Court to Hear Experimental Drugs Case

WASHINGTON – A federal court agreed Tuesday to rehear a case that would have given terminally ill patients early access to experimental drugs unlikely to be approved before they die.

The full 10-judge U.S. Court of Appeals for the District of Columbia probably will hear the case next summer, said Richard Samp, chief counsel for the Washington Legal Foundation. The group, with the Abigail Alliance for Better Access to Developmental Drugs, sued the Food and Drug Administration in 2003 in seeking broader access to drugs that have undergone preliminary safety testing in as few as 20 people but have yet to be approved by the FDA.

In 2004, a district court dismissed the case. In May, a three-judge appeals panel reinstated the lawsuit in a 2-1 decision.

The FDA in turn appealed the May decision and asked for the full court to rehear the case.

“We had asked that the rehearing not be granted, but we are confident when all the judges on the court hear the facts, they will agree with the original panel’s decision,” Samp said.

FDA spokeswoman Kristen Neese said in a statement that the agency was pleased with the decision.

“We believe that access to lifesaving treatments is essential but need to find the right balance between earlier access and evaluation of safety,” Neese said.

The Abigail Alliance wants to expand the availability of drugs in the initial phases of human testing beyond the limited “compassionate use” programs now permitted.