Abigail Alliance v. von Eschenbach (2007)

United States, court ruling. Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695, was decided by the full United States Court of Appeals for the D.C. Circuit on 7 August 2007 by eight votes to two; the Supreme Court declined to hear the case in January 2008. The Alliance was founded by Frank Burroughs after his daughter Abigail died of head and neck cancer in 2001 having been unable to obtain cetuximab or gefitinib, then in trials.

What the court decided: a three-judge panel had ruled in 2006 that the Due Process Clause protects a terminally ill patient's right to access potentially life-saving investigational drugs once they have passed phase 1 safety testing. The en banc court reversed, holding that there is no such fundamental right deeply rooted in the nation's history, that the government has long regulated drugs, and that the balance between access and evidence belongs to Congress and the FDA. Judge Rogers dissented, arguing the ruling left patients with no remedy.

What changed afterwards: the FDA rewrote its expanded access regulations in 2009, the Alliance and the Goldwater Institute turned to state legislatures, Colorado passed the first right-to-try law in 2014, and Congress passed the federal Right to Try Act in 2018. The case remains the legal anchor for the position that access to unapproved medicines is a matter of policy rather than constitutional right.