FDA Faces Congressional Scrutiny on Drug Risks


The Food and Drug Administration remains in the Congressional hot seat, after concerns over how it handled GlaxoSmithKline's Avandia diabetes medication. Dr. Mark McClellan, former FDA commissioner, shared insights on “Morning Call.”

Fixing the FDA

Last month, the New England Journal of Medicine published a study linking Avandia, the world’s best-selling diabetes pill, to a 43% increased risk of heart attack. The FDA had put the risk at 40%. Now, McClellan said, Congress is considering legislation that would give the FDA more resources to monitor drug safety on the market: ”If done right, these hold the promise of being able to do a better job of proving that drugs are safe and effective.”

Currently, the FDA relies on phone calls from doctors and patients to track adverse events. Reforms, however, would provide additional resources and a stronger infrastructure.

McClellan also offered criticisms on U.S. health care. “To get more affordable coverage for everyone we got to change the way that health care is delivered,” he said. “Put more of an emphasis on personalized care and prevention, and these FDA reforms can help.”