

The decisions in the other circuits on which the FDA relies
likewise fail to support its position that there is no substantive
due process right of access to potentially life-saving treatment.
United States v. Burzynksi Cancer Research Institute, 819 F.2d
1301 (5th Cir. 1987), which held that the doctor and patient had
not stated a constitutional tort based on the allegedly improper
seizure of the doctor’s patient records and thus that they did not
overcome the defendant’s claim of qualified immunity, id. at
1310-11, bears no legal or factual relevance to the question
before this court. The statement in Carnohan v. United States,
616 F.2d 1120, 1122 (9th Cir. 1980), that “[c]onstitutional rights
of privacy and personal liberty do not give individuals the right
to obtain [the cancer drug] laetrile free of the lawful exercise of
government police power,” was dictum; the Ninth Circuit never
reached the merits of the claimed fundamental right of access as
the complaint was dismissed for failure to exhaust
administrative remedies.

Further, as the Alliance pointed out in its brief, the
terminally ill patients in Rutherford v. United States, 616 F.2d
 29

455 (10th Cir. 1980), like those in Carnohan, sought access to
laetrile, a new cancer drug that had not cleared FDA’s Phase I
safety hurdle and thus had not been approved for expanded
testing on humans in ongoing clinical trials, see id. at 456-57.
The Tenth Circuit rejected a right to laetrile, reasoning that the
choice of a particular treatment or medication is “within the area
of governmental interest in protecting public health.” Id. at 457.
Of course, the government’s interest in regulating has no bearing
upon the identification of a fundamental right. Rather, its
interest is to be considered only if, and after, a court recognizes
a fundamental right; at that point, the burden shifts to the
government to demonstrate a narrowly tailored “compelling
interest” in burdening that right. Because the FDA had neither
eliminated the possibility that laetrile was a poison nor approved
the drug for basic human testing in Phase I trials, the
government’s interest in Rutherford might well have been
sufficiently compelling to warrant restricting access to the drug.
In this case, the government’s interest may prove to be weaker
because the Alliance seeks only access to investigational new
drugs that the FDA, after Phase I human trials, has deemed
sufficiently safe for human testing on a substantial number of
human beings. In other words, the Alliance seeks for its
members the same right of access enjoyed by those terminally
ill patients lucky enough to secure a spot in Phase II trials.

Accordingly, we hold that the district court erred in
dismissing the Alliance’s complaint pursuant to Rule 12(b)(6) for
failure to state a claim. We conclude, upon applying the
Glucksberg analysis and heeding the protected liberty interests
articulated by the Supreme Court, that where there are no
alternative government-approved treatment options, a terminally
ill, mentally competent adult patient’s informed access to
potentially life-saving investigational new drugs determined by
the FDA after Phase I trials to be sufficiently safe for expanded
human trials, warrants protection under the Due Process Clause.
 30

The prerogative asserted by the FDA — to prevent a terminally
ill patient from using potentially life-saving medication to which
those in Phase II clinical trials have access — thus impinges
upon an individual liberty deeply rooted in our Nation’s history
and tradition of self-preservation. See Glucksberg, 521 U.S. at
721; Flores, 506 U.S. at 302. The district court never reached the
question of whether the challenged FDA policy violates this
protected liberty interest, and we therefore remand the case to the
district court to determine whether the FDA’s policy barring
access to post-Phase I investigational new drugs by terminally ill
patients is narrowly tailored to serve a compelling governmental
interest.
 GRIFFITH, Circuit Judge, dissenting: Experimental drugs
present a variety of potential risks and benefits to patients.
Some drugs may harm patients; others may help. Acting at the
direction of Congress, the Food and Drug Administration
(“FDA”) determines and balances those risks and benefits
during the testing process for new drugs with input from the
scientific and medical communities. Sometimes initial scientific
conclusions support providing seriously ill patients early access
to experimental drugs or hastening the testing process.
Sometimes they do not. The FDA examines the science behind
each new drug and makes a judgment about what level of access
will provide patients with an effective drug that carries an
acceptable level of risk. One group of terminally ill patients
believes the FDA is too cautious. The Abigail Alliance for
Better Access to Developmental Drugs (the “Alliance”) favors
a different balance that would allow terminally ill patients
access to all experimental drugs after the first phase of FDA
testing is complete. The Alliance argues that the Constitution
guarantees them this access.

Courts must, of course, be cautious about acceding to a
litigant’s claim of a newly-discovered constitutional right. To
succeed here, the Alliance must show that the access to
experimental drugs it seeks for terminally ill patients is a
“fundamental right[] and libert[y] which [is], objectively,
‘deeply rooted in this Nation’s history and tradition,’”
Washington v. Glucksberg, 521 U.S. 702, 720-21 (1997)
(quoting Moore v. East Cleveland, 431 U.S. 494, 503 (1977)
(plurality opinion)), and “‘implicit in the concept of ordered
liberty,’ such that ‘neither liberty nor justice would exist if [it]
w[as] sacrificed,’” 521 U.S. at 721 (quoting Palko v.
Connecticut, 302 U.S. 319, 325-26 (1937)). Although others
previously have argued for the creation of a similar right, until
today, no circuit court has assented to such a claim. The
majority creates a fundamental right by making a series of
inferences prohibited by Glucksberg. From the fact that the
Government has not always regulated drugs, the majority infers
 2

a constitutional right to be free from such regulation. From the
common law defense of necessity and the tradition prohibiting
battery and forced medication, the majority infers a fundamental
right of access to medication. From the fact that drugs in the
first phase of FDA testing have undergone some testing, the
majority infers that those drugs will probably have a medical
benefit with sufficiently minimal risk. But there is no evidence
in this Nation’s history and traditions of a right to access
experimental drugs. Balancing the risks and benefits found at
the forefront of uncertain science and medicine has been, for
good reason, the historical province of the democratic branches.
Because I can find no basis in the Constitution or judicial
precedents to remove that function from the elected branches, I
respectfully dissent.

I.

