On March 29, the Food and Drug Administration's Center for Veterinary Medicine solicited comments related to Veterinary Feed Directive (VFD) drugs through an advance notice of proposed rulemaking (view it at http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm206400.htm).
While this subject is likely new to most beef producers, it's familiar to swine producers and those in aquaculture. In swine, tilmicosin is used in feed as Pulmotil (Elanco); we use the same active ingredient in cattle as the injectable drug Micotil. We use florfenicol in cattle as the injectable formulations of Nuflor (Intervet Schering-Plough); in catfish, it's labeled for use in feed as Aquaflor. In both of these feed examples, use is approved only under the supervision of a veterinarian through a VFD, which requires extensive paperwork. There is an electronic VFD process available for Pulmotil.
Why should the beef industry be concerned when none of our feed antimicrobials are labeled as requiring a VFD? I think it's because the writing is on the wall that veterinary oversight of our feed antimicrobials will likely increase in the future. The VFD process is one possible way to do this, and our industry should be engaged in the discussion related to how this process would work. We may see new approvals in the future with VFD status, or we may see reevaluation of existing labels with subsequent modification to a VFD or VFD-like status.
There are no provisions for extralabel use under the VFD system in swine and aquaculture, just as there are no legal provisions for extralabel use of feed additives with our current labels for cattle. There are already restrictions on drug use in feed that are unique to this method of application.
Two feed additive drugs can't be used together unless labeled for concurrent use.
Topdressing of a feed drug on a ration that contains another drug is considered concurrent use.
Feeding one drug in the morning and another in the afternoon (AM/PM feeding) is considered concurrent use.
The most likely change the beef industry would see is a movement to feed drugs (primarily antimicrobials) being used within the confines of a veterinary-client-patient relationship as currently is in place for prescription drugs. Regulatory attention to the existence of over-the-counter antimicrobials is also mounting.
Concerns have been voiced about having enough food-animal veterinarians to absorb this additional oversight responsibility. There are a lot of additional questions. Will the oversight be like writing a prescription for current prescription products, or something similar to the current VFD process?
Would the oversight be on the basis of an individual group of animals, or applicable to a location for a specified period of time? Would the veterinarian be required to diagnose the need in each group, or establish conditions of use and educate on the proper use of the drug as in the current prescription process? Will the practice of veterinary medicine be regulated by stipulating the precise criteria the veterinarian must apply to establish a need for use?
We've talked here in the past about legislation pertaining to antimicrobial use in food animals. But this isn't about legislation, it's about regulation. