Goodman Continues On Rising Star Arc As FDA’s Chief Medical Officer
This article was originally published in The Tan Sheet
Executive Summary
Jesse Goodman has become FDA's acting chief medical officer and is the agency's lone representtative on the Federal Coordinating Committee on Comparative Effectiveness Research
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Jesse Goodman has become FDA's acting chief medical officer and is the agency's lone representtative on the Federal Coordinating Committee on Comparative Effectiveness Research. Goodman's assignment as CMO and his role on the comparative effectiveness research panel signal a more prominent role ahead as FDA realigns its management in anticipation of the arrival of Commissioner-designate Margaret Hamburg and Principal Deputy Commissioner Josh Sharfstein. The final line-up of leadership positions at FDA will not be set for some time. Hamburg will have to undergo Senate confirmation before joining the agency (see 1 (Also see "Hamburg/Sharfstein Appointments Do Not Signal Split Duties At FDA" - Pink Sheet, 23 Mar, 2009.) ). In the near term, Goodman may end up as the de facto deputy to Sharfstein, who is expected to join the agency before Hamburg since his position does not require confirmation. Goodman was named CMO in early March, at the same time the administration finalized its nomination of Hamburg as commissioner (2 (Also see "Nominations To Lead FDA Coming Soon For Hamburg And Sharfstein" - Pink Sheet, 9 Mar, 2009.), p. 9). Goodman has been director of the Center for Biologics Evaluation and Research since the end of 2002, when FDA was reassigning all therapeutic biologic reviews to CDER. That cemented CBER's position in the industry's perspective as the "junior" center for regulatory policy issues. However, Goodman led CBER's work in a renaissance of vaccine development and approvals, both for commercially significant products like Gardisil and for pandemic or bioterrorism preparedness efforts. Goodman, a virologist by training, joined FDA in 1998 to direct the Interagency Task Force on Antimicrobial Resistance. His background in infectious disease and experience working across agencies on microbial resistance may prove useful given the urgency of food safety on FDA's agenda. After returning to academia, he came back to the agency as CBER deputy director, where his work on bioterrorism preparedness brought him into the same orbit as commissioner nominee Hamburg. The two served on several Institute of Medicine panels focused on microbial threats and bioterrorism preparedness in 2002 and 2003. Goodman is likely to be the most familiar point of contact for the biopharma industry on the Coordinating Committee on Comparative Effectiveness Research, which also includes Agency for Healthcare Research and Quality Administrator Carolyn Clancy and Office of Management and Budget Special Advisor Ezekiel Emanuel. Of the 15 government officials named to the committee, Clancy and Emanuel appear likely to have the most influence over how the $1.1 billion in funding included in the American Recovery and Reinvestment Act for comparative effectiveness research actually is spent (3 (Also see "Plan For Spending Comparative Effectiveness Money Due July 30" - Pink Sheet, 2 Mar, 2009.), p. 18). Clancy is the lone agency head on the committee and also is the only Department of Health and Human Services agency head to survive the transition from the Bush administration to the Obama administration. That position may be tenuous; the HHS transition team is believed to have contacted potential replacements already. However, her position on the committee presumably indicates she will be leading the agency at least through the tight schedule for setting the research priorities for comparative effectiveness research. Emanuel, on the other hand, has a more free-ranging role in the administration, with no explicit portfolio but plenty of influence. His position with OMB gives him a window into all aspects of health policy - and the fact that his brother Rahm is chief of staff to Obama lends weight to his positions. HHS Health IT Chief HHS also has announced David Blumenthal, a Harvard professor and director of Massachusetts General Hospital's Institute for Health Policy, as the administration's choice for health information technology national coordinator. Blumenthal, who was a major contributor to the Obama health plan, was considered a strong candidate for a number of important positions either in the administration. As health IT coordinator, Blumenthal will lead the implementation of the nationwide interoperable, privacy-protected infrastructure called for in the American Recovery and Reinvestment Act. - Michael McCaughan ([email protected]) |