Although the principle of personal autonomy is commonly accepted as the proper guide for health care decisions, that principle has been conspicuously absent in the area of drug regulation, where the FDA has the unquestioned power to keep drugs off the market if it deems them either unsafe or ineffective. In the difficult area of cancer drugs, undue reliance on FDA expertise has serious deleterious effects. The most conspicuous sign that its regulatory role is often counterproductive is the widespread off-label use of drugs to treat conditions in ways that have not been approved by the FDA. These uses are not undertaken by individual doctors on a whim but are subject to systematic, voluntary oversight within the profession, which works more swiftly and sensibly than the FDA itself. The clear policy recommendation is that the FDA should work hard to speed new drugs to the market given the other superior mechanisms available to collect and evaluate the information on whether, and if so how, these drugs should be used.
Volume 94 - No. 1
- Note: Maximizing the Min-Max Test: A Proposal To Unify the Framework for Rule 403 Decisions
- Note: Anticompetitive Until Proven Innocent: An Antitrust Proposal To Embargo Covert Patent Privateering Against Small Businesses
- New Economy, Old Biases
- Will LGBT Antidiscrimination Law Follow the Course of Race Antidiscrimination Law?
- “The More Things Change . . .”: New Moves for Legitimizing Racial Discrimination in a “Post-Race” World
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