The new FDA powers are a response to serious problems that emerged in patients who took Merck & Co Inc's withdrawn arthritis drug Vioxx and other medicines. Critics said the FDA was too slow to respond to signs linking Vioxx to heart attacks and strokes, as well as risks associated with antidepressants and other drugs. Lawmakers decided the agency needed clear authority to compel drugmakers to add new warnings or finish post-approval studies that might detect risks not seen in pre-market trials. The legislation extends for five years and increases the fees that drug and medical device makers pay to help fund product reviews. Pharmaceutical company payments will total nearly $393 million in fiscal 2008, which begins October 1, about $87 million more than the current level. Drugmakers will pay an additional $225 million over five years to help fund post-approval safety monitoring. The amount could go down if Congress provides money for the same purpose. For the first time, drug and device makers must post basic results for clinical trials of approved products in a public database. The bill also includes an FDA and industry agreement for companies to pay fees to fund agency reviews of television commercials that are submitted voluntarily
Senate OKs FDA drug safety bill - washingtonpost.com
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