FDA Funds Duration of Use Studies
The U.S. Food and Drug Administration has awarded two $250,000 grants to fund research projects in fiscal year (FY) 2019 aimed to help target and define durations of use for certain medically important antimicrobial drugs approved for use in the feed of food-producing animals. Defining targeted durations of use is one component of the FDA’s five-year plan, "Supporting Antimicrobial Stewardship in Veterinary Settings," published last September that outlines key goals and objectives for FY 2019 - FY 2023. This plan applies a risk-based approach to antimicrobial resistance and supports the FDA's ongoing efforts to slow the development of antimicrobial resistance by fostering the judicious use of medically important antimicrobial drugs in animals.
These research projects will generate publicly available data, which can be used by sponsors of affected approved animal drug applications to update product dosage regimens and better target when and for how long a drug may be used.
The first project is from a researcher from Kansas State University and sets out to define targeted durations of use for tylosin phosphate to prevent liver abscess formation in feedlot cattle.
The second project, from another researcher from Kansas State University, plans to evaluate the timing and duration of use for chlortetracycline treatment of bovine anaplasmosis in adult cattle.
Depending on available funding and satisfactory progress by the awardees, FDA may grant an additional year of support of up to $250,000 each for the researchers to continue their studies in FY 2020.
In addition, FDA continues to explore options for expanding the availability of relevant data to address this issue, including the possibility of providing another funding opportunity for research proposals.
For more on FDA’s antibiotic stewardship programs, see these articles from BovineVetOnline:
FDA Releases Draft GFI to End OTC Sales of Most Animal Antibiotics
FDA Extends Comment Period on Withdrawal Times
