”Some side effects will make a medicine too dangerous to keep around. But the decade-long age of mass-market drug recalls – in which an average of one medicine a year has been withdrawn from the U.S. market – looks to be ending thanks to new powers the FDA was granted by a 2007 law, the Food and Drug Administration Amendments Act (FDAAA).
The USFDA can exercise its ability to forcibly change drug labeling and compelling drug companies to publicly register clinical trials. But the most effective new power has been the risk evaluation and mitigation system (REMS).
The FDA says there are currently REMS approved for 146 products. Ninety-six of these include only a medication guide, which warns patients about the risks and benefits of a drug. Thirty-three include a communication plan that takes additional steps to approve the drug. Fifteen have what the FDA calls “elements to assure safe use,” which includes much more extreme steps to make sure that the medicine is used properly. As the Avandia case seems likely to show, these requirements can almost eliminate a drug from the market without withdrawing it.”