FDA Commissioner McClellan's nomination to be administrator of the Centers for Medicare & Medicaid Services could usher in an era of increased cooperation between the two agencies.

In a memo to FDA staff, McClellan said that after moving to CMS, he believes there will be opportunities for him to continue working with his colleagues at FDA.

"In my new activities at CMS, I am looking forward to continuing to work with my colleagues and friends here at FDA," he said. "After all, at the heart of it, we have exactly the same mission: helping Americans live healthier, longer, better lives."

President Bush announced Feb. 20 that he "intends to nominate" McClellan as CMS administrator, a position where he will be responsible for implementing most of the provisions of the Medicare prescription drug legislation. Former CMS Administrator Tom Scully left immediately after the Medicare Rx law was enacted (¹ Also see "Medicare Rx Benefit Will Be Implemented By New CMS Team; Scully Resigns" - Pink Sheet, 8 December, 2003., p. 16).

When McClellan was going through the confirmation process for his FDA position just over a year ago, he expressed his intention to foster more collaboration between the two agencies (² Also see "FDA, CMS Coordination On Coverage Decisions May Improve Under McClellan" - Pink Sheet, 14 October, 2002., p. 9).

This time around, McClellan's intention to work cooperatively will be facilitated by the fact that most of his closest advisors, many of whom were also brought into FDA under President Bush, are expected to remain at FDA.

Another Bush appointee, FDA Deputy Commissioner Lester Crawford, will serve as acting commissioner after McClellan's departure (see ³ Also see "Crawford Will Lead A Reorganized FDA As McClellan Leaves For CMS" - Pink Sheet, 23 February, 2004. ).

McClellan mentioned the "quality of care" initiatives included in the Medicare Rx legislation, which his experience at FDA could help him implement.

At CMS, he will be in charge of "using the new law to take steps to improve quality of care such as promoting electronic prescribing, developing better evidence on safety and effectiveness of medical treatments, and providing more useful information to patients and health professionals," McClellan said.

Although the Medicare law provides for development of comparative outcomes trials, that task is left to the Agency for Healthcare Research & Quality. However, McClellan's view on outcomes trials is favorable to the pharmaceutical industry: he has said the appropriate time for such trials is after commercial marketing (⁴ Also see "Outcomes Research Should Come After Approval, FDA’s McClellan Says" - Pink Sheet, 16 February, 2004., p. 28).

One of the primary motives the Administration had in naming McClellan appears to be capitalizing on his potential as a convincing spokesman for Medicare Rx.

In his memo, McClellan displayed the sort of boosterism for the Medicare drug benefit that will likely become a trademark of his public appearances as CMS administrator.

"We have a unique opportunity not only to safely lower drug costs for seniors and persons with disabilities, but also to usher in fundamentally better medical care for all Americans in the years ahead," he said.

A physician and an economist, McClellan has experience appropriate to heading CMS. Before joining FDA, he was intimately involved in developing the Administration's Medicare policy as a member of the White House Council of Economic Advisers, and he will now be charged with implementing the new law.

"Taking advantage of this unique opportunity requires many urgent steps - immediately implementing a new drug discount program with new financial assistance to lower-income beneficiaries, drafting and finalizing major regulations to provide drug coverage and more modern health insurance options for all beneficiaries by early next year, and using the new law to take steps to improve quality of care," he said.

Unlike Scully, who sometimes made remarks that ruffled drug manufacturers, McClellan has good relations with the industry. Following the White House announcement, the Pharmaceutical Research & Manufacturers of America said "Mark McClellan has made a very positive impact at the FDA, and we're confident he will do the same at CMS."

McClellan's nomination will need to be approved by the Senate following a confirmation hearing before the Finance Committee. He has cleared the Senate as a nominee twice before, once for the Council of Economic Advisers and again for FDA.

FDA’s McClellan To Head CMS: Will Greater FDA/CMS Cooperation Ensue?

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