HHS Nominee Sebelius Aims To Restore Science-based Approach At FDA

Kathleen Sebelius, President Obama's nominee for Department of Health and Human Services secretary, said she intends to restore trust in FDA by ensuring the agency's decisions are science-based.

Kansas Gov. Sebelius faced the Senate Finance Committee at an April 2 confirmation hearing and the Senate Health, Education, Labor and Pensions Committee at a March 31 hearing.

In a statement, she pointed out the agency regulates goods that account for 25 percent of U.S. consumer spending, more than $1 trillion, but "there is growing concern that the FDA may no longer have the confidence of the public and Congress."

Sebelius said as HHS secretary she would send "a clear message from the top that the president and I expect key decisions at the FDA to be made on the basis of science - period."

FDA recently incurred scathing criticism in a court ruling that found extensive political influence in the agency's handling of the Rx-to-OTC switch application for the Plan B emergency contraceptive (¹ (Also see "Plan B Ruling Sets A Precedent That Could Give FDA Pause" - Pink Sheet, 30 Mar, 2009.), p. 6).

The agency's Plan B decision-making also came under fire in a letter from FDA staffers to President Obama. The staffers - whose names were redacted in a copy of the letter released by Sen. Chuck Grassley, R-Iowa, - cited the court ruling and asked the president to discipline officials who may have violated rulemaking procedures (see ² (Also see "FDA Scientists Say Plan B Decision-Makers At CDER “Should Be Removed”" - Pink Sheet, 6 Apr, 2009.) ).

HELP Committee Chairman Ted Kennedy, D-Mass. - an influential figure in whether Senate Democrats support nominees for health-related posts - introduced Sebelius as "the right person for the job."

"Although her duties as secretary may begin with health reform, they do not end there. Food safety. Drug safety. Medical research. Disease prevention. All these and more need urgent attention," Kennedy said in his written statement.

Tobacco Under FDA

During the HELP hearing, Sebelius voiced support for giving FDA regulation of tobacco products. The day before the House passed legislation giving FDA authority over tobacco products (see ³ related story ).

Smoking is linked to illnesses that create the largest hospitalization costs, she told the committee.

Sebelius' position on tobacco aligns with the president's.

The Family Smoking Prevention and Tobacco Control Act, H.R. 1256, would create a Center for Tobacco Products within FDA. The legislation also passed the House in 2008 before stalling in the Senate (⁴ (Also see "Tobacco Oversight Looks More Likely, But Is It Bad For FDA’s Health?" - Pink Sheet, 9 Mar, 2009.), p. 3).

Separate Food Agency "Premature"

Similarly, Sebelius' position on the creation of a separate food agency echoed that of prominent Democrats.

Sebelius said it is "premature" to consider splitting FDA to create a separate food agency. The first step in improving food safety is strengthening supply chain security, she added.

The White House has not taken an official position on splitting FDA. The president appointed an interagency working group to advise him on strengthening food safety, including improving cooperation and collaboration between agencies currently responsible in this area.

Attention to FDA's food safety enforcement capabilities prompted some lawmakers to call for creation of a standalone food agency, but key lawmakers including House Energy and Commerce Chairman Henry Waxman, D-Calif., and Sen. Dick Durbin, D-Ill., the assistant majority leader, put that issue on the back burner (⁵ (Also see "First Course For Waxman: Fix Food Safety, Hold The Separate Agency Plan" - Pink Sheet, 16 Mar, 2009.), p. 16).

Pleased With Prevention

At the Finance hearing, Sebelius said she "was very pleased" the federal stimulus package enacted in February included $1 billion for HHS' Prevention and Wellness Fund (⁶ 'The Tan Sheet' March 26, 2009, In Brief).

Sebelius said with the "historic investment," HHS has "an opportunity to get the best strategies and hopefully have a major impact on the health of Americans by promoting personal responsibility."

She said while she served as governor, Kansas changed its state employee health care plan "to really have a significant focus" on the individual in part by offering "financial incentives to employees who will do everything from smoking-cessation programs to weight-loss programs to exercise programs."

Also of note during the March 31 hearing, Sebelius confirmed that the administration and Democratic lawmakers are not ruling out reconciliation - a parliamentary tactic that limits debate - in the process of developing health care reform legislation. Republicans have called on leaders not to reconcile.

Off the Fast Track

Finance Chairman Max Baucus, D-Mont., sought to fast-track the committee's vote on Sebelius and send her nomination to a floor vote before the Senate adjourned for the Easter recess. However, a Republican member objected on procedural grounds and the committee's vote is delayed until after Congress returns April 20.

Tobacco regulation and food safety also will likely surface in the confirmation hearings for Obama's FDA commissioner nominee, Margaret Hamburg. No hearings are scheduled for Hamburg's nomination.

Principal Deputy Josh Sharfstein is acting commissioner as of March 30 while Hamburg awaits confirmation.

Sebelius is Obama's second pick to head HHS after former Senate Democratic Leader Tom Daschle withdrew from consideration (⁷ (Also see "Daschle Withdrawal Shuffles Lead Roles On Health Care Reform Stage" - Pink Sheet, 16 Feb, 2009.), p. 14).

- Malcolm Spicer ([email protected]); Dan Schiff ([email protected]) contributed to this story.