FDA calls for new antimicrobials

FDA commissioner Scott Gottlieb recently unveiled a 2019 Strategic Approach for Combatting AMR (antimicrobial resistance) at a meeting organized by Pew.

Pharmaceutical Executive reports how the plan includes policies and programs to encourage development of new drugs, diagnostic tests and vaccines; to promote responsible stewardship of antimicrobials in animals and humans; to improve surveillance of antimicrobial use and resistance; and to advance research for developing new tools, standards and policies in this area.

Gottlieb outlined proposals for devising innovative milestone payments and subscription fees for developers of products targeted at multi-drug resistant organisms. To maintain a robust pipeline for antibiotics, Gottlieb recognized the need to “change the perception that the costs and risks of antibiotic innovation are too high relative to their expected gains.” One proposal is a subscription-based model that charges hospitals a flat rate or licensing fee for access to a certain number of doses each year of a new antimicrobial. By creating a predictable revenue stream, this kind of “pull incentive,” Gottlieb explained, would “create natural markets for drugs targeted to rare but dangerous, multi-drug resistant pathogens that can threaten human health.”

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology