Against Permititis: Why Voluntary Organizations Should Regulate the Use of Cancer Drugs
35 Pages Posted: 14 Nov 2009
Date Written: November 13, 2009
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 that it does not deem safe and effective. In many difficult areas, especially with cancer drugs, undue reliance of FDA expertise has serious deleterious defects. The most conspicuous sign that its regulatory role often is counterproductive is the widespread off-label uses of drugs to treat conditions for uses 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 market given the other superior mechanisms available to collect and evaluate the information on whether, and if so how, these drugs should be used.
Keywords: FDA, drug regulation
Suggested Citation: Suggested Citation