CVM MEMO
CVMM-12
PRESCRIPTION NEW ANIMAL DRUG ADVERTISING
FOOD AND DRUG ADMINISTRATION, CENTER FOR VETERINARY MEDICINE COMMUNICATIONS AND EDUCATION BRANCH, HFV-12, 301/594-1755
Revised January 1995
Center for Veterinary Medicine
D.H.H.S. Pub. No. (FDA) 95-6001
U.S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
7500 Standish Place, HFV-12, Rockville, Maryland 20855
Pharmaceutical houses producing veterinary prescription drugs, and firms planning to enter this field, are advised that advertising for such drugs falls under the same regulations that affect human prescription drug advertising. Firms should be alerted that the advertising regulations will be uniformly applied for all veterinary prescription drugs.
When an advertisement is developed for a new animal prescription drug, the firm should be sure that adequate documentation is on file in the appropriate New Animal Drug Application (NADA). Undocumented claims of effectiveness or superiority of drugs are considered "false and/or misleading advertising." In addition, Title 21 of the Code of Federal Regulations (CFR), Part 510.300(b)(3) states that "advertising ... devised for the promotion of new animal drugs shall be submitted (to the Center for Veterinary Medicine) at the time ... of initial publication of any advertisement for prescription drugs and at the time of initial dissemination of promotional labeling."
Failure to comply with these regulations may result in withdrawal of approval of the firm's New Animal Drug Application.
Pharmaceutical houses in the veterinary prescription drug business are urged to check on regulations regarding these drugs in order to avoid violations. 21 CFR 202.1 (Prescription Drug Advertising) spells out FDA regulations concerning prescription drug advertisements. This section provides specific guidelines regarding permissible advertising materials. Firms are urged to use these guidelines in the development of their advertising.
Changes in the regulations may be made from time to time. Such changes are published in the Federal Register (FR) and become part of Title 21 CFR. These publications may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.
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