1. U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

2. Purpose of Today’s VMAC Meeting Comments by Dr. Linda Tollefson, D.V.M., MPH Deputy Director Center for Veterinary Medicine October 13, 2004 Rockville, Maryland

3. Microbial Safety FDA reviewing microbial safety of all new animal drugs  originals, supplements FDA uses thorough risk assessment process described in GFI #152 Starting with hazard characterization  to determine if risk assessment is needed

4. If Risk Assessment Needed Release assessment  probability that use results in emergence, selection of resistant bacteria Exposure assessment  likelihood of human exposure Consequent assessment  to address human health consequences

5. Risk Estimation Three assessments integrated into overall risk estimation  low, medium, high FDA develops corresponding risk management strategies, including VMAC review

6. Importance of VMAC Advisory Committee review microbial safety part of GFI #152  “When making an approval decision regarding a Category 1 or select Category 2 drugs, FDA may choose to convene an advisory committee to discuss the application” We used public forum for openness and transparency

7. Goals of Today’s Meeting Present information on importance of macrolides to human, animal medicine Present information on tulathromycin in cattle, swine  microbial food safety Hear public comments on proposed use Gain VMAC’s insight

8. Questions for VMAC CVM will ask VMAC series of questions to determine acceptance of CVM assessment 1.Do the findings presented in the sponsor’s (qualitative risk) assessment demonstrate that tulathromycin is safe with respect to the potential for transfer of antimicrobial resistant organisms to humans?

9. Questions for VMAC 2.Are there other issues to consider relative to this class of antimicrobial agents (macrolides/triamilides)?  other species for which it should/should not be approved?  routes of administration that are/are not acceptable?  indications that are/are not appropriate?  other relevant issues?

10. Questions for VMAC 3.Are the risk management recommendations appropriate, or should they be modified?

11. Today’s Presentations John Powers, M.D., FACP, CDER  importance of macrolides in human medicine Mike Apley, D.V.M., Ph.D., Iowa State University  importance of macrolides in animal health Scott Brown, D.V.M., Ph.D., Pfizer Animal Health  product presentation