From a Constitutional Right to a Policy of Exceptions: Abigail Alliance and the Future of Access to Experimental Therapy

Abstract

In 1999, nineteen-year-old Abigail Burroughs was diagnosed with head and neck cancer. Abigail underwent the conventional treatments-chemotherapy and radiation therapy-with no success. Her physician recommended that Abigail attempt to enroll in clinical trials for two unapproved drugs that her physician hoped might have an effect on her tumor. Abigail, however, was unable to enroll in the trials because she did not meet the scientific criteria for inclusion. In June 2001, shortly after enrolling in a clinical trial of a third unapproved drug, Abigail passed away. Following her death, her father founded the Abigail Alliance for Better Access to Developmental Drugs (Abigail Alliance) to advocate for increased access to unapproved drugs for terminally ill patients. In January 2003, the Abigail Alliance submitted to the Food and Drug Administration (FDA) a proposal for new regulations to increase access to unapproved therapy. They proposed creating a tiered approval system that would allow terminally ill patients to purchase unapproved drugs that had completed Phase 1 clinical trials. In April 2003, the FDA rejected this proposal because it "would upset the appropriate balance that [the FDA is] seeking to maintain, by giving almost total weight to the goal of early availability and giving little recognition to the importance of marketing drugs with reasonable knowledge for patients and physicians of their likely clinical benefit and their toxicity." The Abigail Alliance then filed a formal citizen petition with the FDA (a required step before one can file a lawsuit against the agency), again calling for a tiered approval system. Before the FDA responded to the citizen petition, Abigail Alliance filed suit, alleging that FDA regulations that restrict terminally ill patients' access to unapproved drugs violate a fundamental constitutional right protected by the Due Process Clause of the Fifth Amendment. A D.C. district court judge dismissed Abigail Alliance's case, finding that a constitutional right to access unapproved drugs did not exist and that the government's policy restricting access to unapproved drugs survived rational basis review. The Alliance appealed to the D.C. Circuit. In a decision that surprised many commentators, Judges Rogers and Ginsburg reversed the district court's decision and held that terminally ill patients did, in fact, have a constitutional right to access unapproved drugs. The FDA then filed a petition for rehearing en banc. That petition was granted, and the en banc court vacated the panel's decision. Subsequently, the Supreme Court denied Abigail Alliance's petition for certiorari. The D.C. Circuit is widely recognized as having special expertise on matters of administrative law, and the Abigail Alliance opinion is now considered an authoritative judgment on the topic of a constitutional right to access experimental therapies.