Secretary Sebelius requested the review because of challenges HHS encountered with the 2009 H1N1 pandemic influenza vaccine.

HHS Wants Faster Approval of Medical Countermeasures

Following a review undertaken because of challenges presented by the H1N1 flu vaccine, the department wants a better pipeline to move vaccines, medical equipment, and supplies for medical emergencies.

U.S. Health and Human Services Secretary Kathleen Sebelius issued a review Thursday of the government's current pipeline for producing medications, vaccines, medical equipment, and supplies for health emergencies. These are known as medical countermeasures, and the review ("Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs") makes recommendations to streamline the process.

"Our nation must have a system that is nimble and flexible enough to produce medical countermeasures quickly in the face of any attack or threat, whether it's a threat we know about today or a new one," she said. "By moving towards a 21st Century countermeasures enterprise with a strong base of discovery, a clear regulatory pathway, and agile manufacturing, we will be able to respond faster and more effectively to public health threats."

Sebelius requested the review because of challenges HHS encountered with the 2009 H1N1 pandemic influenza vaccine. The review examined R&D and FDA approval of the various countermeasures, finding FDA needs increased scientific and regulatory capacity. HHS announced it will "make a significant investment to provide FDA scientists with the resources to develop faster ways to analyze promising new discoveries and give innovators a clear regulatory pathway to bring their products to market."

Because the review recommends a manufacturing process to produce multiple medications or vaccines rather than only one type, HHS soon will issue a draft solicitation for one or more Centers of Innovation for Advanced Development and Manufacturing to focus on new countermeasures manufacturing platforms in the United States and to assist startup companies.

Federal agencies participating in the review were DHS, the Department of Defense, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Food and Drug Administration.
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