One of the ways CVM accomplishes its mission of establishing programs that promote and protect animals, as well as the humans who are exposed to them, is by strategically partnering with intergovernmental organizations that successfully use One Health strategies that decrease the spread of zoonotic diseases and enhance the societal importance of the human-animal bond globally.
In May 2011, CVM applied to and was accepted as an OIE Collaborating Center (CC) for veterinary drug regulatory programs. The criteria used for our selection for this designation included:
- our scientific and technical standing at national and international levels,
- the place CVM occupies in the U.S.’s animal health, scientific and educational structures;
- the quality of our scientific and technical leadership
- the working relationship CVM has with other institutions in the US and in the global community, and,
- the technical and geographical relevance of our activities to the OIE’s program priorities
In addition to our work as a CC, in 2010, with support from the Office of International Programs, the FDA began an additional strategic alliance with the OIE through a Cooperative Agreement (CoAg).
In an effort to reduce barriers and promote harmonization of standards and guidelines, the FDA signed a CoAg for the Global Implementation of the Veterinary Medicinal Products Guidelines. Although this CoAg originated before FSMA became a law, it is in alignment with the strategic framework of Section 305 of FSMA which calls on FDA to develop a comprehensive plan to expand the technical, scientific, and regulatory capacity of foreign governments.
The CoAg extended capacity to developing and in-transition countries so they can become more self-sufficient and have more effective early diagnostic capabilities, surveillance, prophylaxis and control.
Support from this CoAg was also used to strengthen OIE Regional Laboratory and CC twinning projects for the transfer of knowledge, training and expertise by linking an existing Reference Laboratory or Collaborating Center with a selected Candidate from a lesser developed country. Currently, twinning projects have been established for more than 40 institutions across the Americas, the Middle East, Asia, Africa, and Europe. The principal objective of these opportunities is to establish more Reference laboratories and Collaborating Centers in areas where there is a need.
This CoAg also facilitated our ability to provide subject matter experts to participate in and provide leadership for regional training seminars that allowed us to train the majority of the OIE’s 178 member countries’ Focal Points on U.S. requirements for safe veterinary products.
Some of the topics our experts addressed during those regional seminars included:
- Veterinary legislation and good governance
- Counterfeit and substandard veterinary drugs
- Pharmacovigilance and post market surveillance
- Responsible use of veterinary products including establishing maximum residue limits and withdrawal times for veterinary drugs that are used in food producing animals
- Analysis and making relevant comments on draft VICH guidelines that support the harmonization of requirements for licensing or registration
- Establishment of effective residue and antimicrobial resistance monitoring plans
In 2011, an ad hoc group of interested donors to the OIE established the OIE World Fund Results Framework Taskforce. Their charge is to define and apply metrics to measure the benefits and outcomes of the OIE’s initiatives - including the training seminars for Focal Points and the Twinning programs. Dr. Don Prater, who is Deputy Director, FDA Europe Office, is the agency’s representative on this Taskforce.
The Task Force met twice in 2012 and adopted a model of performance indicators that is used by the World Bank. In addition, they selected some activities to begin piloting the model. We are hopeful that at least some of the preliminary results will be available for use for the next rolling cycle of regional training seminars which is set to begin in this calendar year.