It has come to our attention that there are a number of products available over-the-counter (OTC) for the topical treatment of wounds in livestock that have not been subjected to the Federal Drug Administration (FDA) approval process. Use of these products in food-producing animals is illegal for producers and veterinarians even under the Animal Medicinal Drug Use Clarification Act (AMDUCA), which only allows for the extra-label use of APPROVED products.
According to the FDA, there are many animal and human health products available for sale OTC that have not received agency approval. While FDA officials admit these products should not be available for purchase, many have been marketed for years with no apparent adverse effects. The challenge is to determine which products have received FDA approval and which have not. All FDA-approved products are assigned a New Animal Drug Application (NADA) number. According to officials, however, there is no requirement that the NADA number appear on the label or that the label contain any information indicating that the product is FDA approved. Therefore, you cannot look at a product label and determine that it is, in fact, approved for use in animals or humans, unless it happens to display a NADA number.
The only way to know for sure that the products you purchase are FDA approved is to look for a NADA number on the label or verify that the product is listed on the FDA’s database of approved animal drugs. This database, entitled “Animal Drugs@FDA,” is available online (http://www.accessdata.fda.gov/scripts/animaldrugsatfda/) and can be searched by NADA number, ingredient, common name, species, route of administration, dose form, or manufacturer. If a product is not on this list, it is not approved for use, even in an extra-label manner, in food-producing animals.
Unfortunately, there are no FDA-approved products for the topical treatment of wounds specifically in swine. So what options are available for swine producers and veterinarians to address the welfare and animal-health concerns associated with wound treatment in pigs? Upon review of the FDA database, approximately 20 products are approved for use in animals as a topical wound treatment. Of these products, five are available OTC. Two of these, Trypzyme®Aerosol and Granulex Aerosol Spray, do not list a particular species, but rather just state for use “in animals.” According to communications with FDA officials, veterinarians and producers could use either of these two products legally in swine as per label instructions. The other three OTC products, Nolvasan®Antiseptic Ointment, Kopertox®, and Horseshoer’s Secret Thrush Treatment Aid (formerly Thrush-XX), all indicate for use in species other than food animals, and thus their use in swine would be considered extra-label. They could, however, be prescribed for use in swine by a licensed veterinarian under the guidelines of AMDUCA if the two approved products were found to be ineffective.
Many of the prescription products on the approved list of topicals have established tolerances for tissue residues in food-animal species, although they are not approved for use in those species. These tolerances can be found in the FDA database and may provide some guidance when determining withdrawal periods if prescribed for use under AMDUCA. You will also notice that many of the product labels contain the statement “not for use in animals intended for food” or something to that effect. According to FDA officials, this statement does not preclude the use of these products in food animals: it simply means the product has not been evaluated for use in animals intended for human consumption. Therefore, as approved products, they could be prescribed by a veterinarian for use in swine in an extra-label manner under the conditions set forth in AMDUCA.
Members of AASV can access a spreadsheet on the AASV website, entitled “FDA Approved Topicals” (http://www.aasv.org/members/only/FDAApprovedTopicals.pdf), listing the 20 approved topical products for wound treatment in animals. Take note, however, that of the 20 products, only the two trypsin-based products can be used in food-producing animals without veterinary prescription. The other products on the list could be prescribed by a licensed veterinarian on an extra-label basis assuming the criteria set forth under AMDUCA are met.
Note: Following the initial publication of this article on October 28, we received a number of questions about a couple of products being promoted for the treatment of wounds in swine which were not included on the list of approved topical products. The AASV contacted FDA for clarification of the status of these specific products; FDA officials confirm that the only products that are legally available for use in the topical treatment of wounds in swine are those that are listed on the FDA’s approved drug database. If you have a question regarding a specific product that is not included on the FDA’s list, we suggest you contact FDA directly at 240-276-9300 or by e-mail at AskCVM@fda.hhs.gov.
Alternate Student Delegate to AASV board selected
The AASV Student Recruitment Committee has selected Jessica Hendrickson (University of Illinois, 2012) as the incoming Alternate Student Delegate to the AASV Board of Directors.
Jessica’s family owned a farrow-to-finish operation until the 1990s and she has expressed an interest in swine medicine throughout veterinary school. She has worked at the University of Illinois’ Swine Research Center and was selected in 2009 by the Swine Vet Center in St Peter, Minnesota, for their summer internship program. In 2007, she traveled to Denmark to work with the Danish Institute of Agriculture conducting swine research.
Jessica will replace Darin Miller as alternate delegate during the 2010 AASV Annual Meeting in Omaha, Nebraska. Darin will succeed Jess Waddell as Student Delegate. Along with Darin, Jessica will represent student interests within AASV as nonvoting members of the board of directors. Please join us in welcoming Jessica to the board.
AVMA supports comprehensive surveillance system
Dr Bill Hollis, the AASV’s delegate to the American Veterinary Medical Association’s (AVMA’s) House of Delegates (HOD), authored a resolution seeking support from the AVMA for the swine industry’s efforts to promote a comprehensive and integrated swine surveillance (CISS) system. The resolution was considered by the HOD during their winter meeting January 9 in Chicago, Illinois.
The AASV and the swine industry have been working with the United States Department of Agriculture (USDA) for a number of years to promote a change in the way animal-disease surveillance programs are undertaken. The goal is to move away from disease-specific surveillance programs to a more comprehensive system that adds additional flexibility to monitor a broader list of pertinent diseases, including emerging syndromes and zoonotic diseases. The need for this type of surveillance program was highlighted by the recent novel H1N1 outbreak. This change is also in line with the vision of the USDA 2015 strategy and has received support from USDA as a model for a potential shift for all surveillance programs.
Following some discussion during the AVMA’s Allied Caucus meeting, the HOD passed the resolution by a unanimous vote. The group expressed interest in broadening the support in the future to include a similar effort for all pertinent animal species. For more information about the CISS, please read the “Advocacy in action” column in this issue of JSHAP