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