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Limiting Access to Investigational Drugs

By Janice G. Inman
March 27, 2007

The U.S. Court of Appeals for the District of Columbia in March began reconsideration of its decision that held it was unconstitutional for the Food and Drug Administration (FDA) to withhold experimental drugs from terminally ill patients. The original decision, in Abigail Alliance for Better Access to Developmental Drugs v von Eschenbach, 445 F.3d 470 (D.C.Cir.2006), challenging the FDA's policy against permitting anyone to take unapproved drugs outside the normal channels, such as the clinical study setting, was decided by a three-judge panel of the court last May. The order for rehearing en banc was issued in November 2006. The case pits dying, often desperate, patients against the FDA and its policies aimed at protecting the public from dangerous and unproven medications.

The Plaintiffs

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