United States: ACI's Legal, Regulatory And Compliance Forum On Animal Health And Veterinary Drugs And Therapeutics-Part III: Governance Of Veterinary Drugs

Last Updated: September 18 2015
Article by Nancy E. Halpern, DVM, Esq.

A number of presenters at this recent conference described the landscape of federal and state oversight of veterinary drugs and therapeutics.

Here is a quick primer on the topic:

USDA's Center for Veterinary Biologics (CVB) is authorized, under the Virus-Serum-Toxin Act (VSTA) of 1913, amended by the Food Security Act of 1985, to license and regulate veterinary biologics, which are defined as "vaccines, bacterins, allergens, antibodies, antitoxins, toxoids, immunostimulants, certain cytokines, antigenic or immunizing components of live organisms, and diagnostic components."

As David A. Brake, BioQuest Associates, LLC, explained, the key to understanding what USDA-CVB regulates, compared to products regulated by FDA, is whether the veterinary biologic in question   "function[s] through an immunological process for treatment of an animal disease; including: Antibody products, immunomodulators and immunostimulants."

FDA is authorized to regulate animal drugs.  "The term 'drug' means. . .(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man; or other animals. . ."    21 U.S.C. 321(g)(1).

Whether a biologic is regulated by USDA or FDA is based on consideration of its primary mechanism of action.

Biologics that do not function through an immunological process but are used to diagnose, cure, mitigate, treat or prevent disease in animals would be regulated by FDA.

USDA and FDA have signed a memorandum of understanding to confer with each other if there is a question about which agency should regulate a certain animal product.

Similarly, pesticides may be regulated by EPA under  the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), FDA under the Federal Food Drug Cosmetic Act (FFDCA), based on its systemic or local effect. (States also regulate pesticides under relevant state laws).

Each animal product, regardless of the agency in control, must be safe, efficacious, labeled as authorized by the governing agency, and approved based on rigorous agency-review of the relevant application and required facts and documents.

As antibiotic use in animals, particularly food animals, is increasingly scrutinized, other animal products are under development to combat infectious diseases.  New products, recently developed to replace antibiotics,  including monoclonal antibodies, will be carefully reviewed to determine if their mechanism of action is immunological or not.  The tension between USDA, FDA, and EPA will likely increase, as pharmaceutical companies continue to expand their use of newer technologies to treat diseases.

And we should not leave out FTC, whose mission is "to prevent business practices that are anticompetitive or deceptive or unfair to consumers . . . without unduly burdening legitimate business activity."   As recently described, FTC has begun to closely scrutinize the accessibility of prescription medications to pet owners.

FTC's Strategic Goals include:

  1. Protect Consumers: Prevent fraud, deception, and unfair business practices in the marketplace.
  2. Maintain Competition: Prevent anticompetitive mergers and other anticompetitive business practices in the marketplace.
  3. Advance Performance: Advance the FTC's performance through organizational, individual, and management excellence.

FTC's influence over the historically state-authorized practice of veterinary medicine remains to be seen.

It is clear that animal health, animal health products, and veterinary medicine has captured the attention of local, state and federal lawmakers, large and small businesses, pet and animal owners, as well as the general public.

As reported by VCA ANTECH INC, in its annual report filed 03/01/13 for the period ending 12/31/12:

According to American Pet Products Association, Inc.'s ("APPA") 2011-2012 APPA National Pet Owners Survey, the United States population of companion animals is approximately 189 million, including about 165 million dogs and cats. APPA estimates that over $30 billion was spent in the United States on pets in 2012 for veterinary care, supplies, medicine and boarding and grooming. The survey indicated that the ownership of pets is widespread with approximately 73 million, or 62%, of U.S. households owning at least one pet, including companion and other animals. Specifically, 46 million households owned at least one dog and 39 million households owned at least one cat.

It is clear that animal health products and the animals they are developed to protect, will be increasingly under scrutiny by all relevant federal and state agencies.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Authors
Nancy E. Halpern, DVM, Esq.
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