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11 FDA Veterinarian 1 (1996)

handle is hein.animal/fdavt0011 and id is 1 raw text is: IS HE To.- 'J DOCUMENT PERIODICAL January/February 1996 ~F DA N PIMN Vol. XI, No. I DOES NOT C(W LATE WI ERNARL4N ,WHY VETERINARY DRUGS ARE NOT ALWAYS AVAILABLE CVM has adopted a new strategic plan which emphasizes the Center's role in enabling the availability of effective animal drugs, food additives, feed ingredients, medicated feeds, and animal devices that are safe to animals, humans, and the environment. The Center is very sensitive to veterinarians' need for effective and safe drug therapies to provide for the health and welfare of animals under their care. CVM also recognizes that veterinarians are concerned when they seem to have a shrinking supply of approved animal drugs on the market. In addition, some have questioned why certain drug products have been withdrawn from the market when there are no approved products to replace them. The following article discusses this issue. Animal drugs, food additives, and animal devices are regulated un- der the Federal Food, Drug, and Cos- metic Act (the Act). The Act requires that new animal drugs be shown to. be safe and effective by the sponsor before the products are approved by the Food and Drug Administration (FDA). Safety for food animal drugs covers three main areas: safety of the food products to humans, safety to the target animal, and safety to the environment. In addition, com- panies must show that they can con- sistently manufacture the drug to a specific potency and purity, and pro- vide adequate methods for detect- ing drug residues or metabolites in target tissues such as muscle, liver, kidney, fat, milk, and/or eggs. Lack of New Animal Drug Applications In some cases, animal drug com- panies choose not to go through the time and expense of having a new animal drug approved because, for certain types of drugs, the market is too small to justify the expense. Thus, the profit from a new approval does not project a favorable return on the research investment. A prime example of this problem is in the case of drugs needed for use in minor animal species or in any animal spe- cies for the control of a disease that occurs infrequently. To help increase availability of mi- nor use/minor species drugs, CVM has been an active supporter of the National Research Support Project (NRSP) #7 (formerly the IR-4 Pro- gram.) This program is dedicated to developing new drugs for use in mi- nor animal species or in any animal species for the control of a disease that occurs infrequently or in limited geographical areas. CVM supports the NRSP #7 in a number of ways. A full time em- ployee assists the program, and CVM cosponsors various workshops and meetings with NRSP #7 to provide a forum for exchange of ideas among minor species producers, drug manu- facturers, researchers, and govern- ment agencies on approaches to dis- ease problems and drug priorities. As a result of the NRSP #7, 20 pub- lic master files (PMFs) have been published in the Federal Register. PMFs contain target animal safety and effectiveness data and environ- mental assessment to be used in support of new animal drug applica- tions (NADAs) or supplemental NADAs. These PMFs are for small ruminants (such as goats, sheep, and reindeer), game birds (such as pheas- ants, quail, and chukar partridge); aquatic species (such as catfish, lob- ster, shrimp); and for fur-bearing species (such as rabbits and foxes). Approximately 85 percent of these PMFs have led to drug approvals. Drug companies may also be reti- cent to go through the approval pro- cess when they recognize that other drugs approved for different species/ indications are being used in an ex- tra-label manner. Extra-label use (ELDU) would be any use of an ap- proved drug product in a manner other than as directed on its label. Drug companies may be aware that a drug approved for use in humans is commonly used in an extra-label manner in dogs and cats. The com- panies may decide not to pursue an NADA for the drug in dogs or cats because some veterinarians might continue to use a human product, rather than purchase an approved veterinary product. This is especially true if the increased production costs of short manufacturing runs for the animal drug are expected to compete CVM is completely com- mitted to improving the availability of approved new animal drugs. in price with the human product which has longer and more efficient manufacturing runs. CVM is improving the drug ap- proval process to encourage more (Continued, next page) In This Issue Current Issues at CVM .......... 5 Anti-Microbial Drug Screening Tests for Milk Monitoring ... 7 Analysis of Tissue Residues ... 11 CVM Announces Opinion on Dipyrone Products........ 12 U.S DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR VETERINARY MEDICINE

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