Avanda Controvery Exposes FDA’s Murky Drug Approval Guidelines

The Associated Press reports (7/1, Marchione) that the FDA did not have firm rules for deciding when a drug is too risky to stay on the market.  “Each drug has its own complex story,” said Dr. Joshua Sharfstein, the FDA’s principal deputy commissioner. Regarding the debate surrounding the GlaxoSmithKline diabetes pill Avandia (rosiglitazone), Sharfstein indicated that the case will not be decided in reference to Vioxx (rofecoxib) but would stand on its own.  The FDA sought advice from a group of outside scientists (The Institute of Medicine) and scheduled a special meeting in July to hear from experts on its endocrinology and drug safety panels. Sharfstein stated that “the internal staff analyses of risks have not been released yet, and will shed more light on the situation.”