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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Holds Second Open Forum for Its Stakeholders

by David L. Lynch
FDA Veterinarian Newsletter July/August 1999 Volume XIV, No IV

CVM held its second open forum for stakeholders on April 28, 1999, as a part of an FDA-wide initiative to solicit feedback from our stakeholders. The Center's meeting took place at the Johnson County Community College in Overland Park, Kansas, while other FDA Center meetings occurred at other locations across the country. The host of the meeting was the FDA Kansas City District Office Director, Mike Rogers, who made everyone, stakeholders and Headquarters CVMers alike, feel welcome. Other Kansas City District Office employees, particularly Tywanna Paul, provided a great deal of assistance to the Center in the planning and logistics of the meeting.

The meeting opened with a welcome by Dr. Linda Tollefson, Director of CVM's Office of Surveillance and Compliance, who also presented to the stakeholder group a summary of what the Center heard at the previous Open Forum, held on September 19, 1998. Dr. Tollefson described the initiatives that the Center had developed to implement the ideas and suggestions that were made at that earlier meeting. She also provided an update on the status of each of those initiatives.

Following that was a satellite broadcast of FDA Commissioner, Dr. Jane Henney and Senior Associate Commissioner, Dr. Linda Suydam, giving their priorities and views on various FDA initiatives. They then took questions from across the country from stakeholders, by phone and telefax, as well as answering questions submitted by the live audience or that had been previously submitted to the stakeholder docket. To help with questions that were too specific for Drs. Henney and Suydam to answer, a panel of representatives from each of the FDA Centers was assembled and standing-by.

After the satellite broadcast, Dr. Stephen Sundlof, Director of the Center for Veterinary Medicine, set the stage for the local CVM meeting by giving an update of the Center's budget situation for Fiscal Year 1999 and what is expected for Fiscal Year 2000. The rest of the afternoon was spent with the two stakeholder panels providing information to the CVM panel. The stakeholder panels were composed of representatives of the industry, producer groups, academia, consumers, and consumer groups. The CVM panel was composed of representatives from each of the CVM offices and Dr. Sundlof. The CVM panel's job was to listen to what the stakeholder panels said and to ask clarifying questions.

Several of the stakeholder panelists reiterated their support (from the September meeting) for CVM maintaining a strong science base, and encouraged the Center to base its regulatory decisions more on scientific data and less on other sources. The hottest topic at the meeting was antimicrobial use in food animals, and discussion of the Center's Framework Document concerning the same topic. Several of the panelists voiced their concerns about the provisions of the Framework Document and encouraged the Center to move forward quickly with its scientific risk assessment of antimicrobial use in food animals. They also supported continued development of the judicious use guidelines for antimicrobials and encouraged the Center to enhance and expand the National Antimicrobial Resistance Monitoring System (NARMS).

Other ideas and suggestions offered by the stakeholder panelists were:

  • a reiteration of their encouragement for the Center to more strongly enforce current regulations and to remove unapproved animal products from the market, to include more veterinarians and food-animal producers in the Center's decision-making process on antimicrobials and other CVM issues,
  • to continue and expand the use of compassionate INADs,
  • to move forward with and finalize the regulations on Veterinary Feed Directives (VFDs), feed mill licensing and minor use/minor species,
  • to develop a veterinary drug database on the CVM Home Page on the World Wide Web (WWW), and
  • a plea for better communications between CVM and consumers and veterinary practitioners, particularly concerning the benefits versus the risk of using veterinary drugs.

Currently the Center is analyzing the transcript of the meeting to develop the list of ideas and recommendations provided by the stakeholder panelists, and to develop initiatives to implement them. Keep in mind however, that not every idea or recommendation can be implemented, for example, some are contrary to current law and some would require more resources than the Center can afford to put into them at this time.

The Center considers this meeting highly successful, just as it did the September 1998 meeting, and for the same reasons. CVM received strong support for most initiatives and sound advice and ideas for ways to improve those that were not supported. The Center thanks the Kansas City District Office for their excellent job as hosts, and all of the stakeholders who participated, particularly the panelists who presented their ideas and recommendations.

VMAC SUMMARY

The January 25-26, 1999, meeting of the Veterinary Medicine Advisory Committee (VMAC) was held to assess the proposed FDA Center for Veterinary Medicine (CVM) Framework Document as it would impact human health through the veterinary drug approval process. The following summarizes the Committee responses to questions posed by the FDA.

Question 1: Framework Concept

FDA's goal is to protect the public health by ensuring that the efficacy of human antimicrobial therapies is not compromised due to use of antimicrobials in food animals while providing for the safe use of antimicrobials in food animals. Do the concepts laid out in the document entitled "A Proposed Framework for Evaluating and Assuring the Human Safety of Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals" provide a sound scientific basis for achieving this goal if implemented?

