STAT, September 14, 2018
Ike Swetlitz

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ASHINGTON — The Food and Drug Administration is talking with other federal agencies and even the private Bill and Melinda Gates Foundation about new ways to encourage drug makers to develop more antibiotics, agency Commissioner Scott Gottlieb said in a speech Friday.

The problem Gottlieb wants to address is twofold. First, as bacteria become immune to the current arsenal of antibiotic medicines, more than 20,000 Americans are dying each year from these hard-to-treat infections. Drug companies, however, have few financial incentives to develop better drugs.

But Gottlieb has a new idea: Instead of hospitals paying for each individual prescription, they could buy an antibiotic “subscription,” giving them access to a certain number of doses of a particular drug. That could guarantee more money to the manufacturer upfront, enabling the company to more quickly recoup its investment.

“These subscription fees could be priced at a level to create a sufficient return on the overall investment to develop drugs with a certain profile,” Gottlieb said. “This should have the effect of creating a natural market for drugs that meet certain important specifications.”

The pitch is the latest example yet of the FDA chief stepping outside the traditional purview of his agency. In the past, officials at the Health and Human Services Department or the Centers for Medicare and Medicaid Services would be first to propose new ways to pay for drugs or health care services [...]

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