People of good will wish for scientists to develop effective,
safe cures for terminally ill patients as quickly as possible. The
Alliance could have taken its argument to Congress and
attempted to convince our Nation’s lawmakers that the current
balance between safety and risk is scientifically or morally
misguided and that terminally ill patients should have the early
access to experimental drugs that the Alliance seeks. Congress
could have held hearings on the subject and heard the
viewpoints of scientists, doctors, patients, advocacy groups (like
the Alliance), moralists, ethicists, and citizens. Congress could
then exercise its lawmaking function by striking a new balance
between early availability and the need for sufficient
understanding of the toxicity and potential benefits of
experimental drugs. The Alliance could also work with the
FDA, as the agency suggested in a letter to the Alliance, to “help
expand patient access to promising new treatments [by]
work[ing] with sponsors and with [the] FDA to better
understand the reasons sponsors choose not to create these [early
 3

access] programs [already existing under the FDA’s regulations]
and to identify additional incentives for participation.” Just as
the Supreme Court reminded litigants who argued last term in
Gonzales v. Raich that substantive due process allowed them to
use marijuana for medicinal purposes, “perhaps even more
important than these legal avenues is the democratic process, in
which the voices of voters allied with these respondents may one
day be heard in the halls of Congress.” 125 S.Ct. 2195, 2215, __
U.S. __, __ (2005). Of course, changing the present level of
access to experimental drugs through the democratic branches
would involve intense and complicated scientific and moral
debates about how best to regulate new drugs.

Instead of allowing the elected branches to resolve these
debates, the Alliance argues that the Constitution mandates its
desired outcome, regardless of the particular balance already
struck by Congress and the Executive. In the Alliance’s view,
the Due Process Clause of the Constitution guarantees
terminally ill patients a fundamental “right of access to drugs
that have cleared Phase I trials” because those drugs are “safe
enough to be tested in humans” and “simply ha[ve] not yet met
FDA’s standards.” Based upon that argument, the majority
creates a fundamental right and concludes that, under the
Constitution, “a terminally ill, mentally competent adult
patient’s informed access to potentially life-saving
investigational new drugs determined by the FDA after Phase I
trials to be sufficiently safe for expanded human trials warrants
protection under the Due Process Clause.” Maj. Op. at 29.

The Alliance’s proposed new constitutional right would
exempt terminally ill patients from much of the legislative and
regulatory approval process created by Congress and the FDA
for new experimental drugs. Section 505(a) of the Food, Drug,
and Cosmetic Act (“FDCA”), 21 U.S.C. § 355(a), bars the
introduction of new drugs into interstate commerce until the
 4

FDA has approved a sponsor’s application. A new drug
application must contain “full reports of investigations which
have been made to show whether or not such drug is safe for use
and whether such drug is effective in use.” Id. § 355(b)(1)(A).
Before testing a new drug on humans for safety and
effectiveness, a sponsor must submit for the FDA’s approval an
investigational new drug application (“IND”), see id.
§ 355(i)(1); see also 21 C.F.R. pt. 312, containing detailed
information establishing that human testing is appropriate, see
21 C.F.R. § 312.23.

Testing a new drug for safety and effectiveness in treating
humans generally requires three or sometimes four phases. See
id. § 312.21. Phase I involves the initial introduction of a new
drug into human subjects. A Phase I study usually consists of
twenty to eighty subjects and is “designed to determine the
metabolism and pharmacologic actions of the [new] drug in
humans, the side effects associated with increasing doses, and,
if possible, to gain early evidence on effectiveness.” Id.
§ 312.21(a)(1). The majority and I differ in our understanding
of the importance of the testing that occurs after Phase I. The
majority implies that the FDA is primarily concerned with
effectiveness after Phase I and that the right argued for by the
Alliance would only override FDA regulation for effectiveness.1

1
See Maj. Op at 14 (“The Alliance’s claim also does not
challenge . . . the government’s authority to regulate substances
deemed harmful to public health, safety, and welfare.”); id.
(suggesting that only the “side effects of the investigational new drugs
may still be in question after the Phase I trials have been completed,”
and not addressing the fact that later studies address risks, safety, and
the overall benefit-risk relationship of a new drug) (emphasis added);
id. at 22 (“Only in 1962 did Congress require drug manufacturers to
provide empirical evidence of the effectiveness of a drug as opposed
to merely the drug’s safety.”); id. at 24 (“Government regulation of
drugs premised on concern over a new drug’s efficacy, as opposed to
 5

Contrary to the majority’s suggestion, all phases of the FDA’s
testing process for new drugs involve testing for safety. In
addition to addressing the effectiveness of a new drug, Phase II
studies are used “to determine the common short-term side
effects and risks associated with the drug.” Id. § 312.21(b).
Phase III studies “gather . . . additional information about
effectiveness and safety that is needed to evaluate the overall
benefit-risk relationship of the drug.” Id. § 312.21(c). The FDA
further requires some drugs to go through Phase IV studies,
which “delineate additional information about the drug’s risks,
benefits, and optimal use.” Id. § 312.85.

To guide this process, Congress has directed the FDA to
establish “[s]cientific advisory panels” to “provid[e] expert
scientific advice and recommendations to the Secretary
regarding a clinical investigation of a drug or the approval for
marketing of a drug.” 21 U.S.C. § 355(n)(1). Quite specifically,
Congress has mandated that the FDA include on these panels
scientists from a variety of disciplines. See id. § 355(n)(3).2

its safety, is of recent origin.”).
2
Section 355(n)(3) of Title 21, United States Code, provides:

The Secretary shall make appointments to each
panel . . . so that each panel shall consist of—

(A) members who are qualified by training and
experience to evaluate the safety and effectiveness of
the drugs to be referred to the panel and who, to the
extent feasible, possess skill and experience in the
development, manufacture, or utilization of such
drugs;

(B) members with diverse expertise in such fields as
clinical and administrative medicine, pharmacy,
 6

Thus, at issue today is whether terminally ill patients have a
fundamental right to procure and use an experimental drug
before the FDA and the scientific community have evaluated its
scientific and medical risks and corresponding benefits as called
for in the FDCA and its accompanying regulations.

