|FDA Commissioner Margaret Hamburg|
Dr. Margaret Hamburg is stepping down as FDA commissioner in March after 6 tumultuous years in the job, government sources say.
As The Wall Street Journal reports, FDA chief scientist Dr. Stephen Ostroff will serve as commissioner until President Obama appoints--and Congress confirms--a replacement. The news is not as surprising as it might have been before last month, when Hamburg selected Dr. Robert Califf of Duke University as deputy commissioner for medical products and tobacco. Industry watchers see Califf as a potential successor.
Since she took the FDA helm in 2009, Hamburg has juggled many contentious issues. She came under fire after a deadly meningitis epidemic was traced to a New England compounding pharmacy, and then led a crackdown on the compounding business. She stepped up plant inspections in the U.S. and abroad, expanding the agency's international reach to keep tabs on quality shortfalls. And Hamburg was forced to defend approvals of powerful painkillers amid worries about rampant opioid abuse--not to mention calls for her resignation over the issue.
But Hamburg's reign as commissioner hasn't been all doom and gloom. The FDA stepped on the gas in drug approvals, speeding up the process for potentially life-saving drugs. As Hamburg pointed out in a recent FDA blog post, the agency approved 51 novel drugs and biologics in 2014--the most in almost 20 years--including 17 "first in class" treatments.
"These developments are a testament not just to our expanding understanding of human biology, the biology of disease and the molecular mechanisms that drive the disease process, but also to FDA's innovative approaches to help expedite development and review of medical products that target unmet medical needs, while adhering to the established standards for safety and efficacy," Hamburg said in the blog post.
Hamburg has also focused on quality issues in emerging markets. Early last year, Hamburg made her first trip to India to inspect conditions at manufacturing plants. In November, she traveled to China to meet with the country's top regulatory officials about working together on drug food and safety.
Meanwhile, the FDA could face an uphill battle in naming Hamburg's successor. The post requires congressional approval, which is often difficult to obtain in a polarized political climate. But Califf, widely respected in the scientific community and the industry, may encounter fewer roadblocks than other candidates might, the WSJ reports.
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