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Limiting Access to Investigational Drugs
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
The Abigail Alliance was incorporated in 2001 as a group dedicated to bringing as-yet unapproved drugs to the terminally ill. It was named in honor of a woman who had died of cancer at the age of 21, after she was unsuccessful in her efforts to become a subject in tests for two drugs that were still in the experimental stage. Although Abigail was accepted into the clinical trial of a third promising drug, it was too late to save her. Her family, other gravely ill patients and their families and other interested parties formed the Abigail Alliance to advocate for access to experimental drugs by people who are mentally competent but terminally ill.
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