Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-04-05350/USCOURTS-caDC-04-05350-2/pdf.json

Nature of Suit Code: 440
Nature of Suit: Other Civil Rights
Cause of Action: 

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United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued March 1, 2007 Decided August 7, 2007

No. 04-5350

ABIGAIL ALLIANCE FOR BETTER ACCESS TO

DEVELOPMENTAL DRUGS AND

WASHINGTON LEGAL FOUNDATION,

APPELLANTS

v.

ANDREW VON ESCHENBACH,

IN HIS OFFICIAL CAPACITY AS 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)

J. Scott Ballenger argued the cause for appellants. With

him on the briefs were Daniel J. Popeo, David A. Price, and

Richard A. Samp.

Brian P. Brooks and Arthur W.S. Duff were on the brief for

amici curiae John E. Calfee, et al. in support of appellants.

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John J. Edmonds was on the brief for amici curiae Emil

Freireich and Stephen Strum in support of appellants.

Jonathan F. Cohn, Deputy Assistant Attorney General,

U.S. Department of Justice, argued the cause for appellees.

With him on the brief were Peter D. Keisler, Assistant Attorney

General, Jeffrey A. Taylor, U.S. Attorney, Jeffrey S. Bucholtz,

Principal Deputy Assistant Attorney General, Michael J. Ryan

and Rhonda C. Fields, Assistant U.S. Attorneys, Mark B. Stern

and Scott R. McIntosh, Attorneys, Daniel Meron, General

Counsel, U.S. Department of Health and Human Services, Eric

M. Blumberg, Deputy Chief Counsel for Litigation, and Karen

E. Schifter, Associate Chief Counsel. R. Craig Lawrence,

Assistant U.S. Attorney, entered an appearance.

Samuel D. Turner was on the brief for amici curiae

American Society of Clinical Oncology, et al. in support of

appellees.

William B. Schultz was on the brief for amici curiae

National Organization for Rare Disorders, et al. in support of

appellees.

Before: GINSBURG, Chief Judge, SENTELLE, HENDERSON,

RANDOLPH,ROGERS,TATEL,GARLAND,BROWN,GRIFFITH, and

KAVANAUGH, Circuit Judges.

Opinion for the Court filed by Circuit Judge GRIFFITH.

Dissenting opinion filed by Circuit Judge ROGERS, with

whom Chief Judge GINSBURG joins.

GRIFFITH, Circuit Judge: This case presents the question

whether the Constitution provides terminally ill patients a right

of access to experimental drugs that have passed limited safety

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trials but have not been proven safe and effective. The district

court held there is no such right. A divided panel of this Court

held there is. Because we conclude that there is no fundamental

right “deeply rooted in this Nation’s history and tradition” of

access to experimental drugs for the terminally ill, see

Washington v. Glucksberg, 521 U.S. 702, 720-21 (1997)

(quoting Moore v. East Cleveland, 431 U.S. 494, 503 (1977)

(plurality opinion)), we affirm the judgment of the district court.

I.

A.

The Abigail Alliance for Better Access to Developmental

Drugs (the “Alliance”) is an organization of terminally ill

patients and their supporters that seeks expanded access to

experimental drugs for the terminally ill. The Food, Drug, and

Cosmetic Act (“FDCA” or “Act”), however, generally prohibits

access to new drugs unless and until they have been approved by

the Food and Drug Administration (“FDA”). See 21 U.S.C.

§ 355(a). Gaining FDA approval can be a long process. First,

an experimental drug’s sponsor (e.g., a drug company) must

submit an application for approval. See id. § 355(a). Because

no drug may be approved without a finding of “substantial

evidence that the drug will have the effect it purports or is

represented to have,” id. § 355(d)(5), an 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). Such reports rely

in large measure on clinical trials with human subjects.

But before a sponsor can even begin human testing, it 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

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1

 In FDA parlance, experimental drugs that have not yet been

approved for public use are deemed “investigational drug[s].” See 21

C.F.R. § 312.3(b).

testing is appropriate, see 21 C.F.R. § 312.23. Once the

application for human testing has been approved, see id.

§ 312.20, several phases of clinical testing begin. The

Alliance’s amended complaint alleges that this testing process

is an extremely lengthy one, requiring nearly seven years for the

average experimental drug.1

 Am. Compl. ¶ 15. 

Clinical testing for safety and effectiveness requires three

or sometimes four phases. See 21 C.F.R. § 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). Although

gathering data on effectiveness may be part of Phase I, its

primary focus is to determine whether the drug is safe enough

for continued human testing. See id. Phase II studies are “well

controlled” and “closely monitored” clinical trials of no more

than several hundred subjects, used to evaluate both the

“effectiveness of the drug for a particular indication” and its

“common short-term side effects and risks.” Id. § 312.21(b). 

Phase III studies are expanded clinical trials of several

hundred to several thousand subjects designed to

“gather . . . additional information about effectiveness and safety

that is needed to evaluate the overall benefit-risk relationship of

the drug and to provide an adequate basis for physician

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2

 In some circumstances, a Phase IV review is conducted,

which “delineate[s] additional information about the drug’s risks,

benefits, and optimal use.” 21 C.F.R. § 312.85. 

3

 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,

pharmacology, pharmacoeconomics, biological and

physical sciences, and other related professions;

(C) a representative of consumer interests, and a

labeling.” Id. § 312.21(c).2 At any time during the clinical

trials, a drug sponsor is required to notify the FDA of “[a]ny

adverse experience associated with the use of the drug that is

both serious and unexpected,” id. § 312.32(c)(1)(A), and the

FDA may order a “clinical hold” halting the trials if it

determines that safety concerns so warrant, id. § 312.42. To

guide the clinical testing 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). These panels must

include scientists from a variety of disciplines. See id.

§ 355(n)(3).3

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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.

4

 The FDA has several other regulatory programs designed to

hasten research of the safety and effectiveness of drugs for terminally

or severely ill patients and allow early access where scientifically and

Terminally ill patients need not, however, always await the

results of the clinical testing process. The FDA and Congress

have created several programs designed to provide early access

to promising experimental drugs when warranted. For example,

under the “treatment IND” program, the FDA may approve use

of an investigational drug by patients not part of the clinical

trials for the treatment of “serious or immediately lifethreatening disease[s]” if there exists “no comparable or

satisfactory alternative drug or other therapy,” 21 C.F.R.

§ 312.34(a), (b)(1)(i)-(ii); if “[t]he drug is under investigation in

a controlled clinical trial,” id. § 312.34(b)(1)(iii); and if the

drug’s sponsor “is actively pursuing marketing approval of the

investigational drug with due diligence,” id. § 312.34(b)(1)(iv).

The FDA reserves the right, however, to deny any treatment

IND request if (1) the agency believes there is no “reasonable

basis” to conclude that the drug is effective; or (2) granting the

request “[w]ould . . . expose the patient[] . . . to an unreasonable

and significant additional risk of illness or injury.” Id.

§ 312.34(b)(3). Sponsors may not profit from any approved

treatment IND program and may only “recover costs of

manufacture, research, development, and handling of the

investigational drug.” Id. § 312.7(d)(3).4

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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 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. 

B.

Concluding that the FDA’s current process for early access

to new drugs was inadequate to meet the needs of its terminally

ill members, the Alliance submitted its own proposals to the

FDA. Those proposals culminated in a “citizen petition” to the

FDA, see 21 C.F.R. § 10.25, arguing that there is a “different

risk-benefit tradeoff facing patients who are terminally ill and

who have no other treatment options.” Abigail Alliance Citizen

Petition, In re Tier 1 Initial Approval Program to Expedite the

Availability of Lifesaving Drugs 9 (June 11, 2003). 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 . . . [,] these steps may well entail a delay that is

fatal” for terminally ill patients. Id. The Alliance contended

that these patients “should have the ability to opt for a new

treatment that has met a lower evidentiary hurdle with respect to

safety and efficacy.” Id. The Alliance’s proposal suggested that

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the FDA allow early access based upon “the risk of illness,

injury, or death from the disease in the absence of the drug.” Id.

at 4. Accordingly, the Alliance requested that the FDA

promulgate new regulations that would allow sponsors to market

experimental drugs, under some circumstances, after the

completion of Phase I trials. 

The FDA never responded to the Alliance’s citizen petition,

but did respond to the Alliance’s earlier submissions. After

noting that a number of senior FDA officials had reviewed those

submissions, the agency 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.” Letter from Peter J.

Pitts, Associate Commissioner for External Relations,

Department of Health and Human Services, to Frank Burroughs,

President, Abigail Alliance for Better Access to Developmental

Drugs 3 (Apr. 25, 2003). The officials concluded that the early

access proposed by the Alliance “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.” Id. at 4. 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.” Id. 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.” Id.

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Relying upon its experience exercising its scientific and

medical judgment in creating its regulations for experimental

drugs and, in certain circumstances, exceptions to those

regulations for the terminally ill, the FDA noted 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.

Id. For example, most experimental cancer drugs “have

potentially lethal toxicity, with potentially large effects on a

patient’s remaining quality of life.” Id. Accordingly, “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.” Id. at 4-5.

The FDA concluded that accepting the Alliance’s proposal

“would upset the appropriate balance that [it 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.” Id.

at 5. 

Having thus been rejected by the FDA, the Alliance turned

to the courts, arguing that the United States Constitution

provides a right of access to experimental drugs for its members.

In a complaint that mirrored much of its earlier submissions to

the FDA, the Alliance argued that the FDA’s lengthy clinical

trials, combined with the “FDA’s restrictions on pre-approval

availability[,] amount to a death sentence for these [terminally

ill] patients.” Am. Compl. ¶¶ 15-17. Nor, the Alliance argues,

are the FDA’s exceptions to the clinical testing process

sufficient to provide the terminally ill the access they need

because they “are small, when they exist at all,” and the ban on

profits prevents many drug sponsors from participating. Id.

¶ 18.

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“Terminally ill patients,” in the Alliance’s view, “are

typically willing to assume risks . . . .” Id. ¶ 19. Before the

district court, the Alliance argued that the Constitution

guarantees them the right to do so. The district court rejected

that argument, holding that “there is no constitutional right of

access to unapproved drugs.” Abigail Alliance for Better Access

to Developmental Drugs v. McClellan, No. 03-1601, 2004 WL

3777340, at *1 (D.D.C. Aug. 30, 2004). A divided panel of this

Court reversed, concluding 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.”

Abigail Alliance for Better Access to Developmental Drugs v.

von Eschenbach, 445 F.3d 470, 486 (D.C. Cir. 2006). We

vacated that decision and granted rehearing en banc. See

Abigail Alliance for Better Access to Developmental Drugs v.

von Eschenbach, No. 04-5350 (D.C. Cir. Nov. 21, 2006).

As framed by the Alliance, we now consider:

Whether the liberty protected by the Due Process

Clause embraces the right of a terminally ill

patient with no remaining approved treatment

options to decide, in consultation with his or her

own doctor, whether to seek access to

investigational medications that the [FDA]

concedes are safe and promising enough for

substantial human testing.

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5

 The dissent has recast the Alliance’s proposed right away

from the terms used in its briefs and oral argument—a right to access

investigational new drugs—into a right “to try to save one’s life,”

which has “its textual anchor in the right to life [expressed in the Fifth

Amendment].” Dissent at 2-3. Regardless of how it is described, we

must examine the proposed right under Glucksberg, which specifically

cautions against the type of broad generalization the dissent now

employs. See Glucksberg, 521 U.S. at 721 (requiring a “‘careful

description’ of the asserted fundamental liberty interest”). If the

asserted right is so broad that it protects a person’s efforts to save his

life, it might subject to strict scrutiny any government action that

would affect the means by which he sought to do so, no matter how

remote the chance of success. The Supreme Court rejected a similar

attempt to broadly define the right at issue in Reno v. Flores when it

refused to accept the petitioner’s definition as the “freedom from

physical restraint” and instead cast the right as the “right of a child

who has no available parent, close relative, or legal guardian, and for

whom the government is responsible, to be placed in the custody of a

willing-and-able private custodian rather than of a

government-operated or government-selected child-care institution.”

