By Marc Kaufman
Washington Post Staff Writer
Wednesday, May 3, 2006
Terminally ill patients have a constitutional right to obtain experimental drugs before the Food and Drug Administration has decided whether to approve them, a federal appeals court ruled yesterday.
Saying that dying patients have a basic "right of self-preservation," the court held that drugs that have passed the first phase of FDA review -- which determines whether a product is safe -- should be made available if they might save someone's life.
The 2 to 1 decision by the U.S. Court of Appeals for the District of Columbia Circuit overturned a lower court's ruling. The judges sent the case back to the district court for a full hearing and possibly a trial.
The case was brought by the Abigail Alliance for Better Access to Developmental Drugs -- which advocates making experimental drugs available earlier to dying patients -- and was argued by the Washington Legal Foundation, a public interest law firm that has frequently challenged regulatory agencies.
The appeals court found that "barring a terminally ill patient from the use of a potentially life saving treatment impinges on this right of self-preservation." It also agreed with the alliance that the Supreme Court's 1990 decision establishing a "right to die" in the case of Nancy Cruzan, a brain-dead Missouri woman who was ultimately disconnected from life support, applied in reverse in this case.
"If there is a protected liberty interest in self-determination that includes a right to refuse life-sustaining treatment, even though this will hasten death, then the same liberty interest must include the complementary right of access to potentially life-sustaining medication, in light of the explicit protection accorded 'life,' " Judge Judith W. Rogers wrote.
Judge Thomas B. Griffith dissented, saying that the ruling goes against the "expressed rule" of Congress and the president. "The majority's approach injects courts into unknown questions of science and medicine," he wrote.
In its opposition to the challenge, the FDA had said that the agency already has programs that make potentially lifesaving drugs available before final approval. In addition, it said that allowing large numbers of patients to take unapproved drugs could put many at unacceptable risk, even if they are terminally ill.
"We remain sympathetic to the desire of terminally ill patients to gain access to experimental treatments when they have exhausted other therapeutic options, and are exploring a number of new efforts to improve how we make investigational drugs available through expanded access programs," said Scott Gottlieb, deputy commissioner for medical and scientific affairs.
The Arlington-based Abigail Alliance was founded in 2001 by Frank Burroughs, whose 21-year-old daughter died of cancer. The family had tried to enroll her in a number of clinical trials of promising cancer medications but was rebuffed, and Burroughs decided to continue his fight to expand access to experimental drugs after her death. He said several of the potentially lifesaving drugs that his group sought to make available while they were still under regulatory review went on to be approved and widely used.
Burroughs said yesterday that he hopes the FDA will work with his group and others to make unapproved drugs more easily available to dying patients.
The alliance has sought access to medications that have passed Phase I of the FDA review, which generally involves studies of 20 to 80 patients and results in a determination of whether the drug is safe enough for further human testing. Phase II trials determine whether a drug is effective, and Phase III studies involve larger groups and give a better sense of whether a drug is safe and useful.