Bush’s FDA Nominee Finds Himself in a New Arena

Dr. Mark McClellan, an authority on the wonky price side of health care, faces a completely different challenge as President Bush’s choice to head the agency responsible for the safety of medical and consumer products used by every American.

If the Senate confirms the economist-physician nominated Wednesday as Food and Drug Administration commissioner, it would be a new arena for Bush’s top advisor on health policy.

McClellan’s resume lists strong credentials relating to Medicare and other funding issues the FDA is not supposed to consider, but no experience in how to tell whether a new drug is safe enough to be sold, what to do about tainted food or how to ensure blood safety.

Bush, in a statement announcing McClellan’s selection, gave him the task of paying special attention to measures to protect the nation from bioterrorism threats, speeding patient access to breakthrough medical treatments, and making medical treatments safer.

Supporters say he is a quick study whose understanding of everyday health constraints will bring a fresh perspective to the FDA, which regulates products that make up a fourth of the economy.

“He’s a very, very smart guy who ... has very sophisticated understanding of policy and the many needs that need to be balanced in setting policies, including those governing drug approval,” said Dr. Alan Garber, a health-economics professor at Stanford University, where McClellan once worked.

“FDA needs some strong leadership,” said Dr. J. Edward Hill, chairman of the American Medical Assn. He said McClellan was “a very thoughtful person who’s willing to hear all views,” important in a regulator.

Also, McClellan meets a line-in-the-sand requirement from Sen. Edward M. Kennedy, the Massachusetts Democrat whose endorsement is critical, that no prospective FDA commissioner have ties to the many industries the agency regulates.

The long-awaited nomination comes at a crucial time for the FDA, which has been leaderless since Bush took office.

A General Accounting Office report this week said the FDA has a hard time keeping skilled scientists it needs to evaluate drug safety, with turnover rates higher than among any other federal scientific agency. Critics also contend that increasingly speedy approvals of new drugs have contributed to the recent banning of a number of unsafe medications--and they worry that McClellan’s lack of experience with such issues could hurt.

“He’s inheriting a situation with low morale, due in our view to a sweatshop atmosphere that now exists at the agency, which requires both a management and stronger scientific response. He doesn’t show evidence of either,” said Dr. Peter Lurie of Public Citizen, a consumer advocacy group.

The Senate must confirm McClellan, and aides could not say whether the required hearing before Kennedy’s Health, Education, Labor and Pensions Committee could be scheduled before Congress adjourns this fall.