Reno v. Flores, 507 U.S. 292, 302 (1993). The dissent suffers from

the same flaw in arguing that this is about the right to save one’s life,

because, in the end, this case is about the right to access experimental

and unproven drugs in an attempt to save one’s life, which we

conclude under Glucksberg is not deeply rooted in our Nation’s

history and traditions. By describing too broadly at the outset a

proposed right that will cover the Alliance’s more narrow claim, the

dissent fails Glucksberg’s threshold requirement of a carefully

described right. We need not pursue the arguments that follow that

initial misstep.

Appellants’ Br. at 1.5 That is, we must determine whether

terminally ill patients have a fundamental right to experimental

drugs that have passed Phase I clinical testing. If such a right

exists, the Alliance argues that both 21 C.F.R. § 312.34(b)(3)

(preventing access to experimental drugs for terminally ill

patients where there is insufficient evidence of effectiveness or

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where there is an unreasonable risk of injury) and 21 C.F.R.

§ 312.7 (prohibiting drug manufacturers from profiting on the

sale of experimental drugs) must be subjected to strict scrutiny

because they interfere with a fundamental constitutional right.

We do not address the broader question of whether access to

medicine might ever implicate fundamental rights.

II.

The Due Process Clause of the Fifth Amendment 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 protections of the

Amendment “guarantee[] more than fair process.” Glucksberg,

521 U.S. at 719. The Court has stated that “[t]he Clause . . .

provides heightened protection against government interference

with certain fundamental rights and liberty interests,” id. at 720

(citing Reno v. Flores, 507 U.S. 292, 301-02 (1993); Planned

Parenthood of Se. Pa. v. Casey, 505 U.S. 833, 851 (1992)),

including “the rights to marry, to have children, to direct the

education and upbringing of one’s children, to marital privacy,

to use contraception, to bodily integrity, and to abortion,”

Glucksberg, 521 U.S. at 720 (citations omitted).

As such rights are not set forth in the language of the

Constitution, the Supreme Court has cautioned against

expanding the substantive rights protected by the Due Process

Clause “because guideposts for responsible decisionmaking in

this unchartered area are scarce and open-ended.” Collins v.

Harker Heights, 503 U.S. 115, 125 (1992) (citing Regents of

Univ. of Mich. v. Ewing, 474 U.S. 214, 225-26 (1985)). There

is an additional and substantial concern that courts must also

consider: “By extending constitutional protection to an asserted

right or liberty interest, we, to a great extent, place the matter

outside the arena of public debate and legislative action.”

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Glucksberg, 521 U.S. at 720. Thus, the Supreme Court has

directed courts to “exercise the utmost care whenever we are

asked to break new ground in this field, lest the liberty protected

by the Due Process Clause be subtly transformed into the policy

preferences of the [courts’ members].” Id. (quotation marks and

citations omitted); see Moore, 431 U.S. at 502 (“As the history

of the Lochner era demonstrates, there is reason for concern lest

the only limits to such judicial intervention become the

predilections of those who happen at the time to be Members of

this Court.”) (footnote omitted).

In Glucksberg, the Supreme Court described its

“established method of substantive-due-process analysis” as

having “two primary features.” Glucksberg, 521 U.S. at 720. 

First, we have regularly observed that the Due

Process Clause specially protects those

fundamental rights and liberties which are,

objectively, deeply rooted in this Nation’s history

and tradition and implicit in the concept of

ordered liberty, such that neither liberty nor

justice would exist if they were sacrificed.

Second, we have required in

substantive-due-process cases a careful

description of the asserted fundamental liberty

interest.

 

Id. at 720-21 (quotation marks and citations omitted).

We will assume arguendo that the Alliance’s description of

its asserted right would satisfy Glucksberg’s “careful

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6

 We nonetheless have serious doubt about whether the

Alliance’s description of its proposed constitutional right could ever

pass constitutional muster. The Alliance’s claimed right depends on

a regulatory determination that the drug is safe for testing, prompting

an obvious question: How can a constitutional right be defined by an

administrative regulation that is subject to change? Would an FDA

decision requiring increased testing for safety and efficacy before the

commencement of human clinical trials affect the Alliance’s

constitutional right? Moreover, we find it difficult to imagine how a

right inextricably entangled with the details of shifting administrative

regulations could be “deeply rooted in this Nation’s history and

tradition and implicit in the concept of ordered liberty.” Glucksberg,

521 U.S. at 721 (quotation marks and citations omitted).

description” requirement.6 Looking to whether the Alliance has

demonstrated that its right is deeply rooted in this Nation’s

history, tradition, and practices, the Alliance’s claim for

constitutional protection rests on two arguments: (1) that

“common law and historical American practices have

traditionally trusted individual doctors and their patients with

almost complete autonomy to evaluate the efficacy of medical

treatments”; and (2) that FDA policy is “inconsistent with the

way that our legal tradition treats persons in all other lifethreatening situations.” Appellants’ Br. at 31. More

specifically, the Alliance argues that the concepts of selfdefense, necessity, and interference with rescue are broad

enough to demonstrate the existence of the fundamental right

they seek—a right for “persons in mortal peril” to “try to save

their own lives, even if the chosen means would otherwise be

illegal or involve enormous risks.” Id. at 32. 

A.

“We begin, as we do in all due process cases, by examining

our Nation’s history, legal traditions, and practices.”

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Glucksberg, 521 U.S. at 710. The Alliance argues that its right

can be found in our history and legal traditions because “the

government never interfered with the judgment of individual

doctors about the medical efficacy of particular drugs until

1962,” i.e., when major amendments were made to the Food,

Drug, and Cosmetic Act. Appellants’ Br. at 44 (emphasis

added); see id. at 23 (“[T]he common law consistently left

judgments about the efficacy of medical treatments in the hands

of individual doctors and their patients. Governmental review

of the effectiveness of drugs did not exist in this country at all

until 1962 . . . .”) (emphasis added).

The Alliance has little to say, however, about our Nation’s

history of regulating the safety of drugs. The Alliance’s effort

to focus on efficacy regulation ignores one simple fact: it is

unlawful for the Alliance to procure experimental drugs not only

because they have not been proven effective, but because they

have not been proven safe. Although the Alliance contends that

it only wants drugs that “are safe and promising enough for

substantial human testing,” id. at 1, i.e., drugs that have passed

Phase I testing, current law bans access to an experimental drug

on safety grounds until it has successfully completed all phases

of testing. See 21 C.F.R. § 312.21(b) (requiring that Phase II

studies examine “common short-term side effects and risks” of

new drugs) (emphasis added); id. § 312.21(c) (requiring Phase

III studies to “gather . . . additional information about

effectiveness and safety that is needed to evaluate the overall

benefit-risk relationship of the drug”) (emphasis added). Thus,

to succeed on its claim of a fundamental right of access for the

terminally ill to experimental drugs, the Alliance must show not

only that there is a tradition of access to drugs that have not yet

been proven effective, but also a tradition of access to drugs that

have not yet been proven safe.

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7

 Drug regulation also has a long history in England,

beginning no later than Henry VI’s royal decree in 1447 that gave

grocers the power to inspect “anis, wormseed, rhubarb, scammony,

spikenard, senna and all sort of drugs belonging to medicine, so as not,

in the buying of these to be hurt in their bodily health.” EDWARD

KREMERS, KREMERS AND URDANG’S HISTORY OF PHARMACY 111 (4th

ed. 1976). The Pharmacy Wares Drugs and Stuffs Act in 1540

allowed inspectors to search apothecaries’ [i.e., pharmacists’] shops

for drugs that were “defective, corrupted and not meet nor convenient

to be ministered in any medicines for the health of man’s body.” John

P. Griffin, Venetian Treacle and the Foundation of Medicines

Regulation, 58 BRIT. J. OF CLINICAL PHARMACOLOGY 317, 319

(2004); see also John P. Griffin & Rashmi R. Shah, History of Drug

Regulation in the United Kingdom, in THE TEXTBOOK OF

PHARMACEUTICAL MEDICINE 457 (John P. Griffin & John O’Grady

eds., 2006). “[W]hen the Society of Apothecaries 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.” KREMERS,

supra, at 111. “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.

Examining, as we are required to do under Glucksberg, our

Nation’s history, legal traditions, and practice with respect to the

regulation of drugs for efficacy and safety, we conclude that our

Nation has long expressed interest in drug regulation, calibrating

its response in terms of the capabilities to determine the risks

associated with both drug safety and efficacy.

Drug regulation in the United States7 began with the

Colonies and States when the Colony of Virginia’s legislature

passed an act in 1736 that addressed the dispensing of more

drugs than was “necessary or useful” because that practice had

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8

 Although not an example of legislative or regulatory

intervention, in 1630 Nicholas Knopp of Massachusetts was “fined

five pounds, or was whipped, for vending as a cure for scurvy ‘a water

of no worth nor value,’ which he ‘solde att a very deare rate.’” JAMES

HARVEY YOUNG,THE TOADSTOOL MILLIONAIRES:ASOCIAL HISTORY

OF PATENT MEDICINES IN AMERICA BEFORE FEDERAL REGULATION 16

(1961) (quoting Records of the Governor and Company of the

Massachusetts Bay in New England (Boston, 1853), I, 83). 

become “dangerous and intolerable.” EDWARD KREMERS,

KREMERS AND URDANG’S HISTORY OF PHARMACY 158 (4th ed.

1976).8 The Territory of Orleans (Louisiana) passed an act in

1808 requiring a diploma and an examination before permitting

pharmacists to dispense drugs; 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 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

regulating adulteration (impure drugs), and a few others had

laws addressing poisons. Id. at 216. In the early history of our

Nation, we observe not a tradition of protecting a right of access

to drugs, but rather governments responding to the risks of new

compounds as they become aware of and able to address those

risks. See Cowen, supra, at 56 (“The history of state laws

pertaining to pharmacy obviously reflect[s] the development of

pharmacy scientifically, professionally, and economically.”). 

Nor were the States the only regulators of access to drugs.

Although early federal regulation was not extensive, perhaps

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18

9

 As the Alliance notes, “the Supreme Court held that the 1906

Act did not prohibit a drug manufacturer from marketing an

ineffective cancer remedy with false therapeutic claims, so long as it

was not adulterated.” Appellants’ Br. at 45 (citing United States v.

Johnson, 221 U.S. 488 (1911)). But Johnson was merely a question

of statutory interpretation, and the Court specifically noted that it

would “say nothing as to the limits of constitutional power.” Johnson,

221 U.S. at 498. Johnson therefore cannot be read to support the

because “[n]ot until interstate commerce began its great

expansion after the Civil War did the need for Federal

rule-making become widely realized,” Wallace F. Janssen,

Outline of the History of U.S. Drug Regulation and Labeling, 36

FOOD DRUG COSM. L.J. 420, 425 (1981), there are early

examples of federal government intervention. In 1848, the

Import Drug Act, ch. 70, 9 Stat. 237 (1848), banned “imported

adulterated drugs” after a Congressional committee concluded

that “this country had become the grand mart and receptacle of

all the refuse [drug] merchandise . . . , not only from the

European warehouses, but from the whole Eastern world.”

