Regulatory Focus™ > News Articles > Hamburg, FDA Get a New Boss in New HHS Chief Sylvia Burwell

Hamburg, FDA Get a New Boss in New HHS Chief Sylvia Burwell

Posted 06 June 2014 | By Alexander Gaffney, RAC

Hamburg, FDA Get a New Boss in New HHS Chief Sylvia Burwell

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg—and the agency she runs—will soon have a new boss.

On Thursday, 5 June 2014 the full US Senate voted 78-17 to confirm Sylvia Matthews Burwell, former director of the Office of Management and Budget (OMB), to the position of secretary of the Department of Health and Human Services (DHHS).

Burwell, once sworn in next week, will replace outgoing Secretary Kathleen Sebelius.

While much of Burwell's focus will undoubtedly be on the implementation of the Affordable Care Act and its various provisions, Burwell's status as head of DHHS also means she is the de-jure leader of FDA.

Though the secretary's power over FDA is rarely exercised, her predecessor, Sebelius, was the first secretary in history to overrule an FDA decision to approve a drug. In a decision called "political" by some, Sebelius ordered FDA to overturn its over-the-counter approval of Teva Women's Health's Plan B One-Step, saying the agency lacked the necessary data to prove the drug would be safe for use in its youngest potential users. The election-year decision touched off a firestorm of controversy, leading to concerns that DHHS might have opened FDA up to further political interference in the future. After a lengthy court battle, FDA eventually approved the drug for OTC use in May 2013.

Burwell has made no comments on whether Sebelius' comments were appropriate, or if she plans to exercise similar authority in the future.

Burwell has said little about FDA to date, and comes to DHHS without an extensive health policy background. Prior to serving as the director of OMB, Burwell was President of the Walmart Foundation, President of the Global Development Program at the Bill & Melinda Gates Foundation, and a host of economic-focused government jobs in the Clinton administration.

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