FDA Update

1. FDA Update William T. Flynn, D.V.M., M.S. Deputy Director for Science Policy Center for Veterinary Medicine Food and Drug Administration National Turkey Federation Turkey Health and Welfare Committee Meeting February 16, 2012

2. Topics • Judicious use of antimicrobials • Veterinary oversight • Extralabel use of cephalosporins • Unapproved drugs

3. Judicious use of antimicrobials • Draft Guidance (#209) – ‘‘The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals’’ • Published June 2010 • States overall policy direction

4. Judicious Use: Draft Guidance 209 • Focus is not on banning drugs in food-producing animals • Emphasis is on assuring drugs are used as judiciously as possible • Primary concern are “medically important” drugs • Antimicrobials must continue to be available to combat disease in animals, • including treatment, control, and prevention • Goal: preserve availability of effective drugs (for both humans and animals)

5. Judicious Use: Draft Guidance 209 • Underlying principle: drug use is a driver of resistance • “Judicious” use can help curb resistance emergence • Through more targeted drug use • By reducing unnecessary or inappropriate use • Two key principles outlined in draft guidance #209: • Limit use of medically important antimicrobial drugs to those uses considered necessary for assuring animal health (i.e., therapeutic purposes) • Increase veterinary involvement/consultation

6. Draft Guidance 209: Next steps • Intend to provide more detailed guidance on implementation of key principles • Define “medically important” • Process for updating product labels • Data requirements for adding new indications

7. Assuring that animal health needs are met • Important element of implementation strategy • take into consideration the question - When GP use is removed, are new/additional treatment, control, or prevention label indications needed – to fill a gap? • if so, seek to update product labels with new therapeutic indications in conjunction with removing GP use • actively working with animal pharmaceutical industry • your input is needed

8. Veterinary Oversight • One of two key principles described in draft guidance 209 – • Limit the use of medically important antimicrobial drugs to those uses that include veterinary oversight/consultation

9. Veterinary Oversight • Currently, most feed and water use antimicrobials are available OTC • Most approved as OTC >30 years ago • Two most “recent” feed products approved as “veterinary feed directives” (VFDs) • Tilmicosin, florfenicol • No “new” injectable antimicrobials have been approved as OTC in >25 years

10. Implementing second recommendation to “include veterinary involvement/consultation” • Practically means changing marketing status from OTC to Rx or VFD • Primary objective is to include veterinarian in decision-making process • Not meant to mandate direct veterinarian involvement in drug administration

11. Veterinary Feed Directive • Existing framework for veterinary oversight of feed use drugs is the veterinary feed directive (VFD) • FFDCA requires that medicated feeds needing veterinary oversight be designated VFDs • FDA finalized regulations regarding distribution and use of VFDs in January 2001

12. Veterinary Feed Directive • As CVM has discussed phasing in greater veterinary oversight of feed use antimicrobials… • Concerns have been raised about VFD requirements - including: • Limited experience with process • Administrative burden concerns • Veterinary workforce limitations • Increase costs to producers • Impacts on feed industry

13. Workability of VFD process • Have been seeking input on how to make process more efficient and less burdensome • issued ANPRM in March 2010 • effort ongoing to streamline process • seeking input from stakeholders – including AVMA steering committee • revising current process is critical element of overall implementation strategy

14. Updating VFD Process • Changes intended to make process more efficient/workable • Critically evaluating all current requirements • Information required on VFD form • Transmitting VFD • Recordkeeping requirements • definition of valid client patient relationship (VCPR)

15. Implementing greater veterinary involvement • Seeking to minimize negative impacts/burdens • streamlining VFD process important factor • Impacts veterinarians, producers, and feed industry • how VCPR is defined is particularly relevant • Working closely with AVMA to clarify • Enable veterinarians to provide service, consultation to producers in an effective and cost efficient way

16. VFD Process improvements – Next Steps • Hope to make draft of revised regulation available for public comment soon • All aspects of the regulation being considered • Intent is to implement revisions to existing regulation (21 CFR 558.6) as soon as possible • Critically important to establish an efficient and workable process

17. Overall Strategy – Guidance 209 • For medically important antimicrobial drugs: • phase out production uses and • phase in greater veterinary oversight • Focus of strategy is to implement changes through a voluntary approach – seeking collaboration with key stakeholders • Phased-in strategy important for assuring that animal health needs are met, veterinary practice issues are addressed, and impacts on industry are minimized • Implement changes over a number of years to provide for adequate transition period

18. Extralabel use of Cephalosporins • Originally, order of prohibition issued in July 2008 • Order withdrawn (prior to implementation) to consider comments/additional information • Concerns raised included: • Order too broad • Does not meet legal burden of proof

19. Extralabel use of Cephalosporins • Revised order issued Jan. 6, 2012 • Original 2008 order prohibited all extralabel use in all food-producing animals • revised order is more targeted in scope – prohibits certain uses • Responds to public comments by providing for a more targeted approach, which protects public health while considering animal health needs

20. Extralabel use of Cephalosporins • Revised order applies to cattle, swine, chickens, and turkeys • The order prohibits: • Use at unapproved dose levels, frequencies, durations, or routes of administration • Use of cephalosporin drugs not approved for use in that species • Use for prevention purposes • The prohibition does not affect use in minor food species

21. Extralabel use of Cephalosporins • Comment period open until March 6, 2012 • FDA to consider submitted comments • Order will go into effect on April 5, 2012 after comments are considered

22. Unapproved Animal Drugs • There are many unapproved drug products, including those that are compounded outside of what is allowed under AMDUCA • These products may have a long history of use but have not gone through the FDA drug approval process to demonstrate safety and effectiveness • Center is examining unapproved products within the framework of the Federal Food, Drug, and Cosmetic Act to determine if there are ways other than through enforcement discretion to allow veterinarians and animal owners continued access

23. Unapproved Animal Drugs • CVM solicited comments through a Federal Register Notice that asked for input on potential legal homes for these unapproved drug products. • The goal was to hear from all our stakeholders on how to address this concern without disrupting the practice of veterinary medicine. • We are currently reviewing the comments and determining the next steps.

24. Unapproved Animal Drugs • Acknowledge challenges in getting R&D directed towards products to serve needs of turkey industry • Opportunity as part of this initiative to explore alternate mechanisms for obtaining legal marketing status of drug products • Opportunities to collaborate/form coalitions

25. Thank You