Wesley J. Heath, America’s First Drug Regulation Regime: The

Rise and Fall of the Import Drug Act of 1848, 59 FOOD &DRUG

L.J. 169, 175 (2004) (footnote omitted). Congress acted again

when it passed the Biologics Controls Act of 1902, ch. 1378, 32

Stat. 728 (1902), in response to a series of deadly reactions to a

tainted diphtheria vaccine that killed children in New Jersey and

Missouri. Sue McGrath, Only A Matter Of Time: Lessons

Unlearned at the Food and Drug Administration Keep

Americans at Risk, 60 FOOD & DRUG L.J. 603, 604 (2005). This

Act “secure[d] licensing control over both biological drug

laboratories and their products.” Janssen, supra, at 425.

Congress followed with the Pure Food and Drugs Act of 1906,

which prohibited the manufacture of any drug that was

“adulterated or misbranded.” The Pure Food and Drugs Act of

1906, ch. 3915, 34 Stat. 768 (1906).9

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recognition of a constitutional right to access experimental drugs or

consume any drugs regardless of the risks.

10 Looking to Lawrence v. Texas, the FDA argues that “[t]he

history of the FDCA over the past seventy years is entitled to

particular weight in the substantive due process calculus,” Appellees’

Br. at 31, because, in determining the constitutionality of a Texas

statute prohibiting certain intimate sexual conduct between members

of the same sex, the Supreme Court looked to the Nation’s “laws and

traditions in the past half century” as having the “most relevance” to

the constitutional dispute in that case. Lawrence v. Texas, 539 U.S.

The current regime of federal drug regulation began to take

shape with the Food, Drug, and Cosmetic Act of 1938. See

Federal Food, Drug, and Cosmetic Act of 1938, ch. 675, 52 Stat.

1040 (1938) (codified as amended at 21 U.S.C. § 301 et seq.).

The Act required that drug manufacturers provide proof that

their products were safe before they could be marketed. See id.

The new Act also prohibited false therapeutic claims. Id.

Notably, the drug industry “strenuously objected” to the 1938

Act “ostensibly on the ground that it would deprive the

American people of the right to self-medication,” HARRY A.

TOULMIN,JR., LAW OF FOODS, DRUGS AND COSMETICS 8-9 (2d

ed. 1963)—an argument not unlike the Alliance’s position of

today.

We end our historical analysis where the Alliance would

prefer it begin—with the 1962 Amendments to the FDCA.

Undoubtedly, as the Alliance argues at length, Congress

amended the FDCA in 1962 to explicitly require that the FDA

only approve drugs deemed effective for public use. See Drug

Amendments of 1962, Pub. L. No. 87-781, § 102, 76 Stat. 780,

781 (1962). Thus, the Alliance argues that, prior to 1962,

patients were free to make their own decisions whether a drug

might be effective.10 But even assuming arguendo that efficacy

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558, 571-72 (2003) (emphasis added). We need not determine today

whether recent history is particularly relevant in measuring the scope

of rights under the Due Process Clause. In this case, there is no

evidence of a deeply rooted right of terminally ill patients to gain

access to experimental drugs—either throughout our Nation’s history

or during the past half century.

11 In fact, the FDA cites numerous examples in which drugs

have been pulled from the market post-Phase I due to safety concerns.

See, e.g., Alex Berenson, End of Drug Trial Is a Big Loss for Pfizer

and Heart Patients, N.Y. TIMES, Dec. 4, 2006, at A1 (highlighting

Pfizer’s decision to pull torcetrapib from a clinical trial of more than

15,000 patients because those taking the drug were dying at a greater

rate than those taking a placebo); Milton Packer et al., Effect of Oral

Milrinone on Mortality in Severe Chronic Heart Failure, 325 NEW

ENG. J. MED. 1468 (1991) (concluding after expanded clinical trials

that milrinone therapy was “associated with a 28 percent increase in

mortality”); Debra S. Echt et al., Mortality and Morbidity in Patients

Receiving Encainide, Flecainide, or Placebo, 324 NEW ENG.J. MED.

781 (1991) (concluding after expanded clinical trials that “[t]here was

an excess of deaths . . . in patients treated with encainide or

flecainide”). 

regulation began in 1962, the Alliance’s argument ignores our

Nation’s history of drug safety regulation described above. Nor

can the Alliance override current FDA regulations simply by

insisting that drugs which have completed Phase I testing are

safe enough for terminally ill patients. Current law bars public

access to drugs undergoing clinical testing on safety grounds.

The fact that a drug has emerged from Phase I with a

determination that it is safe for limited clinical testing in a

controlled and closely-monitored environment after detailed

scrutiny of each trial participant does not mean that a drug is

safe for use beyond supervised trials.11 FDA regulation of postPhase I drugs is entirely consistent with our historical tradition

of prohibiting the sale of unsafe drugs. 

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12 In exercising the caution the Supreme Court demands when

analyzing claims of fundamental rights, see Glucksberg, 521 U.S. at

720, we note a more plausible explanation for the limited efficacy

regulation—the government was not previously able to systematically

regulate effectively for efficacy: “The history of the effectiveness

requirement in drug regulation is inextricably linked to the advent of

the randomized, controlled clinical trial as the cornerstone of medical

research . . . , [which] would not become widely recognized until the

twentieth century.” Jennifer Kulynych, Will FDA Relinquish the

“Gold Standard” for New Drug Approval? Redefining “Substantial

Evidence” in the FDA Modernization Act of 1997, 54 FOOD & DRUG

L.J. 127, 131 (1999) (footnotes omitted). In fact, “World War II

ushered in the era of the modern clinical trial, when the U.S. military

undertook large-scale, systematic testing of tuberculosis remedies and

antimalarial agents on groups of enlisted soldiers.” Id. Ironically, the

Alliance would use the recent development of tools such as modern

clinical trials to bolster its claim of exemption from regulation made

possible by these very tools.

It was not just advances in statistics and clinical trials,

however, that improved governments’ ability to regulate access to

drugs. The ability of scientists to “detect, identify, and understand”

the components of various drugs has contributed to “new regulatory

But even setting the safety issue to one side, the Alliance’s

argument that effectiveness was not required before 1962 also

fails under closer scrutiny. First, as a matter of history, at least

some drug regulation prior to 1962 addressed efficacy. More

importantly, an arguably limited history of efficacy regulation

prior to 1962 does not establish a fundamental right of access to

unproven drugs. The amendments made to the FDCA by

Congress throughout the twentieth century demonstrate that

Congress and the FDA have continually responded to new risks

presented by an evolving technology. Recent government

efficacy regulation has reflected Congress’s exercise of its wellestablished power to regulate in response to scientific,

mathematical, and medical advances.12

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approaches [that] would not have been feasible and could never have

occurred” without these scientific advances. Peter Barton Hutt, The

Importance of Analytical Chemistry to Food and Drug Regulation, 38

VAND. L. REV. 479, 487 (1985). Further, the need for efficacy

regulation became more pressing “[a]fter World War II [as] the

number of drugs available, the range of diseases and conditions

amenable to drug therapy, and the power of drugs all increased

dramatically.” PETER TEMIN, TAKING YOUR MEDICINE: DRUG

REGULATION IN THE UNITED STATES 5 (1980). 

True, a lack of government interference throughout history

might be some evidence that a right is deeply rooted. But

standing alone, it cannot be enough. If it were, it would be easy

to employ such a premise to support sweeping claims of

fundamental rights. For example, one might argue that, because

Congress did not significantly regulate marijuana until 1937,

relatively late in the constitutional day, see Gonzales v. Raich,

545 U.S. 1, 11 (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. Or because speed limits

are a recent innovation, we have a fundamental right to drive as

fast as we deem fit. But this is most certainly 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. But the lack of prior governmental

regulation of an activity tells us little about whether the activity

merits constitutional protection: “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 nonexistent powers can

be prescripted by an unchallenged exercise.” See United States

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13 The Supreme Court in Glucksberg specifically disapproved

of recognizing new fundamental rights solely based upon “abstract

concepts of personal autonomy.” Glucksberg, 521 U.S. at 725. The

FDA argues that the Alliance’s effort to create a new fundamental

right based upon these three doctrines amounts to precisely this type

of reasoning forbidden by Glucksberg, that is, amounts to the creation

of a right based solely upon abstract concepts of liberty. The Alliance

insists that “reasoning by analogy, and a search for broader principles,

are the only available tools” in cases where there is a “tradition of nonregulation.” Reply Br. at 3. In those circumstances, the Alliance

argues, “there often will be no common law cases precisely on point

v. Morton Salt Co., 338 U.S. 632, 647 (1950). Indeed, creating

constitutional rights to be free from regulation based solely upon

a prior lack of regulation would undermine much of the modern

administrative state, which, like drug regulation, has increased

in scope as changing conditions have warranted. 

B.

The Alliance next turns to several common law doctrines,

arguing that barring access to experimental drugs for terminally

ill patients is “inconsistent with the way that our legal tradition

treats persons in all other life-threatening situations.”

Appellants’ Br. at 31. Specifically, the Alliance argues that

three doctrines—(1) the doctrine of necessity; (2) the tort of

intentional interference with rescue; and (3) the right to selfdefense—each support the recognition of a right to selfpreservation. Such a right to self-preservation, the Alliance

believes, would permit “persons in mortal peril . . . to try to save

their own lives, even if the chosen means would otherwise be

illegal or involve enormous risks.” Id. at 32. Specifically, in

this case, the Alliance believes that a right to self-preservation

would give the terminally ill a constitutionally protected right of

access to experimental drugs.13

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simply because the common law never confronted the precise

problem.” Id. We need not address this FDA argument because none

of the common law doctrines upon which the Alliance relies supports

its proposed right.

14 As an initial matter, the Oakland 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 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,” Oakland, 532 U.S.

at 491, because, as in this case, the federal statute at issue in Oakland

Looking first to the Alliance’s necessity argument, the

Alliance invokes the common law doctrine, which

“‘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)). The Alliance offers,

however, little detail about how necessity would apply to its

case. See Appellants’ Br. at 37. (E.g., would terminally ill

patients have a right to force drug companies to provide them

with experimental drugs?) Nonetheless, the Supreme Court’s

analysis of the common law doctrine of necessity in Oakland

leaves little room for the Alliance’s argument that common law

necessity could justify overriding the Food, Drug, and Cosmetic

Act.

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.” Oakland, 532 U.S. at 490.14

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had specifically reached the value judgment the proponents of an

implied necessity defense sought to override.

15 The lynchpin of the dissent’s argument that preventing

access to experimental drugs implicates a right to preserve one’s own

life is that we have confused “what is necessary with what is

sufficient.” Dissent at 3, 9. Because terminally ill patients have no

other approved treatment options, so the argument goes, any drug

The Supreme Court rejected that argument 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. at 491 (quotation marks omitted).

Although the Court limited its analysis to the statutory issue and

did not address the defendant’s constitutional arguments, see id.

at 494, the learning of Oakland is clear. Congress may limit or

even eliminate a necessity defense that might otherwise be

available. That is precisely what the FDCA has done. 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, the common law doctrine of

necessity provides little support to the Alliance’s proposed right.

The Alliance next invokes the tort of intentional

interference with lifesaving efforts, which the Restatement of

Torts defines as “intentionally prevent[ing] a third person from

giving to another aid necessary to his bodily security.”

RESTATEMENT (FIRST) OF TORTS § 326 (emphasis added). But

that is not this case. The Alliance seeks access to drugs that are

experimental and have not been shown to be safe, let alone

effective at (or “necessary” for) prolonging life.15 Indeed, the

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having passed Phase I, no matter the remaining unexplored risk, is

“necessary” for prolonging a patient’s life. But the dissent ignores the

fact that when these treatment decisions are being made, the safety and

efficacy records of experimental drugs are not fully known. We thus

cannot know until after the clinical testing process has been completed

that these drugs are in fact necessary. This argument also defies

reality as the great majority of experimental drugs ultimately provide

no benefit, and we fail to see how an ineffective and unsafe drug can

be classified as necessary. See, e.g., Peter D. Jacobson & Wendy E.

