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