FDA Speeds Drug Tests to Help AIDS, Cancer Patients : Would Cut Approval Time 1/2 to

The Food and Drug Administration, responding to pleas from people suffering from AIDS and other life-threatening diseases, today announced new rules to speed approval of drugs to fight deadly illnesses.

Under the new procedures, the FDA said the amount of time it takes to test a promising drug could be slashed by from one-half to one-third. Currently, it takes about three to seven years for a drug to clear the FDA’s approval process.

“I’ve seen a lot of people suffer, with AIDS as well as cancer, and I want them to know the agency has a heart as well as a mind,” said FDA Commissioner Frank E. Young, who suggested that the new rules would turn the agency into an active player, rather than just an umpire, in the medical battle against AIDS.

Specifically, the proposed changes would allow “promising” drugs for fatal or seriously debilitating illnesses, such as blindness, to be marketed without going through a major phase of human studies that the FDA calls Phase 3.

Attacked by Activists

In Phase 1, the FDA--which monitors, but does not conduct tests--looks at results of drug company tests to determine whether a drug is safe when given to humans. In larger Phase 2 trials, involving about 50 to 200 patients, the FDA studies data to determine whether the drug is effective. In Phase 3, which involves 200 to 1,000 or more patients, the agency generally tries to expand upon data obtained from the first two phases.

Young said in order for a drug to skip Phase 3 and go directly to the market, the pharmaceutical firm or institution that developed it would have to consult with the FDA to design Phase 2 tests that would best answer the most crucial questions about the drug.

AIDS activists attacked today’s announcement--which came less than three weeks before the presidential election--as a political ploy.

“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.

But the FDA’s Young denied any political motivation.

‘Definite Improvement’

“People suffering is not part of a political campaign,” he said. FDA headquarters last week was besieged by hundreds of protesters demanding quicker access to AIDS drugs.

Young, who had previously predicted that only one or two new AIDS drugs would be available by 1991, said he expects the rule changes to bring “definite improvement.” He refused to speculate on exactly how many more drugs would win approval, saying he did not want to “over-promise” aid to desperately ill people.

Currently, 88 drugs for AIDS and related illnesses are under FDA evaluation. To date, only one AIDS drug, AZT, has received final FDA approval.

Young said he does not think the proposed rule changes indicate that the agency is abandoning its role of protecting the public from harmful drugs. “This policy is not going to make bad drugs into good drugs,” he said.

60 Days for Public Comment

The FDA commissioner said the new procedure, which is open to public comment for 60 days, simply allows the agency to better balance the risks of a drug against its benefits.

“When we are dealing with desperately ill people, in my experience, they are much more interested in taking a risk (than less ill people) to get a benefit,” Young said.

Vic Basile, director of the Human Rights Campaign Fund, an AIDS lobbying group, said Young’s proposal represents the direction in which the FDA should be headed.

However, Basile added, “the proposal is only a first step and is not the answer to the problem. It falls short of ensuring drugs will get to sick people faster.”