By Alicia Ouellette
The Abigail Alliance for Better Access to Developmental Drugs suffered a major (and perhaps fatal) setback in its battle to establish for terminally ill patients a constitutional right of access to experimental drugs. In an 8-2 ruling, the full U.S. Court of Appeals for the District of Columbia reversed a May 2006 ruling by a divided three-judge appeals panel, which recognized such a right (pdf of the decision).
After describing in some detail the FDA process for approval of new drugs, including FDA programs designed to provide early access to promising experimental drugs, the Court rejected the argument 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.”
Writing for the majority, Judge Thomas Griffith stated that “the Alliance’s argument ignores our Nation’s history of drug safety regulation. . .. [T]he Alliance [cannot] override current FDA regulations simply by insisting that drugs which have completed Phase It esting are safe enough for terminally ill patients. Current law bars public access to drugs undergoing clinical testing on safety grounds. The fact that a drug has emerged from Phase I with a determination that it is safe for limited clinical testing in a controlled and closely-monitored environment after detailed scrutiny of each trial participant does not mean that a drug is safe for use beyond supervised trials. FDA regulation of post- Phase I drugs is entirely consistent with our historical tradition of prohibiting the sale of unsafe drugs.”
The Abigail Alliance is sure to seek review by the Supreme Court.
Alicia Ouellette directs the program on Health Law and Bioethics at Albany Law School and the Alden March Bioethics Institute.