Hamburg resigning, future FDA leadership unclear

Margaret Hamburg announced her resignation Thursday as FDA commissioner. In a memo to agency staff, Hamburg said FDA Chief Scientist Stephen Ostroff will serve as acting commissioner when she steps down at the end of March.

Hamburg, who was confirmed by the Senate in May 2009, will have been one of the longest serving commissioners in the agency's history. She took the helm at FDA when it was under attack from Democrats and Republicans in Congress, patient advocates, drug developers, and investors. FDA was accused both of prioritizing industry profits over patient safety, and of institutional risk-aversion that stifled medical progress. During her tenure, Hamburg has repaired relations with politicians and restored confidence of patients and regulated industry. Congress and medical products companies that pay user fees have increased the agency's budget from $2.7 billion in FY2009 to $4.5 billion in FY2015. ...