FDA failure to ensure drug safety

Introduction

The U.S. Food and Drug Administration (FDA) has failed to adequately safeguard the nation’s drug supply, according to various studies and watchdog groups. The agency’s most glaring failure: its lack of action against the popular arthritis and pain medication Vioxx despite clear and convincing evidence that the drug posed a threat to thousands of heart patients. Instead, the FDA — which is responsible for guaranteeing “the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices,” as well as America’s food supply — waited for the drug’s manufacturer to act on its own. In September 2004 the pharmaceutical giant Merck voluntarily withdrew Vioxx after it became evident that the drug increased the risk of cardiovascular events and may have caused tens of thousands of heart attacks. After the tragic failure, FDA whistleblower David Graham testified before a Senate committee that “the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.” The incident raised troubling questions about the adequacy of the FDA’s safety-monitoring and the agency’s record on safety issues. A 2007 report issued by the Institute of Medicine, a center under the National Academies, blamed the FDA’s problems on “a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs’ risks and benefits.” In the past decade, more than a dozen drugs have been withdrawn from the U.S. market, and around the world, because of risks to patients. According to the watchdog group Public Citizen, the agency has made mistakes with at least a dozen drugs, “leading to large numbers of avoidable deaths and injuries.” A spokeswoman for the FDA’s Center for Drug Evaluation and Research told the Center that the agency’s job is “to balance a drug’s benefits against the risks for the drug’s intended use. The agency approves a drug only after determining that the benefits outweigh the risks for most people, most of the time.”

Follow-up:
The Food and Drug Administration Amendments Act of 2007, signed by President Bush, contains several measures to strengthen the FDA. Among the new powers gained by the agency is the authority to issue mandatory label changes and require companies to do more studies on drug safety. Earlier this year, the FDA launched a new electronic database system for monitoring medical product safety. The agency says the system, dubbed the “Sentinel Initiative,” will strengthen its ability to monitor drug performance and could help prevent another Vioxx-like debacle.