FDA focuses on antibiotics
September 25, 2012
THE US Food and Drug Administration has announced the
formation of an “internal task
force” to support the development
of new antibacterial drugs.
The move is part of the
Generating Antibiotic Incentives
Now (GAIN) initiative under the
new Food and Drug Administration
Safety and Innovation Act.
The FDA said research and
development for new antibacterial
drugs had been in decline in recent
decades, with the number of new
FDA-approved antibiotics falling
steadily since the 1980s.
“During this time the persistent
and sometimes indiscriminate use
of existing antibacterial drugs
worldwide has resulted in a
decrease in the effectiveness of
these drugs,” the FDA said.
Antibiotic resistance has become
a “serious issue of global concern,”
with more than 70% of the bacteria
which cause hospital-associated
infections being resistant to at least
one type of antibacterial drug.
The task force is a multidisciplinary
group of 19 scientists and clinicians
who will link with other experts in
the field including from industry,
academia, patient advocacy groups,
professional societies and
government agencies.
It has been asked to explore novel
scientific approaches to facilitate
antibacterial drug development,
such as the broader use of clinical
pharmacology data, statistical
methods, innovative clinical trial
designs, use of additional available
data sources and the “advancement
of alternative measures to evaluate
clinical effectiveness of potential
new therapies”.
The group will also identify issues
relating to unmet medical needs for
antibacterial drugs, and why there
is a lack of a robust pipeline for
antibacterial drug development.
See www.fda.gov.
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