The FDA has several regulatory programs in place to hasten
research of the safety and effectiveness of drugs for terminally
or severely ill patients and allow early access where
scientifically and medically warranted. For example, under its
“Fast Track” program, the agency has “established procedures
designed to expedite the development, evaluation, and
marketing of new therapies intended to treat persons with
life-threatening and severely-debilitating illnesses, especially
where no satisfactory alternative therapy exists.” 21 C.F.R.
§ 312.80. Fast Track allows the FDA to waive its IND
application requirement if it is “unnecessary or cannot be
achieved,” id. § 312.10, and even allows a waiver request to be
made “[i]n an emergency . . . by telephone or other rapid
communication,” id. The Accelerated Approval program
provides a truncated approval process for “certain new drug
products that have been studied for their safety and effectiveness
in treating serious or life-threatening illnesses and that provide

pharmacology, pharmacoeconomics, biological and
physical sciences, and other related professions;

(C) a representative of consumer interests, and a
representative of interests of the drug manufacturing
industry not directly affected by the matter to be
brought before the panel; and

(D) two or more members who are specialists or have
other expertise in the particular disease or condition
for which the drug under review is proposed to be
indicated.
 7

meaningful therapeutic benefit to patients over existing
treatments.” Id. § 314.500. The FDA categorizes some new
drugs, including nearly all cancer drugs, as “priority drugs” and
seeks to accelerate their availability.

The Alliance contends that Congress and the FDA have not
struck the right balance between early access and safety. In its
view, these carefully constructed programs, refined over the
years by experience, do not sufficiently allow its members
access to the experimental drugs they need. Accordingly, the
Alliance developed and submitted to the FDA a comprehensive
proposal that argued there is a “different risk-benefit tradeoff
facing patients who are terminally ill and who have no other
treatment options.” Although the Alliance agreed that
“[e]xtensive marshalling of evidence regarding drug
interactions, dose optimization, and the like” is “appropriate for
new drugs to treat patients with other alternatives,” the Alliance
suggested that “these steps may well entail a delay that is fatal”
for terminal patients. Accordingly, the Alliance contended that
terminally ill patients “should have the ability to opt for a new
treatment that has met a lower evidentiary hurdle with respect to
safety and efficacy.” The Alliance’s proposal suggested, among
other things, that the FDA allow early access based upon “the
risk of illness, injury, or death from the disease in the absence of
the drug.” The FDA should have promulgated a new regulation,
the Alliance contended, that would allow sponsors to market
experimental drugs, under some circumstances, after the
completion of Phase I trials.

Several senior FDA officials reviewed the Alliance’s
proposed regulation. The officials concluded that the Alliance
“raised several important questions about expanded access that
we believe deserve further consideration,” but questioned
whether the specific proposal put forward by the Alliance
“would have the intended desirable effects for patients.” The
 8

officials concluded that the Alliance’s “suggestion points to an
area of significant range of opinion within the patient and
provider communities about the standards that should be met
before a drug is marketed.” Although “some members of the
cancer community have suggested that [the] FDA needs to
maintain a strong clinical trial system as the basis of the
approval of cancer drugs, . . . others, like [the Alliance], have
criticized [the FDA] for relying too heavily on completing
certain trials before approval.” The FDA noted that “[i]n the
realm of reviewing medical products to treat serious and life-
threatening diseases, there is inevitable tension between early
availability of products to patients, especially patients with
refractory disease, and the need to obtain sufficient data to
provide a reasonable expectation of benefit and lack of
excessive harm.”

Having previously exercised its scientific and medical
judgment to “strike the appropriate balance between these two
competing goals,” the FDA noted its conclusion that “a
reasonably precise estimate of response rate” and “enough
experience to detect serious adverse effects” are “critical” in
determining when experimental drugs should be made available.
Most experimental cancer drugs “have potentially lethal toxicity,
with potentially large effects on a patient’s remaining quality of
life.” Accordingly, in the FDA’s judgment, “it does not serve
patients well to make drugs too widely available before there is
a reasonable assessment of such risks to guide patient decisions,
and experience in managing them.” Accepting the Alliance’s
proposal “would upset the appropriate balance that the FDA is
seeking to maintain, by giving almost total weight to the goal of
early availability and giving little recognition to the importance
of marketing drugs with reasonable knowledge for patients and
physicians of their likely clinical benefit and their toxicity.”
With its proposal rejected by the FDA, the Alliance turned to the
courts rather than the Congress and now asks us to create a new
 9

constitutional right that will provide the level of access to
experimental drugs they seek.

To understand the constitutional dispute in this case, it is
critical to understand what this case is not about. Neither the
Constitution nor Congress has authorized this Court to
determine which of these two litigants has a more scientifically
and medically sound view. FDA scientists, physicians, and
officials, acting pursuant to express statutory authority, have
determined that blanket access to experimental drugs for
terminal patients would present unacceptable scientific and
medical risks. Contrary to the FDA’s scientific and medical
views, the Alliance believes that, at least for terminally ill
patients, the benefits of an experimental drug will usually
outweigh its risks after the FDA completes Phase I trials. The
only issue this case presents is a narrow one: whether the Due
Process Clause of the Constitution mandates access to
experimental drugs that have cleared Phase I of FDA testing,
such that Congress cannot protect terminally ill patients from the
risks experimental drugs present unless it uses a means narrowly
tailored toward achieving a compelling interest in limiting
access.

II.

In Glucksberg, the Supreme Court set forth a two-part test
for determining whether an asserted right is fundamental under
the Constitution. “[T]he Due Process Clause specially protects
those fundamental rights and liberties which are, objectively,
‘deeply rooted in this Nation’s history and tradition . . . .’”
Glucksberg, 521 U.S. at 720-21 (quoting Moore, 431 U.S. at
503). A right must also be “‘implicit in the concept of ordered
liberty,’ such that ‘neither liberty nor justice would exist if [it]
w[as] sacrificed.’” 521 U.S. at 721 (quoting Palko, 302 U.S. at
325). The majority properly states the Glucksberg test, but
 10

makes several critical errors in its application.

