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Tony Benitz and Robert Dodemaide are continually involved in a race between science and time. Benitz is Hoechst Roussel Vet's director of research and development in North America, and Dodemaide is manager of quality assurance and regulatory affairs. They are charged with seeking approval for new HR Vet products -- or extended uses for older products -- from the U.S. Food and Drug Administration (FDA), a process that often takes from five to seven years. Guiding Products through the Approval Process After a new compound is developed, HR Vet's International Product Selection Committee decides whether it would be feasible to market the product in the United States. After the feasibility study is completed, Benitz's group draws up a new product proposal and Dodemaide's group sets up a preliminary meeting to discuss the proposal with the FDA.
After this meeting, Benitz's group develops a much more detailed plan, including a step-by-step time table. This plan is carefully checked by Dodemaide, since he is the only direct link with the FDA. The plan is then reviewed with the Center for Veterinary Medicine (CVM), the group in the FDA that approves all animal health care drugs. "We have higher hurdles than human pharmaceuticals because we must produce drugs that are safe for animals and for human beings, since most of HR Vet's products are used in animals that will eventually be consumed," Benitz said. " That's why the full product development and approval process can take five to seven years, and millions of dollars. And, it's getting longer." The key to success is the close teamwork between Benitz's and Dodemaide's groups. One group is basically in charge of setting up the plan which includes all the studies, process checkpoints and the responses to the CVM's suggestions. The other group critiques the process to assure it is as free of errors as possible. Continuous communication with CVM is crucial to maintaining an efficient development process. "Errors up front can cost you critical time down the line," said Dodemaide. "We have to keep in mind that the CVM's primary interest is the safety of the consumer, followed by the safety of the target animal, the environment and then product efficacy. We certainly take all of these objectives very seriously, but we take a very keen interest in product efficacy, which sells our product." Human food safety comes down to withdrawal time, which emerges from three separately tested factors: toxicology studies, metabolism rate and residues. The shorter the withdrawal time, the less complicated the product development, approval and registration process becomes. The goal is to receive "technical section complete" letters in each of the five areas: human food safety; product efficacy; target animal safety; environmental safety; and manufacturing. After receiving these, a New Animal Drug Application, or NADA, is submitted for approval. Timing is Everything Timing rules the whole procedure. "Being first could mean millions of dollars in extra revenues. Then you can go for the bells and whistles, like additional product applications. In a sense, you can build up your label claim as you go along," said Benitz. The process requires precision and some of the most demanding record keeping in the Western Hemisphere. "One must remember the Food, Drug and Cosmetic Act is a criminal code," said Dodemaide. "The FDA can make surprise visits, and we've had them." Stretched-out Approvals In the late 1990's, the approval process has been slowed down. Part of the problem centers around Congress trying to find ways to speed the process up, which causes an increased workload for the people at the FDA, which in turn causes the process to take longer. Concern over high-profile drug approvals, and the drive for new guidelines in such sensitive areas as antibiotic growth promotant use, have helped to turn the process almost glacial. In addition, the FDA budget has been sliced 40 percent in real dollars over the last five years and fewer people are being asked to do more work. The result: Queries that once called for a 45-day response time under the FDA guidelines can now take the better part of a year. Editor's Note: Since this story appeared in the June 1999 issue of Hoechst Roussel Vet's publication, Perspectives, Tony Benitz has left the company for other employment. Dr. Reiner Roepke will be relocating from HR Vet in Germany in January to fill the position. 
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