HHS advisors face short deadline for analyzing biodefense

Feb 10, 2010 (CIDRAP News) – A committee that advises the US Department of Health and Human Services on biodefense issues took the first steps today to meet the tough assignment of analyzing the challenges facing HHS's medical countermeasures program and completing a report by Mar 26.

The National Biodefense Science Board (NBSB) was asked by Dr. Nicole Lurie, HHS assistant secretary for preparedness and response, to take a leading role in a major review of the program for producing countermeasures against biological attacks and other public health threats. HHS Secretary Kathleen Sebelius, citing the slow initial deliveries of H1N1 vaccine, first called for the review in December.

At today's meeting, which was entirely by teleconference because of heavy snow in Washington, DC, the board decided to set up a working group with three co-chairs to take on the assignment. The emphasis in the discussion was on the need to move quickly because of the short deadline.

In a Jan 26 letter, Lurie asked the NBSB to do two things for the review:

  • Organize a workshop to review the "strategic management, leadership, and accountability structure" of the Public Health Emergency Medical Countermeasure Enterprise, or PHEMCE. She commissioned a white paper with case studies to facilitate the discussions
  • Produce a written report by Mar 26 "synthesizing the issues and challenges facing the PHEMCE" and possibly "suggesting policy options to optimize it"

The overall review also includes another track, in the form of a workshop to be held Feb 22-24 by the Institute of Medicine and focusing on regulatory issues, market disincentives to countermeasure development, and other issues.

Speaking at the NBSB conference today, Lurie said, "All this work . . . will come together in a report that I owe Secretary Sebelius by March 31. It is a very short timeline, so what I expect is the majority of the recommendations and further development of the strategy will follow pretty quickly but won't all be presented on the 31st."

She said she wants the overall review to provide a synthesis of new developments in the countermeasures field, an analysis of "market forces that continue to detract from the government's ability to meet its preparedness goal," and an examination of behavioral issues that affect the use of medical countermeasures.

"The behavioral issues are really critically important here, and those things in the long run may drive the procurement and delivery," she said. Referring to public uptake of the pandemic H1N1 vaccine, she added that she wouldn't want to see the nation face a more aggressive pathogen and then find that 50% of the public won't accept the medical countermeasure provided.

Commenting on the work facing the NBSB, member Patrick J. Scannon, MD, PhD, said, "I really think we have to focus on defining the issues and laying out some concepts of a solution but not necessarily solving in great detail between now and March 30 what the solutions would be."

After other members seconded his opinion, Lurie said, "We're not going to have the entire solution set put together by March 31 because it's a very short time frame, but I'd hope that your review and recommendations would at least highlight the major areas where you think change is needed, to the extent the committee has a perspective about what the changes should be. . . . I hope we at least have a diagnosis before we attempt a treatment."

In further discussion, board member John D. Grabenstein, RPh, PhD, a vaccine expert at Merck, suggested setting up a working group to handle the review and offered to serve as one of the co-chairs of it.

The rest of the group agreed, and two other members who volunteered were named as additional co-chairs: John S. Parker, MD, of Scientific Applications International Corp., and Scannon, who is executive vice president of XOMA Ltd.

Earlier in the meeting, the board reviewed and approved a recently completed report, called "Optimizing Industrial Involvement with Medical Countermeasure Development."

The report, written by a working group headed by Grabenstein, makes eight recommendations to the federal government for better defining the priorities of the countermeasure program and speeding it up.

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