The FDA’s plan centers on four main goals: facilitate product development for safe and effective treatments, promote antibiotic stewardship, support antimicrobial-resistance surveillance and advance regulatory science.
As part of this plan, Dr. Gottlieb proposed reimbursement reforms that could include milestone payments or subscription fees for drugmakers who create FDA-approved products targeted at multidrug-resistant organisms and associated with proven clinical outcomes.
“A subscription-based model could see hospitals paying a flat rate for access to a certain number of doses of an important new antimicrobial,” Dr. Gottlieb said. “These subscription fees could be priced at a level to create a sufficient return on the investment to develop drugs with a certain profile.”
The agency is discussing potential approaches to these proposals with CMS and other agencies. The FDA also introduced a new web page that tracks its work on antimicrobial resistance.
“We can’t count on outracing drug resistance. But we can use stewardship and science to slow its pace and reduce its impact on human and animal health,” Dr. Gottlieb said.
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