Proposal to Reform FDA's Approval Processby Sam Kazman
By changing the regulatory process, alternative drugs, devices and treatments could become available under professional supervison. When the Food and Drug Administration announces its approval of a major new drug or device, it is invariably greeted with applause. In fact, however, our response should be quite different. We should instead ask ourselves this question: "If FDA approves a drug that will start saving lives tomorrow, then how many people died yesterday waiting for FDA to act?" It was approximately twenty years ago that the first groundbreaking studies of drug lag first appeared. However, despite the sizable academic literature on this issue that has been developed since then, there is little public realization of the harm that FDA regulation causes in terms of human suffering. The effects of "drug lag" - that is, of delayed access to therapies - remain largely invisible. People who are denied access to needed drugs do not know about FDA's administrative procedures; they know only that their doctors cannot help them. By comparison, while there are relatively few victims of unsafe drugs, these victims are often highly visible. When Congress and the media focus on medical issues, it is this latter group that invariably attracts their attention. The result is an inherent bias within FDA against rapid approval even though, from a public health standpoint, overcaution can be as lethal as lack of caution. "Deadly overcaution" is an apt term for this phenomenon. Competitive Enterprise Institute (CEI) has been involved in this issue since 1987. Our basic proposal is as follows: FDA's current veto power over new drugs and devices should be changed to one of certification. FDA's safety and efficacy standards would remain as they are; however, rather than being banned outright, drugs and devices which did not meet FDA's standards would be available under professional supervision, with clear warning of their unapproved status. Physicians and patients could thus choose to continue using only agency-approved drugs; however, a new option would be created for those individuals who, in conjunction with their doctors, found it medically necessary to look elsewhere. We should recognize that, under such an arrangement, the choice would not be between FDA-approved therapies on the one hand and "chaos" on the other. Instead, new institutions would arise to evaluate unapproved drugs and devices. For example, certain foreign approvals might become highly significant for American physicians - British approval of cardiovascular drugs, for example, might well be regarded as a credible indicator of a drug's worth. Similarly, certain medical schools and laboratories might develop expertise in rapidly evaluating new therapies in particular medical specialties. Many of these alternative entities already exist. Peer-reviewed medical journals, for example, have long had a major impact on the practice of medicine. Under CEI's proposal, these and other entities could, in a sense, compete with FDA in evaluating new therapies. This would be good for the agency, and it would be even better for the American public. This is our long-term proposal. As an immediate measure, however, FDA itself should undertake post-approval audits of its own decision-making, aimed at quantifying the magnitude of the therapeutic benefits that are lost to society due to the length of the agency's approval process. Such audits would answer the basic question raised above - if a drug or device that is approved today will start saving lives tomorrow, then how many people died yesterday waiting for the agency to act? Until we know the answer to this question, we have no grasp of the human cost of FDA regulation. Sam Kazman is the General Counsel of the Competitive Enterprise Institute. CEI is a non-profit free-market advocacy organization that has long been involved in exposing the unrecognized costs of government overregulation. To subscribe to the CEI list, send a message to CEI@digex.com. "The Virtual Hand: CEI's free-market guide to the information superhighway" is available for $5. CEI's monthly newsletter, "CEI UpDate," is free to contributors of $25. Competitive Enterprise Institute 1001 Connecticut Ave. NW #1250 Washington, DC 20036 202-331-1010, fax 202-331-0640
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