THE DRUG LAG DEBATE
AND DEMANDS FOR REFORM
No politician ever lost votes by denouncing the
—James Q. Wilson, political scientist
The third period of U.S. drug review was precipitated by a major drug tragedy primarily occurring in Europe. The revelation of thalidomide's side effects exposed the inherent weaknesses in many European regulatory authorities. This tragedy, which fueled a lingering sense of vulnerability in the United States, coupled with several gradual changes in the U.S. policy subsystem, eventually led to the creation of yet another definable institutional structure. The resulting structure further centralized the U.S. regulatory approach and made the avoidance of Type II errors the FDA's foremost objective. The result of this institutional structure (i.e., the 1962 Kefauver amendments to the Food, Drug and Cosmetic Act) was to profoundly shape FDA behavior. Immediately after the Kefauver amendments went into effect, the agency's cautious approach to drug approvals was widely embraced by most actors in the policy subsystem. Safety was regarded as the sole concern, even at the risk of potentially committing Type I errors.
However, over time, the strength of the principal-agent contract, which enabled the agency to focus on avoiding Type II errors, waned. This weakening was largely the result of increasing criticism of the FDA's regulatory performance in the 1970s and 1980s from a variety of sources. Critics from academia and industry charged that the highly centralized regulatory framework stifled drug innovation and impeded pharmaceutical industry competitiveness. By this time, the relative success of European regulatory review agencies—especially in Great
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Publication information: Book title: Pill Politics: Drugs and the FDA. Contributors: Stephen J. Ceccoli - Author. Publisher: Lynne Rienner. Place of publication: Boulder, CO. Publication year: 2004. Page number: 75.
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