Parmet, A New Era of Unapproved Drugs: The Case of Abigail

Alliance v. von Eschenbach, 297 JAMA 205, 206 (2007) (noting that

only five percent of all cancer drugs beginning clinical trials are

ultimately approved for use and that less than a third that pass Phase

I advance from Phase II to Phase III). The dissent’s position is further

compromised by the fact that the Supreme Court rejected a similar

argument in a statutory challenge to the FDCA because “[f]or 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.” United States v. Rutherford, 442 U.S. 544,

555-56 (1979).

Alliance concedes that taking experimental drugs can “involve

enormous risks.” Appellants’ Br. at 32. In essence, the Alliance

insists on a constitutional right to assume any level of risk. It is

difficult to see how a tort addressing interference with providing

“necessary” aid would guarantee a constitutional right to

override the collective judgment of the scientific and medical

communities expressed through the FDA’s clinical testing

process. Thus, we cannot agree that the tort of intentional

interference with rescue evidences a right of access to

experimental drugs. 

Finally, the Alliance looks to traditional self-defense

principles to support its proposed constitutional right. The

common law doctrine of self-defense provides that “[o]ne who

is not the aggressor . . . is justified in using a reasonable amount

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16 See also Casey, 505 U.S. at 879 (reaffirming exception);

Roe, 410 U.S. at 173 (Rehnquist, J., dissenting) (“If the Texas statute

were to prohibit an abortion even where the mother’s life is in

jeopardy, I have little doubt that such a statute would lack a rational

relation to a valid state objective . . . .”).

of force against his adversary when he reasonably believes (a)

that he is in immediate danger of unlawful bodily harm from his

adversary and (b) that the use of such force is necessary to avoid

this danger.” 2 WAYNE R. LAFAVE, SUBSTANTIVE CRIMINAL

LAW § 10.4 (2d ed. 2003). Self-defense typically arises when a

victim is being attacked by an aggressor and uses reasonable

force to overcome immediate danger. The Alliance argues that

self-defense permits victims to assume two types of risk: (1) the

risk that the victim will kill the attacker; and (2) the risk that

“[f]ighting back may dramatically increase the . . . harm” to the

victim. Appellants’ Br. at 35-36. So, the argument goes, if

victims of crimes are allowed to assume these risks in defending

their lives, terminally ill patients should also be allowed to

assume the risk that an experimental drug may hasten their

deaths.

That self-defense principles should be applied in the

medical context is evidenced, the Alliance argues, by the

Supreme Court’s abortion jurisprudence. The Alliance does not

look to the “right of personal privacy” addressed in Roe v.

Wade, 410 U.S. 113, 152 (1973). Instead, the Alliance argues

that Roe “recognized another, entirely separate right to abortion:

a woman’s right to abort a fetus at any stage of a pregnancy if

doing so is necessary to preserve her life or health.” Appellants’

Br. at 39 (emphasis in original).16 “That right,” the Alliance

argues, “is grounded in traditional self-defense principles rather

than privacy . . . .” Id. Applying that concept here, the Alliance

argues that because its terminally ill members are in immediate

danger of harm from cancer, they can use whatever medical

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17 To be sure, we do not suggest that the law can never strike

the balance between access to experimental drugs and risk that the

Alliance suggests. We limit our analysis to whether the Constitution

demands the balance they desire. The Alliance can, of course,

advocate its position vigorously before Congress and the FDA, and

convince our Nation’s democratic branches that the values the

Alliance favors should be protected. In fact, within the last year, the

political branches have responded to the concerns of the Alliance and

others. The FDA recently issued a notice of proposed rulemaking

that:

propos[ed] to amend its regulations on access to

investigational new drugs for the treatment of

means are necessary to defend themselves. Thus, they argue,

even if a medical treatment might otherwise be prohibited by

law, the doctrine of self-defense justifies access to that

treatment, just as self-defense justifies an assault victim using

physical force otherwise prohibited by law. 

This analogy also fails because this case is not about using

reasonable force to defend oneself (as in most cases involving

self-defense), nor is it about access to life-saving medical

treatment. This case is about whether there is a constitutional

right to assume, in the Alliance’s own words, “enormous risks,”

Appellants’ Br. at 32, in pursuit of potentially life-saving drugs.

Unlike the cases in which the doctrine of self-defense might

properly be invoked, this case involves risk from drugs with no

proven therapeutic effect, which at a minimum separates this

example from the abortion “life of the mother” exception.

Because terminally ill patients cannot fairly be characterized as

using reasonable force to defend themselves when they take

unproven and possibly unsafe drugs, the Alliance’s desire that

the terminally ill be free to assume the risk of experimental

drugs cannot draw support from the doctrine of self-defense.17

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patients. The proposed rule would clarify existing

regulations and add new types of expanded access for

treatment use. Under the proposal, expanded access

to investigational drugs for treatment use would be

available to individual patients, including in

emergencies; intermediate-size patient populations;

and larger populations under a treatment protocol or

treatment investigational new drug application (IND).

The proposed rule is intended to improve access to

investigational drugs for patients with serious or

immediately life-threatening diseases or conditions,

who lack other therapeutic options and who may

benefit from such therapies.

Expanded Access to Investigational Drugs, 71 Fed. Reg. 75,147-01,

75,147 (Dec. 14, 2006).

III.

Although it has not addressed the precise constitutional

argument urged by the Alliance, we find it highly significant that

the Supreme Court has rejected several similar challenges to the

FDCA and related laws brought on statutory grounds. See, e.g.,

Raich, 545 U.S. at 28 (“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). And other courts have rejected arguments that the

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18 No circuit court has acceded to an affirmative access claim.

See, e.g., Mitchell v. Clayton, 995 F.2d 772, 775 (7th Cir. 1993)

(“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. Exam’rs, 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

Constitution provides an affirmative right of access to particular

medical treatments reasonably prohibited by the Government.18

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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, 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.”).

19 As there exists no deeply rooted right, we need not examine

whether a right of access to experimental drugs is “‘implicit in the

concept of ordered liberty,’ such that ‘neither liberty nor justice would

exist if they were sacrificed.’” Glucksberg, 521 U.S. at 720-21

(quoting Palko v. Connecticut, 302 U.S. 319, 325, 326 (1937)). While

we need not and do not address all of the Alliance’s arguments

regarding whether their proposed right is implicit in our Nation’s

system of ordered liberty, we note a crucial difference between this

case and one of the cases relied upon by the Alliance in making that

In keeping with those decisions, we conclude that the

Alliance has not provided evidence of a right to procure and use

experimental drugs that is deeply rooted in our Nation’s history

and traditions. To the contrary, our Nation’s history evidences

increasing regulation of drugs as both the ability of government

to address these risks has increased and the risks associated with

drugs have become apparent. Similarly, our legal traditions of

allowing a necessity defense, prohibiting intentional interference

with rescue, and recognizing a right of self-defense cannot

justify creating a constitutional right to assume any level of risk

without regard to the scientific and medical judgment expressed

through the clinical testing process.19

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argument, Cruzan v. Director, Mo. Dep’t of Health, 497 U.S. 261

(1990). 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.” Id. at 279. Looking to Cruzan, the Alliance argues that

“[i]f a patient has a fundamental right to medical self-determination

that gives them the right to starve themselves to death, then surely they

have a right to choose to fight for their lives even if that means taking

a drug that has not yet met the FDA’s full approval standards.”

Appellants’ Br. at 27. Cruzan’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 medical

treatment.” Glucksberg, 521 U.S. at 725 (discussing Cruzan); see also

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. 

IV.

Because the Alliance’s claimed right is not fundamental,

the Alliance’s claim of a right of access to experimental drugs

is subject only to rational basis scrutiny. See Glucksberg, 521

U.S. at 722 (noting that “a challenged state action [must]

implicate a fundamental right” to avoid rational basis review).

The rational basis test requires that the Alliance prove that the

government’s restrictions bear no rational relationship to a

legitimate state interest. See, e.g., Harrah Indep. Sch. Dist. v.

Martin, 440 U.S. 194, 198 (1979); Glucksberg, 521 U.S. at 735.

The challenged policy “need not be in every respect logically

consistent with its aims to be constitutional. It is enough that

there is an evil at hand for correction, and that it might be

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33

20 We are mindful of the fact that this case is before us

pursuant to the FDA’s motion to dismiss, brought under Federal Rule

of Civil Procedure 12(b)(6). The Seventh Circuit has noted some

tension between the Rule 12(b)(6) standard and rational basis review.

See Wroblewski v. City of Washburn, 965 F.2d 452, 459 (7th Cir.

1992) (“The rational basis standard requires the government to win if

any set of facts reasonably may be conceived to justify its

classification; the Rule 12(b)(6) standard requires the plaintiff to

prevail if relief could be granted under any set of facts that could be

proved consistent with the allegations. The rational basis standard, of

course, cannot defeat the plaintiff’s benefit of the broad Rule 12(b)(6)

standard.”) (quotation marks and citations omitted). In this case,

however, we need not worry about the outer realm of Rule 12(b)(6)

protection because, as we explain below, the Alliance’s pleadings

themselves make our rational basis determination straightforward. Cf.

Trudeau v. FTC, 456 F.3d 178, 193 (D.C. Cir. 2006) (noting that it “is

possible for a plaintiff to plead too much: that is, to plead himself out

of court by alleging facts that render success on the merits impossible”

(quoting Sparrow v. United Air Lines, Inc., 216 F.3d 1111, 1116 (D.C.

Cir. 2000))).

thought that the particular legislative measure was a rational

way to correct it.” Williamson v. Lee Optical of Okla., Inc., 348

U.S. 483, 487-88 (1955).20

The Alliance acknowledges the risk inherent in taking

experimental drugs. See Am. Compl. ¶ 19 (“Terminally ill

patients are typically willing to assume risks . . . .”). The

Alliance would rather that individual patients make decisions

about this risk than have the FDA decide which drugs are safe

enough for limited access to the terminally ill. The FDA

counters that “[w]ithout a requirement of FDA approval, patients

could be exposed to unreasonable risks from investigational

drugs that may be neither safe nor effective.” Appellees’ Br. at

55-56.

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34

Applying the rational basis standard to the Alliance’s

complaint, we cannot say that the government’s interest does not

bear a rational relation to a legitimate state interest. That

conclusion is compelled by the Supreme Court’s decision in

United States v. Rutherford, 442 U.S. 544 (1979). In that case,

terminally ill patients sought to prevent the FDA from

prohibiting access to the drug laetrile, even though the drug had

not been approved for public use. In rejecting a challenge by

terminally ill patients claiming that the FDCA’s safety

requirement did not apply to them, the Supreme Court held that

“[f]or 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.” Id. at 555-56; see also id.

at 558 (noting that history has demonstrated that numerous

“resourceful entrepreneurs” might try to take advantage of an

unregulated market, which “suggest[s] why Congress could

reasonably have determined to protect the terminally ill, no less

than other patients, from the vast range of self-styled panaceas

that inventive minds can devise”). 

Although terminally ill patients desperately need curative

treatments, as Rutherford holds, their deaths can certainly be

hastened by the use of a potentially toxic drug with no proven

therapeutic benefit. Thus, we must conclude that, 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. We therefore hold that the

FDA’s policy of limiting access to investigational drugs is

rationally related to the legitimate state interest of protecting

patients, including the terminally ill, from potentially unsafe

drugs with unknown therapeutic effects. 

