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Bush Nominates Administration Policy Adviser to Head FDA

http://www.medscape.com/viewarticle/442061

By Ori Twersky
Sept 25, 2002
Reuters Health
WASHINGTON

President Bush on Wednesday nominated Dr. Mark McClellan, an administration health policy adviser, to be Commissioner of the US Food and Drug Administration (FDA), a post that has been vacant since Bush took office.

If confirmed by the Senate, as is required by law, Dr. McClellan will take the reins from FDA Deputy Commissioner Dr. Lester Crawford, who currently is the top-ranking agency official.

Rumors of McClellan's potential nomination have been circulating for about two months. The nomination may finally end what has become a politically contentious issue.

Industry representatives and critics of the Bush administration have taken the government to task for failing to fill the post, but the administration's nomination of candidates has been hampered by the insistence of Senator Edward M. Kennedy that any future commissioner have no industry ties.

Senator Kennedy chairs the Senate committee that will act on the nomination. In a statement, Sen. Kennedy said Wednesday that he looks forward to reviewing Dr. McClellan's nomination.

"Dr. McClellan has impressive credentials both as a physician and as an economist, and I look forward to learning more about his views on issues critical to the FDA," the Massachusetts Democrat said.

Health and Human Services Secretary Tommy G. Thompson called Dr. McClellan a "superb" choice for commissioner, noting that he has a "strong background in medicine, science, public policy and economics" that would "serve him well at the FDA."

McClellan is a Harvard-educated physician with a doctorate in economics from the Massachusetts Institute of Technology, who presently serves on Bush's three-member Council of Economic Advisers.

As a member of the council, McClellan worked on a broad range of health policy issues, including the president's position on a Medicare prescription drug benefit. McClellan, who is from a prominent Texas family, has also appeared at a number of events to promote the president's agenda.

Prior to joining the White House, McClellan was an associate professor of medicine and economics at Stanford University and worked as a deputy assistant treasury secretary for economic policy during the Clinton administration.

News of the nomination also received a warm welcome from certain industry groups regulated by the FDA.

"We are pleased that the Bush Administration has made a selection to fill this critical FDA position, and, from Dr. McClellan's educational background and experience in medicine, healthcare, and economic policy, he appears to be an exceptional candidate," said Biotechnology Industry Organization (BIO) President Carl B. Feldbaum. BIO is an industry association that represents more than 1,000 biotechnology companies.

"It is important to have a nominated and confirmed candidate to deal with a wide range of issues, including the speed of drug approvals and manufacturing standards," added Pharmaceutical Research and Manufacturers of America (PhRMA) spokesman Jeff Trewhitt in an interview with Reuters Health.

Trewhitt said a commissioner was also needed to ensure that the FDA is properly funded. However, Trewhitt said the organization still needs to learn more about Dr. McClellan prior to taking a stance on whether he is the correct candidate for the job.

Industry analysts were more reserved about the potential impact of Dr. McClellan's appointment.

"It will eliminate the excuse that things aren't happening," regulatory analyst Ira Loss of Washington Analysis told Reuters Health. "But is it going to open the flood gates for new product approvals? Probably not."

In a separate memo to FDA staff, Dr. Crawford said he looks forward to working with Dr. McClellan should he be confirmed. "I have gotten to know Mark well over the last year and consider him an excellent choice to lead the agency," Dr. Crawford said.
 

© 2002 Reuters Ltd