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
All these approaches aim to spur development of a broad array of medical countermeasures, including antivirals, antibiotics,
diagnostics, and vaccines. The current MCM pipeline is full of "leaks, choke points, and dead ends," explained HHS Secretary
Kathleen Sebelius at an August press briefing. Countermeasure development has been "slower and more costly than anticipated,"
under the HHS Project BioShield program, the report notes, and the new HHS plan urges greater investment in infrastructure
that can rapidly produce effective MCMs when needed.
A key part of the plan is to streamline the regulatory framework for vaccine and MCM development and oversight by bolstering
regulatory science at FDA. HHS proposes to give the FDA $170 million to expand its scientific workforce and infrastructure
and to develop additional tools for assessing vaccine and countermeasure safety, efficacy, and quality. The added resources
will enable agency staffers to prepare more guidance describing MCM development pathways and to pre-qualify mobile or convertible
manufacturing facilities. Cross-FDA action teams will work with sponsors to identify and resolve scientific issues as early
as possible and to rapidly evaluate high-priority MCM products and platforms. A larger research budget will fund studies to
identify and qualify animal models and surrogate measures of product efficacy, and to improve potency, safety, and stability
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.