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Pulling Out The Stops

Faster FDA product review urged

This story appears in the June 1996 issue of Entrepreneur. Subscribe »

Small drug, medical device and food companies have been among the louder complainants about the plodding pace at which the Food and Drug Administration (FDA) reviews new product applications. Under Commissioner David Kessler, M.D., the agency has definitely shifted into higher gear. But Sen. Nancy Kassebaum (R-KS), chair of the Senate Labor and Human Resources Committee, hopes to urge greater speed with a bill (S. 1477) that would force the FDA to adhere to statutory approval deadlines-which, in the case of new drugs, for example, are 180 days.

Failure to do so would allow a company to market the product in the United States if it has already been approved in the United Kingdom or the European Union, unless the Secretary of the Department of Health and Human Services disapproves marketing within 30 days of the applicant's request.

Kassebaum held hearings on her bill on February 21 and 22; a House bill on the issue is imminent. Testifying before Kassebaum's committee, Kessler argued, "The time frames are unrealistic, and they would lower current safety and efficacy standards." Further debate on the issue is expected.