The Regulation of Biotechnologies

38 HASTINGS CTR. REP. 57 (2008)

2 Pages Posted: 9 Apr 2008 Last revised: 2 Jun 2013

See all articles by Dov Fox

Dov Fox

University of San Diego: School of Law

Date Written: 2008


The Food and Drug Administration's regulation of drugs, cosmetics, and devices takes the form of risk-benefit analyses on the basis of two criteria: safety and efficacy. The problem is that enhancement uses cannot be singled out effectively in FDA review. The FDA's evaluative framework is one-size-fits-all. It requires the agency to express concerns about competitive fairness or resource allocation in the language of safety and efficacy, or to filter arguments about social prejudice and subtle coercion through the lens of cost-benefit analysis. This stacks the deck in favor of automatic approval for safe uses of enhancement products, which merit more careful scrutiny. Instead of, Do the product's benefits outweigh its harms? we should be asking, Is this a good use of medical technology? What we need is a more holistic decision-making strategy to govern biomedical enhancement activity. I propose four structural changes that we should make to the FDA's decisionmaking process.

Keywords: FDA, food and drug law, Federal Food Drug and Cosmetic, off-label activity, direct-to-consumer advertising

JEL Classification: I00, I18

Suggested Citation

Fox, Dov, The Regulation of Biotechnologies (2008). 38 HASTINGS CTR. REP. 57 (2008), Available at SSRN:

Dov Fox (Contact Author)

University of San Diego: School of Law ( email )

5998 Alcalá Park
San Diego, CA 92110
United States
(619) 260-4600 (Phone)


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