main content
National Academy of Sciences
National Academy of Engineering
Institute of Medicine
National Research Council
 
An Overhaul of U.S. Drug Safety

The controversy began in September 2003, when a pharmaceutical company withdrew the popular anti-inflammatory drug Vioxx after a study revealed that long-term use doubled the risk of heart attack and stroke. Earlier studies had shown cardiovascular risks for patients taking the drug, but the FDA took no action other than adding a "precaution" to the drug's label in 2002. In a later congressional hearing, an FDA drug safety reviewer estimated that as many as 55,000 Americans may have died as a result of taking the painkiller. Congress promptly asked the Institute of Medicine to review the agency's drug approval process.

The resulting IOM report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, identified 25 concrete steps that the federal government should take to ensure that consideration of safety extends from before drug approval through the entire time the product is marketed and used. Released in September 2006, the hard-hitting report called for a big boost in funding and staffing for the FDA; new labeling requirements and advertising limits; and mandatory registration of clinical trial results to facilitate public access to drug safety information.

Since then, Congress passed major legislation boosting FDA's funding by more than 50 percent from 2008 to 2012, with a significant allocation specifically for drug safety. In addition, the law allocates funds for improving the agency's approach to ensuring drugs are safe after they are on the market and to strengthen FDA's authority in requesting changes in drug labeling. FDA was also instructed to establish a mandatory clinical trials registry.