Medicare Compliance & Reimbursement

Former FDA chief approved after contentious hearing on drug importation.

It wasn't pretty, but it's official. Mark McClellan, MD, is the new Centers for Medicare & Medicaid Services Administrator.
 
The Senate confirmed McClellan by voice vote March 11, after Sen. Byron Dorgan (D-ND) released the hold he had placed on the nomination over McClellan's refusal to testify before the Senate Commerce Committee regarding the importation of cheaper Food and Drug Administration-approved drugs from abroad without the manufacturer's consent. Dorgan favors allowing importation -- often called "reimportation" because most of the drugs originate from U.S. plants -- while McClellan has consistently said FDA, which he has headed since November 2002, does not have the resources or authority under current law to ensure the safety of reimported drugs.

Reimportation proponents were angered by McClellan's initial selection as the chair of a Bush administration task force charged with conducting a congressionally mandated study on the issue. Health and Human Services Secretary Tommy Thompson announced March 11 that McClellan would not lead the study, and the Secretary said a new task force chair would be named soon.

McClellan, who had said he would appear in front of Commerce only after being confirmed as CMS administrator, reversed course and testified there in a contentious hearing on the morning of the 11th. As he had at his March 8 confirmation hearing before the Senate Finance Committee, McClellan said in general terms that he and the administration would work with Congress on ways to give FDA the authority and resources needed to effectively police reimporation.

However, because he felt McClellan had consistently dodged the specific questions put to him, Dorgan was still undecided after the hearing about releasing his hold, the North Dakotan's spokesperson Barry Piatt told MLR. Dorgan agreed to let the nomination go forward after Senate Majority Leader Bill Frist (R-TN) promised to bring together a bipartisan group to work towards legislation providing for safe reimportation.

All the hullabaloo provided additional evidence of the political momentum behind finding ways to reduce drug prices in general and behind reimportation specifically. For instance, Finance Chair Chuck Grassley (R-KS) said that he and Sen. Edward Kennedy (D-MA) were working on reimportation legislation, and Sen. Trent Lott (R-MS), who has opposed reimportation, announced at the Commerce hearing that he would vote in favor of allowing the practice at the next opportunity.