Animal Drug Approval Process
The FDA must approve a new animal drug on the basis of quality, safety, and efficacy before it can be marketed in the United States. For drugs used in food-producing animals, not only must the safety to the animal be demonstrated, but also the safety of food products intended for human consumption derived from the treated animals.
Review of information submitted by drug sponsors who desire to obtain approval to manufacture and market animal drugs is the major responsibility of the ONADE. The new drug cannot be marketed until there is an approved New Animal Drug Application (NADA).
Animal drug products are regulated by two main processes:
- Investigational New Animal Drug (INAD) - involves experimental drugs used for testing in animals. This testing may require drugs be given to animals that produce human food products. It is the FDA’s responsibility to ensure that food products derived from these experimental animals will be safe for human consumption. More information on the INAD can be found here:
- New Animal Drug Application (NADA) – NADA review includes the evaluation of data regarding an animal drug's safety to the target animal, and to humans who might consume products from the treated animal. The review also evaluates effectiveness for claimed purposes. A new animal drug product must be approved under an NADA in order to be legally marketed in the United States.
There are three different types of New Animal Drug Applications (NADAs):
- NADA - An NADA (New Animal Drug Application) is used to seek approval of a new animal drug, and any subsequent supplemental applications.
- ANADA - An ANADA (Abbreviated NADA) is used to seek approval for a generic new animal drug, which is a copy of an approved new animal drug for which patents or other periods of exclusivity are near expiration. An ANADA is also used for any subsequent supplements to an approved ANADA.
- CNADA - Applications for CNADA (Conditional NADA) approval apply to new animal drugs intended for Minor Use/Minor Species (MUMS), which allows a drug sponsor to legally market the new animal drug after proving it is safe, but before collecting all the necessary effectiveness data. While collecting the effectiveness data required, if the FDA approves the sponsor's annual renewal requests, the drug sponsor can keep the product on the market for up to five years.
The initial application for approval of a new animal drug, the "original" NADA, should contain all of the following information: a signed copy of the FDA 356V (New Animal Drug Application), and a well-organized summary of the information in the application.
Drug manufacturers, and/or feed or food manufacturers, university researchers, contract researchers, and private practitioners are among the usual sponsors of INADs and NADAs. FDA field personnel validate sponsors’ data generation processes through on-site inspections. Reports covering laboratory practices relating to toxicology and safety research, and the functions of clinical investigators and sponsors, are forwarded to the FDA’s Center for Veterinary Medicine (CVM) for evaluation. Usually, the drug approval process begins with the sponsor submitting a request for an exemption to use a particular substance for experimental purposes. The CVM can grant this under an INAD.
Certain tests must be conducted by the sponsor to show that a drug is safe for the target animal, has the intended effect, and that edible products derived from treated animals are safe for human consumption. Authorization from the FDA is needed for the slaughter for consumption of animals that receive an investigational drug. The slaughtering of these animals must occur in a federally inspected facility, and be monitored by a USDA inspector.
Whether an animal drug should be approved for marketing is determined by ONADE. A new animal drug must be clinically tested for effectiveness and safety before it receives FDA approval. For products intended for use in a food-producing animal, the edible animal products must also be tested to be free of unsafe drug residues, and for safety to human consumers. It is the responsibility of the drug sponsor (the individual or firm seeking FDA approval of the drug product) to develop analytical methods to detect and measure drug residues in edible animal products, and to conduct the necessary tests.
The various groups in ONADE review the information along with any amendments to the NADA. The appropriate review division determines whether a drug will be classified an OTC (over-the-counter) drug, a prescription drug, or a VFD (veterinary feed directive) drug. After the review, a determination is made as to whether the information provided in submissions shows the new animal drug to be safe and effective for its intended use. A recommendation that the NADA should be approved is provided to the CVM Director, if the information shows the drug is safe and effective. The application is approved if the Director agrees, and a notice of approval is published in the Federal Register. More information on the NADA process can be found at:
Minor Use Drugs/Minor Species (MUMS)
Minor use drugs are for diseases that occur infrequently, or in limited geographic areas, which only affect a small number of animals annually. Minor use drugs are intended for uses in major species (horses, dogs, cats, cattle, pigs, turkeys, and chickens).
Minor species are all animals other than humans and major species. Animals such as zoo animals, ornamental fish, parrots, ferrets, and guinea pigs are all considered minor species. Additionally, some animals of agricultural importance (e.g., sheep, goats, catfish, game birds, honey bees, etc.) are also considered minor species.
There are certain provisions for the approval of Minor Use/Minor Species (MUMS) drugs designed to offset the financial burden in bringing these products to such a limited market. These provisions include:
Conditional Approval - the sponsor can apply for conditional approval of a MUMS drug through the Office of New Animal Drug Evaluation (ONADE). Conditional approval allows a drug sponsor to legally market the MUMS drug after proving it is safe, but before collecting all the necessary effectiveness data. While collecting the effectiveness data required, if the FDA approves the sponsor's annual renewal requests, the drug sponsor can keep the product on the market for up to five years.
Designation – modeled on the "Orphan Drug Act" for humans, the incentives for "designated" new MUMS animal drugs include grants, to support drug approval or conditional approval, and seven years of exclusive marketing rights after approval or conditional approval is granted.
Indexing – applies to cases where a minor species drug is intended for use in species that are too rare or too varied to be the subject of adequate and well-controlled studies in support of a drug approval. Drugs for species such as zoo or endangered animals, or classes of animals that include numerous different species, such as ornamental fish would fit this category. These minor species drugs may be added by the FDA to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index). It is important to note that this provision is limited to minor species that are not used as food for humans or other animals.
Additionally, sponsors of minor use and minor species drug development projects are eligible to apply for waivers from user fees. Waiver requests are handled by the Office of New Animal Drug Evaluation (ONADE), although it is the Office of Minor Use/Minor Species (OMUMS) that determines whether a particular intended use in a major species constitutes a "minor use".
More detailed information on Minor Use/Minor Species (MUMS) may be accessed via the following link:
Minor Use/Minor Species (MUMS) Grant Program
A grant program to support the development of new animal drugs intended for Minor Uses in major species (e.g., horses, dogs, cats, cattle, pigs, turkeys and chickens) or Minor Species (MUMS), was initiated in May 2009. Currently, for the fiscal year ending September 30, 2009, the FDA has $750,000 to offer in MUMS grants.*
MUMS grant awards are for the express purpose of defraying the costs of qualified safety and effectiveness testing expenses incurred in connection with the development of designated new animal drugs.
|MUMS grants for:
| Routine studies
|| $50,000 per year for up to two years
| Studies of unusual complexity, duration or size
|| $100,000 per year for up to two years
| Long-term toxicology study
|| $300,000 total for three years
Further details about the MUMS Grant Program can be accessed via the following link: http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm161627.htm
Current Good Manufacture Practices (cGMP)
In the U.S. the Good Manufacture Practices (GMP) regulations for veterinary and human drugs are identical, the only difference being that they are enforced by separate regulatory bodies within the FDA, namely the CDER (Center for Drug Evaluation and Research), CBER (Center for Biologics Evaluation & Research), or CVM (Center for Veterinary Medicine). Current Good Manufacture Practices guidance documents may be accessed via the following link:
Research by Diane Meade