U.S. Congress urged to pass bill to speed development of antibiotics

[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 safety.

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 on investment.

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 market exclusivity.

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 requires.

"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.

The meeting followed the Obama administration's announcement on Thursday that it would establish a task force on the threat of antibiotic resistance.

Some experts testified that the ADAPT bill could hurt patient safety.

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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