Ethics and Law in FDA Decisionmaking

Abstract:     
The Food and Drug Administration, the agency responsible for regulating drugs and devices, determines their approval based exclusive on whether these products are safe and effective. This Article argues that the FDA's singular reliance on these cost/benefit criteria is a mistake for "enhancement" products that treat no medical condition or departure from normal functioning. Agency review of products to improve mood, sharpen memory, smooth wrinkles, and increase height requires richer analysis than safety and efficacy alone allow.

I argue the safety/efficacy framework, codified long before federal lawmakers anticipated the biomedical enhancements on the market today, misses a constellation of concerns that cannot be filtered through the narrow lens of safety and efficacy. I draw on a number of case studies to demonstrate that, however careful the FDA's scrutiny of clinical data about side effects and success rates, its safety/efficacy framework crowds out powerful concerns about subtle coercion, group prejudice, social conformity, competitive fairness, and collective self-defeat. I reject sweeping bans on approval, prescription, off-label use, or direct-to-consumer advertising of enhancement products in favor of reforms that equip administrators to ask the right questions and account for the relevant arguments.

Number of Pages in PDF File: 63

Keywords: FDA, food and drug law, off-label activity, direct-to-consumer advertising, biomedical enhancement, human growth hormone

JEL Classification: I18, L65, L66, I31, K32, O38

Accepted Paper Series