It has been a year since the FDA announced their goals for the future of animal and veterinary products in the Animal and Veterinary Innovation Agenda (available here: Animal and Veterinary Innovation Agenda). The Agenda is intended to make the Center for Veterinary Medicine, and its accompanying regulations, standardized, thereby bringing it in line with its Centers for Biologics Evaluation and Research and Drug Evaluation and Research. It also aimed to promote cooperative competition for veterinary drug development. Much progress has already been made over the past year.
Of particular interest to veterinary drug researchers and manufacturers are (1) a proposed Labeling Rule, (2) the publication of new Guidance for Industry, and (3) the establishment of several new collaborations between FDA and industry. The first two encourage standardization, while the third encourages cooperative competition.
Encouraging Standardization
The Proposed Rule for veterinary drug labeling is nearing Final Rule status, as it was published in the Federal Register on March 12, 2024, and the comment period ended August 9, 2024 (available here: Federal Register :: Labeling Requirements for Approved or Conditionally Approved New Animal Drugs). If codified as written, the Proposed Rule will require all approved or conditionally approved animal drugs to change their labeling to comply with the new regulations within the next six years, or risk being deemed unsafe under the Federal Food, Drug, and Cosmetic Act. Like the labeling requirements for human drugs, all veterinary drug labeling requirements would be located in a single part of the Code of Federal Regulations and would be comprehensive in scope. The labeling requirements for prescription veterinary drugs will look familiar to those already versed in human prescription drug labeling requirements, though sans the "Highlights of Prescribing Information" section. So, too, will the OTC labeling requirements seem familiar to those already versed in human OTC labeling requirements. This similarity seems purposeful—familiarity with one type of drug labeling will now mean familiarity with another and will, hopefully, lead to a more streamlined application process for new drugs, more generally because all labeling requirements will be similarly standardized.
Manufacturers, prepare to overhaul your veterinary drug labeling to comply with the likely new regulations. The staggered schedule for required labeling changes is based on application number and can be found in Table 1 of the Proposed Rule. Any New Animal Drug Application, Conditional New Animal Drug Application, and certain supplements to existing applications that are submitted 180 days after the effective date of the final rule, for example, will need to include conforming labeling as part of the application/supplemental application. Those applications or supplements that are pending as of the effective date of the final rule or submitted less than 180 days after that date will need to submit conforming labeling no later than 180 days after the approval date of that application/supplemental application. As the dates of approval become more distant from the effective date of the final rule, more time is given to submit conforming labeling.
New Guidance for Industry is also aimed at standardizing and clarifying FDA's requirements and recommendations for certain areas of veterinary medicine. In December 2023, FDA released an updated Guidance for Industry on the special considerations, incentives, and programs to support the approval of new animal drugs for use in horses, dogs, cats, cattle, pigs, turkeys, and chickens, where there is a "small number" of animals affected by the disease the drug is intended to treat, and for new animal drugs intended to treat other species of animals. This Guidance appears to be modeled after the existing Guidance for the development of drugs for rare diseases in humans. (You can find that Guidance here: CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species | FDA.)
In May 2024, FDA released final Guidance for Industry on heritable intentional genomic alterations in animals. At the same time, it released draft revised Guidance for Industry on the approval process for such genetic alterations. (Guidance documents are available here: CVM GFI #187A Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach | FDA and here: Guidance for Industry #187B - Heritable Intentional Genomic Alterations in Animals: The Approval Process.) Besides these final and draft Guidance for Industry documents, FDA has issued several guidance documents clarifying their policies on a broad range of topics, including enforcement of rules concerning certain animal food additives, acceptable amounts of residual solvents in animal medicines and in products derived from treated food-producing animals, and informed consent for studies enrolling client-owned companion animals. (CVM GFI #116 (VICH GL23 (R2)) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2) | FDA; CVM GFI #100 (VICH GL18 (R2)) Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2) | FDA; CVM Guidance for Industry #282 - Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals.)
Researchers and veterinary drug manufacturers alike should familiarize themselves with these new guidance materials, both to better identify potential areas of innovation and to ensure compliance with the updated regulations and recommendations.
Encouraging Cooperative Competition
On September 18, 2024, the Center for Veterinary Medicine announced the establishment of Animal and Veterinary Innovation Centers at University of Wisconsin-Madison, University of California at Davis, Kansas State University, and the University of Arkansas. These universities are partnering with the Center to research highly pathogenic avian influenza and other emerging zoonotic disease threats, intentional genomic alterations in animals, and unmet veterinary medical needs in all animal species that create a significant animal or public health burden (available here: FDA Announces Animal and Veterinary Innovation Centers Partnerships | FDA).
There are, thus, additional opportunities for industry and research to collaborate with the Center for Veterinary Medicine to develop new drugs for unmet needs and, thereby, to alleviate significant health burdens.
The continued implementation of the Animal and Veterinary Innovation Agenda should come with further standardization of, and clarity in, the veterinary drug approval process. Having clearer, comprehensive regulations and guidance, along with the additional support for cooperative innovation laid out in the Agenda, is intended to improve and simplify the regulatory approval process for veterinary drugs. Time will tell whether the Agenda will fulfill its promises.