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Federal Court RESCINDS Approval of Experimental Drugs for Dying Patients

As reported by Greg Freeman on 8/30/07 in BioWorld Perspectives… “The D.C. Court of Appeals recently reversed an earlier decision by it own three-judge panel and ruled 6-2 against allowing dying patients to take potentially life-saving drugs that have not yet been approved by the FDA.  The case had been filed in 2003 by the Abigail Alliance for Better Access to Developmental Drugs, along with the Washington legal Foundation.  The Abigail Alliance is named for Abigail Burroughs, a 21-year-old college student who died of cancer in 2001 after being denied access to Erbitux, the then investigational drug from ImClone Systems, Inc. that early trials indicated might have helped her.

Over the past five years, the alliance has pushed for access to 12 drugs that had cleared at least Phase I testing.  Some had completed Phase II or Phase III testing and were considered extremely promising.  All of them have been subsequently approved by the FDA, and patients benefit from them every day.  The patients who died before the FDA approval also could have benefited if only the government had allowed tightly controlled access before full approval.”

The Cancer Cure Coalition is supporting the Abigail Alliance in its work to obtain earlier access by critically ill patients to therapies that might save their lives, and  since its inception, the Cancer Cure Coalition has been working for improvement at the FDA.

 

 


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