Financial Incentives for Accelerated Development of Antibiotics

Congress is being pressured to pass a bill that allows for financial incentives and a more flexible regulatory approach for drug companies in order to develop new antibiotics, according to drug industry and public health experts. However, some warned that modifying the drug approval process could jeopardize patient safety.

The experts said at a hearing of the 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 people 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 encouraging antibiotic development, 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 5 years of market exclusivity.

Since then, additional bills have been introduced, including the Antibiotic Development to Advance Patient Treatment Act, which would allow the FDA to approve antibiotics based on much more limited data than is typically required for drug approvals.

The meeting followed the President Obama’s administration’s announcement last week that it would establish a task force on the threat of antibiotic resistance.—Kerri Fitzgerald

Source: Thomson Reuters. 2014; U.S. Congress urged to pass bill to speed development of antibiotics.