Assessing the FDA via the Anomaly of Off - Label Drug Prescribing

I t is commonly thought that the U.S. Food and Drug Administration (FDA) regulates the use of all pharmaceutical drugs in the United States. In fact, most hospital patients are given drugs that are not FDA-approved for the prescribed use. The FDA does require that drugs undergo extensive testing before they are released onto the market and, if it concludes that a new drug is unsafe or not effective, the FDA can decline to approve it. The agency can also recall a previously approved drug. The FDA is the final authority on a drug's approved uses, which are indicated on its label. Despite these considerable powers, the agency is limited in important ways. Once a drug has been approved for some use, the FDA has almost no control over how that drug is actually prescribed. The prescribing of drugs for non-FDA-approved uses, called " off-label prescribing, " is widespread. Drugs prescribed off-label have not met the FDA's requirements for proving efficacy in the off-label applications. The practice of off-label prescribing therefore raises interesting questions. Why does the FDA, in effect, require that some drugs be tested for efficacy but not others? If there are good reasons for the FDA to have strong pre-approval powers regarding efficacy, shouldn't FDA post-approval powers be commensurate? Alternatively, if there is good reason for widespread off-label prescribing, doesn't this call into question the FDA's pre-approval powers? In this article, I review the extent of off-label prescribing in the United States and explain why physicians prescribe off-label. Next, I evaluate the costs and benefits