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Groups Oppose Ruling on Access to Experimental Drugs

Groups Oppose Ruling on Access to Experimental Drugs

WASHINGTON—Three cancer organizations have joined in supporting FDA in an appeal to the District of Columbia Circuit Court of Appeals to overturn a decision that terminally ill patients have a fundamental right of access to experimental drugs.

In May 2006, in response to a lawsuit brought by the Abigail Alliance for Better Access to Developmental Drugs, a three-judge appeals panel ruled 2 to 1 that once FDA determines after phase I trials that a drug is sufficiently safe for expanded human trials, terminally ill patients have a right to seek treatment with that drug if there are no other FDA- approved drugs available to the patient.

The National Coalition for Cancer Survivorship (NCCS), American Society of Clinical Oncology (ASCO), and Association of American Medical Colleges (AAMC) filed a friend-of-the-court brief opposing the May 2006 ruling. They contend that prior Supreme Court decisions do not support the creation of this right to access. They argue that phase I tests do not provide an adequate assessment of safety and do not determine efficacy, and thus investigational drugs should not be made commercially available.

"As an organization dedicated to serving people with cancer, NCCS is deeply sympathetic with patients desperate for the latest new drug, but we do not believe either individual patients or the overall system of cancer care in the country will be served by commercializing drugs lacking in proof of safety or efficacy," said NCCS president Ellen Stovall.

ASCO's executive vice president and CEO, Allen S. Lichter, MD, said that if the ruling is upheld, "cancer patients could receive treatments that do not work or are actually harmful. In addition, the Abigail Alliance position could also harm the nation's ability to develop effective new drugs for all cancer patients by deterring participation in clinical trials."

The brief also expressed concern about the effect on insurance reimbursement for cancer therapy, and potential liability risk for both physicians and industry.

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