WASHINGTON - It's official.
After little more than a year serving as FDA commissioner, Mark McClellan will vacate his post to accept the position as administrator of the Centers for Medicare and Medicaid Services.
In a voice vote Friday morning, the Senate approved McClellan's nomination, days after the Senate Finance Committee voted in favor of the move.
As head of the CMS, McClellan will have the unique opportunity of implementing the massive $538 billion Medicare law signed Dec. 8 by President Bush.
McClellan, a Texas-born physician and economist, leaves the FDA after a successful stint that saw a slightly improved drug review time period and gave him a reputation within the medical community as a superstar. (See BioWorld Today, Feb. 23, 2004.)
Lester Crawford, the deputy commissioner and veterinarian who temporarily headed the agency before McClellan took the job in late 2002, is expected to resume his role as interim commissioner.
Crawford was behind the decision in September 2002 to transfer certain responsibilities of the Center for Biologics Evaluation and Research to the Center for Drug Evaluation and Research. That move is credited with helping to improve review times of biologics license applications, which often are lengthy and complex. (See BioWorld Today, Sept. 9, 2002.)
What lies ahead at the FDA in terms of more permanent leadership is not known.
At a recent Medicare conference in Washington, William Testerman, former senior health policy adviser for Senate majority leader Bill Frist (R-Tenn.), said it is possible that the FDA might go without a leader for some time. Before McClellan was named to the post, Testerman said Frist's office sent several names to the White House and all were rejected. Not to mention, Testerman said, the pending election might slow the process.
Testerman, principal at Ernst & Young in Washington, was among the speakers at the recently held National Medicare Prescription Drug Congress here.
Leaving the FDA does not mean McClellan will rid himself of the controversy surrounding the reimportation of FDA approved drugs from Canada.
The issue has been floating around Washington for years, gaining high-profile support in recent months as senior citizens have vocally complained about the cost of prescription drugs.
While it is illegal to reimport prescription drugs, the FDA essentially looked the other way.
McClellan, in line with President Bush, has opposed reimportation on the grounds of safety. The new Medicare law permits the practice if Tommy Thompson, secretary of Health and Human Services, certifies that it is safe.