SuperbugsNew FDA plan focuses on antibiotic development, stewardship

The US Food and Drug Administration (FDA) last week announced a multipronged strategy to address antimicrobial resistance (AMR) that emphasizes new measures to spur development of antibiotics and alternative therapies, promote antibiotic stewardship in animal health, advance antibiotic resistance surveillance, and enhance regulatory science.

“We can’t count on outracing drug resistance,” FDA Commissioner Scott Gottlieb, MD, said in announcing the strategy. “But we can use stewardship and science to slow its pace and reduce its impact on human and animal health.”

Noting the agency’s role in overseeing and regulating drug development, safety, and use, Gottlieb said the strategy aims to combat AMR by addressing the “full continuum” of antibiotic development and use in both humans and animals.

“Because of the FDA’s statutory responsibility for assuring safe and effective products that promote and protect both human and animal health, we have a unique vantage point for coordinating all of these aspects of a product’s development and application to health,” Gottlieb said.

The strategy was developed by members of the FDA’s Center for Veterinary Medicine, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, and National Center for Toxicological Research.

Changing the antibiotic reimbursement model
CIDRAP reports that leading the new strategy is a focus on ways the agency can facilitate development of new antibiotics.

Speaking to an audience at the Pew Charitable Trusts in Washington, DC, Gottlieb praised efforts to stimulate antibiotic research and development, highlighting the Generating New Antibiotics Now (GAIN) Act and the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) program. But he said these “push” incentives, designed to get product research and development off the ground, are not enough to stem the tide of pharmaceutical companies that are dropping antibiotic-development programs.

“I think much more emphasis needs to be placed on developing ‘pull’ incentives,” Gottlieb said. “I’m deeply concerned that without stronger ‘pull’ incentives that encourage more research and development, we’ll see a far less robust pipeline of products than we need to address antimicrobial resistance.”