The majority structures its analysis around the first
Glucksberg inquiry—whether the claimed right is “deeply
rooted”—and gives short shrift to the second part—whether it is
part of “ordered liberty.” The majority relies upon three
common law concepts, none of which is advanced by the
Alliance, as evidence of a fundamental, deeply rooted right to
procure and use experimental drugs: (1) the common law
defense of necessity; (2) an individual’s common law interest in
being free from battery; and (3) common law liability for
interference with a rescue. The majority does not discuss,
however, evidence of a fundamental right to procure and use
experimental drugs—because none exists. In the absence of
such a tradition, the majority is left to argue for the creation of
a fundamental right from a series of inferences. Glucksberg,
mindful of the danger in courts minting new rights from an
amalgam of interests, prohibits us from creating new substantive
due process rights by inference.

Fundamental rights may “not [be] simply deduced from
abstract concepts of personal autonomy.” Glucksberg, 521 U.S.
at 725. Instead, to be fundamental, there must be evidence that
the “asserted right has any place in our Nation’s traditions.” Id.
at 723 (emphasis added). Quite simply, the majority has
provided no evidence of a right, deeply rooted in our Nation’s
history and traditions, to procure and use experimental drugs.
To the contrary, the majority concedes that new drugs have been
regulated since the early part of the last century. See Maj. Op.
at 20. But even where other “decision[s] . . . may be just as
personal and profound as the decision to refuse unwanted
medical treatment,” these other decisions are not protected as
fundamental rights if they “ha[ve] never enjoyed similar legal
protection.” Glucksberg, 521 U.S. at 725.
 11

Nor is a common law interest alone sufficient to establish
a fundamental right under the Constitution. See Glucksberg,
521 U.S. at 725 (inquiring whether a right is consistent with
“this Nation’s history and constitutional traditions”) (emphasis
added); Ingraham v. Wright, 430 U.S. 651, 673 (1977) (looking
to “‘those privileges long recognized at common law as
essential to the orderly pursuit of happiness by free men’”)
(emphasis added) (quoting Meyer v. Nebraska, 262 U.S. 390,
399 (1923)). I cannot agree that the common law concepts
discussed by the majority demonstrate a fundamental right under
Glucksberg. At common law, “[a] necessity defense
‘traditionally covered the situation where physical forces beyond
the actor’s control rendered illegal conduct the lesser of two
evils.’” United States v. Oakland Cannabis Buyers’
Cooperative, 532 U.S. 483, 490 (2001) (quoting United States
v. Bailey, 444 U.S. 394, 410 (1980)). Putting aside the
difference between a common law defense and a constitutional
right, I have serious doubt about how a court can know, as a
matter of constitutional law, that the lesser of two evils will be
achieved by providing all terminally ill patients access to all
Phase I experimental drugs, given the risks these drugs present.
In any event, the Supreme Court’s guidance in Oakland
indicates that the common law doctrine of necessity is not
deeply rooted in this Nation’s history and traditions.

In Oakland, a group of patients seeking access to marijuana
for medicinal purposes argued that “because necessity was a
defense at common law, medical necessity should be read into
the Controlled Substances Act.” Id. at 490. As an initial matter,
the Court noted that “it is an open question whether federal
courts ever have authority to recognize a necessity defense not
provided by statute.” Id. (emphasis added). “Even at common
law, the defense of necessity was somewhat controversial. And
under our constitutional system, in which federal crimes are
defined by statute rather than by common law, it is especially
 12

so.” Id. (internal citations omitted). The Court did “not decide,
however, whether necessity can ever be a defense when the
federal statute does not expressly provide for it,” id. at 491,
because “[u]nder any conception of legal necessity, one
principle is clear: The defense cannot succeed when the
legislature itself has made a determination of values,” id.
(quotation marks omitted). The structure of the FDCA does just
that: Congress has prohibited general access to experimental
drugs, see 21 U.S.C. § 355(a), and has prescribed in detail how
experimental drugs may be studied and used by the scientific
and medical communities, see id. § 355(i). Given the Supreme
Court’s conclusion that the common law defense of necessity
remains controversial and cannot override a value judgment
already determined by the legislature, I cannot see how the
majority’s proposed right is supported by the common law
doctrine of necessity.

The Supreme Court has “required in
substantive-due-process cases a careful description of the
asserted fundamental liberty interest.” Glucksberg, 521 U.S. at
721 (quotation marks omitted). The right at issue in this case,
and the right that the majority concludes has been carefully
described by the Alliance, is a right of terminally ill patients to
access potentially life-saving drugs when no alternative
treatment is available. See Maj. Op. Part III(A). The Alliance
has narrowly described its asserted right. Cf. Glucksberg, 521
U.S. at 723 (carefully-described asserted right was “a right to
commit suicide which itself includes a right to assistance in
doing so”). The majority never provides evidence, however,
that the Alliance’s asserted right is deeply rooted and implicit in
ordered liberty. Instead, the majority infers its new right from
several broad principles, none of which would meet
Glucksberg’s careful description requirement. See Maj. Op. Part
III(B), at 18 (the “right of control over one’s body”), id. (the
“right to self-defense”), id. (“the right to self-preservation”), 19-
 13

20 n.12 (“the specific right to act in order to save one’s own
life”), 24 n.24 (the “fundamental right to take action, even risky
action, free from government interference, in order to save one’s
own life”); Part III(C), at 26 (the right to “be free to decide . . .
whether to assume any known or unknown risks of taking a
medication that might prolong . . . life”), 27 n.26 (the “right of
access to life-saving treatment” with “the key [being] the
patient’s right to make her own decision free from government
interference”).

