Dying? Experimental Medications Not an Option

The U.S. Court of Appeals for the District of Columbia on March 1 will reconsider a case dealing with the FDA's regulatory authority covering pharmaceuticals to permit expanded use of experimental medications. The case against the FDA before the Court was filed in 2003 by the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation. The litigants seek to obtain access to experimental medications for terminally ill cancer patients. The court is asked to order the FDA to provide a special initial approval of experimental medications that appear effective and to allow their sale and distribution to terminally ill patients who have no other approved treatment options.

The FDA opposes the relief requested, stating that programs currently exist to provide experimental medications to terminally ill patients and that increased access to such treatments would lead to unacceptable risk. In May 2006, a three-judge panel of the court ruled that terminally ill patients have a "right of self-preservation" and should have access to experimental medications that have not reached Phase II clinical trials. According to the 2-1 decision, which reversed the dismissal of the lawsuit by a lower court, "barring a terminally ill patient from the use of a potentially lifesaving treatment impinges on this right of self-preservation." FDA appealed the decision and asked the full court to rehear the case. In November 2006, the court vacated the decision and agreed to rehear the case