Academic journal article Harvard Law Review , Vol. 121, No. 6
In deciding substantive due process cases, courts often rest legal analysis on scientific assertions by the parties. When those scientific assertions are made by agencies, courts may use the doctrines of administrative law in their assessments. Recently, in Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, (1) the en banc D.C. Circuit held that terminally ill patients have no fundamental right to obtain medications still undergoing the testing required by the Food and Drug Administration (FDA). In reaching this decision, the court relied on the FDA's judgment that the medications at issue were neither safe nor effective to preclude the use of common law doctrines such as necessity and self-defense as support for the asserted right. The court, however, failed to subject that scientific judgment to any independent scrutiny. It should have instead separated the FDA's loose combination of legal interpretation and factual findings and applied the corresponding standards of review, although the findings would nevertheless have been likely to stand.
The Abigail Alliance for Better Access to Developmental Drugs (the Alliance) is a nonprofit organization that seeks to increase the availability of experimental medications to the terminally ill. (2) Under the Food, Drug, and Cosmetic Act (3) (FDCA), FDA regulations require three or four stages of clinical testing before a drug can be sold to the public. (4) In early 2003, the Alliance submitted a proposal to the FDA that suggested making drugs available to the terminally ill for purchase after the earliest stage of testing. (5) When the FDA rejected this proposal, the Alliance filed suit seeking to enjoin FDA administrators from enforcing the ban on sale of unapproved drugs against certain terminally ill individuals. (6)
The Alliance claimed that the FDA's ban (7) violated its members' privacy rights, liberty rights, and due process right to life. (8) The FDA moved to dismiss, arguing that no constitutional right of access to experimental drugs exists. (9) The district court granted the motion, holding that neither the Supreme Court nor the D.C. Circuit had ever recognized a fundamental right to receive medical treatment and that the Alliance's analogies to due process rights like the right to refuse medical treatment were too strained. (10) The court further held that the FDA's ban was sufficiently related to its legitimate interest in protecting public health to survive rational basis scrutiny. (11)
A panel of the D.C. Circuit reversed and remanded in a 2-1 split. (12) Applying the test that the Supreme Court articulated in Washington v. Glucksberg (13) to examine whether the "right of control over one's body" (14) was "deeply rooted in [American] history and tradition," (15) the majority found that the liberty interest asserted by the Alliance, encompassing the rights of self-defense and self-preservation, was deeply rooted in common law. (16) In contrast, the court noted, there was no tradition of drug regulation at all in America until 1906, and no governmental review of medication safety until 1938, a tradition insufficient to overturn the longer-standing right of self-preservation. (17) The court also noted that the Supreme Court had implied due process protection for a right to refuse lifesaving treatment, and the court used a similar analysis to conclude that the Due Process Clause protects the liberty interest asserted by the Alliance. (18) It therefore remanded the case to the district court for a strict scrutiny analysis of the FDA's policies. (19) In dissent, Judge Griffith argued strongly for the importance of the current regulatory structure and the right of the political branches to resolve the scientific and moral debates inherent in the Alliance's proposal. (20) He similarly applied the Glucksberg test, but noted that Glucksberg "prohibits [a court] from creating new substantive due process rights by inference. …