Classifying RX and OTC Animal Drugs

A Brief Overview of CVM’s Drug Approval Process

A Brief Overview of CVM’s Drug Approval Process

Under the Act, the term “drug” means articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary; 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. It also includes articles intended for use as a component of a drug.

Once a product is determined to be a drug for animal use, the next step is to determine whether or not it is a new animal drug. The Act defines a new animal drug (in part) as any drug intended for use for animals other than man, the composition of which is not generally recognized, among experts qualified by scientific training and experience, as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. By virtue of Supreme Court interpretations of the necessary basis for general recognition, there are, for all practical purposes, no animal drugs which are not also new animal drugs. The Animal Drugs @ FDA, accessible from the CVM Home Page contains a searchable database of all FDA-approved animal drugs.

An unapproved new animal drug may be distributed in accordance with 21 CFR Part 511 if the drug will be used for research, i.e., for the collection of data intended to be submitted in support of an NADA approval. Investigational New Animal Drug (INAD) regulations provide that such drugs may be distributed for use only by experts, qualified by scientific training and expertise, to investigate the safety and effectiveness of animal drugs.

Before a new animal drug may receive FDA approval, the sponsor must establish that the new animal drug is safe and effective.

Safe includes safety to the animal, safety of food products derived from the animal, safety to persons administering the drug or otherwise associated with the animal, and safety in terms of the drug’s impact on the environment.

Effective means that the product will consistently and uniformly do what the labeling claims it will do.

Drug sponsors submit a New Animal Drug Application (NADA) along with supporting data, including all adverse effects associated with the drug’s use. The NADA must also include information on the drug’s chemistry; composition and component ingredients; manufacturing methods, facilities, and controls; proposed labeling; analytical methods for residue detection and analysis if applicable; an environmental assessment; and other information. The sponsor of a new animal drug is responsible for submitting all appropriate data to establish effectiveness and safety. If the drug product is intended for use in a food-producing animal, residues in food products must also be established as safe for human consumption.

FDA review of the NADA submitted by drug sponsors is very detailed and comprehensive. FDA scientists will determine whether the data have been developed in accordance with either Good Laboratory Practice Regulations or clinical trial guidance. If the studies were conducted properly, the data are evaluated with respect to drug safety and effectiveness. The animal safety data for a drug product must relate to the dosage levels and routes of administration proposed in the labeling. The primary objective is to determine the safety of the product relative to labeled usage.

At the conclusion of the animal safety review, a summary is prepared which explains why the product is safe or not shown to be safe. If the product has been shown to be safe but some restrictions or constraints on use are needed, all warning and precaution statements to be placed on the label must be enumerated and included in the summary, as well as any expected side effects.

All effectiveness data submitted must relate either directly or indirectly to the specific label and labeling claims made for the product. The sponsor must demonstrate that the product produces the claimed effect.

With respect to human food safety, it is the responsibility of the producer or sponsor of the animal drug to furnish FDA with the scientific information and experimental data that demonstrate that the presence of residues of the animal drug in the edible food products of the animal are safe for the consumer of the food product. The term “residues” applies to the parent drug and/or its metabolites. Detailed guidance on the studies required for animal drug approval is available from the Center for Veterinary Medicine (CVM). To assure that human food of animal origin can be monitored for the presence of drug residues, FDA requires sponsors of drugs for food animal use to provide acceptable analytical methods capable of determining and confirming the animal drug or its metabolites in the animal tissue.

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