"Regulation for Dummies:  Is the FDA necessary?", by Todd Seavey.  A review of Protecting America's Health:  The FDA, Business, and One Hundred Years of Regulation, by Philip J. Hilts.  Review published in Reason, Vol. 35 No. 11 (Apr 2004), pp. 51-55.

Criticized by Steven Blatt


"Should the law be fashioned for stupid people?"  p. 51

"Think of the FDA, when it functions properly, not merely as a hobbling bureaucracy but as anti-fraud law applied to food and medicine.  The question is how to tease out the FDA's useful functions--preventing fraud and injury--while eliminating its more burdensome regulatory functions."  p. 54

"Where one comes down...will hinge in part on how savvy one thinks the general public is, relative to scientific experts (such as the ones who end up working for the FDA), about evaluating medical claims.  To anyone acquainted with the general public's track record, the case for the bureaucracy looks surprisingly strong."  p. 54

    My criticism is that Seavey doesn't consider a particular alternative to FDA regulation:  The FDA could offer the same approval processes that it does now, but participation by pharmaceutial companies would be voluntary.  People would be allowed to buy drugs which had not been submitted to the FDA for approval; they would also be able to buy drugs which had been submitted for approval before the approval process finished, or if approval had been denied--but in any of these cases the purchasers would be required to have one or more conversations with an FDA official who would try to convince them not to use the product.  Of course, people could use drugs that had been successfully approved by the FDA just as they do now, with no "conversation" required.  This proposal would greatly decrease the "inherently coercive nature" (p. 55) of the FDA.  At the same time it would preserve to a great extent the FDA's anti-fraud role:  Someone who decides to try a product after being fully informed that it is ineffective or unsafe is not the victim of a typical fraud.

    There are objections to this proposal.  Also, if we decide the proposal is a winner we would have to agree with Seavey that "there is no avoiding some sort of legal constraint on food and drug sales" (p. 55).  And Seavey's article is intended as a book review, not a comprehensive survey of the FDA issue.  Nevertheless, I think the mandatory conversation approach is an important alternative to keep in mind when discussing the FDA and that Seavey's article would be better if he had considered it.


Return to main Criticisms page.
This page maintained by Steven Blatt. Suggestions, comments, questions, and corrections are welcome.