Washington - The America's Food and Drug Administration (FDA) defended its approval of five prescription medications which a staffer dubbed unsafe on Thursday, when he warned the drugs present possible risks so severe they should face tougher restrictions or be pulled off the market.
Steven Galson, acting director of the FDA's Centre for Drug Evaluation and Research, noted that the testimony by David Graham, associate director of the agency's Office of Drug Safety, "does not reflect the views" of the FDA.
"The five specific drugs that Dr Graham identified in his oral testimony are currently approved as safe and effective for use in the United States," Galson said in a statement late on Thursday.
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"The FDA evaluates the safety and effectiveness of all drugs independently, on a case-by-case basis, before they are approved to enter the marketplace and also evaluates reported adverse events with all drugs already on the market to assess whether unforeseen safety concerns need to be addressed."
Graham told lawmakers during a hearing on the anti-inflammatory drug Vioxx Thursday that there are also serious risks posed by the diet drug Meridia, from US-based Abbott Laboratories; the cholesterol-lowering medication Crestor, from Britain's AstraZeneca; the acne medicine Accutane, from the Swiss pharmaceutical firm Roche; the anti-inflammatory drug Bextra, from the US firm Pfizer; and the asthma medication Serevent, from Britain's GlaxoSmithKline.
In the largest drug recall in history, pharmaceutical giant Merck withdrew Vioxx from the market on September 30, after a company-sponsored trial found that patients who took the medication for more than 18 months doubled their risk of heart attack or stroke.
"I would argue," Graham said in testimony to the Senate Finance Committee, "that the FDA as currently configured is incapable of protecting America against another Vioxx. We are virtually defenceless."
"One of my concerns is that the FDA has a relationship with the drug companies that is too cosy," said committee chairman Senator Chuck Grassley.
"That's exactly the opposite of what it should be. The health and safety of the public must be the FDA's first and only concern," Grassley declared, adding that legislative reform may be necessary to ensure that is the case.
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