FDA considers an “unapproved animal drug” to be a drug that:
- Is intended for use in animals; and
- Meets the definition of “new animal drug” in the Federal Food, Drug, and Cosmetic (FD&C) Act; but
- Does not have legal marketing status, meaning FDA has not approved, conditionally approved, or indexed the drug.
To better understand this, a couple of definitions are in order.
First, what’s a drug? The FD&C Act defines “drug” to include, among other things, “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”1
The intended use of a product determines if it’s a drug. Here are a few examples to illustrate this concept:
- When a company sells bottled water for people to drink as a beverage, the water is not a drug. But if the company sells those same bottles of water as a cure for cancer in dogs, then the water is a drug under the FD&C Act because the intended use is to cure a disease (cancer) in dogs.
- When a company sells formaldehyde for a car manufacturer to use to make automotive parts, it’s not a drug. But when a company sells formalin—a solution of formaldehyde—for a fish biologist to use to kill external parasites on finfish, it’s a drug under the FD&C Act because the intended use is to treat a disease (parasitism) in fish.
- When a company sells a product claiming it makes cows ovulate at the same time, the product is a drug. Although it’s not treating or preventing a disease in the cows, the product’s intended use is to change how their bodies function, which makes it a drug under the FD&C Act.
Second, what’s a new animal drug? The FD&C Act defines “new animal drug” as a drug intended for use in animals that is not Generally Recognized As Safe and Effective (GRASE) by qualified experts for the uses listed on the label.2 Taken in the reverse, if a drug is GRASE, then it’s not a new animal drug under the FD&C Act. For an animal drug to be GRASE, the experts must generally agree that, based on published studies, the drug is safe and effective for its intended uses.
There is a very narrow exception to the definition of a new animal drug and that is grandfathered drugs. For an animal drug to be grandfathered, it must have been approved under the 1906 Food and Drug Act and before June 25, 1938 (the date President Franklin Roosevelt signed the FD&C Act into law), and its label and composition have not changed since that time. If a drug is grandfathered, then it’s a not a new animal drug under the FD&C Act.
FDA thinks it’s very unlikely that any currently marketed animal drug would be considered GRASE or would qualify for the “grandfather” exception. And so, if a drug is intended for use in animals, it’s almost certain to be a new animal drug.
The entire term “new animal drug” is defined by law and applies to any product which fits that definition. The adjective “new” doesn’t mean the drug just went on the market; some “new animal drugs” have been marketed for years. For example, the drug ivermectin has existed for decades and even though FDA originally approved it to prevent heartworm disease in dogs in March 1987,3 ivermectin is still a “new animal drug” under the FD&C Act.
As required by the FD&C Act, new animal drugs must be reviewed by FDA for safety and effectiveness and obtain legal marketing status before they can be marketed. The pre-market review is integral to FDA’s ability to protect public health. During the review, the agency evaluates information submitted by the drug company to make sure the drug is safe and effective for its intended use and that the drug is properly manufactured and properly labeled.
The FDA pre-market review is also necessary for the drug to obtain legal marketing status through an approval, conditional approval, or indexed listing.4 After the drug company gets a new animal drug approved, conditionally approved, or indexed by FDA, the company can legally market it for the uses listed on the label.
Unapproved animal drugs are new animal drugs that don’t have legal marketing status. They have not been approved, conditionally approved, or indexed by FDA. It’s illegal for drug companies to market unapproved new animal drugs because they haven’t gone through the FDA pre-market review and obtained legal marketing status under the FD&C Act. Unapproved animal drugs may not meet the agency’s strict standards for safety and effectiveness and may not be properly manufactured or properly labeled.
An approved animal drug has gone through the New Animal Drug Application (NADA) process, or for an approved generic animal drug, the Abbreviated New Animal Drug Application (ANADA) process. If the information in the NADA or ANADA meets the requirements for approval, FDA approves the animal drug. FDA’s approval means the drug is safe and effective when it is used according to the label. FDA’s approval also ensures that the drug’s strength, quality, and purity are consistent from batch to batch, and that the drug’s labeling is truthful and complete.
A conditionally approved animal drug has gone through the New Animal Drug Application process except the drug has not yet met the effectiveness standard for full approval. FDA’s conditional approval means that when used according to the label, the drug is safe and has a “reasonable expectation of effectiveness.”
The conditional approval is valid for one year. The drug company can ask FDA to renew the conditional approval annually for up to four more years, for a total of five years of conditional approval. During the 5-year period, the drug company can legally sell the animal drug while collecting the remaining effectiveness data. After completing the effectiveness requirement, the company then submits an application to FDA for full approval. The agency reviews the application and, if appropriate, fully approves the drug. Conditional approval is only available for drugs for minor species or minor uses in a major species.
Minor species are all animals that are not major species. The seven major species are cattle, horses, pigs, chickens, turkeys, dogs, and cats. Ferrets, eagles, fish, and sheep are examples of minor species.
A minor use in a major species is using a drug in a major species for a condition that occurs:
- Infrequently and in only a small number of animals each year; or
- In limited geographic areas and in only a small number of animals each year.
For example, using a drug to treat a rare disease in dogs is a minor use in a major species.
Learn more about minor species and minor uses by visiting the following website:
Learn more about the drug approval process by visiting the following websites:
- New Animal Drug Applications; and
- From an Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process
Learn more about the conditional drug approval process by visiting the following website:
An indexed animal drug is a drug on FDA’s Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, referred to as “the Index.” Although technically unapproved, a drug listed on the Index has legal marketing status. It can be legally marketed for a specific use in certain minor species. Indexing is allowed for drugs for:
- Non-food-producing minor species, such as pet birds, hamsters, and ornamental fish. These animals are typically not eaten by people or food-producing animals; and
- An early non-food life stage of a food-producing minor species, such as oyster spat (immature oysters). Because people do not generally eat oyster spat, a drug to treat a disease in spat can be indexed, but a drug to treat a disease in adult oysters, which people commonly eat, cannot be indexed.
Indexing a drug is a three-step process. A panel of qualified experts outside FDA reviews the drug’s safety in the specific minor species. The panel also reviews the drug’s effectiveness for the intended use. All members must agree that, when used according to the label, the drug’s benefits outweigh the risks to the treated animal. The panel submits a report containing its recommendation to FDA. If FDA agrees with the panel, the agency adds the drug to the Index.
Learn more about indexing by visiting the following websites:
1 Section 201(g)(1)(B) & (C) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(g)(1)(B) & (C)]
2 See Section 201(v) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(v)]
3 HEARTGARD-30, New Animal Drug Application (NADA) 138-412
4 Conditional approval and indexing, created by the Minor Use and Minor Species Animal Health Act of 2004, are only available for certain uses.
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