The Regulation of Biotechnologies


Dov FoxFollow

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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.

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38 HASTINGS CTR. REP. 57 (2008)