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Panel seeks incentives for AIDS drugs, wins FDA pledge

Drug companies are rapidly abandoning efforts to develop new medicines for AIDS because they anticipate few profits, a federal task force told the Clinton administration Thursday.

To get things moving, the National Task Force on AIDS Drug Development recommended tax credits of 50 cents per dollar invested in AIDS drug research, and years of special market exclusivity for the resulting medicine.

"This is a major threat," said Peter Staley of the activist Treatment Action Group. Not just cash-strapped small firms but "larger companies simply are dropping AIDS when they do economic calculations of what research to pursue," he said.

The task force won a pledge from the Food and Drug Administration to put in writing exactly when it will approve a drug based on just one test in humans.

The agency normally requires more data but has made exceptions for drugs to treat life-threatening diseases. But so few companies know this exception exists _ and consequently spend valuable time pursuing more trials _ that the FDA promised to issue guidelines.

"We can commit certainly to one trial for serious and life-threatening diseases," FDA Commissioner David Kessler said. "But I'm not sure I'm ready to commit to do it for everything."

The federal task force, composed of patients, drugmakers, and government and private scientists, said money is the main stumbling block for new AIDS drugs.

Companies can't spend millions researching AIDS drugs that don't make a big profit when both federal and Wall Street drug investment is plummeting, said Dr. Daniel Hoth of Cell Genesys Inc.

The FDA has approved four drugs to fight HIV. Protease inhibitors, a new class that appears to be the most potent yet, will be next when at least one company applies later this year.

But after protease inhibitors, "the future appears considerably more uncertain," Hoth told the task force. "The investment environment is chilly to hostile with respect to investing in AIDS drugs."

The task force spent a year studying ways to recharge AIDS drug development, and forwarded recommendations Thursday to Donna Shalala, secretary of Health and Human Services. Topping the list:

Give several years of market exclusivity to all HIV and AIDS treatments. AIDS drugs once automatically got seven years of exclusivity under a law that pushes treatments for rare diseases, but too many Americans now have AIDS for those drugs to qualify any longer as "orphan disease" therapies.

Offer a 50 percent tax credit for all clinical research into potential HIV-AIDS drugs.

Offer a 50 percent tax credit for studying additional uses for approved AIDS drugs, something manufacturers rarely do because doctors on their own prescribe drugs in new, unapproved ways.

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