Politwoops

To slow the pace and reduce the impact of AMR on human and animal health, I believe we need an all-hands-on deck, multi-faceted initiative. That’s why last week I unveiled FDA’s 2019 Strategic Approach for Combating AMR, which builds on our previous efforts.

The FDA strategy calls for fostering product development; supporting antimicrobial stewardship; enhancing AMR surveillance and monitoring; and finally, advancing regulatory science to help facilitate product development. https://t.co/eCp4Bz9m0A

We have some tools now to facilitate human drug development for antimicrobials. Using GAIN, we can designate Qualified Infectious Disease Products. If approved, they'll get a 5-year exclusivity extension. As of August, the #FDA has approved 15 QIDPs. https://t.co/Rd3j7sK1iU

The 21st Century Cures Act created the Limited Population Pathway for Antibacterial and Antifungal Drugs or LPAD to help advance human antimicrobial development. We issued a draft guidance in June and we’re seeing meaningful early interest from innovators. https://t.co/q0ZUK0mNxY

#FDA is also working to advance the development of non-traditional antimicrobial products including bacteriophages (as shown), which destroy bacteria, microbiome-based therapies (e.g., fecal microbiota transplantation) https://t.co/OSMCTEB2S3 and vaccines. https://t.co/5B6DvwkQDl

Antibiotic stewardship in veterinary medicine promotes the judicious use of antibiotics in food animals, which includes the concept that medically-important antimicrobial drugs should only be used in animals when necessary for treatment, control or prevention of specific diseases

This approach has eliminated production use of medically-important antimicrobials and brought the therapeutic use of such drugs in animal feed and water under veterinary oversight https://t.co/azYUGncJGA. https://t.co/VtVhOwQalZ

FDA’s Center for Veterinary Medicine’s new 5-year plan builds on existing progress. It would bring the remaining 5% of medically-important antimicrobials approved for use in animals, such as certain injectable antimicrobials, under the oversight of vets. https://t.co/7pMGD4zo8m https://t.co/62zsLfjpKx

CVM will also devise a strategy to ensure that all medically-important antimicrobials used in animal feed and water are labeled with appropriate durations of use. Look for an FDA public meeting on the 5-year plan sometime this fall.

To support stewardship in human medicine, we’re working with manufacturers on new generation diagnostics that may reduce from days to hrs. the time to separate viral from bacterial infections, and rapidly ID the cause and appropriate antibiotic treatment for some infections.