Regulating equine plasma products

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The Executive Board has approved a position statement on the regulation of equine plasma products. The statement indicates that the AVMA urges the Food and Drug Administration and Department of Agriculture to identify a means to regulate all equine plasma products intended for use in horses, according to the USDA standards for animal blood product quality. The AVMA Council on Biologic and Therapeutic Agents recommended the position statement.

Blood products that are used to treat animals, but do not have a particular treatment or disease claim on their label, are produced without any active federal regulation of product and quality. There are no assurances that a product is what it purports to be, pure, and uncontaminated. Blood products include whole blood, plasma, red blood cells, and platelets.

Animal blood and blood products are "drugs" within the meaning of the section 201 (g) of the Federal Food, Drug, and Cosmetic Act, but, currently, the FDA considers regulating these products a low priority. The FDA Center for Veterinary Medicine does not require drug listing of animal blood and animal blood products. In contrast, the USDA Center for Veterinary Biologics regulates the quality of blood products that bear immunologic treatment or disease label claims under the Virus-Serum-Toxin Act using Antibody Product Standards.

Recently, COBTA recognized and set out to study this complex issue. The council considered theoretical risks of unregulated drug products, personal professional experiences, feedback from firms that produce blood products, possible adverse impacts of imposing regulations, voluntary industry standards, and the distinction between facilities that maintain their own blood donors and those that offer their services commercially. It also considered the lack of veterinarian awareness that non-claim blood products are not actively federally regulated and the need for education.

After much study, COBTA was not convinced that the benefits of regulating all blood products for all species currently outweigh the risks of regulation, especially because regulation could limit product availability.

The COBTA, however, is particularly concerned about equine plasma, which is most often used to treat failure of passive transfer in foals. Equine plasma that doesn't have a disease claim on its label is free from federal oversight concerning the quality of the product, including sourcing of the donor animals and testing for infectious diseases. In addition, there is no oversight of the laboratory practices used during collection. Most existing state regulations govern zoning, health laws, and animal welfare standards for donor animals, not the quality of the blood product itself.

After weighing all pros and cons, COBTA recommended that the AVMA approve a position statement encouraging the oversight of equine plasma.