RPM Report - FDA Commissioner Hamburg: Administration Closing In On Official Announcement | Friends of Cancer Research

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RPM Report - FDA Commissioner Hamburg: Administration Closing In On Official Announcement

By Ramsey Baghdadi

Former New York City Health Commissioner Margaret Hamburg is preparing for confirmation hearings with the White House set to announce her nomination as FDA Commissioner shortly.

Baltimore Health Commissioner Joshua Sharfstein will serve as Hamburg’s principal deputy commissioner.

Hamburg’s name was understood to be formally pushed by transition team co-chair and former White House Chief of Staff John Podesta, which explains her quick rise to the top of the Administration’s FDA shortlist late in the process. Podesta is currently CEO of the liberal think tank Center for American Progress.

FDA’s nationwide recall of peanut products due to salmonella tainting likely made Hamburg a more serious candidate for the job given her experience as head of health for the largest city in the US from 1991-1997.

Hamburg brings a number of important experiences and skills to the position. An MD who specializes in bioterrorism preparedness research, she served on the HHS transition for the Obama Administration.

Hamburg’s service under the Clinton Administration and head of a large health system appear to be two other important qualities for a top health post in this administration. In 1997, she left the NYC health department and was named assistant secretary for policy and evaluation at HHS under President Clinton.

Hamburg will reportedly handle food and tobacco issues—assuming FDA is given regulatory authority over those products—while Sharfstein will oversee drug, biotech and medical device issues.

While the arrangement raises questions over the effectiveness of a de facto two-headed agency, it serves as a palatable compromise among Congressional lawmakers and key industry stakeholders.

It became common knowledge that the drug industry opposed Sharfstein as FDA Commissioner due to his close ties to House Energy & Commerce Committee Chairman Henry Waxman (D-Calif.); he was previously a health policy advisor to Waxman on the Democratic staff for the House Government Reform Committee.

Naming Sharfstein principal deputy gives Waxman access to FDA without the perception of total control over the agency, while also ceding authority over the drug industry to the former Waxman staffer. The number two position also saves Sharfstein from going through the Senate confirmation process.

The nomination of Kansas Governor Kathleen Sebelius as HHS Secretary appears to have had little consequence on the choices at FDA and CMS, which were cemented before the withdrawal of Tom Daschle as HHS Secretary on Feb. 3.

Institute for Health Care Improvement CEO Don Berwick is expected to be named CMS Administrator with an unusually large number of deputies as Medicare takes center stage in the health reform debate. Harvard economist David Cutler will serve as principal deputy with authority over Medicare coverage reform.