FDA Awaits Word On Commissioner McClellan; Is He Headed To CMS?

The public speculation about FDA Commissioner McClellan's next move within the Bush Administration indicates the importance of the Medicare prescription drug bill to the White House heading into the November elections.

McClellan has been widely viewed as the most likely successor to HHS Secretary Thompson, perhaps as soon as the November elections are over.

However, press reports Feb. 12 suggest that McClellan will be announced as the next head of the Centers for Medicare & Medicaid Services.

The position has been vacant since Tom Scully left immediately after the signing of the Medicare Rx law in December.

Officially, FDA is still treating the speculation as rumors meriting no formal response.

However, within the agency there is a growing recognition that the reports appear to have reached the informal, pre-nomination trial balloon stage.

McClellan, both a physician and an economist, is in many ways the ideal candidate for the CMS position. He is widely respected within Washington by both parties and by most FDA constituents.

The dietary supplement industry has been largely supportive of McClellan, given his stated interest in handling supplement safety issues within the framework of the Dietary Supplement Health & Education Act. The commissioner oversaw the development of the legal argument banning ephedra.

The over-the-counter drug industry also has seen positive impact from McClellan's tenure, as review times for NDAs have decreased.

He emphasized OTC drugs and Rx-to-OTC switches as ways of reducing healthcare costs. Still, there are concerns that FDA could support switches initiated without a sponsor's consent.

As FDA commissioner, McClellan frequently has talked about broad health care economic issues not traditionally considered to be under the purview of the agency.

Within Washington, FDA is considered the more attractive health care policy position. McClellan has not been pursuing the CMS post; he appears much more interested in moving up in HHS.

However, McClellan is unlikely to turn down a direct request that he take over the Medicare agency, particularly if the Administration concludes that President Bush's prospects in November hinge on perceptions of the new drug benefit.

CMS faces a huge challenge in implementing the Medicare law, beginning with ensuring that the Medicare discount/debit card program makes a good impression on seniors.

FDA, on the other hand, appears to be in a position where it could handle another caretaker period - especially with many Bush Administration appointees in place at lower levels in the agency.

Deputy Commissioner Lester Crawford already served as acting commissioner for about a year after he first joined the agency in 2002 (¹ (Also see "HHS Puts Stamp On FDA: Crawford Named Acting Commissioner" - Pink Sheet, 4 Mar, 2002.), p. 12).

In addition to the Bush Administration appointees at FDA, Center for Drug Evaluation & Research Director Janet Woodcock recently has moved to the commissioner's office to work on several aspects of McClellan's "strategic" plan for the agency (² (Also see "CDER Deputy Galson Will Run Drug Center For At Least Six Months" - Pink Sheet, 13 Oct, 2003.) p. 7).

During a Feb. 12 conference call, Merck CEO Ray Gilmartin was asked about the impact on FDA if McClellan departs.

McClellan has been an "effective" commissioner who "has had a big impact on the agency already," Gilmartin said.

However, the Merck CEO added, any change in FDA's leadership is unlikely to have a significant effect on drug approvals. "I wouldn't expect to see much change along those lines."