Although in the Alliance’s view the FDA has unjustly erred

on the side of safety in balancing the risks and benefits of

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35

experimental drugs, this is not to say that the FDA’s balance can

never be changed. The Alliance’s arguments about morality,

quality of life, and acceptable levels of medical risk are certainly

ones that can be aired in the democratic branches, without

injecting the courts into unknown questions of science and

medicine. Our Nation’s history and traditions have consistently

demonstrated that the democratic branches are better suited to

decide the proper balance between the uncertain risks and

benefits of medical technology, and are entitled to deference in

doing so. As the Supreme Court has held: 

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

modes was likely to be the most effective for the

protection of the public against disease.

Jacobson v. Massachusetts, 197 U.S. 11, 30 (1905); see also

Gonzales v. Carhart, 127 S. Ct. 1610, 1636 (2007) (“The Court

has given state and federal legislatures wide discretion to pass

legislation in areas where there is medical and scientific

uncertainty.”); cf. Greenwood v. United States, 350 U.S. 366,

375-76 (1956) (“The 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.”). Consistent with

that precedent, our holding today ensures that this debate among

the Alliance, the FDA, the scientific and medical communities,

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36

and the public may continue through the democratic process.

See Glucksberg, 521 U.S. at 735. 

V.

For the foregoing reasons, the judgment of the district court

is affirmed.

So ordered.

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ROGERS, Circuit Judge, with whom Chief Judge GINSBURG

joins, dissenting: Today, the court rejects the claim that

terminally ill patients who have exhausted all governmentapproved treatment options have a fundamental right to access

investigational new drugs. The court’s opinion reflects a flawed

conception of the right claimed by the Abigail Alliance for

Better Access to Developmental Drugs and a stunning

misunderstanding of the stakes. The court shifts the inquiry

required by Washington v. Glucksberg, 521 U.S. 702 (1997), by

changing the nature of the right, by conflating the right with the

deprivation, and by prematurely advancing countervailing

government interests. The court fails to come to grips with the

Nation’s history and traditions, which reflect deep respect and

protection for the right to preserve life, a corollary to the right

to life enshrined in the Constitution. The court confuses this

liberty interest with the manner in which the Alliance alleges

that the liberty has been deprived, namely by denying terminally

ill patients access to investigational medications under the

narrow conditions described by the Alliance. The court

conflates the inquiry as to whether a fundamental right exists at

all with whether the government has demonstrated a compelling

interest, when strictly scrutinized, rendering its restrictive policy

constitutional. 

These missteps lead the court to rely upon how rights and

liberties have been limited and restricted — addressing

regulations to prevent fraud in the sale of misbranded and

adulterated medications or safety restrictions applicable to all

medicines for any palliative purpose — which says little about

the historic importance of the underlying right of a person to

save her own life. Likewise, in its treatment of the common law

doctrines of necessity, interference with rescue, and self defense,

the court points to evolved limitations on those doctrines while

ignoring the core concerns that animate them, namely the special

importance of life and attempts to preserve it. That the ultimate

protection of such varying attempts to save life is cabined by the

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2

precedents — regarding what constitutes “necessity,” the related

“necessity” of any aid being given to a third party, and the

“reasonable” and “necessary” limitations on any force used in

self-defense — does not suggest the absence of an underlying

right to attempt to protect life, but rather the recognition of

competing governmental interests that in various circumstances

justify the deprivation of or a limitation upon the right.

The common law doctrines remain good evidence of a

history and tradition of protecting life and attempts to preserve

life as a deep-seated personal right. That the right may be and

has been denied in the face of compelling governmental interests

is no reason for conflating the two stages of the analysis and

looking only to the results of past cases in order to avoid the

analysis prescribed by the Supreme Court in Glucksberg, 521

U.S. at 720-21. Contrary to today’s view of the court and the

Federal Drug Administration (“FDA”), nothing in the prior

opinion of the court would give “total weight” to the interests of

the terminal patients or deny the FDA the ability to put its

competing governmental interests into the balance. The court

was explicit on this point, requiring precisely such weighing and

proof of the proposed government concerns, rather than merely

accepting, under the rubric of rational basis scrutiny, any

assertions the FDA chooses to offer. See Abigail Alliance for

Better Access to Developmental Drugs v. von Eschenbach, 445

F.3d 470, 486 (D.C. Cir. 2006) (“Abigail Alliance I”) (vacated

upon grant of rehearing en banc).

In the end, it is startling that the oft-limited rights to marry,

to fornicate, to have children, to control the education and

upbringing of children, to perform varied sexual acts in private,

and to control one’s own body even if it results in one’s own

death or the death of a fetus have all been deemed fundamental

rights covered, although not always protected, by the Due

Process Clause, but the right to try to save one’s life is left out

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3

in the cold despite its textual anchor in the right to life. This

alone is reason the court should pause about refusing to put the

FDA to its proof when it denies terminal patients with no

alternative therapy the only option they have left, regardless of

whether that option may be a long-shot with high risks. The

court is on even weaker footing when it relies upon the risks

entailed in medical procedures to wrest life-and-death decisions

that once were vested in patients and their physicians. The court

commits a logical error of dramatic consequence by concluding

that the investigational drugs are somehow not “necessary.” Op.

at 25 & n.15; accord id. at 26. While the potential cures may

not prove sufficient to save the life of a terminally ill patient,

they are surely necessary if there is to be any possibility of

preserving her life. 

It bears outlining the history and common law basis for the

Alliance’s claim in order to demonstrate, once again, that the

history and traditions of this Nation support the right of a

terminal patient, and not the government, to make this

fundamentally personal choice involving her own life. Because

judicial precedents and the historical record require strict

scrutiny before upsetting rights of this magnitude, the FDA must

demonstrate a compelling governmental interest before its

policy restricting access can survive. Accordingly, I would

remand the case to the district court to make the initial

determination as to whether FDA has met its burden, and I

respectfully dissent.

I.

The Fifth Amendment of the Constitution proscribes the

“depriv[ation] of life, liberty, or property.” U.S.CONST. amend.

V. The Alliance claims a corollary to the right to life itself,

namely the right to attempt to preserve it. As alleged by the

Alliance, this right is deprived without due process of law when

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4

1 The Glucksberg framework arose from a situation involving

a non-literal liberty interest. Although, as described below, the right

to act to preserve one’s own life passes the test laid down in that case,

the healthy skepticism that Glucksberg prescribed for new-fangled

non-literal liberty interests may be unduly restrictive as applied to a

claim with a firm textual anchor in the right to life expressly protected

by the Fifth Amendment to the Constitution.

the FDA makes it practically impossible for Alliance members

for whom conventional treatments have failed to access

investigational new drugs that have been approved for

substantial human testing. Under Glucksberg, 521 U.S. at 720-

21, a substantive due process right qualifies as fundamental if it

is both “‘deeply rooted in this Nation’s history and tradition,’”

id. at 721 (quoting Moore v. City of E. Cleveland, 431 U.S. 494,

503 (1977) (plurality opinion)), and “‘implicit in the concept of

ordered liberty,’” id. (quoting Palko v. Connecticut, 302 U.S.

319, 325 (1937)).1 If the Alliance has correctly alleged a

fundamental right, then the FDA policy can survive only upon

proof of a compelling government interest that overcomes the

liberty interest. 

A.

The Glucksberg analysis begins with a “‘careful

description’ of the asserted fundamental liberty interest.” 521

U.S. at 721-23. As the court’s opinion in this case demonstrates,

the description of the right is of crucial importance — too broad

and a right becomes all-encompassing and impossible to

evaluate; too narrow and a right appears trivial. See Abigail

Alliance I, 445 F.3d at 477. The court asserts that “[t]his case is

about whether there is a constitutional right to assume . . .

‘enormous risks’ in pursuit of potentially life-saving drugs.”

Op. at 28 (emphasis in original) (citation omitted). This

description can be characterized as “careful” only if the

objective of Glucksberg analysis is to produce abstractions that

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5

2 Similarly, the Tenth Circuit has held that although parents

have a fundamental constitutional right to direct the education and

upbringing of their children, this right does not “allow parents to

dictate that their children will attend public school for only part of the

school day.” Swanson ex rel. Swanson v. Guthrie Indep. Sch. Dist.

shield a court from acknowledging the rights underlying a

party’s claims. As the court notes, fundamental rights cannot be

“solely based upon ‘abstract concepts of personal autonomy.’”

Op. at 23 n.13 (quoting Glucksberg, 521 U.S. at 725). However,

were it impermissible to draw any inferences from a broader

right to a narrower right, nearly all of the Supreme Court’s

substantive due process case law would be out of bounds. See,

e.g., Moore, 431 U.S. at 503 (extrapolating specific right to

determine extended family living arrangements from broader

constitutional protection for “the sanctity of the family”); Roe v.

Wade, 410 U.S. 113 (1973) (identifying specific right to

terminate a pregnancy from broader right to privacy); Griswold

v. Connecticut, 381 U.S. 479, 484-86 (1965) (inferring specific

right to use contraception from general right to be free from

intrusion into “sacred precincts of marital bedrooms”). In any

event, the Alliance’s liberty claims are not grounded in the

abstract notion of personal autonomy but rather in the specific

right to act to save one’s own life.

The court fundamentally misunderstands the right claimed

by the Alliance and trivially casts it as a function of the

regulatory scheme. See Op. at 14 n.6. But the Alliance should

not be penalized for anticipating a justification for infringing the

right that might survive strict scrutiny. Applying the court’s

reasoning today, had “Jane Roe” been prescient enough to claim

a right to abort a pre-viable fetus by a procedure that is

demonstrably safer than all other alternatives, cf. Gonzales v.

Carhart, 127 S. Ct. 1610, 1638 (2007), she would have failed to

show a fundamental right to an abortion.2

 Again, the claimed

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6

No. I-L, 135 F.3d 694, 702 (10th Cir. 1998). By the court’s reasoning,

if parents had come to court claiming a fundamental right to educate

their children but acknowledging that if they sent their children to

public school, they could do so only full-time, the fundamental right

never would have been recognized. But see Meyer v. Nebraska, 262

U.S. 390 (1923); Pierce v. Soc’y of Sisters, 268 U.S. 510 (1925).

fundamental right is to attempt to preserve one’s life; whether

the risks associated with doing so justify restraining that right is

properly considered only after the right is deemed fundamental.

Under Glucksberg, the court’s analysis should begin with an

assessment of whether the right to attempt to preserve life can be

found in the Nation’s history and tradition. See Abigail Alliance

I, 445 F.3d at 479. A review of this history demonstrates that

this Nation has long entrusted in individuals those

fundamentally personal medical decisions that lie at the core of

personal autonomy, self-determination, and self-defense.

1. The heritage of this right predates the Founding. Samuel

Adams referred to “the duty of self preservation” as “the first

law of nature.” Samuel Adams, The Rights of the Colonists:

Report of the Committee of Correspondence to the Boston Town

Meeting, 7 OLD SOUTH LEAFLETS 417 (No. 173) (Burt Franklin

1970) (1772). The common law’s eminent commentator,

William Blackstone, wrote of three “principal or primary

articles” historically comprising “the rights of all mankind.”

First among these was “[t]he right of personal security . . . in a

person’s legal and uninterrupted enjoyment of his life, his limbs,

his body, [and] his health.” WILLIAM BLACKSTONE, 1

COMMENTARIES *129. Blackstone described the guarantee of

“[t]he preservation of a man’s health from such practices as may

prejudice or annoy it.” Id. at *134. 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

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7

as done upon the highest necessity and compulsion.” Id. at

*130.

