Document Type

Article

Publication Title

Yale Journal of Health Policy, Law, and Ethics

Abstract

This Article addresses two interlocking issues. Part I develops a simple model to determine which drugs should be released into the marketplace and why. Its central point is that the inherent heterogeneity in all populations cuts strongly in favor of a relaxation in the standard of pre-market approvals, as is urged in a recent paper by Malani and Hu. The regulator who works upstream of the physician and patient lacks any knowledge of individuated circumstances that should rationally influence the decision of which drug, if any, to take, and in what dosage. So long as physicians and patients have some skill in locating the patient's position in the distribution, there is no reason to rely on the upstream averages that the FDA uses. Patients and physicians should be allowed to incorporate downstream knowledge into their decisions. As far as I can tell, there are no substantive provisions in the current legislation, with its mandates that drugs be both safe and effective, that prevent the FDA from considering the variation in responses across individuals in setting the appropriate standards for decision. In light of this basic situation, Part II then argues that this model should carry over to questions of withdrawal and recall of drugs from the marketplace, either by government mandate or firm decision. So long as individual users have acquired knowledge of their personal benefits and side effects of particular drugs, companies should be reluctant to pull drugs from the marketplace, and the government should be cautious in ordering them off.

First Page

741

Volume

5

Publication Date

2005

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