FDA shortens approval time on new Medications, Serlect Due out Soon.

The Food and Drug Administration smashed its record for approving new drugs in 1996, including ground-breaking treatments for AIDS, neurological diseases like multiple sclerosis and five different kinds of cancer.

The FDA approved 53 new chemical entities -- drugs never before used -- compared with 28 in 1995 and well above the record of 30 set in 1985 and 1991. As in every year, numerous existing medicines were approved for new uses.

The agency, drug industry and Wall Street analysts all credited a new system of "user fees" passed by Congress in 1992.

"The companies agreed to pay the FDA for reviewing their applications in exchange for faster approvals," said Mariola Haggar, a drug industry analyst with Deutsche Morgan Grenfell in New York.

However the industry isn't celebrating just yet.

A spokesman complained that the FDA makes companies do more extensive research prior to filing an application -- so the number of years between the initial discovery of a drug in a lab to a sale at the corner pharmacy hasn't changed.

FDA spokesman Don McLearn said the user fees allowed the agency to boost its drug review staff by 600 in the past four years, and it shows.

He said the agency took roughly 14 months to approve new drug applications in 1996, down from nearly 16 months in 1995.

"You used to have things waiting in queue for when someone was available," he said.

The FDA, long criticized for approving drugs more slowly than its European counterparts, is now faster, he said.

However, Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America, said the FDA now requires companies to test their drugs on more people than in the past.

"In our view, one of the effects of that has been to make the process more cumbersome and delay development times," he said.

For this reason, it still takes about 8 1/2 years from the start of human experiments to final marketing approval and that time span hasn't changed since 1990, he said.

Major new drugs that are near final approval include Fareston, by Schering-Plough for advanced breast cancer and Serlect by Abbott Labs for schizophrenia.

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