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Next Column
 Dr. Jim Randolph
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There has been a tremendous slowdown in the animal drug approval
process in recent years despite the quadrupling of research and
development dollars spent developing new treatments. As a result, both
food and companion animals have suffered from a lack of animal drugs
available to treat disease conditions.
Dr. Stephen Sundlof, the Director of Food and Drug Administration's Center for Veterinary Medicine, also believes that a lack of animal drugs constitutes the largest threat to food safety. In the last five years, only six new animal drugs have been approved for use in food animals. Needed drugs go undeveloped because of the prohibitive time it takes to get a drug through the FDA approval process. Export laws regarding animal drugs are also extremely prohibitive and force many companies to locate their facilities overseas causing a loss of U. S. jobs. The Coalition for Animal Health, consisting of the American Veterinary Medical Association and many producer and pharmaceutical industry groups, has spent many months reviewing the current FDA approval process and pinpointing areas that cause slowdowns. Legislation has been developed to address these critical issues. An example of the effect, which will hit close to home, is the breakthrough anti-flea medication, Program. It has been available in Europe and Caribbean countries for over 5 years. FDA just approved it for use in the US this year. Think of how many other medications you know of on the human side which have proven themselves safe and effective in other countries, but still are not available here. The same thing happens with animal-use drugs. Some drugs just never even get invented. The Coalition for Animal Health has drafted legislation which aims to increase animal drug availability while maintaining stringent human health requirements for proving that a product is safe for people and animals. The Senate legislation was introduced by Senator Nancy Kasselbaum (R-KS). A companion bill, H.R. 2508, was introduced on the House side by Reps. Wayne Allard (R-CO), Scott Klug (R-WI) and Charles Stenholm (D-TX). There is strong bi-partisan support for these bills. If you would like to help, contact Congressman Gene Taylor, and ask him to co-sponsor H.R. 2508 by calling Lora James of Congressman Allard's staff at 202-225-4676. In addition, contact Senators Lott and Cochran to ask them to co-sponsor the Senate bill. Your pet's doctor, and your pet are counting on you, for health's sake.
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