Congress urged to pass bill to speed development of antibiotics
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[September 20, 2014]
By Toni Clarke
WASHINGTON (Reuters) - Financial
incentives and a more flexible regulatory approach are needed to
persuade drug companies to develop new antibiotics, drug industry and
public health experts told U.S. lawmakers on Friday, though some warned
that modifying the drug approval process could jeopardize patient
The experts said at a hearing of the U.S. House of Representatives
Energy and Commerce health subcommittee that the business model for
developing antibiotics is broken: Drug companies make money by
selling as many drugs as possible but public health requires less
use of antibiotics to curb drug resistance.
At least 23,000 die from them each year, according to the Centers
for Disease Control and Prevention. Yet most drug companies no
longer develop antibiotics since they do not generate enough return
Experts offered various suggestions for sweetening the pot,
including tax credits, shortening the clinical trial process and
extending patent protection.
Some measures have already been taken. In 2012 Congress passed
legislation to improve antibiotic innovation by promising companies
a speedy review of some new products and an additional five years of
Since then additional bills have been introduced, including the
Antibiotic Development to Advance Patient Treatment Act, or ADAPT,
which would allow the Food and Drug Administration to approve
antibiotics based on much more limited data than it typically
"By allowing drug developers to rely on smaller datasets, and
clarifying FDA's authority to tolerate a higher level of uncertainty
for these drugs when making a risk/benefit calculation, ADAPT would
make the clinical trials more feasible," Allan Coukell, director of
drugs and medical devices at The Pew Charitable Trusts, testified.
Dr. Janet Woodcock, head of the FDA's pharmaceutical division, told
the panel that there is an urgent need to develop effective new
antibiotics. Still, she said, "there are trade-offs for putting
these incentives in place."
If a drug were approved in this way, she said, a clear signal would
have to be sent to the medical community that the drugs were special
and only meant for limited use.
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The meeting followed the Obama administration's announcement on
Thursday that it would establish a task force on the threat of
Some experts testified that the ADAPT bill could hurt patient
Dr. John Powers, an associate professor of medicine at George
Washington University School of Medicine and former lead medical
officer for antimicrobial development and resistance issues at the
FDA, said data should not be limited to that gained from test tubes,
animals or mathematical models.
"Focusing studies on well-defined patients with disease due to
resistant pathogens will allow for smaller studies," he said.
Powers also recommended that incentives be provided only to those
drugs for which a diagnostic test is also developed.
"The lack of diagnostics that not only select patients with a
specific disease but also select patients who will benefit from
specific new therapies is long overdue," Powers said.
(Editing by Grant McCool)
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