FDA Failed Public on Vioxx, Staff Reviewer Says
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The U.S. Food and Drug  Administration failed the public in its oversight of Merck & Co  Inc.'s MRK.N withdrawn painkiller Vioxx and is "incapable of  protecting America" from another dangerous drug, an agency  researcher told Congress on Thursday.
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Health care advocates, providers and FDA officials over the weekend &#39;sparred&#39; over alleged problems with the FDA prescription drug safety review process and the safety of five medications currently on the market, after an FDA safety reviewer on Thursday
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WASHINGTON - The Food and Drug Administration silenced one of its drug experts who raised safety concerns weeks before Merck & Co. yanked the blockbuster drug Vioxx due to increased risks for heart attack and strokes, the chairman of the Senate Finance Committee said Thursday...
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The US Food and Drug Administration on Friday asked an outside group to review the way it monitors safety risks associated with medicines already on the market, such as Merck &amp; Co.
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U.S. health officials said on Friday they would review whether to take regulatory action over Merck & Co Inc  and Schering-Plough's  cholesterol medicine Vytorin following the drug's failure to work better than a generic drug in a study of plaque build-up in neck arteries.
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NEW YORK - An internal survey conducted by the Food and Drug Administration (FDA) indicates that 66% of FDA scientists lacked confidence that the agency adequately monitors the safety of prescription drugs that are already on the market.
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The Food and Drug Administration lacks clear regulatory authority and is chronically underfunded, shortcomings hindering its ability to evaluate the safety of drugs used by millions of Americans, according to outside scientists the agency asked to critique its performance.
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Merck failed to warn doctors about the risks of its painkiller Vioxx and must pay a retired FBI agent $50 million to compensate for the heart attack he suffered after taking the drug, a federal jury found Thursday.
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U.S. health officials said on Friday  they would review whether to take regulatory action over Merck  & Co Inc  and Schering-Plough's  cholesterol  medicine Vytorin following the drug's failure to work better  than a generic drug in a study of plaque build-up in neck  arteries.
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WASHINGTON - Congress is looking into whether the Food and Drug Administration shirked its duty by ignoring safety concerns about Vioxx raised by its own reviewers and outside scientists.
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Nov. 19, 2004 -- New allegations from an FDA scientist that the agency is failing at its job of ensuring the safety of the drugs it approves has many Americans thinking twice before taking their daily dose.
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A US Food and Drug Administration reviewer who criticized the agency&#39;s handling of Merck &amp; Co. Inc.&#39;s now-withdrawn Vioxx painkiller may be forced to another position
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Government questions about ''basic data integrity&quot; derailed publication of a report raising safety concerns about arthritis drug Vioxx on the eve of a contentious congressional hearing, according to an e-mail exchange.
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Merck officials had evidence far back as 2001 that Vioxx might not help thousands of users of the arthritis and pain drug.
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Pharmaceutical giant Merck & Co Inc.  had evidence by 2000 that its painkiller Vioxx, which was  pulled off the market on Sept. 30, was not safe, a heart  specialist told CBS News program "60 Minutes" on Sunday.
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The recent Vioxx withdrawal and testimony from an FDA insider accusing the agency of failing to protect public health are fueling such heightened concern over drug safety that valuable medicines could be kept from patients, doctors said on Friday.
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U.S. drug safety regulators are coming under fire for their response to years of suspicions, confirmed last week, that arthritis drug Vioxx increased the risks of heart attacks and strokes.