Congress' Pusillanimity Prevents Real FDA Reform

Congress has lost a stunning opportunity to reform the Food and Drug Administration (FDA). The authorization for the agency's critical "user fees"-approximately $100 million paid annually by regulated industry to help FDA expedite the approval of new medicines-expired on October 1. The need for another five-year reauthorization provided a strong incentive for the Clinton administration to accept meaningful reforms. Characteristically, however, the Congress settled for a half-baked compromise di

Henry Miller
Dec 7, 1997

Congress has lost a stunning opportunity to reform the Food and Drug Administration (FDA). The authorization for the agency's critical "user fees"-approximately $100 million paid annually by regulated industry to help FDA expedite the approval of new medicines-expired on October 1. The need for another five-year reauthorization provided a strong incentive for the Clinton administration to accept meaningful reforms.

Characteristically, however, the Congress settled for a half-baked compromise dictated by FDA itself and by Democratic defenders of expansive federal regulation.

FDA reforms are overdue. Physicians routinely report in surveys that FDA's policies actually threaten the well-being of their patients. In large part this is because the United States drug-approval system is significantly slower, more costly, and more intrusive than that of other industrialized nations. Seventy-three percent of drugs approved by FDA during 1987-93 already had been approved abroad. FDA has constantly sought out new mandates and promulgated new requirements,...

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