The White House is set to nominate former New York City Health Commissioner Margaret Hamburg as FDA commissioner, according to sources knowledgeable about the selection process.

Baltimore Health Commissioner Joshua Sharfstein - another final candidate for the top spot - will serve as Hamburg's principal deputy commissioner, they say.

The nominations would bring President Obama's health team into sharper focus following the March 2 announcement of Kansas Gov. Kathleen Sibelius as nominee for Department of Health and Human Services secretary.

Hamburg was boosted by Obama administration transition team co-chairman John Podesta, which explains her quick rise to the top of the FDA shortlist late in the process. Podesta, who was chief of staff for President Clinton, currently is CEO of the liberal think tank Center for American Progress (¹ Also see "Hamburg Joins Sharfstein On FDA Commissioner Shortlist" - Pink Sheet, 23 February, 2009., p. 12).

Hamburg brings a number of important experiences and skills to the position. A physician who specializes in bioterrorism preparedness research, she was named assistant secretary for policy and evaluation at HHS under Clinton in 1997.

FDA's nationwide recall of peanut products may have made Hamburg a more serious candidate for the job given her public health experience; she was head of health for New York City from 1991-1997 (² Also see "Calls For Reporting Requirements, Recall Authority Remain As PCA Crumbles" - Pink Sheet, 16 February, 2009., p. 8).

Hamburg and Sharfstein both served on the Obama administration's Department of Health and Human Services transition group.

The administration is planning a new arrangement between the top two officials, sources say. Hamburg likely would handle food and tobacco issues - assuming FDA is given regulatory authority over those products - while Sharfstein will oversee drug, biotech and medical device issues.

The arrangement raises questions about the effectiveness of a de facto two-headed agency, but it serves as a palatable compromise for congressional lawmakers and key industry stakeholders.

Some in industry opposed Sharfstein as FDA commissioner due to his close ties to House Energy and Commerce Committee Chairman Henry Waxman, D-Calif. Sharfstein previously was a health policy advisor to Waxman on the Democratic staff for the Government Reform Committee.

Naming Sharfstein principal deputy gives Waxman access to FDA without the perception of total control over the agency. The move also cedes authority over the drug industry to the former Waxman staffer, who was the point person in a citizen petition that prompted FDA's ongoing review of OTC pediatric cough/cold drugs (³ Also see "Calls For Cough/Cold Collaboration As FDA Inches Toward Rulemaking" - Pink Sheet, 6 October, 2008., p. 3).

The dual responsibilities could also be a step toward - or an alternative to - carving out a separate food agency to address the growing concerns with food safety. Some in Congress support the idea of a separate agency, including Rep. Rosa DeLauro, D-Conn., and Sen. Dick Durbin, D-Ill.

HHS secretary and FDA commissioner nominations require Senate confirmation.

The nomination of Sebelius appears to have had little consequence on the FDA choices, which apparently were cemented before the withdrawal of Tom Daschle as HHS secretary nominee on Feb. 3 (⁴ Also see "FDA Commissioner Announcement Complicated By Daschle, Peanut Butter" - Pink Sheet, 9 February, 2009., p. 7).

Democrats say Sebelius' role as Kansas insurance commissioner from 1995-2003 may be the most important attribute that will help her in the reform debate, pointing out the insurance industry has been the most vocal and aggressive opponent of reform.

Obama also picked former Medicare chief Nancy-Ann DeParle to head the White House Office of Health Care Reform.

DeParle has served as Tennessee's health commissioner as well as Medicare administrator and gained federal budget know-how from time at the Office of Management and Budget. She also has spent recent years explaining health policy and finances to the investment community, which could be important as the administration sells its health care fix as integral to repairing the economy.

- Ramsey Baghdadi (r.baghdadi@elsevier.com)

Nominations To Lead FDA Coming Soon For Hamburg And Sharfstein

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