In 2003 the Abigail Alliance For Better Access To Developmental Drugs ("Abigail Alliance") and the Washington Legal Foundation proposed that the Food and Drug Administration ("FDA") issue regulations allowing terminally ill patients excluded from FDA clinical trials to gain access to investigational new drugs. The Abigail Alliance then filed a Citizen Petition according to 21 C.F.R. §10.30. When the FDA failed to respond to the Petition within 180 days, the Abigail Alliance sued in the D.C. District Court to challenge the FDA's drug approval policy, arguing that the court should recognize the right to life under the Due Process Clause of the United States Constitution as allowing terminally ill patients access to drugs that have completed Phase I (dosage) trials. The District Court dismissed the suit under F.R.C.P. 12(b)(6), finding that the plaintiffs had failed to state a claim upon which relief could be granted.
In a 2 to 1 decision, the Court of Appeals for the D.C. Circuit reversed, concluding that
where there are no alternative government-approved treatment options, a terminally ill, mentally competent adult patient's informed access to potentially life-saving investigational new drugs determined by the FDA after Phase I trials to be sufficiently safe for expanded human trials, warrants protection under the Due Process Clause.
The Court of Appeals also remanded so that the District Court could consider whether the FDA's policy of refusing drug access violates the "protected liberty interest" of terminally ill patients "is narrowly tailored to serve a compelling governmental interest."
It is difficult to imagine this case not ending up in the Supreme Court. If the D.C. Circuit's decision stands, then FDA's role of guarantor of drug safety and efficacy may be significantly diminished, at least with respect to the terminally ill. Meanwhile, public health and patients' rights hang in the balance.
More later on this watershed case from Elizabeth Weeks and Andrew Torrance.