No constitutional right to experimental drugs

The U.S. Court of Appeals in the District of Columbia last Tuesday held that terminally ill patients do not have a constitutional right to be treated by experimental drugs not approved by the Food & Drug Administration, even if they in all likelihood would be dead before such medication might ever be approved. (Article) (Decision )

Writing for the majority, Judge Thomas B. Griffith said, “Terminally ill patients desperately need curative treatments , but their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit.”

The Abigail Alliance, an organization for terminally ill patients and their families, sought to expand access to “experimental drugs,” approaching the Food & Drug Administration with an administrative petition back in the summer of 2003, and on several occasions after that, each of which was rejected.

Abigail then filed suit in D.C. District Court in July 2003, challenging as unconstitutional the FDA policy of barring their sale of investigative drugs to terminally ill patients. The District Court found against them, holding that they had “not invoked a recognized constitutional right,” and that the FDA’s policy was “rationally related to a legitimate state purpose.” (Opinion)

The district court opinion was first appealed to a three-judge tribunal in May 2006, which reversed & remanded the case, saying that the Supreme Court’s 1990 decision in Cruzan v. Missouri Dept. Health -- that an individual had a due process right to refuse life-saving medical treatment, was similar – “the right to access potentially life-sustaining medication where there are no alternative government-approved treatment options.” (Opnion)

After filing a simple petition for rehearing – which was denied -- the FDA filed a second petition for an en banc rehearing , challenging the merits of the court’s decision and raising, for the first time, a Article III constitutional issue. The Court, on November 21st., agreed to rehear the case, vacating the May 2nd. decision.

Disagreeing with its early decision, the Court last Tuesday affirmed the District Court’s decision and citing Washington v. Glucksberg said that “there is no fundamental right ‘deeply rooted in this Nation’s history & tradition’ of access to experimental drugs for the terminally ill.”