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U.S. Department of Health and Human Services

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Meeting Summary - 2004 VMAC

Microbial Food Safety Review of a Antimicrobial New Animal Drug under Guidance for Industry #152

Double Tree Hotel
Rockville , MD
October 13, 2004

Meeting Minutes Summary

The meeting was convened at 8:30 AM with a brief welcome and overview from

Dr. Sundlof. He introduced and welcomed current members of the VMAC, consultants, and future members, as well as AIDAC consultants and other experts present to provide input to the committee. Dr. Sundlof reminded the attendees that this was in fact an historic meeting of the VMAC, since this would be the first new antimicrobial drug application to be reviewed under Guidance for Industry #152.

Dr. Tollefson provided a brief background for the deliberations, and then the committee members heard from two experts, Dr. John Powers and Dr. Mike Apley on the importance of macrolides to human and animal medicine, respectively.

The committee members and consultants asked many good and pointed questions of the experts before hearing public comments. Several public commentors requested that currently approved macrolides used in food-producing animals be evaluated. The committee then deliberated on the questions presented by the Director, CVM.

The first question before the committee was:

"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?"

  • The committee members voted 14 to 2 in the affirmative;
  • The dissenting votes were qualified by these two members, stating that there is insufficient data to answer the question to their satisfaction.

The second question put to the VMAC actually had four sections:

"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?

The committee members were asked to address each portion of this question separately.

  • As to the first part concerning "other species", the committee was split - the majority opinion was to take a cautious approach, allowing the articles to be used in the proposed food animal species (cattle and swine), minor species, and companion animals, but not be used in chickens and turkeys. Some of the dissenters on this issue qualified their answer by stating that they would prefer more data.
  • The second portion of this question concerning alternative routes made for the only unanimous opinion of the meeting. Nearly every member expressed the need for more information on this topic prior to looking at alternative routes.
  • The third part of the second question pertaining to alternative indications was similarly weighted by the committee towards limiting the use of tulathromycin to therapeutic use there were some members that expressed concerns over limiting indications in light of limited data.
  • As to "other relevant issues" surrounding tulathromycin approval, at least one member of the committee mentioned the following concerns:

    • "Withdrawal times: more data is needed especially as this article has been shown to be excreted primarily through feces;"
    • On a similarly related issue, some members raised concerns over the potential environmental impact;
    • One member bemoaned the fact that in a situation such as we face with macrolide use in food animal production, there is such a low incidence of resistance that it is difficult to make an appropriate qualitative assessment;
    • We should always consider the potential benefits for and the impact that any new article may have on animal welfare.

The third and final question for the committee was: "Are the risk management recommendations appropriate, or should they be modified?"

The majority opinion of the committee was that the risk management recommendations brought before the committee were adequate. The majority stated extra-label use should not be allowed for food-producing species other than those approved in the labeling; however, there were several qualifications of this answer. Some of these qualifications were mentioned with answers to the first two questions before the committee. Some of the items mentioned by those members in the minority were:

  • Much more data, especially in the drug use information arena, are needed for further decisions;
  • Expansion of NARMS, especially for Campylobacter at the retail level and from human samples, is needed;
  • There is hesitance to place restrictions on ELDU especially for minor species and companion animals; however, some effort should be made by the FDA to ensure that ELDU in major food animal species is controlled;
  • In vivo research would be needed for better evidenced based decision.

In summary, the chair would like to thank the Center for bringing the various experts and consultants together to consider this new article within GFI #152.