To better tackle future biological threats and global pandemics, the Obama administration is proposing a $2 billion strategy to create a more "nimble and flexible" system able to respond quickly to new pathogens and to provide surge capacity for vaccine production. Officials at the Department of Health and Human Services (HHS), research scientists, and manufacturers have acknowledged the shortcomings of traditional flu vaccine production methods for years, and the problems were clearly evident in dealing with the H1N1 pandemic last year. Now, a new HHS report ("The Public Health Emergency Medical Countermeasures Enterprise Review," August 2010, available from http://www.hhs.gov/secretary) outlines initiatives for biopharmaceutical companies to work with federal agencies to produce vaccines and medical countermeasures (MCMs) that meet emergency health needs. The plan proposes to strengthen science at the US Food and Drug Administration, finance multi-use manufacturing operations, provide more assistance to innovative researchers, encourage investment in start-up biotech firms, and modernize influenza vaccine development and production.
SUPPORT FOR FDA SCIENCE
The FDA also will explore the use of "restricted" or "conditional" licenses for products that could be placed in the national stockpile for emergency use, but not made available on the general market until granted full FDA approval. The agency further hopes to clarify how it may collect clinical data on treatments used during emergencies to support future product approval, along with ways to make the animal efficacy rule more useful.