January 01, 2009

 
EXECUTIVE BOARD COVERAGE

 Drug-related policies adopted, liaisons ended - January 1, 2009

posted December 15, 2008
 

The AVMA has adopted policies concerning new animal drugs and the sharing of isolates of emerging disease agents.

The AVMA Council on Biologic and Therapeutic Agents recommended that the Executive Board approve replacing the policies New Animal Drug Application (NADA) Approval Process and User Fees for Sponsors of New Animal Drug Applications with the following policy:

Funding of the New Animal Drug Application (NADA) Approval Process

To help ensure adequate availability of veterinary drugs, the AVMA supports increased Congressional funding of the FDA Center for Veterinary Medicine for the NADA approval process indexed to keep pace with cost increases.

The AVMA supports user fees for new animal drug applications only if such fees are directed toward expediting the review and approval process for animal drug products.

The board approved the council's recommended policy encouraging cooperation among academic institutions, vaccine manufacturers, and government with regard to the sharing of isolates of emerging disease agents. The new policy reads as follows:

Development of Emerging Disease Agent Biologics

Although the AVMA recognizes the need to protect intellectual property, the failure of researchers to share isolates of emerging agents with other investigators has the potential of adversely impacting animal health and well being by delaying disease research and the development of diagnostic modalities and preventive measures such as vaccines. The AVMA encourages cooperation between researchers, biotechnology and animal health industries, and regulatory agencies for the promotion of animal health.

In addition, the board approved revisions to the following policies, which now read as stated:

Withdrawal of FDA Approval for Animal Drug Products

Loss of an animal drug product can have adverse effects on animal health, animal welfare and food safety. Before withdrawing approval of an animal drug product or taking action that may result in a product being withdrawn from the market by the drug sponsor, the AVMA urges FDA-CVM to balance the magnitude of the adverse effects against the risk that may result from continued availability of the drug.

Vaccinovigilance

The AVMA supports the monitoring of vaccine safety and efficacy via a publicly available central reporting system. The system should collect reports of all vaccine associated adverse events including any perceived failures in safety and/or efficacy. The reporting system should be user-friendly and readily available to facilitate adverse event reporting by veterinary practitioners. The reports should follow a standardized, systematic template. Any compilation or interpretation of these reports should be provided in a form that is useful to biological firms and clinically relevant for veterinarians. Implementation of the central reporting system needs to be a high priority for the USDA-APHIS Center for Veterinary Biologics and adequate funding must be provided. The need for vaccinovigilance is significant and urgent to ensure that animal health, public health and food safety are protected.

Revaccination Interval

The AVMA encourages the USDA APHIS Center for Veterinary Biologics to ensure the scientific basis of vaccine label revaccination interval recommendations.

The Executive Board also approved the council's recommendations to rescind the AVMA's liaison to the Animal Health Institute and to the Environmental Protection Agency's Pesticide Program Dialogue Committee.

Cooperation and collaboration with the AHI on matters of joint interest continue to be highly important. The COBTA recommended that the formal liaison position be rescinded, however, because the organizational relationship is being nurtured in other ways, making the liaison unnecessary.

As for the EPA, the Executive Board had earlier approved the establishment of a liaison to the EPA Pesticide Program Dialogue Committee.

The AVMA had received encouraging remarks from EPA regarding the Association's participation at the time the liaison was being established. In May 2008 the AVMA was notified that its liaison had not been selected, however.

A representative of the AVMA Governmental Relations Division continues to attend the public meetings.