WASHINGTON, May 2, 2006-In a major victory for the Washington Legal Foundation (WLF), the U.S. Court of Appeals for the District of Columbia Circuit ruled today that terminally ill patients have a “fundamental right” – protected by the U.S. Constitution – to access to experimental drugs that have not yet been fully approved by the Food and Drug Administration (FDA). The decision caps a three-year WLF effort to establish such a right.  Because of FDA’s refusal to recognize such a right, WLF filed suit in 2003 on behalf of itself and the Abigail Alliance for Better Access to Developmental Drugs, a patients-rights group. 

The appeals court held 2-1 that once FDA has determined, after Phase I trials, that a potentially life-saving investigational new drug is sufficiently safe for expanded human trials, terminally ill patients have a constitutional right to seek treatment with the drug if there are no other FDA-approved drugs available to the patient.  The court held that the Fifth Amendment’s Due Process Clause encompasses a right, recognized throughout American history, of all individuals facing terminal illnesses to make fundamental decisions regarding whether to seek or not to seek medical treatment.  The court said that if FDA wishes to prevent such patients from gaining access to investigational drugs that have completed Phase I trials, it bears the burden of demonstrating that its restrictions are “narrowly tailored” to serve a compelling governmental interest.  Commenting on the Court’s decision, WLF Chief Counsel Richard Samp said: 

Under FDA regulations, the vast majority of patients with life-threatening illnesses do not have access to promising new medications during the years of clinical testing and review required by FDA.  The drugs remain unavailable even though there is evidence that they are safe and effective and even though patients have no alternative to the drugs other than to wait for their own deaths.  We are hopeful that today’s decision will reverse that policy.

Unless FDA appeals, the case now returns to the district court, where FDA will have an opportunity to demonstrate that it has a “compelling interest” in restricting the constitutional rights of terminally ill patients.  WLF is hopeful that it can work with FDA to develop a new policy that takes into account FDA’s legitimate concerns while also respecting the rights of those in need of access to potentially life-saving medications.

Richard A. Samp, counsel for WLF in the Abigail Alliance case, is available for comment at (202) 588-0302.  A copy of WLF’s brief is available at its website, www.wlf.org.