Extralabel drug use policy revised

AVMA to send FDA comments on new antimicrobial order
Published on February 15, 2012
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A revised policy approved by the AVMA Executive Board will be used to comment on the Food and Drug Administration's further restrictions on the use of cephalosporin-class antimicrobials in most food animals. Notably, discussion before the vote revealed ongoing frustration members of both the House of Delegates and board have with the Association's current governance structure.

Dr. Meyer
Dr. Thomas F. Meyer, District XI Executive Board representative, discusses with fellow members the merits of referring a revised policy on limited prohibition of extralabel drug use to the AVMA House of Delegates. (Photo by R. Scott Nolen)

The board amended and approved the AVMA's "Policy on Limited Prohibition on Extralabel Drug Use" at its Jan. 6 meeting prior to the AVMA Veterinary Leadership Conference in Chicago. The new version is available here.

The vote came as a result of a joint policy recommendation by the AVMA Council on Biologic and Therapeutic Agents, Clinical Practitioners Advisory Committee, Animal Agriculture Liaison Committee, Aquatic Veterinary Medicine Committee, Council on Public Health and Regulatory Veterinary Medicine, and Food Safety Advisory Committee.

Changes to the document reflect the AVMA's position that a science-based risk analysis should be performed by any regulatory authorities considering prohibitions on extralabel drug use and that any such prohibitions should be as narrow in scope as possible, consistent with protection of the food supply, public health, and animal welfare. These revisions also reflect the entities' desire for policy language that can be used by the AVMA whenever any type of extralabel drug use prohibition is under consideration, whether for antimicrobial or non-antimicrobial drug products and for food and non–food animal species.

As it so happened, the FDA issued an order two days earlier that limits, effective April 5, extralabel use of cephalosporin antimicrobials in cattle, chickens, swine, and turkeys by banning disease prevention uses and limiting prescription applications (see JAVMA, Feb. 15, 2012). The agency had opened the order for comments; the AVMA anticipated sending a letter to the FDA and including the revised policy for context.

At the same time, the House Advisory Committee had asked that the board refer the policy to the House of Delegates for consideration at its Jan. 7 session, in conjunction with the AVMA Veterinary Leadership Conference, because under the AVMA Bylaws, the HOD is responsible for establishing policy for matters relating to veterinary medicine.

Dr. Stewart "Chip" Beckett, Connecticut delegate, told Executive Board members at the board meeting that delegates would like to feel their trip to Chicago is of value to the Association. Referring the new policy to the House, he said, was "the best way to not let them feel neglected."

Dr. Thomas F. Meyer, District XI Executive Board representative, responded that he was surprised the HOD asked to see the policy at such a late stage, when the board was ready to make a decision on it. The policy had come before the board first in April 2011 and again in November 2011. Both times, it was referred to relevant AVMA entities such as COBTA and CPAC for their input. In December 2011, the respective entity chairs, Executive Board liaisons, and applicable AVMA staff held a joint conference call, during which the policy was reviewed and revised. Concurrence was eventually achieved within the full membership of all six entities.

"This is an area where we've been as open as we can be. There's been ample opportunity for the HOD to comment, and at the 18th hour, they want a few more months to look at this. Why? I would pass this (policy). Not to keep HOD out of this, but when do they step to the plate and get in the game?" Dr. Meyer asked.

Board Chair Ted Cohn added that the HOD can rework the policy whenever it wants, and ultimately, the board declined to refer the policy to the House.

Looking forward, work continues on analyzing the governance structure of the AVMA, including the Executive Board and HOD. The Task Force on Governance and Member Participation is charged with reviewing all entities and examining their purpose and effectiveness; member election or appointment method; and the quality, outcome, and satisfaction of membership involvement.

The 11-member task force was recently named (see sidebar) and will soon determine the date of its first meeting.

Model ordinance, practice act

In other actions, the Executive Board invited the HOD to review and comment on a policy postponed to the April 19-21 board meeting. The Council on Public Health and Regulatory Veterinary Medicine had submitted the revised "Policy on Model Dog and Cat Control Ordinance" to the board.

According to the background to the council's recommendation, the council changed the definition of "feral" from "an animal that has never been owned" to "existing in a state of nature: not domesticated or cultivated, having escaped from domestication and become wild."

The board also postponed until April consideration of those sections of the AVMA Model Veterinary Practice Act pertinent to the definition of the veterinarian-client-patient relationship, so it may solicit feedback from the membership, HOD, and various other AVMA entities.

The Model Veterinary Practice Act Task Force had recommended that the Executive Board approve revisions to update and clarify portions of the practice act dealing with the definition and scope of the veterinarian-client-patient-relationship at its January meeting.

According to the recommendation's background, this topic generated several divergent comments from various AVMA entities during the comment period for the practice act.

The draft proposed changes to these sections are open for comment by AVMA members and entities until March 1 at www.avma.org/issues/policy/mvpa_vcpr-comments.asp.

Once comments have been received, they will be directed back to the task force, which will make any changes as necessary and send a revised version to the board in April for further action. Then, the wording will likely go for final approval to the HOD at its meeting in August.

The board had approved the remaining practice act revisions this past November, and the HOD approved them at its Jan. 7 session (see story).

The Task Force on Governance and Member Participation was created this past August to evaluate the AVMA governance structure, including the Executive Board, House of Delegates, and all other entities, including councils, committees, task forces, commissions, and trusts.

In January, the AVMA announced the committee members who had been appointed. They are as follows: Ralph Johnson, Denver, chair; Richard Alampi, Hillsborough, N.J.; Dr. Sarah Babcock, Washington, D.C.; Dr. Stewart "Chip" Beckett, Glastonbury, Conn.; Dr. Grace F. Bransford, San Anselmo, Calif.; Bridget Heilsberg, Fort Collins, Colo.; Dr. Adam J. Langer, Atlanta; Dr. Stacy L. Pritt, Chino Hills, Calif.; Dr. Kathy M. Reilly, Keene, N.H.; Dr. Rebecca E. Stinson-Dixon, Reidsville, N.C.; and Dr. Lori M. Teller, Houston.