NECC1702: Establishment of a Formal Structure for the Minor Use Animal Drug Program

(Multistate Research Coordinating Committee and Information Exchange Group)

Status: Active

NECC1702: Establishment of a Formal Structure for the Minor Use Animal Drug Program

Duration: 10/01/2017 to 09/30/2022

Administrative Advisor(s):


NIFA Reps:


Statement of Issues and Justification

Globalization of food markets has allowed countries with less stringent animal drug approval requirements to dominate U.S. sheep, goat, farmed shrimp and fish, venison, honey and game bird production industries. At the same time, the growing concern in the U.S. over antibiotic resistance in human health and the use of antibiotics in food producing animals threatens to eliminate or severely curtail antimicrobial use in veterinary medicine. In April of 2013, the Center for Disease Control and Prevention (CDC) released their report entitled, “Antibiotic Resistance Threats in the United States 2013”. With respect to the issue of antibiotic use in food animals, the CDC report concluded “Because of the link between antibiotic use in food-producing animals and the occurrence of antibiotic-resistant infections in humans, antibiotics should be used in food-producing animals only under veterinary oversight and only to manage and treat infectious diseases, not to promote growth.” Since the release of this report, efforts have grown to sharply eliminate any use of antibiotics in animals without veterinary oversight. There appears little doubt that the next several years will introduce a new era of antimicrobial use in veterinary medicine. The Minor Use Animal Drug Program is the only national program designed and organized to address the issues of the prudent use of antibiotics, anthelmintics and production drugs in minor species of food- and fiber-producing animals, and for minor uses in major animal species.


 


The following issues require a formal structure for the Minor Use Animal Drug Program (MUADP):



  1. The termination of the NRSP-7 program has left 88 Investigational New Animal Drug Applications (INADAs) filed at the Food and Drug Administration Center for Veterinary Medicine (FDA/CVM) scheduled to terminate for lack of sponsor. Loss of these INADAs will result (1) in a collective loss of work estimated in excess of $5 million dollars and (2) loss of stakeholder incentive to provide support for the Program.

  2. The MUADP has received a $250,000 grant from Animal and Plant Health Inspection Service (APHIS) for continued research on ivermectin blocks for cattle tick fever as well as chlortetracycline and meloxicam for sheep.

  3. Dr. Sonny Ramaswamy, director of the National Institute of Food and Agriculture (NIFA), has proposed a tactical science initiative within NIFA merging the Minor Crop Pest Management Program (IR-4/NRSP4), Food Animal Residue Avoidance Program (FARD), and Minor Use Animal Drug Program (MUADP) into a single funding entity.


 

Objectives

  1. Provide the formal structure necessary to maintain the 88 INADAs held in the name of the MUADP.
  2. Continue APHIA funded research on cattle fever tick and sheep drug approvals.
  3. In conjunction with NIFA and stakeholders, identify a stable funding source to work with the FDA/CVM to facilitate their approval of animal health products and provide information for the safe and efficacious use of these materials in specialty animal species.

Procedures and Activities

1. Continue research on cattle fever tick and ASI drug requests under APHIS funding. Complete report on research conducted to date is included in Attachments.


2. Teleconference and meet with NIFA associates to address the development of a tactical science initiative and formation of a unified Regulatory Systems Support Program that would include Minor Crop Pest Management, Food Animal Residue Avoidance Program and the Minor Use Animal Drug Program. An abbreviated summary (two pages from a total of 15 pages) from NIFA entitled, “Call to Conversation on Tactical Sciences for Protection of the U.S. Agricultural Enterprise” hosted by the University of Maryland College of Agriculture and Natural Resources on February 15 and 16, 2017 is included in the Attachments.

Expected Outcomes and Impacts

  • Objective 1: The establishment of a formal structure for the MUADP will prevent the loss of the 88 INADAs filed at the FDA/CVM scheduled to terminate for lack of sponsor.
  • Objective 2: A summary of the APHIS funded research is provided as Attachment #1. This quarterly report has been submitted to APHIS. The Program expects continued support from APHIS based upon progress in critical areas of stakeholder need.
  • Objective 3: Input and assistance provided to NIFA on the logistics of merging the Minor Crop Pest Management Program, Food Animal Residue Avoidance Program and Minor Use Animal Drug Program into a single funding entity with a consolidated regulatory support system, that can provide research ensuring the safety and diversity of agricultural products. Comments: Both Drs. John G. Babish, National Coordinator MUADP and Meg Oeller, DVM, Director, Office of Minor Use & Minor Species Animal Drug Development, attended the Call to Conversation on Tactical Sciences for Protection of the U.S. Agricultural Enterprise, hosted by the University of Maryland College of Agriculture and Natural Resources on February 15 and 16, 2017 in support of the MUADP. At the Call to Conversation, participants agreed that current investments in tactical sciences are not sufficient to address growing challenges posed by the threats to our nation’s food supply. The group identified several major forces that are likely to impact the security of the U.S. agriculture and food system enterprise in the coming years, and agreed that a major initiative to protect the biosecurity of our nation’s food systems by raising the stature and increased support for tactical sciences is timely, necessary, and worthwhile. To continue the momentum generated by the conversation, a working group of key, representative stakeholders was formed to provide recommendations for strengthening the tactical science portfolio. As nominated by Dr. Babish, Dr. Oeller was selected to represent Minor Animal Drug interests in the working group. This select subset of stakeholders will be asked to: 1) Develop a vision for a robust, coordinated framework of tactical science capabilities that will ensure the biosecurity of the U.S. food and agricultural system; 2) Develop an aspirational outcome that will strengthen tactical science capabilities in the United States; and 3) Develop a communication strategy that effectively conveys the importance of tactical sciences to relevant audiences. Ideally, the efforts of this working group will result in a national initiative to strengthen tactical science programs and enhanced protection of the U.S. food and agricultural system from existing and emerging threats.

Projected Participation

View Appendix E: Participation

Educational Plan

Organization/Governance

The recommended Standard Governance for multistate research activities include the election of a Chair, a Chair-elect, and a Secretary. All officers are to be elected for at least two-year terms to provide continuity. Administrative guidance will be provided by an assigned Administrative Advisor and a NIFA Representative.

Literature Cited

USDA NIFA. 2017. Report of Call to Conversation on Tactical Sciences for Protection of the U.S. Agricultural Enterprise. 15-16 February 2017, University of Maryland College of Agriculture and Natural Resources, College Park MD. 15 pp.

Attachments

Land Grant Participating States/Institutions

CA, IA, MD, NY

Non Land Grant Participating States/Institutions

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