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November 22, 2006
How Critical is the Critical Path?
by Peter Pitts
New Hearing for Suit Against FDA
Associated Press
A federal court agreed yesterday to rehear a case that aims to get 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 Circuit will probably hear the case next summer, said Richard A. 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. It is seeking broader access to drugs that have undergone preliminary safety testing in as few as 20 people and 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 to 1 decision.
The FDA, in turn, appealed and asked for the full court to rehear the case.
Posted by Peter Pitts at November 22, 2006 08:41 AM
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