The majority concludes that these principles are deeply
rooted based upon a passage from Blackstone describing an
individual’s interest in being free from battery at common law,
see WILLIAM BLACKSTONE, 1 COMMENTARIES *129, *134, and
a provision of the Restatement discussing when one person will
be liable under the common law for preventing aid from
reaching another, see RESTATEMENT (FIRST) OF TORTS § 326
(1934). The majority infers from these principles a liberty
interest in procuring and using experimental drugs. But
Glucksberg does not authorize courts to create substantive due
process rights by inference. These principles are precisely the
type of “abstract concepts of personal autonomy” that do not
constitute evidence of a fundamental right. Glucksberg, 521
U.S. at 725. They are indeterminate concepts that cannot meet
Glucksberg’s careful description requirement. The majority has
provided no evidence that the Alliance’s “asserted right has any
place in our Nation’s traditions.” Glucksberg, 521 U.S. at 723
(emphasis added). Simply put, under Glucksberg, the Alliance’s
asserted right fails because it is not deeply rooted and implicit
in ordered liberty, and the various principles described by the
majority fail because they are not carefully described.3

3
In an effort to support its inferences from common law
interests, the majority briefly turns to several privacy cases, see Maj.
Op. at 19 n.12, 27, cases that the majority earlier concludes are not
 14

The remainder of the majority’s analysis sets out to prove
an unremarkable proposition: the federal government has only
regulated drugs for approximately 100 years. From the lack of
federal regulation prior to 1906, the majority infers a
constitutional right to be free from regulation. It is not difficult
to see the sweeping claims of fundamental rights that such an
analysis would support. Because Congress did not significantly
regulate marijuana until relatively late in the constitutional day
(i.e., 1937), see Gonzales v. Raich, 125 S.Ct. 2195, 2202, __
U.S. __, __ (2005), there must be a tradition of protecting
marijuana use. Because Congress did not regulate narcotics
until 1866 when it heavily taxed opium, a drug created long
before our Nation’s founding, see United States v. Moore, 486
F.2d 1139, 1215-16, 1218 n.50 (D.C. Cir. 1973) (Wright, J.,
dissenting), it must be that individuals have a right to acquire
and use narcotics free from regulation. But this is not the law.
A prior lack of regulation suggests that we must exercise care in
evaluating the untested assertion of a constitutional right to be
free from new regulation. Indeed, in considering an asserted
fundamental right, Glucksberg directs us to “‘exercise the
utmost care whenever we are asked to break new ground in this
field.’” 521 U.S. at 720 (quoting Collins v. Harker Heights, 503
U.S. 115, 125 (1992)). But the fact that the Government has not
always regulated a concern tells us little about whether an
individual has a constitutional right to pursue that concern. See
United States v. Morton Salt Co., 338 U.S. 632, 647 (1950)
(“The fact that powers long have been unexercised well may call
for close scrutiny as to whether they exist; but if granted, they
are not lost by being allowed to lie dormant, any more than

necessary to support its holding, see id. at 12. The majority misses the
critical distinction this case presents. The Supreme Court has never
suggested that an individual has a right to override the government’s
regulation of drug safety and to take drugs with, at best, unknown
risks and, at worst, fatal consequences.
 15

nonexistent powers can be prescripted by an unchallenged
exercise.”).

The majority devotes a great deal of analysis to the history
of the FDCA, setting out to show that, “[i]n contrast to these
ancient principles” evidenced in Blackstone and the
Restatement, “regulation of access to new drugs has a history in
this country that is of recent origin.” Maj. Op. at 20. But the
majority concedes in a footnote that it only analyzes the history
of the FDCA to “establish that the Government has [not]
acquired title to this right by adverse possession.” Id. at 24 n.24.
Thus, the majority appears to agree that the history of the FDCA
provides no evidence, under Glucksberg, that would help the
Alliance meet its burden. That is, the history of the FDCA does
not demonstrate a tradition protecting an individual’s right to
procure and use experimental drugs; it only establishes that the
federal government has not always regulated experimental
drugs.

The majority also fails to recognize that drug regulation did
not begin with the FDCA. In England, “when the Society of
Apothecaries [i.e., pharmacists] was chartered independently
([in] 1617), its master and wardens were empowered to inspect
any pharmacy and to burn before the offender’s door all drugs
and preparations they deemed corrupt or unwholesome.”
EDWARD KREMERS, KREMERS AND URDANG’S HISTORY OF
PHARMACY 111 (4th ed. 1976). “In the 18th century, power to
examine the shops of apothecaries, chemists and druggists was
given to the College of Physicians ([in] 1723), and cases
involving questionable drugs were judged by a court composed
partly of physicians and partly of apothecaries ([in] 1730).” Id.
at 111-12.

In this Nation, the Colony of Virginia passed an act in 1736
addressing the dispensing of more drugs than was “necessary or
 16

useful” because that practice had become “dangerous and
intolerable.” Id. at 158.4 The Territory of Orleans (Louisiana)
passed an act in 1808 requiring a diploma and an examination in
order for pharmacists to dispense drugs and thus grant access to
the public; Louisiana also prohibited the sale of deteriorated
drugs and restricted the sale of poisons. Id. at 182-84, 214; see
David L. Cowen, The Development of State Pharmaceutical
Law, PHARMACY IN HISTORY, Vol. 37 No. 2, 1995, at 49, 54
(noting that the 1808 act prohibited the sale of drugs that were
“injured, moulded, discomposed, or sophisticated” and placed
restrictions on the sale of “any suspicious or dangerous
remedy”). South Carolina enacted legislation in 1817 requiring
pharmacists to obtain licenses, Kremers, supra, at 184, 214,
followed by Georgia in 1825 and Alabama in 1852, id. at 214.
By 1870, at least twenty-five states or territories had statutes

4
Specifically, Virginia’s act regulated “the Practice of
Physic[] in this Colony.” Id. The Act noted that physic (the art or
practice of healing disease, by, among other things, dispensing drugs)
“is most commonly taken up and followed, by Surgeons,
Apothecaries, or such as have only served Apprenticeships to those
Trades, who often prove very unskillful in the Art of a Physician” and
sought to address the concern that

too often, for the Sake of making up long and
expensive Bills, [surgeons, apothecaries, and their
apprentices] load their Patients with greater
Quantities thereof, than are necessary or useful,
concealing all their Compositions, as well to prevent
the Discovery of their Practice, as of the true Value of
what they administer; which is become a Grievance,
dangerous and intolerable, as well to the poorer Sort
of People, as others.

