How FDA will measure success of new VFD rule

How will the industry know if the new VFD guidelines have been effective?

FDA has target dates in place for finalizing its data-collection plan, as well as for determining whether efforts to promote the “judicious use” of antibiotics in food animals is having an impact on antibiotic resistance.

The agency already collects sales and distribution data but it doesn’t have detailed information about how antibiotics are actually being used in farm animals, according to Michael R. Taylor, FDA deputy commissioner, Foods and Veterinary Medicine, FDA.[1]

FDA is evaluating how to obtain detailed information about species, indications, dosages and duration of antibiotic use to better understand possible links between usage patterns and trends in antibiotic resistance, he explained.

Toward that end, FDA, USDA and the Centers for Disease Control and Prevention held a public meeting in fall of 2015 to discuss possible approaches for collecting additional on-farm antimicrobial drug use and resistance data. At the meeting, William Flynn, DVM, MS, deputy director for science policy, Center for Veterinary Medicine, FDA, outlined goals: [2]

• Early 2016: Finalize data-collection plan

• End of 2016: Drug sponsors will have implemented all changes recommended in FDA’s #213 guidance document

• January 2017: Changes recommended in #213 guidance document take effect

• 2018: Publication of the first practice-use assessment

The outcome of data collection should yield greater transparency about the use of antibiotics in food animals, Flynn said.

It should also help assess how effectively changes outlined in FDA’s Guidance for Industry #213 have been adopted, help gauge the implementation and success of stewardship efforts and guide their continued evolution and optimization. Lastly, data will enable a better understanding of antimicrobial-use practices associated with resistance, he said.

[1] Taylor MR. Veterinary Feed Directive Will Protect Both People and Animals. FDAVoice. June 2, 2015. http://blogs.fda.gov/fdavoice/index.php/2015/06/veterinary-feed-directive-will-protect-both-people-and-animals/ Accessed December 17, 2015

[2] Flynn W. Goals and Objectives for Data Collection. FDA, USDA, CVM. September 30, 2015. Washington, DC. http://www.fda.gov/downloads/AnimalVeterinary/NewsEvents/WorkshopsConferencesMeetings/UCM464318.pdf Accessed December 18, 2015