October 01, 2007
FDA wins experimental drugs decision
The Washington, DC Court of Appeals has ruled in the FDA's favor that terminally ill patients have no "fundamental right 'deeply rooted in this nation's history and tradition'" to have access to experimental drugs. Late last year, the FDA won a petition to have the full US Court of Appeals for DC reconsider a ruling that mentally competent terminally ill patients should have access to post-phase I investigational drugs if there are no government-approved alternative treatments available.
The court agreed 2-1 that patients have a right to unapproved drugs, and said an earlier court opinion had erred.
Speaking on an FDLI audio conference later, FDA deputy chief counsel Jeff Senger said that accessing these drugs is not a fundamental constitutional right and thus the FDA needs only a “rational” basis for its regulatory drug development policy.