Id. (emphasis added).
 17

regulating adulteration, and a few others had laws addressing
poisons. Id. at 216. The history of drug regulation in this
country does not evidence a tradition of protecting a right of
access to drugs; instead, it evidences government responding to
new risks as they are presented. See Cowen, supra, at 56 (“The
history of state laws pertaining to pharmacy obviously reflect[s]
the development of pharmacy scientifically, professionally, and
economically.”). The majority’s historical analysis of the FDCA
demonstrates that Congress has expressed a keen interest in
regulating drugs as science has progressed. Congress has
responded to evolving medical technology with evolving
regulation. But, unlike the majority, I do not see how the
decision by Congress to regulate an area of concern in the early
part of the twentieth century demonstrates a fundamental right
to be free from regulation today.

Nor does the majority’s analogy to Cruzan v. Director,
Missouri Department of Health, 497 U.S. 261 (1990), and forced
medication at common law explain why there is a fundamental,
deeply rooted right to “self-preservation,” Maj. Op. at 30,
protecting a “terminally ill, mentally competent adult patient’s
informed access to potentially life-saving investigational new
drugs determined by the FDA after Phase I trials to be
sufficiently safe for expanded human trials,” id. at 29. In
Cruzan, the Supreme Court “assume[d] that the United States
Constitution would grant a competent person a constitutionally
protected right to refuse lifesaving hydration and nutrition,”
although the Court indicated that “the dramatic consequences
involved in [a particular] refusal of [life-sustaining] treatment
would inform the inquiry as to whether the deprivation of that
interest is constitutionally permissible.” 497 U.S. at 279. The
Court’s assumption that there is a right to refuse lifesaving
treatment in some circumstances was predicated upon “the
common-law rule that forced medication was a battery[] and the
long legal tradition protecting the decision to refuse unwanted
 18

medical treatment.” Glucksberg, 521 U.S. at 725 (discussing
Cruzan); see Cruzan, 497 U.S. at 269. But a tradition protecting
individual freedom from life-saving, but forced, medical
treatment does not evidence a constitutional tradition of
providing affirmative access to a potentially harmful, and even
fatal, commercial good.5

In light of Cruzan’s discussion of the “right of a competent
individual to refuse medical treatment,” see 497 U.S. at 277
(emphasis added), the majority attempts to limit its new right to
a patient who is “mentally competent” and has “informed
access” to experimental drugs. Maj. Op. at 29. The majority
never explains what mental competence, in this context, would
require. As the FDA noted in response to the Alliance’s
proposal, “with so little data available, it is hard to understand
how a patient could be truly informed about the risks—or
potential benefits—associated with the drug.” By injecting
patients into an early stage of the FDA’s process for testing
experimental drugs, the majority’s approach allows terminally
ill patients to take experimental drugs unknowingly—that is,
without anyone having knowledge of potential risks and
benefits. I fail to see how such a right is supported by Cruzan.
Cruzan rejected an argument that an incompetent person has a

5
The majority argues that “Cruzan recognized . . . that an
individual has a due process right to make an informed decision to
engage in conduct, by withdrawing treatment, that will cause one’s
death.” Maj. Op. at 26 (emphasis added). As Glucksberg specifically
noted, however, in rejecting the argument that there is a fundamental
right to commit suicide and receive assistance in doing so (i.e., engage
in conduct that will cause one’s death), “although Cruzan is often
described as a ‘right to die’ case, [the Supreme Court] w[as], in fact,
more precise: [the Court] assumed that the Constitution granted
competent persons a ‘constitutionally protected right to refuse
lifesaving hydration and nutrition.’” Glucksberg, 521 U.S. at 722-23
(quoting Cruzan, 497 U.S. at 279) (emphasis added).
 19

right to withdraw treatment absent intent expressed while
competent and, instead, upheld a state’s requirement of clear and
convincing prior evidence regarding an incompetent person’s
wishes to withdraw treatment. 497 U.S. at 279-80. As the Court
explained, “[t]he difficulty with petitioners’ claim is that in a
sense it begs the question: An incompetent person is not able to
make an informed and voluntary choice to exercise a
hypothetical right to refuse treatment or any other right.” Id. at
280. Under the majority’s decision, terminally ill patients seem
to have a right to make an uninformed and involuntary choice.

It does not help the majority’s cause that the Supreme Court
has rejected several similar challenges to the FDCA and related
laws brought on statutory grounds. See, e.g., Raich, 125 S.Ct.
at 2212, __U.S. at __ (“the dispensing of new drugs, even when
doctors approve their use, must await federal approval”); United
States v. Rutherford, 442 U.S. 544, 552 (1979) (“we are
persuaded by the legislative history and consistent
administrative interpretation of the [FDCA] that no implicit
exemption for drugs used by the terminally ill is necessary to
attain congressional objectives”); cf. Oakland, 532 U.S. at 490
(with respect to whether there is an implied “medical necessity”
exemption to prosecution for marijuana use under the Controlled
Substances Act, generally speaking, “[w]hether, as a policy
matter, an exemption should be created is a question for
legislative judgment, not judicial inference”) (quotation marks
omitted). To be sure, the Supreme Court has not addressed the
constitutional argument raised by the Alliance. But contrary to
the tradition asserted by the majority, there is a tradition of
courts rejecting arguments that the Constitution provides an
affirmative right of access to particular medical treatments
reasonably prohibited by the Government.6

6
No circuit court has acceded to an affirmative access claim.
See, e.g., Mitchell v. Clayton, 995 F.2d 772, 775 (7th Cir. 1993)
 20

