Court allows suit for drug access

WASHINGTON — Terminally ill patients, seeking early access to experimental drugs unlikely to be approved before they die, won a legal reprieve Tuesday in a federal appeals court.

A three-judge panel reinstated a lawsuit against the Food and Drug Administration filed on behalf of the patients and returned the case to the district court that had dismissed it in 2004.

"Barring a terminally ill patient from the use of a potentially lifesaving treatment impinges on this right of self-preservation," Judge Judith W. Rogers wrote in the 2-1 opinion from the panel of the U.S. Circuit Court of Appeals for the District of Columbia.

The Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation sued the FDA in 2003, seeking access for terminally ill patients to drugs that have undergone preliminary safety testing in as few as 20 people but have yet to be approved.

FDA approval of drugs generally requires extensive testing that can involve years of trials and thousands of patients.

The Abigail Alliance, in an earlier FDA petition, asked that the agency create a three-tiered drug-approval system that would allow some experimental drugs to gain restricted approval following initial, phase 1 testing. The FDA said it was studying the opinion and would consult with the Department of Justice on its next steps.

In 1979, the Supreme Court ruled unanimously that there should be no exemption to the FDA's safety and effectiveness standards, which all drugs must meet, for medicines sought by terminally ill patients.

The U.S. District Court had dismissed the Abigail Alliance lawsuit in 2004, and the groups appealed shortly thereafter. Tuesday's opinion revives their case, but also means that years more of litigation are likely. The FDA can ask for the full appeals court to rehear the case. Otherwise, it returns to the lower court.

Judge Thomas B. Griffith, in a dissenting opinion, said the case raises "a number of vexing questions," including whether patients could access any drug, including marijuana, that they and their doctors believe is potentially lifesaving. Griffith also noted that allowing access to a toxic drug can hasten a terminally ill patient's death.

Sen. Sam Brownback, R-Kan., introduced legislation last year that would require the FDA to create a three-tiered approval system similar to what the Abigail Alliance proposed. It would expand access to experimental drugs for patients with serious or life-threatening conditions and diseases. The bill, SB 1956, was referred to committee in November.