Veterinary pharmaceuticals (veterinary drugs) are those products which achieve their effect through chemical reaction or metabolism in the body. This mechanism of action distinguishes veterinary pharmaceuticals from veterinary medical devices or veterinary biologics. In addition to the mechanism of action, the distinction between a veterinary drug and veterinary biologic is also related to it’s intended use. Before beginning the process of developing a product for veterinary medicine, it is very important to understand how a product will be regulated as the development process and manufacturing requirements can be very different among the various agencies that regulate veterinary products.
Veterinary Drugs and Veterinary Pharmaceuticals
Developing Veterinary Drugs
There are a variety of steps to developing veterinary drugs / veterinary pharmaceuticals. Woods Consulting, LLC can assist companies in opening and Investigational New Animal Drug file (INAD), and reviewing the fees associated with New Animal Drug Applications as described in the Animal Drug User Fee Act (ADUFA).
New Animal Drug Applications (NADA): at a minimum, the following technical sections are a component the submission of a veterinary drug master file.
- Target Animal Safety
- Substantial Evidence – Target Animal Efficacy
- Human Food Safety
- Chemistry, Manufacturing and Controls
- Environmental Impact
Veterinary Pharmaceutical Regulations
General Overview of Veterinary Drug Regulations
In the United States, veterinary drugs are subject to the Food, Drug and Cosmetics Act and must receive an approval from the FDA-CVM before they can legally marketed. Before entering confirmatory veterinary clinical trials in support of an approval (New Animal Drug Application or NADA), Sponsors must open an Investigational New Animal Drug Application and obtain a Notice of Claimed Investigational Exemption (NCIE). The veterinary clinical trials should be designed to support the label claims, and meet the criteria for evidencing substantial evidence of safety and efficacy (often referred to as target animal safety studies and target animal efficacy studies). In addition, there are very specific requirements on the manufacturing of products, such as applying Good Manufacturing Practices, and there can be different requirements for labeling and reporting adverse events.
Extralabel use of FDA approved Drugs in Veterinary Medicine:
Veterinarians are also permitted to prescribe, under extralabel use, certain approved new animal drugs and approved human drugs according to the Animal Medicinal Drug Use Clarification Act (AMDUCA). Veterinary extralabel use of drugs approved by the FDA is defined as “Actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease and other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from labeled withdrawal time based on these different uses.”
Veterinary Pharmaceuticals Regulated Under Minor Use Minor Species (MUMS) Act
MUMS is the pathway for veterinary drug development designed specifically for the minor use in a major species or for minor species. Minor use in a major species (horses, dogs, cats, cattle, pigs, turkeys, and chickens) are veterinary drugs intended to be developed for diseases that have low incidence or prevalent, or for diseases that found only in a limited geographical area. Minor species are those non-human animals that are not major species (listed above), such as exotic animals, zoo animals, ferrets, etc. Link to FDA MUMS page.
The specific number of animals that are considered the maximum threshold for MUMS designation are as follows (by species).
- Dogs: 70,000
- Cats: 120,000
- Horses: 50,000
- Cattle: 310,000
- Pigs: 1,450,000
NOTE: the FDA periodically reviews the MUMS requirements, and the above numbers are subject to change.
Animal Drug User Fee Act
ADUFA was established in 2003 to allow the FDA to secure fees for animal drug applications, products, establishments and veterinary drug sponsors. The fees collected by the FDA are amended on an annual or less frequent basis. Waivers or reductions in ADUFA fees may be granted under certain conditions; including:
- ADUFA fees would represent a significant barrier to innovation. For instance, would the ADUFA fees result in financial constraints that would prohibit further development by the applicant.
- The animal drug application (including supplemental applications) is intended for minor use or minor species indications.
- The application represents the first (initial) application submitted by a small business or its affiliate.
More information on ADUFA fees and waiver can be found here:
Veterinary Drug Registration Outside of the United States
Veterinary drugs being developed for sale and distribution in foreign countries may be subject to different regulatory agencies. The following provides a few resources concerning foreign veterinary drug development.