Review of Medical Countermeasures and a New Federal Approach

On Thursday, 19 August 2010, had the privilege of listening to the insightful keynote address by Kathleen Sebelius, Secretary of the U.S. Department of Health and Human Service (HHS), and the valuable as well as thought-provoking presentations by such other senior government officials as Dr. Nicole Lurie, HHS Assistant Secretary for Preparedness and Response; Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health; Dr. Robin Robinson, Director, Biomedical Advanced Research and Development Authority, HHS; Dr. Margaret Hamburg, Commissioner, U.S. Food and Drug Administration; Dr. Thomas Frieden, Director, Centers for Disease Control and Prevention; Dr. Harold Varmus, Former co-chair, President’s Council of Advisors on Science and Technology (PCAST) and former co-chair, PCAST Influenza Vaccinology Working Group; and Dr. Eric Lander, Co-chair, PCAST, and co-chair, PCAST Influenza Vaccinology Working Group.

These distinguished speakers released – and discussed the conclusions of – an examination of the federal government’s current system to produce the medications, vaccines, equipment, and supplies needed for a major health emergency anywhere in the United States. That system is more commonly known as “medical countermeasures.”

In Secretary Sebelius’s own remarks, she commented that, “To reach our national stockpiles, most countermeasures travel the same path. They begin as a discovery in a lab. Then the discovery gets translated into a useful product. Next, that product gets tested for safety and effectiveness. And then someone manufactures it.

“If this process works well,” Secretary Sebelius continued, “there is a steady output of new countermeasures targeted at our biggest potential threats.  But the closer we looked at our countermeasures pipeline,” she also noted, “the more leaks, choke points, and dead ends we saw.”

Greater Safety, Future Plans & Breakthrough Initiatives 

To keep Americans safer – there is no 100 percent “perfect” safety in today’s world – from modern-day threats, Secretary Sebelius announced: (1) the start of a new 21st-century countermeasures enterprise; and (2) The allocation of $1.9 billion to help get that enterprise underway as soon as possible, and at flank speed. One ancillary topic of major importance that she also emphasized in her presentation was the unique, sometimes costly, but absolutely necessary countermeasures needed by the nation’s “special needs” populations – with particular focus on children’s needs.

Secretary Sebelius also announced plans, and the applicable guidelines, for five new breakthrough initiatives, as follows:

  • Strengthen 21st-Century Regulatory Science at FDA by providing FDA scientists additional resources to improve the process of analyzing and approving new products and technologies;
  • Develop flexible manufacturing and advanced development core services partnerships, including new Centers of Innovation for Advanced Development and Manufacturing;
  • Upgrade the manufacturing process of flu vaccines;
  • Exploit the discovery and translation of various product concepts; and
  • Start an independent strategic investment firm for innovations in medical countermeasures. plans to address all of these initiatives, and several closely related topics, in the upcoming issue of the DomPrep Journal. We also will provide additional information to help emergency responders cope with the growing concerns of the nation’s special needs populations during future crisis situations that might occur – and, in fact, are probably inevitable. Several “practitioner writers” from multiple disciplines will share their knowledgeable views on the issue of medical countermeasures, with particular focus on U.S. special needs populations, as the initiatives announced by Secretary Sebelius move forward and the needs themselves change.


For additional information on the Sebelius initiatives and related topics see

Martin D. Masiuk

Martin (Marty) Masiuk is president and founder of International Media Representatives Inc. (IMR Group Inc.), which was established in 1986 as an American-based media representation firm for overseas, aerospace, and defense publications. In 1998, under the IMR Group, he established, which has evolved into a highly trusted, and important information service for the multi-disclipline, multi-jurisdiction preparedness community. In 2014, he transitioned the DomPrep40 into the Preparedness Leadership Council to lessen the burden on and increase the effectiveness of operational preparedness professionals and help policy professionals make better-informed decisions. Prior to IMR Group, he served as an account representative for McGraw Hill’s Business Week and Aviation Week & Space Technology publications.



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