Leavitt Pressed on FDA Nominee

Senators on Tuesday pressed Health and Human Services nominee Mike Leavitt (search) for a permanent commissioner for the Food and Drug Administration (search), which has been without one for nearly a year amid rising concerns about the safety of drugs on the market.

Describing the FDA as an "agency in crisis," Sen. Judd Gregg, R-N.H., asked the former Utah governor at a confirmation hearing on his nomination whether someone would be named by the end of January.

"I share with you the view that the agency needs permanent leadership," Leavitt replied during the two-hour hearing before the Senate Health, Education, Labor and Pensions committee.

Pressed further on the point, Leavitt said the White House will make the decision. He added, "I will do all I can to see that it occurs, and it's my sense that it will happen soon."

There was no immediate comment from the White House.

"That's not right for that agency," said Massachusetts Sen. Edward M. Kennedy, the committee's senior Democrat. He said he joined with Gregg "in urging that we get that position filled."

The FDA has been without a commissioner since March 2004, when the Senate confirmed then-director Mark McClellan (search) to oversee the agency that runs the Medicaid and Medicare programs.

So far, the only person mentioned as a possible, permanent replacement for McClellan is Lester Crawford, the acting FDA commissioner, a Senate aide said.

If confirmed, Leavitt, 53, the head of the Environmental Protection Agency (search), would take over the $550 billion, 66,000-employee health and human services department, which includes the FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health.

The FDA is facing questions about its drug-approval process after the arthritis drug Vioxx (search) was pulled from the market in the fall because it doubled patients' risk of heart attack and strokes. Two similar drugs, Celebrex and Bextra, have been associated with increased risk of heart problems.

On other topics, Leavitt said:

— Rolling out a new Medicare (search) prescription drug program will be the "main event" at HHS this year. The benefit was enacted to help seniors cope with rising drug costs and begins next year.

"There will inevitably be flaws, but we will not fail," he said.

Medicaid (search), the federal-state program that provides health care to the poor, is a "vital program" that isn't meeting its potential. He said states need more flexibility to decide how to structure the program because rising costs are eating away at other areas of their budgets.

Kennedy asked about reports that the administration planned deep cuts in Medicaid and Medicare and "whether we're going to be squeezing and denying health benefits." Leavitt responded, "It's always been my belief that we can expand the number of people we serve with the available resources."

When Leavitt was governor, Utah received a rules waiver from the Bush administration that resulted in health insurance for thousands of working families. Critics have said the waivers produced minimal increases in Medicaid enrollment but have cut benefits and increased costs to others in the program.

Hearings on Leavitt's nomination continue Wednesday before the Senate Finance Committee.