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Executive Summary

"POST-APPROVAL AUDITS" FOR NEWLY APPROVED DRUGS PROPOSED by Sam Kazman, general counsel of the free-market advocacy group Competitive Enterprise Institute at an Aug. 3 seminar it sponsored in Washington, D.C. Kazman said such audits could answer the question: "If a drug newly approved by FDA will start saving lives tomorrow, then how many people died yesterday waiting for the agency to act?" The audits would be conducted by either FDA, another federal agency like the Council of Economic Advisors or the Office of Management and Budget, or an outside agency like the National Academy of Sciences. Kazman said the audits would review individual new drug approvals and measure "an otherwise invisible cost of FDA review." Kazman will publish an article on the subject in the debut issue of the National Chamber Foundation's Journal of Regulation and Social Costs, scheduled for publication later in August. Citing the length of the new drug review process, Kazman maintained that if the American people knew about the "invisible victims" of FDA delays, "there would be a very different popular view of what FDA does, which would be a good thing." Fearful of releasing unsafe products, "FDA is inherently overcautious in the area of public health," he said, adding that "overcaution can be just as deadly as lack of caution." Kazman lamented the generic drug scandal because it will lead to a tightening of FDA regulations. The calls for tighter requirements may threaten the recent reforms of the approval process prompted by AIDS activist groups, such as parallel-track mechanisms and treatment INDs. Kazman's group supports not only looser regulations but a total free-market approach to the drug approval process.



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