This principle is of early vintage, for “Anglo-American law

starts with the premise of thorough-going self determination.”

Natanson v. Kline, 350 P.2d 1093, 1104 (Kan. 1960). Long

before regulation of the efficacy of medications was

contemplated by the federal government, courts recognized with

“universal acquiescence” that “the free citizen’s first and

greatest right, which underlies all others,” is “the right to the

inviolability of his person, in other words, his right to himself.”

Pratt v. Davis, 118 Ill. App. 161, 166 (1905), aff’d, 79 N.E. 562

(Ill. 1906). So too, this court has recognized “the concept,

fundamental in American jurisprudence, that ‘[e]very human

being of adult years and sound mind has a right to determine

what shall be done with his own body.’” Canterbury v. Spence,

464 F.2d 772, 780 (D.C. Cir. 1972) (alteration in original)

(quoting Schloendorff v. Soc’y of N.Y. Hosp., 105 N.E. 92, 93

(1914) (Cardozo, J.)).

2. This historical entitlement recognized in the legal

tradition of this Nation is reflected in rights recognized at

common law that are retained by an individual. Most notably,

the right of self-defense enforces the right of a person facing

death to take reasonable steps to protect her own life. Although

this right is not unqualified, self-defense has been described as

“an inherent right of man, older than states or Constitutions.”

People v. Pignatoro, 136 N.Y.S. 155, 160 (Magis. Ct. 1911).

The privilege extends, of course, to repelling the attacks of

aggressors, see, e.g., Brown v. United States, 256 U.S. 335, 343-

44 (1921); cf. Montana v. Egelhoff, 518 U.S. 37, 56 (1996)

(plurality opinion), but also protects incursions into the property

of others, see, e.g., Ploof v. Putnam, 71 A. 188, 189 (Vt. 1908)

(“This doctrine of necessity applies with special force to the

preservation of human life. . . . One may sacrifice the personal

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8

3 A person may assert self-defense rights against animals.

See, e.g., People v. Lee, 32 Cal. Rptr. 3d 745, 754-55 (Ct. App. 2005);

Credit v. Brown, 10 Johns. 365 (N.Y. Sup. Ct. 1813).

property of another to save his life or the lives of his fellows.”

(citation omitted)); Mouse’s Case, 12 Co. Rep. 63, 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 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). Although

the concept of self-defense is most often thought of in terms of

the response to an assault by another human being, its premise

compels the same response in the face of other forms of

aggression against life and limb, whether the aggressor be an

animal3

 or a diseased cell within one’s body. There is,

accordingly, no reason to think that the efforts of Alliance

members to repel their terminal diseases do not implicate this

concept.

Aside from asserting that this case is not about efforts to

preserve one’s life, but rather the “right to assume any level of

risk,” the court further avoids the doctrines of self-defense and

necessity by asserting that Congress can override the common

law. See Op. at 26. This is true but irrelevant. It was also true

in Cruzan v. Director, Missouri Department of Health, 497 U.S.

261 (1990), in which the Supreme Court discussed the

fundamental right to refuse life-sustaining medical treatment, id.

at 278. When the Court recognized that the common law tort of

battery supported the fundamental right to refuse medical

treatment, id. at 269, it did not constitutionalize the tort of

battery. Similarly, recognizing that necessity has historically

been protected does not constitutionalize the doctrine of

necessity. Yet the court resists the implications of the historical

protection for actions prompted by necessity out of an

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9

4 See, e.g., Beck v. Haik, 377 F.3d 624, 633-34 (6th Cir.

2004) (discussing appropriate jury instruction for claim of interference

unwarranted fear that acknowledging the historical record will

constitutionalize the common law. See Op. at 22-23, 26. In so

doing, it forgets the second part of the Glucksberg inquiry. A

tradition of protection does not alone establish a fundamental

right. The subsequent determination of whether a right is

“implicit in the concept of ordered liberty” invalidates the

court’s fears of a slippery slope. 

The common law also recognized the right of protection

against interference with rescue. This right is infrequently

invoked, but as early as 1889, it was acknowledged by the

highest court of the State of Maryland, which explained that

even prolongation of a fading life was not to be obstructed: 

Surely the law does not authorize the husband to say to

his wife: “You shall die of the cancer; you cannot be

cured, and a surgical operation affording only

temporary relief, will result in useless expense.” The

husband had no power to withhold from his wife the

medical assistance which her case might require.

State v. Housekeeper, 16 A. 382, 383-84 (Md. 1889). The

Restatement of Torts, published in 1934, generalized this point

of law: “One 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.” RESTATEMENT OF TORTS § 326; see also id. § 327

(negligence); RESTATEMENT (SECOND) OF TORTS §§ 326, 327;

W.PAGE KEETON ET AL., PROSSER AND KEETON ON THE LAW OF

TORTS 382 (5th ed. 1984). This common law rule is firmly

grounded.4 By interposing itself between a terminally ill patient

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10

with rescue); Ross v. United States, 910 F.2d 1422 (7th Cir. 1990)

(holding that a deputy sheriff committed a constitutional tort by

interfering with efforts to rescue a drowning boy); United States v.

Lawter, 219 F.2d 559, 562 (5th Cir. 1955) (holding that the

government is liable when it prevents others from attempting a rescue

and takes no action itself); Sneider v. Hyatt Corp., 390 F. Supp. 976,

980 & n.2 (N.D. Ga. 1975) (noting that “deliberate interference with

rescue efforts by third parties is a traditional basis for imposing

liability”); Soldano v. O’Daniels, 190 Cal. Rptr. 310, 313, 316-18 (Ct.

App. 1983) (applying Restatement); Thomas v. Williams, 124 S.E.2d

409, 414 (Ga. Ct. App. 1962) (sustaining cause of action for

interference with rescue where defendant prevented rescue of inmate

from jail cell during fire); Riggs v. Colis, 695 P.2d 413, 415 (Idaho

1985) (applying Restatement); Byrne v. Long Island State Park

Comm’n, 323 N.Y.S.2d 442 (Sup. Ct. 1971); see also Commonwealth

v. Marcelli, 441 N.E.2d 270, 271 (Mass. Ct. App. 1982) (criminal

liability); CAL. PENAL CODE § 148.2(1) (same). 

and her only means of prolonging her life, the FDA’s policy

runs counter to the common law’s historical prohibition on

interfering with rescue.

The common law protection, of course, is for rescues that

are reasonably necessary. In an effort to distinguish this

historical protection, the court relies upon the fact that the new

investigational drugs “have not been shown to be safe, let alone

effective at (or ‘necessary’ for) prolonging life.” Op. at 25. But

this confuses what is necessary with what is sufficient. This is

not a case about elective medical treatments. Without access,

Alliance members will die. No doubt the deceased members of

the Alliance who were denied access to experimental drugs that

were subsequently approved by the FDA would have been

surprised to learn that these drugs, under the court’s analysis,

were unnecessary to the preservation of their lives. See Br. of

Appellants at 31 n.15; Reply Br. of Appellants at 23. See

generally Abigail Alliance for Better Access to Developmental

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11

Drugs v. von Eschenbach, 469 F.3d 129 (D.C. Cir. 2006)

(“Abigail Alliance II”). Thus, the court’s apparent understanding

of the meaning of “necessity” is manifestly flawed. See Op. at

25 n.15. By the court’s reasoning, it is not “necessary” for the

driver of a car that is hurtling toward a cliff to press the brake

because we “cannot know until after” he has done so whether the

car will stop in time. Alliance members, like the endangered

driver, will perish without remedial steps. The question

presented in this case is not whether investigational drugs are

necessary to a terminally ill patient who has exhausted

conventional treatment options — they are — but who will make

the subsequent decision about using these medications, the

patient with her doctor or the government. Moreover, as Prosser

and Keeton have explained, “[t]he principle [that one may not

prevent aid by others] has been carried even to the length of

holding that there is liability for interfering with the possibility

of such aid.” KEETON ET AL., supra, at 382.

Throughout its discussion of self-defense and interference

with rescue, the court recognizes that common law rights are not

unlimited but fails to acknowledge that the evolved limitations

on hallowed rights do not undercut the core concerns that

animate them — here, the special importance of life and

attempts to preserve it. That the ultimate protection of such

varying attempts to save life is cabined by precedents discussing

“necessity” speaks not to the absence of an underlying right to

attempt to protect life but rather to the recognition of competing

governmental interests that in various circumstances justify the

deprivation of or a limitation upon the right. Whether similar

countervailing interests exist in this case is a question bearing on

the resolution of strict scrutiny analysis, not on whether it should

apply.

3. Although the Supreme Court has not squarely addressed

the right to use potentially life-saving medications, it has

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12

developed a sizable body of law regarding the right to a

potentially life-saving medical procedure when the life or health

of a pregnant woman is on the line. In Roe, 410 U.S. at 164-65,

and again in Planned Parenthood of Southeastern Pennsylvania

v. Casey, 505 U.S. 833, 846, 880 (1992), the Court held that

even after fetal viability, a state cannot constitutionally proscribe

abortion “where it is necessary, in appropriate medical

judgment, for the preservation of the life or health of the

mother,” Roe, 410 U.S. at 164-65; Casey, 505 U.S. at 879

(plurality opinion); accord Ayotte v. Planned Parenthood of N.

New Eng., 546 U.S. 320, 327-28 (2006). In so doing, the Court

acknowledged the tradition of “‘preserving the life of the

mother,’” Roe, 410 U.S. at 137 (quoting Rex v. Bourne, [1939]

1 K.B. 687 (Crim. App.)), both in the common law, see id., and

in early state statutes, see id. at 138 (citing “model” legislation

enacted in New York in 1828).

In Stenberg v. Carhart, 530 U.S. 914 (2000), the Supreme

Court squarely addressed whether a state may ban a particular

medical procedure in cases where a patient’s health or life is

endangered. The Court held that “the governing standard

requires an exception ‘where it is necessary, in appropriate

medical judgment for the preservation of the life or health of the

mother.’” Id. at 931 (quoting Casey, 505 U.S. at 879). There,

the State of Nebraska could not constitutionally ban particular

abortion procedures, notwithstanding the state’s “interest in the

potentiality of human life,” id. at 930, even though the state

claimed that there were adequate alternatives, id. at 931-32.

Here, the situation is even starker: The Alliance’s terminally ill

members have no remaining alternatives except the medications

to which the FDA denies them access. This Term all nine

justices of the Supreme Court agreed that controlling precedents

forbid the government from banning an abortion procedure “if

it ‘subject[ed] [women] to significant health risks,” Gonzales v.

Carhart, 127 S. Ct. at 1635 (quoting Ayotte, 546 U.S. at 328)

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13

(alterations in original); accord id. at 1641-42 (Ginsburg, J.,

with whom Stevens, Souter, and Breyer, JJ., join, dissenting),

and the Court repeatedly emphasized the availability of safe

alternative procedures before approving the ban, see id. at 1636,

1637, 1638. The right sought by the Alliance pertains only to

those for whom no such alternatives exist.

Consequently, for the court to conclude that the Supreme

Court has not already decided that medical self-preservation is

fundamental, the court is forced to conclude that when a

patient’s life is on the line, medical procedures like abortion are

to be analyzed differently than medical treatments consisting of

prescription medications. To draw this distinction, the FDA

offers only the empty assertion that “the right to abort a fetus to

save the life or health of the mother is simply an aspect of the

underlying constitutional right of abortion recognized in Roe.”

