January 15, 2005


 GRD Focuses on drugs and biologics

Compounding, NARMS, MUMS, FARAD, biologic advisory committee are priorities

Posted Jan. 1, 2005

This past July, the AVMA celebrated when its lobbying efforts, in part, resulted in passage of the Minor Use and Minor Species Animal Health Act. In the upcoming months, the AVMA will focus its efforts on ensuring the implementation of MUMS and four other issues involving drugs and biologics.

First, the AVMA will actively lobby for funds for the Office of Minor Use and Minor Species Animal Drug Development, one result of the passage of MUMS. The office, which falls under the purview of the Food and Drug Administration Center for Veterinary Medicine, will be responsible for designating minor use and minor species animal drugs, administering grants and contracts, reviewing minor species drug index listing requests, and serving as a liaison to those interested in minor use and minor species animal drug development.

Second, the AVMA will support the establishment of a Department of Agriculture Veterinary Biologic Advisory Committee, which could provide advice and counsel to the USDA about licensing issues and the use of veterinary biologics. This committee would operate similarly to the FDA Veterinary Medicine Advisory Committee. It would review and evaluate available data concerning the safety and effectiveness of marketed and investigational biologics and diagnostics for use in animals, and make appropriate recommendations to the secretary of agriculture regarding scientific issues and regulatory policies.

Third, the AVMA will support legislation or executive branch budgeting that provides federal funding for the Food Animal Residue Avoidance Databank, the primary source for scientifically based recommendations for withdrawal intervals after extralabel drug use. Without such a source, extralabel drug use and humane pharmacotherapy of food animals, particularly minor species, will be endangered. FARAD, which is also the primary source of residue mitigation information for food animals exposed to environmental contaminants, has proved its value over the past 22 years and needs sustained, multiyear funding to be able to continue to deliver this valuable service.

Also involving safety is the issue of compounding. The board approved directing the AVMA Governmental Relations Division to be proactive in educating congressional offices, regulatory agencies, and veterinarians about compounding from bulk drugs, to preserve the safety and efficacy protections of the animal drug approval process, and privileges granted to the veterinary profession by AMDUCA.

Currently, compounding pharmacies are pursuing legal challenges to the FDA's stance on compounding drugs from bulk ingredients for nonfood animals. The FDA is in the midst of revising its Compliance Policy Guide on veterinary compounding to address some of the concerns raised by pharmacists, veterinarians, and other groups. And recent communications involving the FDA-CVM, AVMA, and the International Academy of Compounding Pharmacists suggest that there will be legislative efforts that could negatively impact the compounding situation and the veterinary profession. Educating legislators about the issues is crucial at this time.

Another lobbying issue involving drugs that the Executive Board discussed was antimicrobial resistance. The board approved supporting legislation that would increase funding for the animal arm of the National Antimicrobial Resistance Monitoring System, and revised an AVMA position statement to indicate this. The statement reads: "the AVMA recognizes the importance of the NARMS and recommends that the USDA and FDA budget for adequate and equitable funding of the resistance monitoring system for bacterial isolates from animals, animal products, and humans."

The FDA-CVM provides funding for NARMS and disperses it to the national Centers for Disease Control and Prevention and the USDA. Because of budget cuts in the FDA, the agency has had to cut money from projects, including NARMS. The AVMA is concerned that more money has been cut from the USDA than the CDC, and believes the funding reductions should be shared equitably.

The AVMA believes that testing for the antimicrobial susceptibilities of bacteria from animals and animal products is important, especially if test results are intended to aid risk management decisions regarding availability, use limitations, and the labeling of animal drugs. Test results from retail meat samples or from human isolates have little value in informing policy makers about the source of antimicrobial resistance, unless they can be compared and correlated with findings from animals. Funding of the animal arm of NARMS is, therefore, critical.