157215 Right to experimental therapies: FDA new drug approval, constitutional rights, and the public's health

Monday, November 5, 2007: 3:20 PM

Elizabeth A. Weeks, JD , School of Law, University of Kansas, Lawrence, KS
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.

Learning Objectives:
Describe recent groundbreaking court decision recognizing constitutional right to experimental treatment for terminally ill patients and proposed FDA policy expanding access to experimental drugs Criticize the opinion and proposed policy in light of existing legal precedent and regulatory processes Evaluate adverse impact on clinical trial process, development of new drugs, and public safety of expanded access to unapproved therapies Urge reversal of case recognizing constitutional right and rejection of FDA proposed policies in light of public health concerns

Keywords: Drug Safety, Clinical Trials

Presenting author's disclosure statement:

Any relevant financial relationships? No
Any institutionally-contracted trials related to this submission?

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.

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