(“most federal courts have held that a patient does not have a
constitutional right to obtain a particular type of treatment or to obtain
treatment from a particular provider if the government has reasonably
prohibited that type of treatment or provider”); N.Y. State
Ophthalmological Soc’y v. Bowen, 854 F.2d 1379, 1389 (D.C. Cir.
1988) (“We disagree that the constitutional right to privacy
comprehensively protects all choices made by patients and their
physicians or subjects to ‘strict scrutiny’ all government interference
with choice of medical treatment. There is no basis under current
privacy case law for extending such stringent protection to every
decision bearing, however indirectly, on a person’s health and physical
well-being.”), cert. denied, 490 U.S. 1098 (1989); Carnohan v. United
States, 616 F.2d 1120, 1122 (9th Cir. 1980) (“Constitutional rights of
privacy and personal liberty do not give individuals the right to obtain
[the cancer drug] laetrile free of the lawful exercise of government
police power.”); Rutherford v. United States, 616 F.2d 455, 457 (10th
Cir. 1980) (“[T]he patient[’s] . . . selection of a particular treatment,
or at least a medication, is within the area of governmental interest in
protecting public health. The premarketing requirement of the
[FDCA], 21 U.S.C. § 355, is an exercise of Congressional authority to
limit the patient’s choice of medication. This is clear under the
[Supreme Court’s] decisions . . . .”), on remand from 442 U.S. 544
(1979), cert. denied, 449 U.S. 937 (1980); see also Sammon v. N.J.
Bd. of Med. Examiners, 66 F.3d 639, 645 n.10 (3d Cir. 1995); United
States v. Burzynski Cancer Research Inst., 819 F.2d 1301, 1313-14
(5th Cir. 1987); cf. Lambert v. Yellowley, 272 U.S. 581, 588, 590, 596-
97 (1926) (where Congress determined, in implementing Prohibition,
that “practicing physicians differ about the value of malt, vinous, and
spirituous liquors for medicinal purposes, [and] that the
preponderating opinion is against their use for such purposes,” the
Court rejected a physician’s claim of a constitutional right to
“use . . . such medicines and medical treatment as in his opinion are
best calculated to effect [his patients’] cure and establish their health,”
holding that “there is no right to practice medicine which is not
subordinate . . . to the power of Congress to make laws necessary and
proper . . . . High medical authority being in conflict as to the
medicinal value of spirituous and vinous liquors taken as a beverage,
 21

The decision to procure and use experimental drugs has
never enjoyed legal protection, let alone risen to the level of a
“fundamental right[] and libert[y] which [is], objectively, deeply
rooted in this Nation’s history and tradition.” Glucksberg, 521
U.S. at 720-21 (quotation marks omitted). The amendments
made to the FDCA by Congress throughout the twentieth
century, see Maj. Op. 20-24, show that Congress, and the FDA,
have responded continuously to new risks presented by an
evolving technology. Indeed, because the risks and benefits
presented by new experimental drugs are different with each
new drug, the majority is not even sure what level of access its
constitutional right will provide. The majority suggests that
terminally ill patients have a right to “potentially life-saving
treatment,” id. at 19, although the majority appears to exempt
the Controlled Substances Act and state regulation from its
constitutional right, id. at 14, 18 & n.11. The majority’s vague
allusion to potentially life-saving drugs demonstrates its
difficulty in explaining what drugs its constitutional right
protects. That difficulty arises because at issue here is a novel
and unfamiliar area of science. The Alliance contends that
patients would be better served by allowing them to assume
unknown risks regardless of whether any benefit of an
experimental drug remains uncertain. The FDA disagrees and
concludes that terminally ill patients will be best served by
receiving experimental drugs only when there is “reasonable
knowledge for patients and physicians of their likely clinical

it would, indeed, be strange if Congress lacked the power to determine
that the necessities of the liquor problem require a limitation of
permissible prescriptions . . . .”); Watson v. Maryland, 218 U.S. 173,
176 (1910) (“It is too well settled to require discussion at this day that
the police power of the states extends to the regulation of certain
trades and callings, particularly those which closely concern the public
health. There is perhaps no profession more properly open to such
regulation than that which embraces the practitioners of medicine.”).
 22

benefit and their toxicity.” But “[t]he only certain thing that can
be said about the present state of knowledge and therapy . . . is
that science has not reached finality of judgment . . . . Certainly,
denial of constitutional power . . . to Congress in dealing with a
situation like this ought not to rest on dogmatic adherence to one
view or another on controversial psychiatric issues.”
Greenwood v. United States, 350 U.S. 366, 375-76 (1956).
Greenwood addressed an issue of psychiatry, but the same
principle applies to the disputed scientific and medical issues in
this case. In my view, the majority has made its own judgment
about the medical benefits and risks of providing experimental
drugs to terminally ill patients. That is a role Congress has
rightly occupied and has, through the exercise of its Article I
powers, delegated to the FDA for enforcement.

Our Nation’s “‘concept of ordered liberty,’” Glucksberg,
521 U.S. at 721 (quoting Palko, 302 U.S. at 325-26), does not
contemplate that judges should resolve the scientific
uncertainties presented by experimental drugs. The Supreme
Court has “recognized repeatedly the ‘uncertainty of diagnosis
in this field and the tentativeness of professional judgment.’”
Jones v. United States, 463 U.S. 354, 365 n.13 (1983) (quoting
Greenwood, 350 U.S. at 375) (rejecting an argument that
Congress could not constitutionally provide for commitment of
the mentally ill based upon a prior criminal act because, a
litigant argued, his proffered psychiatric research showed that
prior dangerous acts do not predict future dangerousness). “The
lesson [the Court] ha[s] drawn is not that government may not
act in the face of this uncertainty, but rather that courts should
pay particular deference to reasonable legislative judgments.”
Jones, 463 U.S. at 365 n.13. In my view, the majority’s
approach injects courts into unknown questions of science and
medicine and does so contrary to the expressed will of Congress
and the Executive and to the deference courts owe the
democratic branches on such controversial matters.
 23

“These disagreements” over scientific and medical issues
“do not tie the [Government’s] hands in setting the bounds of
its . . . laws. In fact, it is precisely where such disagreement
exists that legislatures have been afforded the widest latitude in
drafting such statutes.” Kansas v. Hendricks, 521 U.S. 346,
356-60 & n.3 (1997) (state’s civil commitment statute
comported with substantive due process in requiring
commitment of a pedophile where “psychiatric professionals
[were] not in complete harmony in casting pedophilia . . . as
‘mental illnesses;’” although other states would not have
required civil commitment, legislature was due wide latitude in
light of medical disagreement). The majority suggests that
drugs which have completed Phase I testing bear a sufficiently
small medical risk. The majority confidently makes that
scientific judgment, but I cannot. These drugs are experimental
by their very nature. Unlike the FDA, see 21 U.S.C. § 355(n),
we do not have Congressionally-provided scientific advisory
panels at our disposal. “When Congress undertakes to act in
areas fraught with medical and scientific uncertainties,
legislative options must be especially broad and courts should be
cautious not to rewrite legislation, even assuming, arguendo,
that judges with more direct exposure to the problem might
make wiser choices.” Marshall v. United States, 414 U.S. 417,
427 (1974).

