FDA's safety project

FDACommissioner Margaret Hamburg has chosen to take a deliberate approach to dealing with her first high profile drug safety controversy, accusations from two U.S. senators that FDA management's failure to heed demands from mid-level staff to withdraw Avandia rosiglitazone has resulted in thousands of preventable heart attacks among diabetes patients.

After meeting with executives from Avandia's manufacturer, GlaxoSmithKline plc, as well as the company's leading critic, Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, Hamburg decided not to take any immediate regulatory action...