Brief for Appellees at 39. This ipse dixit cannot be reconciled

with the fact that a woman’s right to end a life-threatening

pregnancy has long been uncontroversial in the face of state

statutory prohibitions against abortion and distinct from the

considerations that otherwise bear on the procedure. “The

criminal abortion laws passed in every state by 1880 made

exceptions for therapeutic abortions performed in order to save

a woman’s life.” LESLIE J. REAGAN, WHEN ABORTION WAS A

CRIME 5 (1997). Reaching farther back into history, as the

Supreme Court discussed in Roe:

The Ephesian, Soranos, often described as the greatest

of the ancient gynecologists, appears to have been

generally opposed to Rome’s prevailing free-abortion

practices. He found it necessary to think first of the

life of the mother, and he resorted to abortion when,

upon this standard, he felt the procedure advisable.

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14

410 U.S. at 130. This approach continued into the modern era.

When England imposed criminal sanctions for abortion in 1861,

it provided no explicit exception for pregnancies that endanger

the life or health of a mother. Offenses Against the Person Act

of 1861, 24 & 25 Vict., c. 100, § 59. Nonetheless, an English

court determined that the statute could not include procedures

necessary to save the woman’s life, because “as in the case of

homicide, so also in the case where an unborn child is killed,

there may be justification for the act.” Bourne, [1939] 1 K.B. at

690. This history suggests, contrary to the FDA’s view, that a

woman’s right to an abortion as an act of medical self-defense

is independent from her right to an abortion based upon her right

to make deeply personal decisions, see Casey, 505 U.S. at 581.

The court chooses not to distinguish the abortion cases on

this flimsy basis but its approach is no less startling. The court

holds that because the Alliance seeks access only to “potentially

life-saving drugs,” Op. at 28 (emphasis in original), the abortion

cases are distinguishable. Nowhere in the Supreme Court’s

jurisprudence has it intimated that the government may ban

procedures that represent a patient’s only chance of survival

because they might not be successful. The fundamental right

does not accrue only upon a demonstration of surefire

actualization; the trigger is the necessity, which is crucially

different from the sufficiency to which the court repeatedly

refers. Indeed, in Stenberg, the Supreme Court addressed the

level of medical consensus needed for a procedure to become

protected, holding that procedures supported by “substantial

medical authority” could not be proscribed. See 538 U.S. at

938. The Court was careful not to require medical unanimity,

see id. at 937, or even “general medical studies,” see id. at 935,

like those required for FDA approval of investigational new

drugs for commercial marketing, see 21 C.F.R. pt. 312.

Although Gonzales v. Carhart clarifies that government may

regulate to some extent “where there is uncertainty over whether

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15

the barred procedure is ever necessary to preserve . . . health,

given the availability of other . . . procedures that are considered

to be safe alternatives, 127 S. Ct. at 1638, Stenberg remains

good law, and there are no alternatives to preserve life, let alone

health, in this case.

Although the FDA does not contend that its approval

process reflects the Stenberg standard, the court nonetheless

makes the wholly unsupported assertion that “the collective

judgment of the scientific and medical communities [is]

expressed through the FDA’s clinical testing process.” Op. at

26. To the contrary, the Alliance specifically alleges in

attachments to its complaint that the FDA has denied terminally

ill Alliance members access to investigational new drugs

“reported to have great potential,” Decl. of Carole Steele ¶ 3,

and acknowledged by the “medical community” as “far and

away . . . superior to anything then available,” Decl. of Victoria

Jean Doran ¶ 2. At this stage of the proceedings, the court is

required to accept the Alliance’s allegations as true. See, e.g.,

Broudy v. Mather, 460 F.3d 106, 116 (D.C. Cir. 2006). Thus,

there are situations where a terminally ill patient seeks access to

a new medication that has not yet been approved by the FDA for

commercial marketing but that has been recognized by the

medical community as that patient’s best chance to survive. In

such instances, the Fifth Amendment guarantee of due process

protects the terminally ill patient’s pursuit of those medications.

There is, then, no merit to the FDA’s suggestion adopted by

the court that in the medical context there can be no deeply

rooted privilege to attempt to save one’s own life with medical

advances because medical advances capable of saving lives are

a relatively recent phenomenon. Br. of Appellee at 34-35; Op.

at 21 & n.12. As the prior discussion demonstrates, the Alliance

correctly disputes the premise of this argument. 

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B.

Against this substantial historical record demonstrating the

deep roots of the right to preserve one’s own life, it is no

coincidence that neither the court nor the FDA can marshal

evidence from the early history of the Nation demonstrating that

the federal government or any state thought to restrain the

terminally ill from accessing medical treatments and procedures

that had not proven unsafe but were of unknown efficacy. Still,

the court asserts that “a lack of government interference . . .

cannot be enough” to demonstrate that a right is deeply rooted.

This reasoning is misguided. 

First, the most fundamental rights are those that no

government of the people would contemplate abridging — it is

doubtful that many courts or legislatures have discussed whether

the government can determine whether we are allowed to

breathe air, but this does not make our access to oxygen any less

grounded in history. Cf. U.S. CONST. amend. IX (stating that

“[t]he enumeration in the Constitution, of certain rights, shall

not be construed to deny or disparage others retained by the

people”). In considering whether the terminally ill patient’s

interest in self-preservation is protected by the Due Process

Clause, the court overlooks the most fundamental evidence of

the protection that the Alliance claims, namely that the words

“life” and “liberty” are in the Due Process Clause itself. The

right to life, and the asserted corollary right to attempt to

preserve life, is not a second derivative species of “liberty”

whose protection by the Constitution should be approached with

skepticism. Insofar as courts should be skeptical of interfering

with the legislative debate and ongoing democratic discussions

about fundamental issues of life and death, that skepticism is

better applied to the latter portion of the strict scrutiny analysis

— the evaluation of the competing government interests and the

greater or lesser narrowness of the tailoring required in the face

of scientific uncertainty and conflicting opinions. See Abigail

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Alliance I, 445 F.3d at 478 n.9. To deny the constitutional

importance of the right to life and to attempt to preserve life is

to move from judicial modesty to judicial abdication, as well as

confusion, and deprive an express constitutional interest of its

due weight in the court’s analysis.

Second, the Supreme Court’s statements on fundamental

rights do not support the court’s conclusion. In Glucksberg

itself, the Supreme Court determined that the claimed right to

assisted suicide was not deeply rooted because “for over 700

years, the Anglo-American common-law tradition has punished

or otherwise disapproved of both suicide and assisting suicide.”

521 U.S. at 711. In the Court’s words: “[W]e are confronted

with a consistent and almost universal tradition that has long

rejected the asserted right, and continues explicitly to reject it

today, even for terminally ill, mentally competent adults.” Id.

at 723. But the Supreme Court did not say, as the FDA argued

and this court appears to agree, that a right can be fundamental

only if it has been acknowledged by statute or decisional law.

A plurality of the Supreme Court said the opposite in Michael H.

v. Gerald D., 491 U.S. 110, 122 n.2 (1989), in observing that

historical “protection need not take the form of an explicit

constitutional provision or statutory guarantee, but it must at

least exclude . . . a societal tradition of enacting laws denying

the interest.”

Third, the court’s concern that “such a premise [would]

support sweeping claims of fundamental rights” neglects the

existence of the second Glucksberg criterion. Strict scrutiny is

not triggered just by a history of protection — otherwise, the

entire common law would be constitutionalized. It is the second

requirement, that a right be “‘implicit in the concept of ordered

liberty,’ such that ‘neither liberty nor justice would exist if they

were sacrificed,’” 521 U.S. at 702 (quoting Palko, 302 U.S. at

325, 326), that guards against unwarranted expansion of

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18

5 Although the FDA does not stop examining drug safety

after Phase I, nor does it stop after drugs receive full marketing

approval. The FDA has pulled approved such drugs from the market,

but it does not follow that the FDA can take any action abridging any

substantive due process rights. Just as in the context of the

necessity defense at common law, the court conflates these two

distinct inquiries, and in its haste to acquire a limiting principle,

it constructs a significant and unwarranted roadblock to judicial

recognition of fundamental rights. This roadblock starts from

the Supreme Court’s requirement, in the interest of judicial

restraint, that ‘[s]ubstantive due process’ analysis must begin

with a careful description of the asserted right.” Reno v. Flores,

507 U.S. 292, 301 (1993). Although the court appropriately

assumes the Alliance has satisfied the requirement in this case,

the court then errs by effectively holding that the first

Glucksberg criterion can be satisfied only by historical evidence

involving the exact situation that the Alliance presented to us

today. It offers no principled reason for ignoring highly relevant

evidence, particularly with respect to the historical record

concerning abortion to save the life of the mother.

Fourth, in the alternative, the court shifts the target and

looks to historical evidence of regulation for safety. The court

claims that post-Phase I testing is designed not only to test a

drug’s efficacy but also to continue monitoring its safety. Op.

at 15. As support, the court lists instances in which drugs have

been removed from the market after Phase I because of safety

concerns. See id. at 20 n.11. This inquiry confuses the right —

to save one’s life — with the alleged deprivation, which here

occurs by means of an agency policy. Whether the FDA policy

actually impermissibly infringes upon the asserted right is a

factual question that is not properly resolved at the motion-todismiss stage when all reasonable inferences must be drawn to

the plaintiff’s benefit, see, e.g., Broudy, 460 F.3d at 116.5

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19

right, related or not, on the basis of its legitimate interest in safety. At

a certain point, the FDA determines that a drug is safe enough for

widespread testing, and the Alliance alleges that this marker is Phase

I approval, where the FDA authorizes expanded testing in up to

“several hundred subjects,” Am. Compl. ¶ 14; 21 C.F.R. § 312.21. In

fact, between 1997 and 2000, 5.34 percent of fully approved new

drugs were pulled from the market. Kris Hundley, Drug’s Chilling

Path to Market, ST. PETERSBURG TIMES, May 27, 2007, at 1A. Since

then, many more approved drugs have been withdrawn. See, e.g.,

Press Release, Food & Drug Admin., FDA Announces Discontinued

Marketing of GI Drug, Zelnorm, for Safety Reasons (March 30, 2007),

http://www.fda.gov/bbs/topics/NEWS/ 2007/NEW01597.html; Press

Release, Food & Drug Admin., FDA Announces Voluntary

Withdrawal of Pergolide Products (March 29, 2007),

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01596.html

(Permax); Press Release, FDA Asks Purdue Pharma to Withdraw

Palladone for Safety Reasons (July 13, 2005),

http://www.fda.gov/bbs/topics/news/2005/NEW01205.html; Press

Release, Food & Drug Admin., FDA Issues Public Health Advisory

on Tysabri, A New Drug for MS (Feb. 28, 2005),

http://www.fda.gov/bbs/topics/news/2005/NEW01158.html; Press

Release, Food & Drug Admin., FDA Issues Public Health Advisory

on Vioxx as its Manufacturer Voluntarily Withdraws the Product

(Sept. 30, 2004), http://www.fda.gov/bbs/topics/news/2004/

NEW01122.html; see also, e.g., Press Release, Food & Drug. Admin.,

Rezulin To Be Withdrawn from the Market (March 21, 2000),

http://www.fda.gov/bbs/topics/NEWS/NEW00721.html; Press

Release, Food & Drug Admin., FDA Announces Withdrawal

Fenfluramine and Dexfenfluramine (Fen-Phen) (Sept. 15, 1997),

http://www.fda.gov/cder/news/phen/fenphenpr81597.htm; Gina Kolata

& Edmund L. Andrews, Anticholesterol Drug Pulled After Link With

31 Deaths, N.Y. TIMES, Aug. 9, 2001, at A12 (Baycol).

Furthermore, safety restrictions are applicable to all medicines

for any pallative purpose, as well as illegal drugs that serve no

pallative purpose, see Abigail Alliance I, 445 F.3d at 478 & n.9,

and therefore tell us little about the regulation of potentially lifeUSCA Case #04-5350 Document #1058780 Filed: 08/07/2007 Page 55 of 65
20

6 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); Lois K. Perrin, 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, 545 U.S. 1, 11-13 (2005).