Our Nation’s history and traditions contemplate that the
democratic branches will achieve balances between the
uncertain risks and benefits of medical technology. See
Jacobson v. Massachusetts, 197 U.S. 11, 30 (1905) (“We must
assume that, when the statute in question was passed, the
legislature . . . was not unaware of these opposing theories, and
was compelled, of necessity, to choose between them. It was
not compelled to commit a matter involving the public health
and safety to the final decision of a court or jury. It is no part of
the function of a court or a jury to determine which one of two
 24

modes was likely to be the most effective for the protection of
the public against disease.”). Our Nation’s concept of ordered
liberty, along with our traditions and history, do not call for
courts to usurp the judgment of the scientific and medical
communities, expressed through Congress and the Executive
Branch, that science does not warrant allowing the early access
to experimental drugs the Alliance demands.

III.

The majority’s new right to procure and use experimental
drugs raises a number of vexing questions that are now
constitutional issues, potentially insulated from the tug and pull
of the political process. If a terminally ill patient has such a
right, are patients with serious medical conditions entitled to the
benefit of the same logic and corresponding access? If an
indigent cannot afford potentially life-saving treatment, would
the Constitution mandate access to such care under the right
recognized by the majority? Can a patient access any drug (i.e.,
marijuana for medicinal purposes, see Raich, 125 S.Ct at 2215,
__ U.S. at __) if she believes, in consultation with a physician,
it is potentially life-saving? Would the majority’s right
guarantee access to federally-funded stem cell research and
treatment? Perhaps most significantly, what potential must a
treatment have in order for the Constitution to mandate access?

Because the majority does not answer this last question, the
District Court faces an impossible task on remand. The majority
concludes that the District Court must “determine whether the
FDA’s policy barring access to post-Phase I investigational new
drugs by terminally ill patients is narrowly tailored to serve a
compelling governmental interest.” Maj. Op at 30. As a
preliminary matter, the majority never explains why the District
Court must determine that the FDA has a compelling, narrowly
tailored interest in preventing access to all drugs that have
 25

passed or will pass Phase I. Just this term, the Supreme Court
reminded the Court of Appeals that “when confronting a
constitutional flaw in a statute, we try to limit the solution to the
problem. We prefer, for example, to enjoin only the
unconstitutional applications of a statute while leaving other
applications in force . . . .” Ayotte v. Planned Parenthood of N.
New England, 126 S.Ct. 961, 967, __ U.S. __, __ (2006) (citing
United States v. Raines, 362 U.S. 17, 20-22 (1960)). Rather than
requiring the District Court to determine whether all terminally
ill patients should have access to all experimental drugs after
Phase I testing, it remains unclear why the District Court should
not undertake the more restrained inquiry of whether the
majority’s right guarantees access to the specific drugs sought
by individual members of the Alliance.

Under the majority’s facial approach, the District Court
must examine every drug undergoing FDA testing and every
drug that may ever undergo FDA testing. It must then evaluate
whether the FDCA’s prohibition on access to unapproved drugs
and corresponding exemptions for limited access serve a
compelling interest and are narrowly tailored in light of all of
the different potential risks and benefits of all experimental
drugs and the needs of all terminally ill patients. Although the
Government most likely will show that it has a compelling
interest in regulating access to drugs with unknown toxicity and
the potential to hasten death, the unknown risks and benefits of
these experimental drugs will make nearly impossible a judicial
examination of whether some level of access short of a
prohibition would be more narrowly tailored to protect the
majority’s constitutional right of access.

Moreover, the level of benefit a patient will have to show,
in order to demonstrate that under the majority’s right a drug is
potentially life-saving, remains an enigma. Whatever the
majority means by “potentially,” its use of that term suggests
 26

that some drugs will not demonstrate enough potential benefit,
while simultaneously presenting extraordinary risks.
Considering the potential benefits of an experimental drug in
light of its risks will require the District Court to step into the
role of the FDA. Before today, scientists and physicians at the
FDA, in consultation with the greater scientific and medical
communities through scientific advisory panels, applied limited
and often disputed scientific knowledge about an experimental
drug in determining what level of access should be given to
terminally ill patients and what medical circumstances warrant
such access. Under the majority’s approach, the United States
District Court for the District of Columbia must now evaluate
limited scientific knowledge about a Phase I drug and determine
whether that drug is potentially life-saving enough to require
constitutional protection.

Because the Alliance has failed to present objective
evidence establishing a deeply rooted right to procure and use
experimental drugs, I would apply rational basis review to its
due process challenge. See Glucksberg, 521 U.S. at 728. As the
Supreme Court held in rejecting a challenge by terminally ill
patients claiming that the FDCA’s safety requirement did not
apply to them, “the [FDA] generally considers a drug safe when
the expected therapeutic gain justifies the risk entailed by its
use. For the terminally ill, as for anyone else, a drug is unsafe
if its potential for inflicting death or physical injury is not offset
by the possibility of therapeutic benefit.” Rutherford, 442 U.S.
at 555-56. Although terminally ill patients desperately need
curative treatments, their death can certainly be hastened by the
use of a toxic drug. Prior to distribution of a drug outside of
controlled studies, the Government has a rational basis for
ensuring that there is a scientifically and medically acceptable
level of knowledge about the risks and benefits of such a drug.
I would affirm the decision of the District Court.