Congress should consider expanding the Food and Drug Administration's authority to require drug companies to conduct post-market studies on their products, the Government Accountability Office recommended in a new report. The report said the FDA lacked an efficient process for making decisions about and overseeing post-market safety issues and often suffered internal conflicts. For example, in the case of a heartburn medicine associated with cardiovascular side effects, FDA offices had different opinions about whether to modify the drug's label or take stronger actions. The GAO also said the FDA should revise and implement its draft policy on major post-market safety decisions and improve its dispute-resolution process. The FDA said the GAO's recommendations were reasonable and consistent with actions it has begun or has planned. Read the report.
GAO says drugs need more post-market oversight
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