FDA and the Centers for Medicare & Medicaid Services are likely to have a closer relationship under incoming Commissioner McClellan.

"If confirmed, I intend to explore additional areas where these two agencies can further improve their working relationship for the benefit of the American public," FDA nominee Mark McClellan told Senate Health Committee Chairman Edward Kennedy (D-Mass.) in a written question & answer exchange following McClellan's Oct. 7 confirmation hearing (see ¹ Also see "FDA Generic Biologics Policy May Be One Change Under McClellan" - Pink Sheet, 14 October, 2002.).

Kennedy asked McClellan specifically about coordination between CMS and FDA on national coverage decisions.

"What role should FDA's decisions regarding safety and efficacy play in Medicare coverage?" Kennedy asked. "What is your opinion on whether there should be more interaction between FDA and CMS during the approval process for new therapies? What is your opinion of CMS making national determinations about coverage before new therapies have been marketed for some time?"

McClellan noted that FDA and CMS use "different standards" that "may require different analyses" in order to complete their distinct regulatory missions.

"That said, I generally think increased interaction and cooperation among Federal agencies is wise, and I understand that CMS currently works collaboratively with FDA when gathering and considering evidence to make national coverage decisions," McClellan said.

The coordination between FDA approval decisions and CMS coverage decisions is a longstanding issue for the two agencies, and has been a priority for HHS under Sec. Thompson. McClellan's responses, however, illustrate his unique background for an incoming FDA commissioner based on his position as a member of the White House Council of Economic Advisors (² [A#00640390001], p. 3).

McClellan noted that he has "worked closely with CMS Administrator Scully on many issues during my service in the White House."

He elaborated on the distinctions between FDA and CMS' roles in response to more pointed questions from Ranking Republican Judd Gregg (R-N.H.). Gregg asked whether McClellan shares "the view that FDA and CMS have distinct regulatory missions and that any harmonization of their responsibilities should be approached carefully."

"Can you assure me that you would oppose efforts to involve FDA in collecting data related to cost, cost effectiveness, value and other reimbursement considerations in an effort to address concerns with the CMS coverage process, which responsibility would inevitably only result in delaying public access to medical technology?" Gregg asked.

"Certainly, FDA and CMS have distinct roles," McClellan responded. "The activities that you identify relating to cost and reimbursement are not primarily within FDA's mandate under the FD&C Act."

"From the perspective of CMS' authority, just because an item is safe for marketing, it is not necessarily the most medically appropriate item for a beneficiary, or a good use of taxpayer funds," McClellan continued.

One potential area for closer coordination between FDA and CMS in coming years is in drug safety surveillance. The agency has at least one program underway using CMS claims data to track the potential for liver toxicity with Parkinson's agents.

Health Directions Consulting CEO Jonathan Javitt, MD, one of the potential FDA commissioner candidates vetted by the White House, proposed closer coordination between FDA and CMS as one approach to resolving concerns about post-marketing surveillance. Javitt also briefed FDA staff on the idea in January (³ Also see "FDA, Kaiser Discussing COX-2 Myocardial Infarction Study" - Pink Sheet, 21 January, 2002., p. 18).

The unusual background brought by McClellan to the FDA post was also highlighted by some of the questions he fielded during the hearing. He was asked to comment as a Bush Administration representative on issues well outside FDA's authority, such as the Senate's proposal for Medicare "givebacks" to providers and the Administration's recent decision to include coverage of an "unborn child" under SCHIP.

The latter issue now appears to be the final obstacle to McClellan's confirmation; Sen. Jeff Bingaman (D-Mex.) is understood to have placed a "hold" on the nomination until HHS responds to his concerns.

FDA, CMS Coordination On Coverage Decisions May Improve Under McClellan

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