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www.fdanews.com/articles/91906-court-to-vote-on-terminal-patients-access-to-experimental-drugs

COURT TO VOTE ON TERMINAL PATIENTS' ACCESS TO EXPERIMENTAL DRUGS

March 12, 2007

The U.S. Court of Appeals for the District of Columbia recently heard arguments in a landmark case to decide if terminally ill patients have a constitutional right to use drugs that have not been fully approved by the FDA.

The Washington Legal Foundation (WLF) sued the FDA in 2003 to overturn policies denying these patients access to experimental drugs, even when they are the only treatments available. In that case, a three-judge panel ruled in WLF's favor, deciding that terminal patients have a constitutional right to experimental drugs -- drugs approved for clinical testing but not for widespread marketing.

The court later decided to rehear the case in front of all of its 10 judges. According to a statement from WLF, the court is likely to reach a decision within six to eight months.

"It's going to be a relatively close vote," Richard Samp, WLF chief counsel, said. Samp pointed out that three of the judges had heard the case in 2003, and there were no indications they had changed their minds. "We can be fairly sure we begin with two judges on our side and one judge against us," he said.

Samp said that one or two of the new judges appeared to be leaning in favor of the WLF's position, and two appeared to lean against it. Other judges gave no indications of their stance, he added.