1. Fostering Antimicrobial Stewardship in Animals: Overview of FDA Activities William Flynn, DVM, MS Deputy Director for Science Policy Center for Veterinary Medicine U.S. Food and Drug Administration April 13, 2016 1

2. Key areas of focus include: Implementing changes under FDA’s Guidance 213 Enhancing collection of data on antibiotic use and resistance Additional measures to reinforce antibiotic stewardship 2

3. National Action Plan for Combating Antibiotic- Resistance Bacteria Announced by White House in March 2015 Key objectives related to antibiotic use in animals include:  Objective 1.2 - eliminate the use of medically important antibiotics for growth promotion in animals and bring other in- feed uses of antibiotics, for treatment and disease control and prevention of disease, under veterinary oversight  Objective 1.3 - Identify and implement measures to foster stewardship of antibiotics in animals.  Objective 2.4 - enhance monitoring of antibiotic-resistance patterns, as well as antibiotic sales, usage, and management practices, at multiple points in the production chain from food-animals on-farm, through processing, and retail meat 3

4. Key documents: 4

5. Guidance #209: Outlined AMR policy Describes overall policy direction Describes overall policy direction Finalized April 2012 Finalized April 2012 5

6. FDA’s Judicious Use Strategy Two key principles outlined in Guidance #209: Limit use of medically important antimicrobial drugs in food-producing animal to those uses 1.Considered necessary for assuring animal health (therapeutic uses.) 2.That include veterinary oversight or consultation 6

7. Guidance #213: Implementation Finalized December 2013 Finalized December 2013 More detailed guidance on implementing key principles in Guidance #209 More detailed guidance on implementing key principles in Guidance #209  Established 3 year timeline  Defines “medically important” (i.e., what products affected) (i.e., what products affected) 7

8. Guidance #213: Overview December 2016 - Target for drug sponsors to implement changes to use conditions of medically important antibiotics in food and water to: December 2016 - Target for drug sponsors to implement changes to use conditions of medically important antibiotics in food and water to:  Withdraw approved production uses such as for “increased rate of weight gain” or “improved feed efficiency” Therapeutic uses to be retained Therapeutic uses to be retained  Transition products to veterinary oversight Note: After these changes are made, production use or use without veterinary oversight will no longer be legal 8

9. Guidance #213: Veterinary Oversight Key principle is to include veterinarian in decision-making process Key principle is to include veterinarian in decision-making process  Does not require direct veterinarian involvement in drug administration  Does require use be authorized by a licensed veterinarian in the context of a valid veterinary-client-patient relationship (VCPR) This means changing how products are marketed – products will no longer be available as over-the-counter (OTC) This means changing how products are marketed – products will no longer be available as over-the-counter (OTC)  Water soluble products - change to prescription (Rx)  Products used in or on feed – change to veterinary feed directive (VFD) 9

10. Veterinary Feed Directive (VFD) Regulation Requirements relating to distribution and use of VFD drugs (feed-use drugs that require supervision of licensed veterinarian) Requirements relating to distribution and use of VFD drugs (feed-use drugs that require supervision of licensed veterinarian) Regulations amended to improve efficiency of the process Regulations amended to improve efficiency of the process Updated regulations went into effect October 2015 Updated regulations went into effect October 2015 Critical step for facilitating transition to veterinary oversight Critical step for facilitating transition to veterinary oversight 10

11. Enhancing data collection on use and resistance Having sufficient data on use and resistance is critical so that meaningful metrics are in place to assess impact of measures being implemented Important for assessing impact of changes under FDA Guidance 213 Important for assessing impact of changes under FDA Guidance 213 It is also important for helping to gauge success of stewardship efforts more broadly It is also important for helping to gauge success of stewardship efforts more broadly 11

12. Enhancing data collection on use and resistance Enhancements of existing data sources: National Antimicrobial Resistance Monitoring System (NARMS) National Antimicrobial Resistance Monitoring System (NARMS)  Increasing number of samples processed by existing sites  Increasing number of sites participating in program  This effort is ongoing now Antimicrobial sales and distribution data Antimicrobial sales and distribution data  FDA recently enhanced the level of detail provided in its annual summary reports  Enhanced report format used for 2012 reporting year  Summary report for 2014 published December 2015  FDA expects to publish a final regulation this spring to enhance sales data collection for food-producing animals 12

13. Enhancing data collection on use and resistance Plans for collecting additional data Plans for collecting additional data  Additional data is needed to provide a more comprehensive understanding about use and resistance Focusing on gathering on-farm data Focusing on gathering on-farm data  FDA is collaborating with USDA and CDC to develop effective and practical approaches for collecting such data – including leveraging existing systems  Held a public meeting in Sept. 2015 to seek public input  Lack of sufficient funding has been a challenge 13

14. Reinforcing Stewardship Training/outreach to support new VFD rule Training/outreach to support new VFD rule  Veterinarians, producers, feed distributors, FDA/state compliance officers Promote judicious use principles Promote judicious use principles  Veterinary and producer organizations, academia, others, have a role Additional measures needed Additional measures needed  Particular focus on ensuring that remaining therapeutic use (including prevention use) is appropriate/judicious  Other (e.g., companion animals) 14

15. Additional Information See CVM’s Judicious Use Webpage: See CVM’s Judicious Use Webpage: http://www.fda.gov/AnimalVeterinary/SafetyHealth/Antimic robialResistance/JudiciousUseofAntimicrobials/default.htm http://www.fda.gov/AnimalVeterinary/SafetyHealth/Antimic robialResistance/JudiciousUseofAntimicrobials/default.htm 15

16. Thank You 16