Healthy Skepticism Library item: 12420
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Court Declines Experimental Drugs Case
Associated Press 2008 Jan 15
http://ap.google.com/article/ALeqM5h5nS_CMHbmFZG5INFP4JKA7U4a1wD8U5O4381
Full text:
The Supreme Court refused Monday to review a ruling that terminally ill patients have no constitutional right to be treated with experimental drugs – even if that means the patient will likely die before the medicine is approved.
A federal appeals court, siding with the Food and Drug Administration, last year said the government may deny access to drugs that have not gone through extensive testing and received FDA approval. The process can take years.
The Supreme Court did not explain its decision to leave the appeals court ruling undisturbed. Chief Justice John Roberts did not take part in the action.
The Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation sued the FDA in 2003, seeking access for terminally ill patients to drugs that have undergone preliminary safety testing in as few as 20 people but have yet to be approved.
Abigail Alliance was created by Frank Burroughs, whose daughter, Abigail, was denied access to experimental cancer drugs and died in 2001. The drug she was seeking was approved years later.
The alliance said all it was asking for “is a right for terminally ill patients with no remaining treatment options to fight for their own lives.”
The FDA said the appeals court was correct and in line with other rulings “that have rejected constitutionally based demands for access to unapproved investigational drugs.”
The full U.S. Court of Appeals for the District of Columbia Circuit ruled against the alliance after a smaller panel of the same court held that terminally ill patients may not be denied access to potentially lifesaving drugs.
The court said patients can access experimental drugs in certain situations and suggested Congress could change the law to broaden such access.
