Originally Published MX November/December 2002
BUSINESS NEWS
McClellan Confirmed as New FDA Commissioner|
Sidebar: |
An
internist and medical economist, McClellan has been a member of the president's
Council of Economic Advisers since July 2001 (see sidebar).
Disagreements over the qualifications of previous near-nominees had held up appointment of a new commissioner since the beginning of the current Bush administration. Several potential nominees were set aside because of Democratic objections to their previous connections with the pharmaceutical industry.
Although McClellan is well connected within the Bush administration's circle of Hoover Institution fellows—five others have connections with Hoover, including national security advisor Condoleezza Rice—the new commissioner's lack of connections may have been the most telling factor in his confirmation. McClellan was acceptable on both sides of the Senate aisle largely because he had no previous connections with any of the industries regulated by FDA.
During confirmation hearings before the Senate Committee on Health, Education, Labor, and Pensions, questioning of McClellan was milder than previous disagreements would have suggested likely. The committee questioned McClellan for a little more than an hour and did not press him on some of the critical issues that led to earlier disagreements.
On the issue of FDA regulation of direct-to-consumer promotion of drugs—a matter of contention because of its First Amendment implications—McClellan seemed to take a broader view than that maintained by the agency in recent litigation. Noting that such advertising can help to inform consumers, he also allowed that it could stimulate patients to seek out "treatment of conditions that are seriously undertreated."
McClellan expressed strong support for the Medical Device User Fee and Modernization Act of 2002 (HR 5651), which was passed by the Senate on the same day as his confirmation (see related story). Industry associations greeted McClellan's confirmation with support. Noting the passage of the medical device user fee act, AdvaMed president Pamela G. Bailey said that "Congress has passed the legislative reforms to bring FDA into the twenty-first century, and has appointed a commissioner who is well qualified to lead implementation of these reforms in the months and years ahead."
McClellan brings to his new position research-based experience that could prove valuable to an agency whose regulated industries have endured significant cost-reduction pressures in recent years. His research studies and publications have addressed such topics as measuring and improving the quality of healthcare, the economic and policy factors influencing medical treatment decisions, technological change in healthcare and its consequences for health and medical expenditures, and the relationship between health and economic well-being.
Copyright ©2002 MX