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) (hereinafter “Janssen, 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 Nation’s early history there

were no restrictions on a patient’s access to potentially life-saving

medications, 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, supra, at 426-28. But cf. Op. at 16-18. 

saving medicines sought by terminally ill patients who have no

alternative treatment options.

By redirecting its inquiry, the court conveniently avoids the

sparse history of drug regulation for efficacy. See Abigail

Alliance I, 445 F.3d at 481-83. Prior to 1906, there was

essentially no drug regulation in the United States save

protections against fraud and adulteration.6 In 1906, Congress

enacted the Pure Food and Drug Act (“1906 Act”), ch. 3915, 34

Stat. 768 (repealed 1938), which prohibited misbranded and

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21

7 See 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); 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); cf. Minnesota ex rel. Whipple v. Martinson, 256 U.S.

41, 45 (1921).

8 See Salbu, supra note 7, at 407. 

adulterated foods or drugs from entering interstate commerce,

id. § 2, 34 Stat. at 768, and prohibited false and misleading

labeling, id. § 8, 34 Stat. at 770. 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. § 4, 34 Stat.

at 769. 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 by the Harrison Narcotic Act of 1914, ch. 1, 38 Stat.

785.7

In 1938, Congress enacted the Federal Food, Drug, and

Cosmetic Act (“1938 Act” or “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-MASSENGILL, S.DOC.

NO. 75-124, at 1-3 (1937) (“1937REPORT”).8 For the first time,

Congress required that drug manufacturers test, and the FDA

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22

9 See Zelenay, supra note 7, at 264-65. 

10 Id. 

11 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, 295, 300 & n.23 (1999–2000).

review, all new drugs for safety prior to their commercial

distribution. Ch. 653, 52 Stat. 1040 (1938) (codified as

amended at 21 U.S.C. § 301 et seq.); 1937 REPORT, supra, at 1-

3. Under the 1938 Act, a new drug could be commercially

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.9

 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.10 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 that can be used while under a doctor’s

supervision. See Act of Oct. 26, 1951, ch. 578, 65 Stat. 648

(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 evidence of the drug’s safety.11 The Kefauver-Harris

Amendments, Pub. L. No. 87-781, 76 Stat. 780 (1962) (codified

in scattered sections of 21 U.S.C. §§ 301-81), were enacted in

response to the rash of birth defects discovered in babies whose

mothers had taken Thalidomide to ease morning sickness caused

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23

12 See Salbu, supra note 7, at 408 n.41. See generally

HARVEY TEFF & COLIN R. MUNRO, THALIDOMIDE: THE LEGAL

AFTERMATH 1-10 (1976); Janssen, Outline of the History, supra note

6, at 438.

13 See Walsh & Pyrich, supra note 6, at 901; see also

Zelenay, supra note 7, at 266. 

14 Steven R. Salbu, Off-Label 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

v. Heckler, 718 F.2d 1174, 1180 (D.C. Cir. 1983), rev’d on other

grounds, 470 U.S. 821 (1985).

by pregnancy.12 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 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.13 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.”14 Thus,

a doctor may — and approximately 21% of the time does —

prescribe a drug to a patient for a purpose other than that for

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24

15 See David C. Radley et al., Off-Label Prescribing Among

Office-Based Physicians, 166 ARCHIVES INTERNAL MED. 1021 (2006)

(studying 2001 data of office-based physicians).

16 See Salbu, supra note 14, at 189-92. 

17 See id. at 211. 

which the FDA has approved the use of the drug.15 Such “offlabel” use may occur even if the drug is not deemed safe or

effective for that use, such as when a drug studied only for

adults is prescribed for a child. Further, it appears that the FDA

has never prohibited either off-label prescription or off-label use

of drugs.16 In recent years, the FDA has been moving to permit

drug manufacturers to promote the use of their drugs for offlabel purposes in limited circumstances.17 See Food and Drug

Administration Modernization Act of 1997, Pub. L. No.

105-115, 111 Stat. 2296 (codified in scattered sections of 21

U.S.C. §§ 301-81).

For more than half of this 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’ efficacy. Rather, at that time, the FDA could

interrupt the sale of new drugs only if it determined that the new

drug was unsafe. Government regulation of such drugs

premised on concern over a new drug’s efficacy, as opposed to

its safety, is of very recent origin. Even today, a patient may use

a drug for unapproved purposes where the drug may be unsafe

or ineffective for the off-label purpose. In short, encumbrances

on the treatment decisions of a patient and her physician lack the

historical pedigree of the rights that the Alliance seeks to

vindicate.

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25

Instead of confronting this history, the court relies on

statutory restrictions that address misbranded or adulterated

drugs, sales of poisons, and fraudulent curative claims, see Op.

at 17-18 & n.8, government restrictions that are not inconsistent

with the right of a person to attempt to save her own life. None

of the cited restrictions, focusing largely on the licensing of

pharmacists, suggest a physician could not prescribe a new

medication for a terminal patient. While Congress has imposed

increased responsibilities on the drug industry and the FDA

upon evidence of tragic consequences of some new drugs as a

result of new technology, see Abigail Alliance I, 445 F.3d at

482, the FDA does not regulate physicians, id. at 483, and offlabel prescription of medications is a long-standing practice that

has not been outlawed, id. Elsewhere the court relies on straw

men that are either acknowledged by the court to be irrelevant,

Op. at 17 n.8 (an incident in 1630 not the result of “legislative

or regulatory intervention”); or are in fact irrelevant, id. at 30

n.18 (discussing “affirmative access claim[s]” even though the

Alliance makes no such claim); or are speculative, id. at 21 n.12

(noting “a more plausible explanation for the limited efficacy

regulation”); see also Amicus Br. for Economists John E. Calfee

et al. This analysis hardly overcomes the history and

Constitutional recognition of the underlying right to life that the

Alliance claims. 

The common law traditions protecting necessity, forbidding

interference with rescue, and supporting self-defense, and the

Supreme Court’s validation of the fundamental right of a

pregnant woman to undergo a medical procedure to save her

own life demonstrate that the protected liberty interest of the

terminally ill to choose whether to pursue prescription

medications that may save their lives is deeply rooted in this

Nation’s history. Nothing in the history of drug regulation

demonstrates otherwise. In view of the common law history,

there is no occasion to determine how the first Glucksberg

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26

inquiry would be evaluated were there no evidence supporting

or refuting a historical basis for a claimed fundamental right. 

II.

For a right to be fundamental, the Glucksberg analysis

requires that it also be “‘implicit in the concept of ordered

liberty,’ such that ‘neither liberty nor justice would exist if they

were sacrificed,’” Glucksberg, 521 U.S. at 721 (quoting Palko,

302 U.S. at 325, 326). The Supreme Court has explained that

this expression “encompasses and protects the personal

intimacies of the home, the family, marriage, motherhood,

procreation, and child rearing.” Paris Adult Theatre I v. Slaton,

413 U.S. 49, 65 (1973). It also safeguards the “freedom of

thought and speech,” Palko, 302 U.S. at 326, and “[t]he security

of one’s privacy against arbitrary intrusion by the police,” Wolf

v. Colorado, 338 U.S. 25, 27-28 (1949), overruled on other

grounds by Mapp v. Ohio, 367 U.S. 643 (1961). In the context

of criminal trials, matters “implicit in the concept of ordered

liberty” include “the right to counsel at trial,” Teague v. Lane,

489 U.S. 288, 311 (1989) (plurality opinion) (quoting Mackey

v. United States, 401 U.S. 667, 693-94 (1971) (opinion of

Harlan, J.)); the presumption that “all are innocent until the state

has proved them to be guilty,” United States v. Salerno, 481

U.S. 739, 763 (1987); and “[t]he principle that a State may not

knowingly use false evidence, including false testimony, to

obtain a tainted conviction,” Napue v. Illinois, 360 U.S. 264, 269

(1959). 

Unlike Glucksberg’s historical inquiry, this step assesses

whether the Alliance’s claimed right is a component of the

“compendious expression for all those rights which the courts

must enforce because they are basic to our free society.” Wolf,

338 U.S. at 27. As Justice Frankfurter wrote, these rights create

“a realm of sanctuary surrounding every individual and

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infrangible, save in a very limited class of circumstances, by the

agents of government.” Monroe v. Pape, 365 U.S. 167, 208-09

(1961) (Frankfurter, J., dissenting), maj. op. overruled by Monell

v. Dep’t of Soc. Servs., 436 U.S. 658 (1978).

Setting aside the textual anchor of the Alliance’s claim in

the right to life, the claimed right also falls squarely within the

realm of rights implicit in ordered liberty. The core of liberty is

autonomy. As Professor Charles Fried writes, “[l]iberty is the

exercise of our powers as self-conscious, judging individuals,

individuals who in making our own lives cannot be responsible

to anyone . . . else except as we choose to be.” CHARLES FRIED,

MODERN LIBERTY 180 (2007). It is difficult to imagine any

context in which this liberty interest would be stronger than in

trying to save one’s own life. Cf. BRIAN CLARK,WHOSE LIFE IS

IT ANYWAY? (1978).

The Supreme Court engaged in similar analysis in Cruzan.

In evaluating the claim that due process protects a person’s right

to refuse life-sustaining treatment, the Court reasoned that “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.” 497 U.S. at 281. The Court acknowledged

that “[t]he principle that a competent person has a

constitutionally protected liberty interest in refusing unwanted

medical treatment,” could be inferred from its prior decisions.

Id. at 278. 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,

the Alliance seeks only to have the government step aside so as

not to interfere with the individual right of self-determination.

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 been determined to be safe

for substantial human testing. This reasoning tracks Eisenstadt

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v. Baird, 405 U.S. 438 (1972), where the Supreme Court noted

that the right to be free from unwanted government intrusion

into the fundamental decision whether to have children

establishes a right of access to contraceptives, id. at 453. 

In summary, there is no logic to be found, in view of oftlimited rights considered inherent in the nature of ordered

liberty, see Abigail Alliance II, 469 F.3d at 136-37, in the

conclusion that the right to save one’s life is unprotected

notwithstanding the specific protection afforded life in the Fifth

Amendment to the Constitution.

III.

For these reasons, I have serious disagreements with the

court’s assessment of the Alliance’s claim to a fundamental right

protected by the Fifth Amendment to the Constitution. It is no

more than tragic wordplay to suggest that the Alliance’s liberty

claim to potentially life prolonging medications, when no other

government approved alternatives exist, does not involve a

corollary to the right to life enshrined in the Fifth Amendment

to the Constitution. See Op. at 11 n.5. Denying a terminally ill

patient her only chance to survive without even a strict showing

of governmental necessity presupposes a dangerous brand of

paternalism. As the court phrases it, because “[w]e . . . cannot

know until the clinical testing process has been completed that

these drugs are necessary,” Op. at 25 n.15 (emphasis added), the

terminally ill patient, informed by her physician, is denied a

right to decide whether to bear those risks in an attempt to

preserve her life. Such intervention is directly at odds with this

Nation’s history and traditions giving recognition to individual

self-determination and autonomy where one’s own life is at

stake and should extend no further than the result in this case.

Because the right of a terminally ill patient to access potentially

life-saving investigational medications satisfies the Glucksberg

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test, I would remand this case for the district court to assess in

the first instance whether there exists a compelling

governmental interest, narrowly tailored, to overcome the

Alliance’s interest. Flores, 507 U.S. at 302. Accordingly, I

respectfully dissent.

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