Right to experimental therapies: FDA new drug approval, constitutional rights, and the public's health

In May 2006, the U.S. Court of Appeals for the District of Columbia, in a startling, controversial opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients have a constitutional right to experimental drugs. In recognizing the constitutional right, the court relied on mistaken assumptions and failed to consider countervailing concerns for public health. The D.C. Circuit agreed to rehear the case, and it likely will end up before the U.S. Supreme Court.

Meanwhile, in December 2006, the Food and Drug Administration (“FDA”) proposed new guidelines that similarly would ease access to unapproved medications and allow pharmaceutical companies to charge for the drugs in some cases. In February 2007, the American Society of Clinical Oncology, Association of American Medical Colleges, and National Coalition for Cancer Survivorship weighed in against Abigail Alliance, urging that recognizing right to experimental treatment poses a substantial risk not only to individual patients but also the entire clinical trial process.

The core of this controversy calls for a trade-off between the rights of a few terminally ill patients versus the public's access to safe, effective therapies. The topic highlights the 2007 Annual Meeting theme of “Politics, Policy, and Public Health” and the critical interaction among patients' rights, political process, and public health policy. My presentation will describe and critique the newly recognized right and urge that even if a right to experimental treatment exists, it may be restricted to protect other terminally ill patients and the public's health.