Supreme Court Declines to Consider Whether Those Near Death Have Right of Access to Experimental Drugs

(Abigail Alliance v. Eschenbach)

WASHINGTON, Jan. 14, 2008--The U.S. Supreme Court issued an order today declining to take up the issue of whether 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 denial was a setback for the Washington Legal Foundation (WLF), which filed the review petition on behalf of itself and the Abigail Alliance for Better Access to Developmental Drugs, a patients-rights group.

The Court’s decision marks the latest chapter in WLF’s five-year effort to establish rights for terminally ill patients. Because of FDA’s refusal to recognize such rights, WLF filed suit in 2003 on behalf of itself and the Abigail Alliance. In May 2006, a panel of the U.S. Court of Appeals for the District of Columbia Circuit ruled in WLF’s favor on the issue. But in August 2007, a divided appeals court sitting en banc reversed that decision. WLF asked the Supreme Court to hear the case and reinstate the panel decision. Commenting on the Court’s decision not to review the case, WLF’s Chief Counsel said:

We will continue our efforts to persuade FDA that terminally ill patients deserve better access to drugs that FDA has deemed suitable for large-scale clinical trials. 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.

WLF had urged the Court to hold 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. WLF argued 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. WLF argued 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.

Throughout the appellate process, WLF has received invaluable pro bono assistance from Scott Ballenger and other attorneys with the law firm of Latham & Watkins.

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.

Posted: January 2008


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