Bioterrorism, Modernization Among Issues McClellan Would Face If Confirmed as FDA Head

Senior White House health policy advisor 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 Sept. 25 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 (Kaiser Daily Health Policy Report, 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 (Kaiser Daily Health Policy Report, 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 have 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.
  

More 'Challenges'
The New York Times on Sept. 29 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 Sept. 29 profiled McClellan and his extended family, which has "deep roots in Texas and increasing influence on the Potomac." The article is available online

Call for FDA Reforms
McClellan's nomination as FDA commissioner "couldn't have come soon enough," as the agency has "become a bureaucracy that 'protects' people from the drugs that can save their lives," Robert Goldberg, director of the Center for Medical Progress at the Manhattan Institute, writes in a Wall Street Journal opinion piece. Advances in medical science have shifted the responsibilities of the FDA from the "simple job of keeping harmful drugs" off the market to "speedily put[ting] into the marketplace ... new miracle drugs and technologies" to help patients, Goldberg writes. He adds, however, that "careless scientific reasoning" and "bureaucratic incompetence" have increased approval times for new treatments. In addition, he writes that the FDA often delays prescription drug approvals as a result of "quality" or "safety" violations at manufacturing plants, although the violations have not prevented the shipment of other products from the same facilities. According to Goldberg, McClellan should staff FDA advisory committees with "actual" scientists -- doctors and statisticians with medical specialties -- rather than "'public health' policy elites who distrust private innovation." In addition, he writes that the FDA can work with patient groups and companies to monitor the impact of new treatments on the market, rather than wait for the results of "needless clinical trials" that delay approvals. Goldberg concludes: "Successfully reorienting the FDA's philosophy would distinguish Mr. McClellan as the most effective FDA director in a generation" (Goldberg, Wall Street Journal, 9/30).