The Regulatory Approval Process of Animal Drugs
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Drug Information Journal, Vol. 33, pp. 33-39. 1999
Copyright 0 1999 Drug Information Association Inc.
Printed in the USA. All rights reserved.
THE REGULATORY APPROVAL PROCESS OF ANIMAL DRUGS STEPHENJ. GILBRIDE Clinical Safety Manager, Pfizer Inc., New York, New York
MICHAELJ. MCGOWAN,PHD Director, Animal Health Regulatory Affairs and Research Quality and Compliance, Pfizer Inc., Groton, Connecticut
The marketfor animal drugs is viable and lucrative, yet little information on the regulatory processes for them is readily available. This paper provides a review of the regulatory process for animal drugs, directed toward the pharmaceutical professional who understands the regulatory approval process of human drugs but has little exposure to the approval process for animal drugs. Comparisons will be made between the human and animal drug approval process. Key Words: Regulatory approval; Animal drugs; Human drugs
INTRODUCTION
Mine Beecham, American Home Products and Solvay, Boeringer Ingelheim and Fermenta, Rhone Merieux and Merck, and Mallinckrodt and Schering are indicators that the larger pharmaceutical companies are creating strategic alliances to keep sales for animal drugs increasing. These mergers also indicate that this is a viable and lucrative market. This paper intends to review the regulatory process for the approval of animal drugs. It is directed toward the pharmaceutical professional who has knowledge of the regulatory approval process of human drugs, but relatively no exposure to the approval process of animal drugs. In addition, it will compare and contrast the animal drug approval process with the human drug approval process.
ANIMAL HEALTH IS a burgeoning industry and has been so for some time. Very little is written, however, about drugs given to companion animals such as dogs and cats and food animals such as cattle and swine which translate into food that most Americans consume. Neither is there much information readily available on the regulatory processes for animal drugs. To gather such information, one must go beyond the usual pharmaceuticaljournals to periodicals which are industry-specific to animals. Between 1993 and 1995, the sales of prescription drugs for companion animals rose 45% to reach $1 billion, according to the Animal Health Institute. The sales of drugs to farm animals remains twice as high compared to companion animals (1). The recent mergers/acquisitions of Pfizer and Smith-
BACKGROUND Throughout history, governments have long been concerned with the foods people eat. Early Greece and Rome had wine inspectors to guard against adulteration. Even some religious customs dictate which foods can be
Reprint address: Stephen J. Gilbride, Clinical Safety Manager, Pfizer Inc., 235 East 42nd Street, 150/3/58, New York, NY 10017.
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Stephen J. Gilbride and Michael J. McGowan
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ing from the shocking stories detailed in Upton Sinclair’s The Jungle. In his account of the food packing industry i
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