By Carol D. Leonnig
Washington Post Staff Writer
Tuesday, July 29, 2003; Page A02

An advocacy group for terminally ill patients sued the Food and Drug Administration in U.S. District Court yesterday in an attempt to get more experimental anti-cancer drugs into the hands of people who want to try promising new remedies.

The Abigail Alliance for Better Access to Developmental Drugs, based in Arlington, sued the FDA and Department of Health and Human Services, arguing that the government's slow approval process for drugs violates the constitutional rights of people who are not responding to approved drugs and are expected to die.

Alliance founder Frank Burroughs said that the average length of time it takes the agency to approve such drugs -- 6.9 years -- is too long, and drug companies make room for only a tiny fraction of patients in their clinical trials when seeking drug approval. The group is named after his daughter Abigail, who died of head and neck cancer two years ago at the age of 21. She had been trying to get two experimental drugs, Erbitux and Iressa, during her illness. "We're trying to solve the problem that Abigail had and that hundreds of thousands of people have: They run out of options to save their own lives," said Burroughs. An FDA spokesperson said the agency had not yet seen the suit and could not comment until reviewing it.

The complaint, filed by the Washington Legal Foundation on behalf of the Alliance, says FDA policy violates patients' rights to privacy and liberty.

The lawsuit also enumerates the struggle of four Alliance patients who were urged by their physicians to try experimental drugs because traditional drugs and remedies were not working. None of the four could get into the drug companies' clinical trials. The Alliance requests that FDA give a special initial approval to drugs showing effectiveness and allow their sale and distribution to patients with no other approved treatment options.