WASHINGTON -- The Food and Drug Administration nearly doubled the approval rate of new "breakthrough" drugs this year and reduced the review process time by half, outgoing FDA Commissioner David A. Kessler said yesterday in his annual "state of the FDA" speech.
For fiscal 1996, which ended Oct. 1, 46 of the breakthrough drugs were approved, he said in a speech to the nonpartisan Food and Drug Law Institute. Moreover, the average review time dropped to about 15 months from the 30 months it took in the late 1980s, he said.
The speech was Kessler's response to criticism from Republican congressional leaders and others who have accused the FDA of a sluggish pace that causes suffering, and even death.
FDA officials have stressed that, in speeding up the pace of its work, the agency must continue to ensure that public safety is not compromised.
Kessler's remarks came one day after the House Commerce Committee chairman, Thomas J. Bliley Jr., attributed the FDA's gains to congressional prodding.
The Virginia Republican, while acknowledging the agency's accelerated drug approvals process, said: "Our efforts had everything to do with it."
Kessler acknowledged that "we still have our share of critics," but declared that "the United States is a world leader in drug review, any way you look at it."
Altogether, the agency licensed 121 drugs in fiscal 1996; the others being new or different versions of existing drugs.
Alan F. Holmer, president of the Pharmaceutical Research and Manufacturers of America, acknowledged that the FDA has made progress in completing drug reviews in a timely manner.
Nevertheless, he contended it takes too long to bring a drug from its earliest stages in the lab to the patient because of the lengthy requirements of testing the drug in humans.
Pub Date: 12/11/96