02 May, 2006 20:04 GMT
'Barring a terminally ill patient from the use of a potentially lifesaving treatment impinges on this right of self-preservation,' Judge Judith W. Rogers wrote in the 2-1 opinion from the panel of the US Court of Appeals for the District of Columbia Circuit.
Terminally ill patients seeking access to experimental, unapproved drugs won a legal reprieve Tuesday in a federal appeals court. A three-judge panel reinstated a lawsuit filed on behalf of the patients and returned the case to district court, which had dismissed the case in 2004.
The
Abigail Alliance for Better Access to Developmental Drugs and the
Washington Legal Foundation sued the
Food and Drug Administration in 2003, seeking access for terminally ill patients to drugs that have undergone preliminary safety testing in as few as 20 people but that have yet to be approved.
'Right of Self-Preservation'
Agency approval of drugs generally requires extensive testing that can involve thousands of patients.
"Barring a terminally ill patient from the use of a potentially lifesaving treatment impinges on this right of self-preservation," Judge Judith W. Rogers wrote in the 2-1 opinion from the panel of the US Court of Appeals for the District of Columbia Circuit.
Paul Kamenar, senior executive counsel for the Washington Legal Foundation, called the ruling a big defeat for the FDA.
"The FDA has long prohibited lifesaving medicines for terminally ill patients," he said. "We think this is a tremendous victory for patient groups and those who are in need of these kinds of medicines."
The FDA said it was studying the opinion and would consult with the Department of Justice on its next steps.
'Laetrile Redux'
"We remain sympathetic to the desire of terminally ill patients to get access to experimental treatments when they have exhausted other therapeutic options, and have a number of new efforts under way inside FDA to improve how we make investigational drugs available through expanded access programs. We plan to have much more to say about this soon," agency spokeswoman Susan Bro said in a statement.
Donald Kennedy, a former FDA commissioner, called the lawsuit "Laetrile redux."
In the late 1970s, terminally ill cancer patients and their spouses sought access to Laetrile, a then- and still-unapproved drug, eventually suing the FDA -- and Kennedy -- in a case that landed in the Supreme Court.
In 1979, the Court ruled unanimously that there should be no exemption to the FDA's safety and effectiveness standards, which all drugs must meet, for medicines sought by terminally ill patients.
(c) Associated Press
(c) 2006 Daily News Central. All rights reserved.
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