FDA Critics Say Controversy About Diabetes Drug Points To Need For Agency Changes

Reuters: "The controversy surrounding a GlaxoSmithKline Plc diabetes drug points to a need for changes in the way the U.S. Food and Drug Administration handles safety issues, agency critics told lawmakers on Wednesday. The FDA is taking a new look at the safety of Glaxo's Avandia pill, which carries a warning about heart risks. The manufacturer says the drug is safe and effective, and the FDA is advising patients to keep taking the drug as directed. Two drug safety reviewers have recommended that the drug come off the market after concluding it was more dangerous to the heart than rival drug Actos by Takeda Pharmaceutical Co Ltd. That has prompted new calls for more independence and power for the reviewers who analyze a drug's risks after it reaches the market, an idea circulating for years. Critics say more authority lies with the staff who approve drugs and are therefore reluctant to withdraw a medicine they supported" (Richwine, 4/28).

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