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    Celebrex, Bextra Face FDA Scrutiny This Week

    FDA Practices May Also Face Debate, Official Says


    "I don't want to lose them. I qualify that by saying I want to have this whole [safety] issue clarified," says Shiel, who is also editor of, which is owned by WebMD.

    The hearings are also likely to focus attention on whether Cox-2 drugs are inappropriately prescribed to many of the millions of patients who take them, Shiel says. A national study released on Jan. 24 concluded that patients who could have taken older and less expensive arthritis drugs still accounted for 64% of the growth in Cox-2 prescriptions between 1999 and 2002.

    Cox-2 safety concerns have also brought scrutiny on the FDA itself. Shortly after Merck & Company pulled Vioxx from the market in September 2004, FDA safety reviewer David Graham, MD, appeared on Capitol Hill complaining to lawmakers that his repeated warnings about the drug's safety were stifled by higher-ups in the agency.

    Graham cited five other drugs, including Bextra, as suffering from significant safety concerns and warned that the FDA was unable to protect Americans' safety.

    The Institute of Medicine has launched an inquiry into how well the agency monitors the safety of drugs already on the market. Several lawmakers have backed calls to reform the agency by establishing an independent drug safety office.

    FDA officials say that this week's hearings are likely to go beyond Cox-2 drugs to broader issues of how the agency polices the safety of drugs already on the market, FDA officials say. The FDA has also faced questions over how it handled growing evidence that last year led to stricter warnings on an increased risk of suicidal behavior in children who take antidepressants.

    In an interview in late January, acting FDA Commissioner Lester M. Crawford said the agency would also look to experts for cues on how to approach improving safety reviews in general.

    President Bush on Monday nominated Crawford to become the FDA's permanent commissioner, the White House announced. The post has been vacant for more than a year.

    With reporting by Salynn Boyles.

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