On March 1, 2007, the District of Columbia Circuit Court of Appeals heard an oral argument in Abigail Alliance v. von Eschenbach. Previously, a divided court of appeals had ruled that where there are no other FDA-approved treatment options, a terminally ill patient’s access to investigational new drugs was a “fundamental right” protected under the Due Process Clause of the Constitution. The appeals court remanded the case to the district court to determine whether FDA’s policy of restricting access to post-Phase 1 investigational new drugs under the IND regulations was “narrowly tailored” to serve a “compelling governmental interest.” The FDA appealed, and the D.C. Circuit agreed to hear the case en banc.
All 10 judges on the D.C. Circuit participated in the oral argument. Both sides faced lively questioning. The plaintiff’s lawyer was asked, for example, to identify the “fundamental right” to access of drugs for terminally ill patients. The court also asked many questions regarding how that right would be defined, including what is a terminal illness, how is it defined, and who decides whether there is a therapeutic option. The plaintiff was also challenged as to how it could be a fundamental, deeply rooted right when it is based on a very specific regulatory scheme. There were also questions relating to how far this right would extend and what implications it might have in other situations, such as a request to access a drug by a “sick” patient instead of a terminally ill patient, and how the court should rule in cases where a patient demanded a right to investigational stem-cell therapy.
The government’s counsel faced some probing, albeit less intense, questioning. The government’s counsel repeated that fundamental rights were very limited, excluding even a right to access a drug that was agreed to be safe and effective, but had not yet been approved. Somewhat surprisingly, counsel asserted that FDA did consider efficacy even before the 1962 amendments, which added the efficacy requirement to the FDC Act. When asked if a rule enacted by a “Pol Pot administration” that prohibited people from eating would affect a fundamental right, counsel said that while this might be a bad law, it did not implicate a fundamental right.
The Abigail Alliance case is but one component in the early access debate. In December 2006, FDA issued a proposed rule to amend its regulations on access to investigational new drugs for the treatment of patients. On the legislative front, Sen. Sam Brownback (R-KS), in November 2005, introduced S. 1956, the Access, Compassion, Care, and Ethics for Seriously Ill Patients Act, or ACCESS Act.