Pulling Out The StopsFaster FDA product review urged

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

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

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