Under intense pressure from gay activists, the Food and Drug Administration on Wednesday announced new, streamlined procedures that it says will put drugs for AIDS and other life-threatening illnesses on the market more quickly.
The procedures, effective immediately, will give the FDA discretion to cut the drug approval process, which usually takes three to seven years, by a third to half. If the FDA decides that a drug shows promise in early tests, it may allow drug companies to eliminate the final phase of testing and take the product directly to market.
“I’ve seen a lot of folks who are suffering and I want those people who have either cancer or AIDS to know that this agency has a heart as well as a mind,” FDA Commissioner Dr. Frank E. Young told a press conference.
“The plan encourages researchers to accelerate and condense their studies and assures that FDA will realistically balance the risks and benefits of promising drugs in light of the severity” of the diseases, Young said.
The FDA acted eight days after at least 1,000 gay activists attempted to shut down the FDA’s headquarters in suburban Maryland to protest what they called the slow pace of the agency’s drug approval process. About 150 protesters were arrested on misdemeanor charges.
But the FDA’s new procedures immediately drew criticism that they would result in the marketing of drugs with unknown and dangerous side effects.
Waxman Expresses Concern
Rep. Henry A. Waxman (D-Los Angeles), chairman of the House Energy and Commerce subcommittee on health and the environment, said he was “concerned that the FDA continue to monitor the safety and efficacy of drugs for dying people.”
“Smaller, faster trials will identify only the obviously helpful or obviously dangerous drugs,” Waxman said. “Ongoing surveillance will be necessary to avoid throwing away drugs that might be somewhat effective or using drugs that might be somewhat unsafe.”
Many AIDS activists protested that the FDA itself could sabotage the new and expedited procedures simply by declining to use them. And they complained that the agency lacked sufficient funds and personnel to carry out the new procedures.
“These are sound proposals but there’s a big catch: They come without significant dollars attached,” said Dr. Mathilde Krim, co-chairman of the American Foundation for AIDS Research.
Waxman, noting that the FDA staff had been cut from 8,000 to 7,200 under the Reagan Administration, insisted: “Any speed-up of drug approval depends on a commitment of new resources.”
Charge Politics Involved
Many gay activists said that the regulations, which grew from a request by an Administration task force on regulation chaired by Vice President George Bush, were announced now to benefit Bush’s presidential election campaign.
“This announcement must be seen for what it is: a media event staged so that the Bush campaign can capitalize on the tragedy of AIDS,” the National Gay and Lesbian Task Force charged.
Dr. Donald I. Abrams, assistant director of AIDS activities at San Francisco General Hospital, said: “I am nervous about the timing and question whether there is some political motivation here.”
He noted that the new procedures simply make formal the expedited treatment that the agency gave to the AIDS drug AZT more than a year ago.
“It is clear that the FDA has already been reevaluating its processes with regards to AIDS,” Abrams said. “I hope they are not throwing up their hands and saying they will no longer regulate AIDS drugs, because the FDA has a valuable consumer protection role to play.”
The National Gay and Lesbian Task Force, while agreeing with the FDA’s goal of giving AIDS patients ready access to experimental drugs, said that the FDA was going about it the wrong way.
Urge Program Expansion
The task force urged the FDA to expand a program, inaugurated in 1987 and still in effect, that allows some AIDS patients to have access to drugs while they are still being tested by the FDA for safety and effectiveness. The patients are charged the manufacturer’s cost.
Under the new FDA program, the task force argued, the FDA may quit testing drugs that win its approval under its accelerated procedures. Once a drug is marketed, warned Jeff Levi, head of the task force, “there is little control over how it is dispensed.”
More than that, Levi said, AIDS patients will have to pay whatever the manufacturer charges for drugs that win accelerated FDA approval.
The FDA’s Young insisted that the agency would not lose sight of its consumer protection role. “We will also continue to safeguard patients,” he said.
He denied that he had timed his announcement to benefit Bush’s election campaign. “I’ve been working on this for four years,” he said.