Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach
378 U.S. App. D.C. 33, 2007 U.S. App. LEXIS 18688, 495 F.3d 695 (2007)
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Rule of Law:
The Due Process Clause of the Fifth Amendment does not include a fundamental right for terminally ill patients to access experimental drugs that have passed only initial safety trials (Phase I) but have not been proven safe and effective for public use.
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) prohibits general access to new drugs until they pass a multi-phase clinical trial process to prove they are both safe and effective.
- Phase I trials are the initial stage, involving 20 to 80 human subjects primarily to determine a drug's safety for continued human testing, its side effects, and metabolism.
- The Alliance seeks access for its members to drugs that have successfully completed Phase I trials but have not yet completed the more extensive Phase II and Phase III trials required for full FDA approval.
- The Alliance submitted a 'citizen petition' to the FDA, arguing that terminally ill patients face a different risk-benefit tradeoff and should be allowed to access drugs that meet a lower evidentiary standard.
- In response to the Alliance's proposals, the FDA concluded that granting such early access would upset the appropriate balance between the goals of early availability and ensuring drugs have a reasonable knowledge of their 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, challenging the constitutionality of policies restricting access to investigational drugs.
- The district court 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's decision, finding a limited due process right for the terminally ill.
- The D.C. Circuit, upon petition by the FDA as appellee, voted to vacate the panel's decision and granted a rehearing of the case en banc before the full court.
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Issue:
Does the Due Process Clause of the Fifth Amendment provide terminally ill patients with a fundamental right to access investigational drugs that have passed Phase I safety trials but have not yet been approved for general use by the Food and Drug Administration (FDA)?
Opinions:
Majority - Griffith
No, the Due Process Clause does not provide such a right. There is no fundamental right of access to experimental drugs for the terminally ill because such a right is not 'deeply rooted in this Nation’s history and tradition' as required by Washington v. Glucksberg. The court's historical review reveals a consistent tradition of increasing government regulation of drug safety and efficacy as scientific capabilities have advanced, rather than a tradition of unfettered access. The Alliance's analogies to common law doctrines like self-defense, necessity, and interference with rescue fail because those doctrines do not support a right to assume the enormous and unknown risks of unproven medical treatments. Because no fundamental right is at stake, the FDA's regulations are subject only to rational basis review. The government's policy of protecting patients, including the terminally ill, from potentially unsafe and ineffective drugs is rationally related to a legitimate state interest, as affirmed in United States v. Rutherford.
Dissenting - Rogers
Yes, terminally ill patients do have such a fundamental right. The majority mischaracterizes the asserted liberty interest by focusing narrowly on 'access to experimental drugs' instead of the broader, deeply rooted 'right to try to save one's life,' which is a corollary to the right to life explicitly protected by the Fifth Amendment. This right is supported by the Nation's history and traditions, including the common law doctrines of self-defense, necessity, and interference with rescue, as well as the Supreme Court's abortion jurisprudence which recognizes a woman's right to a life-saving procedure. The majority improperly conflates the existence of a right with the government's interest in regulating it. A fundamental right exists, and the court should therefore apply strict scrutiny and remand the case to determine whether the FDA has a compelling interest that is narrowly tailored to justify infringing on this right.
Analysis:
This decision solidifies the FDA's broad authority to regulate access to experimental medications, even for terminally ill patients with no other options. It affirms that the Washington v. Glucksberg test for recognizing new substantive due process rights sets a high bar, requiring a specific, historically-grounded tradition rather than analogies to general principles like self-preservation. The ruling effectively channels the debate over the 'right to try' unapproved drugs away from the judiciary and into the legislative arena, reinforcing judicial deference to Congress and federal agencies in matters of scientific uncertainty and public health policy.
