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Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach

United States Court of Appeals for the District of Columbia Circuit

March 1, 2007, Argued; August 7, 2007, Decided

No. 04-5350

Opinion

 [*697]   [**35]  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 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, 117 S. Ct. 2258, 117 S. Ct. 2302, 138 L. Ed. 2d 772 (1997) (quoting Moore v. East Cleveland, 431 U.S. 494, 503, 97 S. Ct. 1932, 52 L. Ed. 2d 531 (1977) (plurality opinion)), we affirm the judgment of the district court.

The Abigail Alliance for Better Access to Developmental Drugs (the "Alliance") is an organization  [***3] 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,  [*698]   [**36]  containing detailed information establishing that human testing is appropriate, see  [***4] 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. P 15.

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495 F.3d 695 *; 378 U.S. App. D.C. 33 **; 2007 U.S. App. LEXIS 18688 ***

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

Subsequent History: US Supreme Court certiorari denied by Abigail Alliance v. Eschenbach, 128 S. Ct. 1069, 169 L. Ed. 2d 839, 2008 U.S. LEXIS 836 (U.S., Jan. 14, 2008)

Prior History:  [***1] Appeal from the United States District Court for the District of Columbia. (No. 03cv01601).

Abigail Alliance for Better Access to Dev. Drugs v. McClellan, 2004 U.S. Dist. LEXIS 29594 (D.D.C., Aug. 30, 2004)

CORE TERMS

patients, drugs, terminally ill, regulation, fundamental rights, experimental drug, new drug, self-defense, abortion, save, risks, effective, safe, efficacy, rights, testing, Phase, common law, medications, clinical, scientific, Food, medical treatment, life-saving, argues, constitutional right, marketing, rooted, governmental interest, history and tradition

Administrative Law, Agency Investigations, Scope of Authority, General Overview, Business & Corporate Compliance, Governments, Agriculture & Food, Federal Food, Drug & Cosmetic Act, Constitutional Law, Substantive Due Process, Scope, Public Health & Welfare Law, Healthcare, Civil Procedure, Defenses, Demurrers & Objections, Affirmative Defenses, Torts, Intentional Torts, Defenses, Necessity, Defense of Self & Others