Magazine article Drug Topics

Kessler Cites FDA Progress on New Drug Approvals

Magazine article Drug Topics

Kessler Cites FDA Progress on New Drug Approvals

Article excerpt

More drugs are being approved than ever before-and faster, too-was the farewell message David A. Kessler delivered as he prepared to leave the Food & Drug Administration after six sometimes turbulent years.

Speaking last month to an audience consisting largely of FDA critics-some 500 Washington lawyers, lobbyists, and company representatives-Kessler said 1996 was a record-setter for the agency. With several weeks still to go before closing the books for the year, the FDA had approved 41 new molecular entities-products that contain an active ingredient never marketed in the United States-compared with 28 last year. The median approval time in 1996 was 15.1 months; for 27 important Rxs given priority handling, it was 7.8 months.

Kessler reminded the 40th annual meeting of the Food & Drug Law Institute that in the 1980s, the average number of new Rxs the FDA cleared each year was about 22 and that by the end of that decade, the median approval time approached 30 months. He also pointed out that none of the 1996 Rxs has had to be recalled because of safety or efficacy problems.

"Many of the products, often approved in record time, are important new therapies," the pediatricianlawyer said. "We approved six for AIDS, nine for cancer, and new agents also became available to treat difficult conditions such as Lou Gehrig's disease and Alzheimer's. We have approved six new vaccines, a dozen important diagnostic tests, and some of the most advanced biological therapeutics."

Kessler, who announced in November that he would step down as commissioner when a successor was named, defended the agency against charges that changes he instituted were not basic reforms but onetime moves to speed approval of Rxs for the treatment of AIDS and other life-threatening diseases having large and vocal constituencies. "When the total approval time is half of what it used to be for all new molecular entities, that does constitute basic reform," he stated.

Kessler's defense of the FDA has not, however, been enough to stave off renewed efforts on Capitol Hill to overhaul the agency. The day before Kessler's remarks, the chairman of the House committee that tried and failed to pass reform legislation in 1995-96 vowed to move quickly this year. Although he applauded the FDA's improved performance and a "complete change in attitude," Rep. …

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