Court To Hear Appeal In Lawsuit On Experimental Prescription Drug Access

The U.S. Court of Appeals for the District of Columbia on Thursday will reconsider a lawsuit against FDA that seeks to provide terminally ill patients with expanded access to experimental medications, the Baltimore Sun reports (Rockoff, Baltimore Sun, 3/1). The lawsuit, filed in 2003 by the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation, asked FDA to provide a special initial approval of experimental medications that appear effective and allow their sale and distribution to terminally ill patients who have no other approved treatment options. FDA argued 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 (Kaiser Daily Health Policy Report, 2/13). Richard Samp, chief counsel for WLF, said that terminally ill patients with no other approved treatment options have the right to take experimental medications. He said, "Who should be the one making the decision? FDA or the person who's been told, 'There's nothing we can do for you, so go off and die quietly.'"

Some Concerns
However, medical researchers have raised concerns that a decision in favor of the plaintiffs could "encourage many patients who currently enroll in clinical trials to simply request the experimental treatments instead" and "seriously damage new drug development," the Sun reports. In addition, health officials have raised concerns that a decision in favor of the plaintiffs would limit the ability of FDA to monitor prescription drug safety. The pharmaceutical industry also has raised concerns about the financial, legal and safety implications of expanded use of experimental medications (Baltimore Sun, 3/1).

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