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.