The FDA announced this week the final rules for its accelerateddrug approval process that will make more experimental drugsavailable quickly if the drugs show promise in treating fatal ordisabling diseases.

The new rules are the long-awaited result of a draft regulationapproved by FDA Commissioner David Kessler on Aug. 30,1991. A draft version was made available for public commentin April. An FDA representative said the new rules are"virtually unchanged" from the version proposed in April. Thefinal version is scheduled to be published in the FederalRegister on Friday, according to the FDA.

"Accelerated approval, conditional approval -- these wereinnovations built upon the agency's commitment to provideaccess to experimental drugs for those dying of life-threateningdisorders," Kessler said on Tuesday.

Under the new rules, experimental drugs would come to themarket quickly through a short cut in the testing process,which will measure a drug's potential effectiveness based onlab results that scientists think may translate into benefits forthe patient.

Drug companies that receive this speedy approval for a productwill have to continue human tests to confirm that the productworks. If it doesn't work, the rules provide for taking it off themarket quickly.

Henry Miller, the FDA's director of the Office of Biotechnology,said there is room for improvement in the average approvalperiod for biotech drugs, which is currently 21 months.

"This ruling is especially useful for companies that producebiotech products, particularly those companies which are reallysmall," said Miller. "It helps them get products to the marketand to the patients that need them earlier than before.

"There are still many recombinant and hybridoma-basedcompounds that are so useful that their eligibility for thismechanism is disproportionately greater than less," he said.

Miller believes the reform has something for everyone -- theindustry, the patient and the FDA. "I don't really see a downside as the usual standards for safety and efficacy will stillneed to be met before approval is granted."

-- Michelle Slade Associate Editor

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