Daschle’s Prescription for FDA: Leadership, Policy, Money, and Coordination

Restoring confidence in FDA "as the leading science-based regulatory agency in the world" will be a priority for the Department of Health and Human Services, Secretary nominee Tom Daschle told the Senate Health, Education, Labor and Pensions Committee Jan. 8.

"I will 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," he said.

Daschle's appearance before the HELP panel kicked off a two-step review of his nomination; the Finance Committee has formal jurisdiction over his nomination (¹ (Also see "Changing Part D Donut Hole “A Very Expensive Fix,” Daschle Notes" - Pink Sheet, 12 Jan, 2009.), p. 16).

At a time when health care reform is the dominant legislative issue for 2009 - and will be shepherded by Daschle via a separate appointment within the White House - the HHS nominee made clear that he shares the HELP Committee's concerns about FDA.

Daschle outlined four steps to revitalize the agency: (1) putting good leaders in the agency; (2) instituting good public policy; (3) ensuring adequate resources; and (4) improving coordination with the other public health agencies in HHS.

The speed with which the selection of an FDA commissioner is moving underscores Daschle's first priority.

Daschle's concerns about FDA dovetailed with those voiced by several members of the committee, including Barbara Mikulski, D-Md., and Richard Burr, R-N.C.

Burr asked Daschle about how to address inadequate funding, low morale and mission creep at the agency. "We have to show real leadership with regard to priorities, with regard to the kind of motivation of the workforce to do all we can to maximize our opportunities once we've set the policy and found the resources," Daschle replied.

Change In Attitude

Commenting on the need for good policy, Daschle emphasized that "The degree of clarity with regard to what that policy is, is critical."

In a colloquy with Mikulski, Daschle again pledged to remove ideology and politics from regulation.

Mikulski, in particular, espouses the view that political considerations factored in the agency's decision to delay approval of the over-the-counter version of the emergency contraceptive Plan B .

With most of FDA's staff based in Maryland, Mikulski also is an advocate for enhanced resources for the agency. Daschle promised to work with Congress on appropriately funding the agency.

Better coordination between HHS components is the fourth prong in Daschle's strategy for reforms at FDA. "We have to coordinate better," he said. "I worry that the NIH doesn't talk to the FDA, doesn't talk to the CDC, doesn't talk to CMS as much as they should."

Interagency coordination was also a priority in the Bush Administration, where HHS Secretary Tommy Thompson pushed a "one-HHS" policy.

Daschle's vision of coordination will presumably involve different priorities. One example came in response to a question from Sen. Christopher Dodd, D-Conn., suggesting that there needs to be better interagency cooperation on pediatric therapeutics.

"We're going to make a real effort to coordinate, integrate and to provide the kind of mission-driven approach to this that will accommodate the goals you so articulately outlined," Daschle replied.

Finance Hearing Not Yet Scheduled

The former Senate majority leader is considered a shoo-in for confirmation and his cordial reception from both Republicans and Democrats on HELP did not dispel that notion.

However, he will not be in office immediately after Inauguration Day; the Finance Committee's vetting process-including a thorough examination of his tax records-is ongoing.

There is no timetable for a hearing by the committee and one staffer disputes media reports that the confirmation process has hit a snag in the vetting. "There haven't been any delays, as no dates have been set," the staffer said.

-Cathy Dombrowski ([email protected])