Key Pharmaceutical Policy Case

Key Pharmaceutical Policy Case

In 1999, 19-year-old Abigail Burroughs was diagnosed with cancer of the head and neck. After chemotherapy and radiation failed to help, Burroughs tried to enroll in a clinical trial of a new drug treatment, but she didn’t meet the inclusion criteria. She died on June 9, 2001. Shortly afterward, her father founded The Abigail Alliance for Better Access to Developmental Drugs, and in partnership with the Washington Legal Foundation, the alliance submitted a citizen’s petition to the Food and Drug Administration requesting broader availability of investigational drugs for terminally ill patients.

At issue, says SPH Professor Peter Jacobson, who directs the school’s Center for Law, Ethics, and Health, is the FDA’s drug-approval process, which some say is too lax and others blame for blocking patients from potentially lifesaving drugs.

Last year, the U.S. Court of Appeals for the District of Columbia decided in the case of Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach that terminally ill patients have a constitutional right to purchase unapproved drugs that have successfully completed phase 1 testing. Realizing what was at stake, the FDA sought a rehearing before the full D.C. Circuit Court of Appeals. That hearing took place on March 1, 2007, and a ruling is expected soon. The full court’s decision will have broad public policy and clinical implications, says Jacobson, and the case, which raises pivotal questions about issues such as drug safety and the medical care of terminally ill patients, may reach the Supreme Court. Its outcome could reshape the regulation and sale of pharmaceuticals in this country.

Jacobson coauthored a commentary on the case in the January 10, 2007, issue of the Journal of the American Medical Association.

He has also coauthored a new book, False Hope: Bone Marrow Transplantation for Breast Cancer (Oxford, 2007), an examination of a new cancer therapy—high-dose chemotherapy with autologous bone-marrow transplantation—that offered early promise in the late 1980s but eventually failed. By the time the public understood its shortcomings, more than 30,000 women had received the treatment, which shortened their lives and added to their suffering. Jacobson says the debacle “exposed the shortcomings of how new clinical procedures are monitored in this country.”

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At issue: the FDA’s drug-approval process, which some say is too lax and others blame for blocking patients from potentially lifesaving drugs.