Kathleen Sebelius announced the publication of The Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs - a review of the processes required and recommendations for a better approach.
Secretary Sebelius 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.
The challenges posed by the emergence of the 2009 H1N1 pandemic flu (swine flu) and the urgent need to have a vaccine on the market as quickly as possible, triggered Secretary Sebelius' request for the comprehensive review. Having a modernized countermeasure production process is crucial, Sebelius said.
The review looked at research and development, FDA approved drugs and vaccines, medical devices and diagnostic equipment, and supplies for a health emergency. It determined that the FDA's (Food and Drug Administration's) science and regulatory capacity needs to be upgraded.
Consequently, HHS will invest 2 billion US dollars to provide FDA scientists with funds to develop faster was to analyze potentially promising new discoveries and breakthroughs, and give researchers an effective regulatory pathway to get their products onto the market.
There is an urgent need for better and faster manufacturing processes for multiple medication or vaccine requirements, the review determined. Processes that can be used to produce only one type of countermeasure, when more are needed simultaneously, are not effective when facing a threat.
Consequently, as a result of these findings, HHS is soon expected to release a draft solicitation for one or more Centers of Innovation for Advanced Development and Manufacturing. The center(s) will concentrate on new manufacturing platforms that can produce a range of countermeasures. The equipment and methods could provide a way to meet a sudden increase in demand using domestic facilities rather than foreign ones.
Small, emerging biotech companies with limited experience in large-scale manufacturing were identified by the review as having some of the most promising R&D (research and development) on countermeasures. Hence, the Centers of Innovation for Advanced Development and Manufacturing will also serve as resources for these young companies, helping them bring products to market and assisting the U.S. government raise the number of new countermeasures available in an emergency.
New discoveries and breakthroughs need to be nurtured at their earliest stages so that they can be pushed to maturity more quickly, the review stated - something the federal government needs to improve. Therefore, HHS will create new teams at the National Institutes of Health (NIH) to identify promising research and facilitate its translation into vaccines, drugs, and treatments that keep American citizens safe.
Flu vaccine manufacturing is in urgent need of an upgrade, the review stressed. This may include modernizing ways to test a new vaccine's strength (potency) and safety. Ways need to be found to produce early seed virus for vaccines more efficiently. The overall result would be getting an urgently needed vaccine onto the market several weeks earlier. HHS said it will make investments in these areas.
Getting financial backing for countermeasure products, for which there is not market except for government stockpiles, is challenging, especially for private companies. HHS said it is going to explore ways to help private (small) companies attract funding to develop promising countermeasures that have multi-use potential.
"Public Health Emergency Medical Countermeasures Enterprise Review"