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HHS Review Highlights Role of Business in Medical Countermeasures

Vaccination (U.S. Army Corps of Engineers)

(U.S. Army Corps of Engineers)

The Department of Health and Human Services (HHS) today released a report on the federal government’s system to produce medications, vaccines, equipment, and supplies needed to meet a health emergency. The report — Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs — reviews the process and makes recommendations for a better approach. The recommendations include making better use of biotech companies and manufacturers, as well as helping companies overcome investment hurdles to ramp up for emergencies.

HHS Secretary Kathleen Sebelius asked for the review after the challenges faced by HHS and private companies from the 2009 H1N1 pandemic flu vaccine, highlighting the need for a modernized production process for medical countermeasures — the term for responses to medical emergencies. The review covered the steps involved in the research, development, and FDA approval of medications, vaccines, and medical equipment and supplies for a health emergency.

The study found that some of the most promising research and development on medical countermeasures is done by emerging biotech companies with little experience in large-scale manufacturing. As a result, in the coming weeks HHS expects to release draft funding announcements for one or more Centers of Innovation for Advanced Development and Manufacturing, that will help young companies bring products to market and help the U.S. government increase the number of new countermeasures available in an emergency.

The review found that the U.S. must more quickly develop manufacturing processes that can be used for multiple medications or vaccines rather than processes devoted to only one type of countermeasure. A prime responsibility of the proposed Centers of Innovation for Advanced Development and Manufacturing will be to encourage new manufacturing platforms that can produce a variety of countermeasures. New equipment and methods could help meet a surge in demand with facilities in the U.S. rather than relying on foreign manufacturing.

The review found as well that private companies often cannot attract investors to fund countermeasures where there is little or no market for these products outside of that currently needed for government stockpiles. Therefore, HHS will explore ways to help small companies attract investors to develop promising countermeasures that have multi-use rather than single-use potential.

The report identified a need to upgrade the FDA’s science and regulatory capacities. As a result, HHS will make more investments to help FDA scientists develop faster ways to analyze promising new discoveries and give innovative companies a clear regulatory pathway to bring their products to market. HHS also plans to establish new teams at the National Institutes of Health to identify promising research and facilitate its translation into vaccines, drugs, and treatments.

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