updated 5/2/2006 7:57:24 PM ET 2006-05-02T23:57:24

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.

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A three-judge panel reinstated a lawsuit against the Food and Drug Administration filed on behalf of the patients and returned the case to 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. Court of Appeals for the District of Columbia Circuit.

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.

Expanded access to drugs
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. That would expand the availability of those drugs beyond the limited “compassionate use” programs now permitted.

“The FDA has long prohibited lifesaving medicines for terminally ill patients,” said Paul Kamenar, senior executive counsel for the Washington Legal Foundation. “We think this is a tremendous victory for patient groups and those who are in need of these kinds of medicines.”

The FDA said it was studying the opinion and would consult with the Department of Justice on its next steps.

“We remain sympathetic to the desire of terminally ill patients to get access to experimental treatments when they have exhausted other therapeutic options, and have a number of new efforts under way inside FDA to improve how we make investigational drugs available through expanded access programs. We plan to have much more to say about this soon,” agency spokeswoman Susan Bro said in a statement.

'Laetrile redux'
Donald Kennedy, a former FDA commissioner, called the lawsuit “Laetrile redux.”

In the late 1970s, terminally ill cancer patients and their spouses sought access to Laetrile, a then- and still-unapproved drug, eventually suing the FDA — and Kennedy — in a case that landed in the Supreme Court.

In 1979, the top 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.

Tuesday’s ruling comes amid heightened criticism of how the FDA handles access to drugs under its review.

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.

Frank Burroughs, president of the Abigail Alliance, said providing access shouldn’t be solely an FDA decision.

“The decision is the patient’s decision, in consultation with their doctor, knowing at the time the known risks and benefits,” said Burroughs, who founded the group after his daughter, Abigail, died of cancer in 2001.

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