The Food, Drug, and Cosmetic Act was passed in 1938, and the idea that a federal agency should assure the safety and efficacy of prescription drugs has been part of the American healthcare system for almost 70 years.

 But recent recalls of highly publicized new drugs that had been approved as safe and effective by the government's regulatory agency, the Food and Drug Administration (FDA), but which proved disastrous when taken by patients over a period of time, is sparking debate about whether the FDA's mission is too limited and whether it needs new authority in an era of proliferating drugs and influential pharmaceutical companies.

"FDA has a strong safety record and remains the world's gold standard for drug approval and safety," says Steven Galson, the FDA's director for drug evaluation and research. When the FDA talks about drug safety, Galson points out, it is really talking about finding a reasonable balance between benefits and risks for a specific drug, for a specific illness, when used by patients and healthcare providers who have access to up-to-date information about the disease and the drug.

Recent reports from the Institute of Medicine (IOM) and the Government Accountability Office (GAO) have made recommendations for improving drug safety, chief among them being "post-marketing" surveillance for possible adverse reactions. The problem, the reports point out, is that even the best clinical trials of new drugs are limited, in time and in the number of patients they enroll, and the real test of a drug may come only when it is taken by many people over a long period of time.

Galson cited some actions the FDA is taking to try to address reports of "post-marketing adverse effects," which have ballooned from fewer than 200,000 in 1996 to more than 470,000 in 2006. Congress is currently considering reauthorization of the Prescription Drug User Fee Act (PDUFA), which allows the FDA to collect fees from drug companies to finance its operations, and Galson said the agency is pledged to use a recommended $87.4 million increase in drug user fees for fiscal year 2008 to support post-marketing drug safety activities "at any time in the drug's life cycle."

That the post-market problem may not be easy to solve was indicated in the most recent GAO report. Currently, the GAO said, the FDA "lacks specific authority to require drug sponsors to conduct post-market studies" and has relied on the sponsors voluntarily agreeing to conduct such studies. But those voluntary studies are often not completed, the GAO found, or when they are, the results may not be communicated to doctors and patients. A recent meta-analysis published in the New England Journal of Medicine found, for example, that the maker of a popular type 2 diabetes medication  failed to publicize unfavorable information about the drug that had emerged in a number of studies.

Speculating on how safe consumers really require their drugs to be, if the drugs are the only medication available to treat intractable illnesses, researchers writing in the journal Health Affairs suggest the FDA needs better tools to weigh risks and benefits. "As Congress and the FDA move to improve the existing process, we urge them to be attentive to all recommendations and to consider risk and benefit information in a systematic, quantifiable, and explicit manner."