Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach
378 U.S. App. D.C. 33, 495 F.3d 695, 2007 U.S. App. LEXIS 18688 (2007)
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Rule of Law:
The Due Process Clause of the Fifth Amendment does not confer a fundamental right for terminally ill patients to access experimental drugs that have passed initial safety trials but are not yet proven safe and effective for public use. Government regulations restricting such access need only satisfy rational basis scrutiny.
Facts:
- The Abigail Alliance for Better Access to Developmental Drugs is an organization representing terminally ill patients who have exhausted all government-approved treatment options.
- The Food and Drug Administration (FDA), under the Food, Drug, and Cosmetic Act (FDCA), prohibits general access to new drugs until they complete a multi-phase clinical trial process to prove both safety and effectiveness.
- The Alliance sought access for its members to investigational drugs that had completed Phase I trials, which primarily test for basic safety in small, controlled groups, but have not completed later phases to establish effectiveness and broader safety.
- The Alliance submitted a 'citizen petition' to the FDA proposing new regulations that would allow sponsors to market these post-Phase I drugs to terminally ill patients.
- The Alliance argued that terminally ill patients face a different risk-benefit calculation and should be able to opt for treatments that have met a lower evidentiary hurdle.
- The FDA rejected the proposal, stating it would upset the appropriate balance between early availability and the need for reasonable knowledge of a drug's clinical benefit and toxicity.
Procedural Posture:
- The Abigail Alliance sued the FDA and its commissioner in the U.S. District Court for the District of Columbia, seeking access to investigational drugs.
- The district court (a court of first instance) granted the FDA's motion to dismiss, holding that there is no constitutional right of access to unapproved drugs.
- The Alliance, as appellant, appealed to the U.S. Court of Appeals for the D.C. Circuit.
- A divided three-judge panel of the D.C. Circuit reversed the district court, finding a limited due process right for terminally ill patients to access such drugs.
- The D.C. Circuit then vacated the panel's decision and granted the FDA's petition for a rehearing en banc by the full court.
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Issue:
Does the Due Process Clause of the Fifth Amendment protect a fundamental right for terminally ill patients, who have exhausted all approved treatment options, to access investigational drugs that have passed Phase I clinical trials but have not yet been approved for public use by the FDA?
Opinions:
Majority - Griffith
No, the Due Process Clause of the Fifth Amendment does not protect such a fundamental right. To be deemed fundamental, a right must be 'deeply rooted in this Nation’s history and tradition.' A review of American legal history reveals a long and increasing tradition of government drug regulation to protect public safety, not a tradition of unfettered access to unproven medications. The Alliance's attempt to analogize this claim to the common law doctrines of necessity, self-defense, and interference with rescue fails because those doctrines are inapplicable to the act of assuming the risks of unproven and potentially harmful drugs. Because no fundamental right is implicated, the FDA's policy is subject only to rational basis review. The policy is constitutional because it is rationally related to the legitimate government interest of protecting all patients, including the terminally ill, from potentially unsafe and ineffective drugs, as established in United States v. Rutherford.
Dissenting - Rogers
Yes, the Due Process Clause protects a fundamental right to try to save one's own life, which is a corollary to the right to life itself. The majority mischaracterizes the asserted right as merely a 'right to assume risk' and conflates the right with the alleged deprivation. The Nation's history and common law traditions, including self-defense and necessity, reflect a deep respect for the right to self-preservation. Furthermore, the Supreme Court's abortion jurisprudence, which protects a woman's right to a life-saving medical procedure, establishes a right to medical self-preservation. For a terminally ill patient with no other options, an experimental drug is 'necessary' even if it is not proven 'sufficient.' Therefore, the FDA's policy infringes on a fundamental right and should be subject to strict scrutiny.
Analysis:
This en banc decision solidifies the FDA's broad authority to regulate experimental drugs, even in the face of compelling claims from terminally ill patients. By narrowly interpreting substantive due process and rejecting the creation of a new fundamental right, the court reinforced the high bar set by Washington v. Glucksberg for such claims. The ruling effectively removes the judiciary from the complex scientific and ethical calculus of drug approval, leaving such policy balancing to Congress and the FDA. This precedent makes it significantly more difficult for future litigants to challenge government health and safety regulations on the grounds of personal autonomy in medical decision-making.
