Drug Safety at the FDA Under Fire: What to Do?
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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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The US Food and Drug Administration, under fire for its alleged failure to monitor the safety of drugs after they have been approved, is now facing criticism over its lack of leadership during the Bush administration.
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Merck &amp; Co.&#39;s recall of the Vioxx painkiller shows why the US Food and Drug Administration needs its safety monitors to be independent of those who approve new medicines, FDA scientist David J. Graham told a Senate hearing.
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Congress is looking into whether the Food and Drug Administration ignored safety concerns about the drug raised by its own reviewers and outside scientists.
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Group that protects whistle-blowers says the FDA tried to discredit an outspoken safety officer who was challenging the agency's drug safety policies.
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The U.S. 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to review the way it monitors safety risks associated with medicines already on the market, such as Merck & Co. Inc.'s withdrawn painkiller Vioxx.
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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.
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Congress ought to write a detailed prescription for change in US oversight of drug safety. The public deserves better protection from potentially dangerous new medicines.
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The US regulator to beef up monitoring of drug safety after criticism over a painkiller linked to heart disease.
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The problems with Vioxx, taken off the market last week, raise questions about the Food and Drug Administration's safety review process. Observers say longer clinical trials should be required.
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The Food and Drug Administration announced Friday its intentions to conduct a major evaluation of its approach in dealing with safety concerns involving drugs, primarily those that are already marketed.
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Pfizer is the latest drug maker to warn that a product already on the market may pose serious health risks. It took outrage from activists in September to get the Food and Drug Administration to require warning
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ROCKVILLE, Md.  - The U.S. Food and Drug  Administration on Friday asked an outside group to review the  way the agency monitors safety risks of medicines after they  hit the market, such as Merck & Co. Inc.'s withdrawn painkiller  Vioxx.
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The editors of the Journal of the American Medical Association (JAMA) are calling for an end to the US Food and Drug Administration&#39;s (FDA) role in post-market monitoring of the safety of drugs it approves.
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US Food and Drug Administration officials defended their record on drug safety Thursday in the face of attacks from both inside and outside the agency.
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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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Learn a lesson or two from the drugmaker's dance with the FDA.