New approach to federal emergencies needed

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A new HHS report, The Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs, calls for a new federal approach to producing medications, vaccines, equipment and supplies for a health emergency.

The report says the nation “must have the nimble, flexible capacity to produce medical countermeasures rapidly in the face of any attack or threat, known or unknown, including a novel, previously unrecognized, naturally occurring emerging infectious disease.” HHS secretary Kathleen Sebelius asked for the review when the department encountered challenges with the H1N1 pandemic flu vaccine.

The review covered the steps involved in the research, development and approval of medications, vaccines and medical equipment and supplies for a health emergency.

The department will make a significant investment to provide FDA scientists with the resources needed to develop faster ways to analyze new discoveries and give innovators a clear regulatory pathway to bring products to market.

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