Animal Drug Approval Process 

The Food and Drug Administration (FDA)  approves new animal drugs before being marketed in the United States. A new animal drug can be for companion (pet) animals, such as dogs, cats, and horses; or for food-producing animals. A new animal drug is a drug not already recognized as safe and effective for use in animals, including any drug to be added to animal feed. The standards and processes for reviewing pharmaceuticals intended for animals are in many ways similar to those used for reviewing pharmaceuticals intended for humans.[1]

BEGINNING THE NEW ANIMAL DRUG APPROVAL PROCESS

The Center for Veterinary Medicine (CVM) has six offices that work together to approve new animal drugs, as well as monitor the drugs after they are on the market.  The CVM’s Office of New Animal Drug Evaluation (ONADE) is the “pre-approval office,” meaning that it is the lead office for reviewing the information about a new animal drug before it is approved.

However, the drug approval process first starts with the drug sponsor, who begins with an initial laboratory study, or pilot. If the results of a pilot study are promising and there is a potential market for the new drug, BEFORE FILING A NEW DRUG APPLICATION, the drug sponsor should reach out to the CVM. The key to a smooth approval is this early communication. The drug sponsor starts by contacting ONADE to open an INAD (Investigational New Animal Drug) file, which is how the sponsor will share information with the CVM going forward. ONADE and the drug sponsor will then discuss and agree on the information needed to get the drug approved, including the number and types of studies that may be required and the design of each study.[2]

ANIMAL DRUG APPLICATION TYPES

As mandated by the Federal Food, Drug, and Cosmetic Act, a new animal drug cannot be sold in the U.S. unless it has received FDA approval. There are three different types of new animal drug applications:

  • New Animal Drug Application (NADA) - used to seek approval of a new animal drug.

Before submitting a NADA, the drug sponsor must collect information that demonstrates its safety and effectiveness for a specific use in a specific animal species. Once that data is obtained, the drug sponsor submits a NADA to the FDA with the supporting data and all adverse effects associated with its use. The drug sponsor must show that it can manufacture the product so that the product’s composition is consistent from batch to batch, that the product’s active ingredients come from reliable sources, and that it follows good manufacturing practices. If the drug product is to be used in a food-producing animal, residues in food products (such as meat and milk) must be shown to be safe for human consumption.

  • An Abbreviated NADA (ANADA) - used to seek approval of a new generic version of an already approved animal drug for which patents or other periods of exclusivity are near expiration. The information in the ANADA must show that the generic copy has the same quality, performance, and intended uses as the approved brand name drug.
  • A Conditional Approval NADA (CNADA) - used to seek conditional approval of a new animal drug. A CNADA has met all the requirements to support the full approval except for a demonstration of “substantial evidence of effectiveness.” A conditionally approved CNADA allows the applicant to legally market the new animal drug for up to 5 years, provided FDA approves the required annual renewal requests, while the applicant continues to collect the effectiveness data needed to meet the “substantial evidence” standard for full approval.[3]

THE NEW DRUG REVIEW PROCESS

After a NADA has been submitted, the NADA review begins. The review includes an evaluation of data regarding an animal drug’s safety to the target animal, and to humans who might consume products of the treated animal. The review also evaluates effectiveness for claimed purposes. A team of CVM personnel, including veterinarians, animal scientists, biostatisticians, chemists, microbiologists, pharmacologists, and toxicologists, reviews a NADA. The appropriate CVM review division determines whether the drug should be classified as an over-the-counter (OTC), prescription (Rx), or veterinary feed directive (VFD) drug.

The approval process is the same for any new animal drug, whether it’s an OTC, Rx, or VFD. All go through the NADA process. If the CVM determines that adequate “directions for use” can be written on the drug’s label in such a way that a non-veterinarian can use the drug safely and effectively, then it can be marketed as an OTC. If not, then the drug must be marketed as either Rx or VFD – which both require veterinary oversight to be administered.

If the CVM team is in agreement that the new drug is safe and effective when used as directed, the CVM team sends its recommendation that the NADA be approved to the Director of CVM. If the Director agrees, a notice of approval is published in the Federal Register and the drug sponsor can legally sell the drug, under CVM-approved labeling.[4]

To learn more, visit the FDA web page, From an Idea to the Marketplace: The Journey of an Animal Drug Through the Approval Process.

MINOR SPECIES / MINOR USE DRUGS

The CVM classifies horses, dogs, cats, cattle, pigs, chickens, and turkeys as the seven major species.  All other animals, such as zoo animals, ornamental fish, parrots, ferrets, and guinea pigs are minor species. Some animals of agricultural importance are also minor species, including sheep, goats, catfish, game birds, and honeybees, among others.[5]

If a drug is intended for a minor species or a minor use in a major species, both ONADE and the Office of Minor Use and Minor Species Animal Drug Development (called “OMUMS” for short) are involved in the review process. A minor use in a major species is the use of a drug in one of the seven major species for a condition that occurs: infrequently and in only a small number of animals each year; or in a limited part of the country and in only a small number of animals each year - for example, a drug to control pain in dogs with bone cancer is a minor use in a major species because relatively few dogs get bone cancer.[6]

There are certain provisions for the approval of Minor Use / Minor Species drugs designed to offset the financial burden in bringing these products to such a limited market. Learn more here and here.

For all new animal drugs, in addition to animal and human safety considerations, a new drug’s potential impact on the environment is also considered. An Environmental Assessment will be conducted to determine how much drug is expected to get into the environment and its potential environmental effects.[7]

The FDA maintains a searchable online database that includes most FDA-approved and conditionally approved animal drugs. See Animal Drugs @ FDA.

If you are new to the animal drug approval process or unsure who to contact first, you can send general questions to AskCVM@fda.hhs.gov

 

Updated by Tina Allen, November 2020