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FDA Unveils Proposed Hospital Subscription Plan for Antibiotic Use


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FDA Commissioner Scott Gottlieb, MD, said on Friday that the FDA’s plan has four areas of focus: Facilitating product development to ensure robust pipeline of safe and effective treatments to fight antibiotic-resistant organisms; promoting antimicrobial stewardship; supporting the development of surveillance tools to monitor antimicrobial use and determine when pathogens develop resistance; and advancing scientific initiatives to help all stakeholders answer critical questions related to antimicrobial resistance.

Gottlieb said the human cost of antimicrobial resistance is immense, including death and disability from sepsis; extended and expensive hospital stays; and the need for dialysis or organ transplant for those who acquire systemic infections. In addition, the CDC estimates that antimicrobial resistance costs the U.S. economy $20 billion annually, with an additional $35 billion in costs coming from the lost productivity related to infection.

The subscription plan “could see hospitals paying a flat rate for access to a certain number of doses of an important new antimicrobial,” he 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. This should have the effect of creating a natural market for drugs that meet certain important specifications.”

The FDA, which also rolled out a new antimicrobial resistance information page, is in talks with CMS and other agencies to develop this and other approaches to reduce antimicrobial resistance.