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U.S. Department of Health and Human Services

Animal & Veterinary

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20 Years of Generic Veterinary Drugs: Serving Animals and the Public Health

FDA Veterinarian Newsletter 2008 Volume XXIII, No V

CVM’s Generic Drugs Team Headed by Dr. Ken Harshman

The Generic Drugs Team at the Center for Veterinary Medicine is led by Dr. Ken Harshman, a veterinarian with more than 20 years practice experience and a background in pharmacology.

Dr. Harshman became the Generics Drugs Team leader in June 2006. He first came to CVM in November 2002, joining the Generic Drugs Team. Before that, he was a practicing veterinarian, with two clinics in northern Montana. One of the clinics focused on small animals. The other was a mixed animal practice, and his patients included cattle, horses, and an occasional American bison. (He said treating bison posed some special problems. For as large as the animals are, they can be very quick, he said.)

Dr. Harshman received his D.V.M. from Colorado State University College of Veterinary Medicine, and his Master’s degree in pharmacology from the University of Utah. His staff currently numbers 12, an increase of four since Congress passed the Animal Generic Drug User Fee Act (AGDUFA). As additional resources become available under AGDUFA, the team will be expanded to total 16.

In 1988, Congress passed the Generic Animal Drug and Patent Term Restoration Act (GADPTRA), giving the Food and Drug Administration the authority to approve generic animal drugs. Since then, the number of approved generic animal drugs has steadily increased. In fact, over the past 5 years, the Center for Veterinary Medicine has approved more generic new animal drug applications than new, or “pioneer,” animal drugs.

A generic new animal drug is a copy of an approved pioneer animal drug that FDA has already determined to be safe and effective for its intended use or uses. The intent of Congress in passing GADPTRA was to create a program that allows generic animal drug sponsors the opportunity to bring their products to market without duplicating the scientific investigations required for establishing the safe and effective use of the pioneer animal drugs. In lieu of establishing new safety and effectiveness information, the generic drug sponsor must demonstrate that its generic product is bioequivalent to a reference pioneer drug as determined by FDA.

The program has worked well. Ken Harshman, D.V.M., leader of CVM’s Generic Animal Drugs Team, says that the introduction of generic animal drugs to the marketplace has resulted in a reduction in the cost of animal drugs used in companion and food-producing animals. This reduction in cost benefits animal health by ensuring an adequate supply of affordable drugs for the prevention, treatment, and control of disease. In addition, the competitive environment resulting from the availability of generic animal drugs also serves as a stimulus for the pharmaceutical industry to develop new innovative drugs.

Since GADPTRA, CVM has approved more than 270 original generic animal drug applications. The rate of approvals has been increasing. Ninety-four of these approvals, or 35 percent, were approved in just the past 5 years. (Also during the past 5 years, CVM approved 75 pioneer new animal drugs.)

Dr. Harshman attributes this increase in generic animal drug approvals to a growing interest among drug sponsors in the animal health industry to develop an inventory of generic animal drugs. As people see human generic drugs prescribed more frequently, animal owners inquire about the availability of less expensive generic drugs for their animals. This public awareness places a greater demand for the availability of more affordable generic animal drugs.