McClellan Would Face Several Challenges as FDA Commissioner

Senior White House health policy adviser Mark McClellan would face a number of "bi[g] issues" if confirmed as FDA commissioner, the Newark Star-Ledger reports (Schwab/Todd, Newark Star-Ledger, 9/29). President Bush on Wednesday nominated McClellan, who has represented the Bush administration in Congress on several health care issues, such as a Medicare prescription drug benefit and a Medicare "giveback" bill for providers. Analysts had predicted McClellan's nomination for several months but did not expect Bush to make an official announcement until the end of the congressional session because of his role in the administration (California Healthline, 9/26). McClellan will likely win confirmation as FDA commissioner; the Senate has confirmed him as a member of the President's Council of Economic Advisers, and Republicans on the Senate Health, Education, Labor and Pensions Committee, which would consider his nomination as FDA commissioner, earlier this month predicted no problems with confirmation (California Healthline, 9/25). According to the Star-Ledger, as FDA commissioner, McClellan would have a number of issues to address, such as:

• Expedited approvals for prescription drugs: FDA approval times for new treatments increased from 11.7 months in 1999 to 17 months in 2000. Pharmaceutical companies attributed the approval delays to additional studies and information that the FDA has required and said that the delays have contributed to the increased cost of prescription drug development. The Star-Ledger reports that "brain drain" at the FDA also has contributed to the delays. Over the past two years, more senior regulators have left the FDA for the private sector than at "any time in its history," an issue that McClellan would have to address.
  


• Bioterrorism: The FDA does not have an approval process for new vaccines for smallpox and anthrax, although the government has promoted their development, a problem that McClellan would have to resolve. In addition, McClellan would have to address the nation on bioterrorism issues.
  


• FDA modernization: The FDA has proposed a new division to address the "wave of hybrid products" that combine medical devices with prescription drugs -- such as drug-coated stents -- and McClellan will have to determine which part of the agency has authority over the products.
  


• Biotechnology treatments: The FDA recently shifted authority over biotechnology treatments from the Centers for Biologic Evaluation and Research to the Centers for Drug Evaluation and Research. Analysts predict that the move will expedite review times, but the "integration could prove tricky" and will test McClellan's management abilities, the Star-Ledger reports.
  

The New York Times on Sunday featured an interview with Dr. Raymond Woosley, a pharmacologist and vice president for health sciences at the University of Arizona, who discussed the "challenges" that McClellan would face as FDA commissioner. Woosley said that the FDA has a "whole new range of priorities" as a result of the Sept. 11 attacks, such as food safety and expedited reviews of prescription drugs related to bioterrorism defense. Woosley also said that inexperience with issues related to prescription drug approvals and food safety would not present a problem for McClellan as FDA commissioner. "There is no way anyone in that position is going to have the full coverage of expertise needed for that job," he said (Flaherty, New York Times, 9/29). The interview is available online. The Houston Chronicle on Sunday profiled McClellan and his extended family, which has "deep roots in Texas and increasing influence on the Potomac." The article is available online.