Abigail Alliance v. Von Eschenbach, 04-5350.

• Court: United States Courts of Appeals. United States Court of Appeals (District of Columbia)
• Writing for the Court: Rogers
• Citation: 445 F.3d 470
• Parties: ABIGAIL ALLIANCE FOR BETTER ACCESS TO DEVELOPMENTAL DRUGS AND WASHINGTON LEGAL FOUNDATION, Appellants v. Andrew C. VON ESCHENBACH, M.D., in his official capacity as Acting Commissioner, Food and Drug Administration and Michael O. Leavitt, in his official capacity as Secretary, U.S. Dept. of Health and Human Services, Appellees.
• Docket Number: No. 04-5350.,04-5350.
• Decision Date: 02 May 2006

445 F.3d 470 ABIGAIL ALLIANCE FOR BETTER ACCESS TO DEVELOPMENTAL DRUGS AND WASHINGTON LEGAL FOUNDATION, Appellants
v.
Andrew C. VON ESCHENBACH, M.D., in his official capacity as Acting Commissioner, Food and Drug Administration and Michael O. Leavitt, in his official capacity as Secretary, U.S. Dept. of Health and Human Services, Appellees. No. 04-5350. United States Court of Appeals, District of Columbia Circuit. Argued October 21, 2005. Decided May 2, 2006.

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

James S. Ballenger argued the cause for appellants. With him on the briefs were Daniel J. Popeo and David Price. Richard A. Samp entered an appearance.

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

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

Opinion for the Court filed by Circuit Judge ROGERS.

Dissenting opinion filed by Circuit Judge GRIFFITH.

ROGERS, Circuit Judge.

The Abigail Alliance for Better Access to Developmental Drugs ("the Alliance")

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

Upon applying the Supreme Court's test for addressing substantive due process claims set forth in Washington v. Glucksberg, 521 U.S. 702, 710, 117 S.Ct. 2258, 138 L.Ed.2d 772 (1997), we hold that the district court erred in dismissing the Alliance's complaint pursuant to Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim. First, the right at issue, carefully described, is the right of a mentally competent, terminally ill adult patient to access potentially life-saving post-Phase I investigational new drugs, upon a doctor's advice, even where that medication carries risks for the patient. Second, we find, upon examining "our Nation's history, legal traditions, and practices," Glucksberg, 521 U.S. at 710, 117 S.Ct. 2258, that the government has not blocked access to new drugs throughout the greater part of our Nation's history. Only in recent years has the government injected itself into consideration of the effectiveness of new drugs. Third, Supreme Court precedent on liberty indicates that the right claimed by the Alliance can be inferred from the Court's conclusion in Cruzan v. Director, Missouri Department of Health, 497 U.S. 261, 278, 110 S.Ct. 2841, 111 L.Ed.2d 224 (1990), that an individual has a due process right to refuse life-sustaining medical treatment, id. at 279, 110 S.Ct. 2841. Here, the claim implicates a similar right — the right to access potentially life-sustaining medication where there are no alternative government-approved treatment options. In both instances, the key is the patient's right to make the decision about her life free from government interference.

Because the question remains whether the FDA's challenged policy has violated that right, we reverse the dismissal of the Alliance's complaint and remand the case to the district court to determine whether the FDA's policy "is narrowly tailored to serve a compelling [governmental] interest." Glucksberg, 521 U.S. at 721, 117 S.Ct. 2258 (quoting Reno v. Flores, 507 U.S. 292, 302, 113 S.Ct. 1439, 123 L.Ed.2d 1 (1993)).

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

I. A.

The Food, Drug, and Cosmetic Act ("FDCA"), Pub.L. No. 75-717, §§ 1-902,

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52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. § 301 et seq. (2000)), prohibits drug manufacturers from introducing any "new drug" into interstate commerce until manufacturers have applied for, and received, FDA approval. 21 U.S.C. § 355(a). A "new drug" is any substance covered by the FDCA not "generally recognized, among experts . . . as safe and effective for use under the conditions prescribed. . . in the labeling." 21 U.S.C. § 321(p)(1); see also United States v. 50 Boxes More or Less, 909 F.2d 24 (1st Cir.1990). Before a new drug is eligible for full approval and marketing, the Secretary of the U.S. Department of Health and Human Services must find "substantial evidence that the drug will have the effect it purports or is represented to have." 21 U.S.C. § 355(d). Exempted from this general ban are new drugs "intended solely for investigational use by experts . . . ." Id. § 355(i)(1).

The FDCA directs the Secretary to promulgate regulations for testing new drugs. Id. Pursuant to this authority, the FDA has promulgated regulations that require three phases of government testing on humans before investigational new drugs can receive FDA approval and enter the commercial marketplace. In Phase I, new drugs are tested on 20 to 80 human subjects to determine "the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness." 21 C.F.R. § 312.21(a). It takes approximately one year to conduct Phase I testing.¹ FDA counsel acknowledged at oral argument that drugs that survive this phase have been deemed "sufficiently safe for substantial human testing, but [are] not yet proven to be safe and effective to the satisfaction of the FDA [to be commercially marketed]." Oral Argument Tape of Oct. 21, 2005 at 15:57-15:59. Phase II involves targeted, controlled clinical studies of up to several hundred human subjects "to evaluate the effectiveness of the [Phase I investigational new] drug . . . and to determine the common short-term side effects and risks associated with the drug." 21 C.F.R. § 312.21(b). Phase III expanded trials, which can include several thousand human subjects, are "performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug . . . ." Id. § 312.21(c). With narrow exceptions, FDA regulations require informed consent to be obtained from clinical trial participants. Id. §§ 50.1-50.27.

B.

On January 16, 2003, the Alliance submitted a proposal to the FDA for new regulations to render post-Phase I investigational new drugs available to terminally ill patients who were not admitted to the FDA's clinical trials. The FDA rejected the proposal by letter dated April 25, 2003, outlining the FDA's policy. On June 11, 2003, Alliance filed a Citizen Petition, pursuant to 21 C.F.R. § 10.30, challenging the FDA's policy barring the sale of investigational new drugs that have successfully completed Phase I trials to terminally ill patients not selected for clinical trials. The FDA acknowledged receipt of the Citizen Petition but otherwise did not respond within 180 days, thereby entitling the Alliance to seek judicial review of the challenged policy. See id. § 10.30(e)(2).

The Alliance filed suit against the FDA Commissioner and the Secretary of the

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Department of Health and Human Services, seeking to enjoin the FDA from enforcing the policy barring the sale of post-Phase I investigational new drugs to terminally ill patients not in Phase II clinical trials. Noting that the FDA has administrative discretion to define several stages for human testing of new drugs after animal testing has been conducted, the complaint alleges that it takes, on average, just under seven years for investigational new drugs to complete the three phases of clinical human trials and receive FDA approval for commercial marketing and thus become eligible for purchase by persons not in FDA clinical trials. Compl. ¶ 12.² The complaint also alleges that non-commercial options provide relief only to a very small number of terminally ill patients as spaces in clinical trials are "very limited . . . in relation to the need." Compl. ¶ 15. The Alliance asserts that clinical human trials are limited in number and by type of patient who qualifies. Further, the FDA's "compassionate use" programs, which permit drug companies voluntarily to provide new drugs at cost during the pre-approval period, are available only to "a fraction of those in desperate need." Id. Although the FDA may permit "treatment use" of unapproved new drugs, see 21 C.F.R. § 312.34 (1999), and has allowed access for limited groups of persons with AIDS,³ the FDA has refused as a general matter to allow terminally ill patients to have access to investigational new drugs that have successfully completed Phase I trials. Consequently,...