Committee Recommendations

The Committee understands that the framework document is to help FDA respond, in its regulatory role, to a legal dilemma in the approval of drugs for the animal drug industry. The Committee also understands that the Agency proposes the framework for consistency in the drug approval process.

The Committee concludes that the proposed framework to protect public health by ensuring that the efficacy of human antimicrobial therapies is not compromised due to the use of antimicrobials in food animals, while providing for the safe use of antimicrobials in food animals, provides a basis for achieving this goal. A sound scientific basis for the framework must be put together, utilizing a diverse group of experts working in microbiology from government, industry and academia. This should be done quickly.

The Committee recommends that CVM state publicly how it will handle current and future applications until this process is completed.

Question 2: Categorization of Antimicrobial Drugs Based on Their Importance to Human Medicine

The Agency is proposing that the categorization of antimicrobial drugs for human medicine take into account the usefulness of drugs in both foodborne disease and non-foodborne infectious diseases, when evidence exists that the use of the drug may result in the induction of resistant pathogens or the transfer of resistant elements to human pathogens. This approach recognizes not only the well known risk of resistance transfer through classical foodborne pathogens but also the threat of transfer of resistant bacteria or resistance genes from other intestinal bacteria of food-producing animals resulting in resistant infections of humans with other types of pathogens (e.g., resistant E. coli or Enterococcus). Does the Committee agree with this approach?

Committee Recommendations

The Committee concludes that categorization of antimicrobial drugs for food animals considering the importance of antimicrobial drugs for human medicine is a workable concept. Antimicrobial resistant microbes and the ability of transfer of resistance genes from other bacteria of food animals must be considered. The Committee heard several comments from many members requesting that CVM attempt to simplify the categorization. The Committee also voted to have the Agency consider adding a fourth category.

The Committee recommends that the following sentence from the third paragraph, page 14 of the Framework Document be deleted: "Given our current understanding of the mechanisms of resistance, FDA believes that, generally, it would not appear biologically plausible for resistance to be transferred from animal enteric pathogens to the human respiratory pathogen."

Question 3: Monitoring Threshold Levels

A) Should multiple monitoring threshold levels be established and should they be based on animal data, human data or both? Should the levels be tied to specific actions -- e.g., need for further investigation, need for mitigation strategies, need for withdrawal of product from the market?

B) What organism(s) should be the basis for the monitoring thresholds? In the interest of cost containment, would sentinel organism(s) be designated or should a foodborne pathogen(s) be used?

Committee Recommendations

A) Monitoring threshold levels of antimicrobial resistance is the important tool for the proposed framework, and assures the human safety of the microbial effects of new animal drugs. We encourage the use of human, food-producing and pet animal, and other environmental data such as slaughterhouse samples, for making these decisions. The levels should be tied to specific actions.

B) Some members felt that a broad range of gram negative and gram positive organisms should be used for monitoring antimicrobial resistance and others felt that we do not have enough data to make statements about what organisms should be the basis for monitoring thresholds. The Committee agreed that the sole use of sentinel organisms would be inappropriate. Antimicrobial resistance data should be monitored through the National Antimicrobial Resistance Monitoring System (NARMS), animal health diagnostic laboratory data, FSIS HACCP program within plants, the quality assurance programs that various associations are implementing, and an independent central laboratory for on-farm data using sentinel farms. These activities should be supported by government and industry.

Question 4: Resistance Threshold Levels

The Agency has proposed the creation of different levels of resistance transfer to humans that would be acceptable based on the importance of the drug or drug class in human medicine. Category I antimicrobial drugs would require that the use in food-producing animals results in little or no resistance transfer to humans. Category II antimicrobial drugs would require that a predefined level of maximum resistance transfer be established prior to approval that would depend on several factors, such as the existence of alternatives to the drug, the human pathogens of concern, etc. The level of resistance transfer must be low enough that there is a reasonable certainty of no harm to humans associated with the use of the product in food animals. What criteria should the Agency use to safely define the acceptable level of resistance transfer, if any, for antimicrobial drugs that fall into categories I and II?

Committee Recommendations

The Committee agrees that resistance levels for Category I antimicrobial drugs would require that use in food animals result in little or no resistance transfer to pathogens of human importance. If resistance transfer is detected, FDA and an expert group would review the data and discuss mitigation for the future use of the drug in food animals.

Question 5: On-Farm Post-Approval Monitoring Programs

On-farm post-approval monitoring programs will be necessary for certain antimicrobials (Category I, Category II High, and some Category II Medium products). Should on-farm monitoring be instituted immediately post-approval, or triggered by a change in the data generated from other sources such as NARMS?

Committee Recommendations

Slaughterhouse antimicrobial resistance data is of paramount importance to the framework document for making post-approval monitoring decisions. On-farm antimicrobial resistance monitoring utilizing on-farm health quality assurance programs is encouraged by the Committee for post-approval antimicrobial resistance levels of high category antibiotics. Diagnostic laboratory data and an accredited central laboratory should be developed utilizing government and industry money.