News Release
Review calls for new federal approach to medical
countermeasures
HHS Secretary
releases review and recommendations driven by pandemic flu experience U.S. Department of
Health and Human Services Secretary Kathleen Sebeliu=
s
today released an examination of the federal government’s system to
produce medications, vaccines, equipment and supplies needed for a health
emergency, known as medical countermeasures. The Public Health Emergen=
cy
Medical Countermeasure Enterprise Review: Transforming the Enterprise to =
Meet
Long Range National Needs reviews the process and makes recommendatio=
ns
for a better approach. “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,” Secretary Secretary Sebelius requested the comprehensive review when the
department encountered challenges with the 2009 H1N1 pandemic flu vaccine,
highlighting the need for a modernized countermeasure production process.=
The
review covered the steps involved in the research, development, and FDA
approval of medications, vaccines, and medical equipment and supplies for=
a
health emergency. The review identif=
ied a
need to upgrade science and regulatory capacity at the FDA. As a result, =
HHS
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 mar=
ket. The review also fo=
und
that The review found t=
hat
some of the most promising research and development on countermeasures The review made cl=
ear
that the federal government must do a better job nurturing discoveries in
their earliest stages to push them to greater maturity. Therefore, HHS wi=
ll
be creating new teams at the National Institutes of Health to identify
promising research and facilitate its translation&nbs=
p;
into vaccines, drugs, and treatments that keep Americans safe. The review placed a
special focus on the federal government’s flu response, identifying=
a
need to upgrade flu vaccine manufacturing – from modernizing ways t=
o test
a vaccine’s strength, known as potency, to new methods to show that=
the
vaccine is safe, as well as ways to produce the early “seed
virus” for vaccines faster. Taken together, this will shave weeks of
time off vaccine manufacturing. HHS will make investments in these areas =
as a
result of the review. The review also fo=
und
that private companies have difficulty attracting investors in
countermeasures where there is little or no market for these products out=
side
of that currently needed for government stockpiles. As a result of this
finding, HHS will explore ways to help small companies attract investors =
to
develop promising countermeasures that have multi-use potential. The HHS Assistant
Secretary for Preparedness and Response led the review. All federal agenc=
ies
working with medical countermeasures participated, including the Departme=
nt
of Homeland Security, Department of Defense, and HHS divisions of ASPR an=
d ASPR’s Biomedical Advanced Research and Devel=
opment
Authority, the National Institutes of Health, the Centers for Disease Con=
trol
and Prevention, and the Food and Drug Administration. The review also
incorporated input from state and local health departments, two federal
advisory committees of outside experts, industry groups, venture capital
experts, and the Read the review an=
d its
recommendations at www.hhs.gov/=
secretary/. |