“I feel so fortunate to have worked at an organization as remarkable and productive as the FDA,” Hamburg wrote in a letter to FDA staff announcing her departure.
Hamburg cited expedited reviews of drugs and devices as among the most important achievements of her tenure. The average time required to approve medical devices has dropped by roughly one-third since 2010 and almost half of new drugs approved last year went through an expedited process, she said.
Hamburg was confirmed in May 2009. She is the longest serving FDA commissioner since Dr. David Kessler, whose tenure spanned the presidencies of George H.W. Bush and Bill Clinton.
Dr. Stephen Ostroff, who joined the FDA in 2013 and is currently the agency's chief scientist, will step in as acting commissioner.
Last month, Dr. Robert Califf was named deputy commissioner for medical products and tobacco. Califf is viewed as a likely candidate to succeed Hamburg in the top post.
“As hard as it is to leave this agency, I am confident that the leadership team that we have in place will enable FDA to capitalize on, and improve upon, the significant advances we've made over the last few years,” Hamburg wrote.
Hamburg's decision prompted tributes. "She has changed the direction of the FDA, creating an environment of science-based collaboration that has fostered a new era of regulatory science focused on expediting the best treatments to patients,” said Ellen Sigal, chairperson and founder of Friends of Cancer Research, in a statement.
"I am grateful to Dr. Hamburg for her leadership of the FDA. We worked together to find a solution that would help prevent another compounding crisis after the 2012 fungal meningitis outbreak that killed 64 people, including 16 Tennesseans,” Sen. Lamar Alexander (R-Tenn.) said in a statement.
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