FDA Nearly Doubled Approvals of ‘Breakthrough’ Drugs, Kessler Says

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 Tuesday in his annual “state of the FDA” speech.

For the 1996 fiscal year, 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 needless 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 only one day after Rep. Thomas J. Bliley Jr. (R-Va.), chairman of the House Commerce Committee, attributed the FDA’s gains to congressional prodding.

Bliley, 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.

Among the products licensed this year were six AIDS drugs, nine cancer drugs and new agents to treat Lou Gehrig’s disease and Alzheimer’s disease.

There also were six new vaccines and a dozen diagnostic tests.