The legal battle that had been waged by the Abigail Alliance since 2003 ended abruptly on January 14 when the Supreme Court refused to hear the appeal by the patient advocates.

Currently, it is illegal for a drug maker to sell unapproved drugs under the Food & Drug Administration’s (FDA) policy.

The Alliance argued that terminally ill patients who have run out of options have a constitutional right to try experimental drugs without FDA approval. The plaintiffs cited “due process”, saying that it was the patient’s right to choose to take medication of unknown benefit or risk that may save their life. According to the appeal, “If a patient has a right to refuse all treatment and die, surely she also had a right to assume some risks in a good faith attempt to save her own life.”

The Abigail Alliance was founded by Frank, the father of Abigail Burroughs, who died at the age of 21 waiting and fighting for a cancer drug that had not been approved by the FDA. Three years later, that drug was approved. Her father and friends continue her fight now in her memory.

The FDA contended that the suit would have radically altered the process of clinical cancer research. It would have given terminally ill patients practically unregulated legal access to experimental drugs. The FDA argued that these patients, would then have little incentive to enter Phase II and III clinical trials, which are used to determine the side effects and efficacy of new drugs. This could greatly affect all cancer patients. Originally, a federal district judge dismissed the Alliance’s case, but in May 2006, a court of appeals in Washington DC voted two to one in favor of the plaintiffs. The FDA then urged the Court of Appeals rehear the case.

The America Society of Clinical Oncology (ASCO) along with National Coalition for Cancer Survivorship (NCCS) and the Association of American Medical Colleges (AAMC) filed an amicus brief supporting the FDA’s position. Stating that they were, “deeply disturbed by the panel’s decision… because establishment of the individual “right” sought by appellants will not only pose unreasonable risk to individual patients but also threaten the cancer clinical trial system as it currently exists.” The parties followed this statement by citing a National Cancer Institute (NCI) Cancer Trends Progress Report and asserting, “It is only though clinical trials that we are beginning to see tangible results in progress against cancer.” In August 2007, a full appeals court reversed the panel’s decision by an eight to two vote.

This appeal by the Alliance to the Supreme Court was the final step in the case.

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Erin Kristoff
Author: Erin Kristoff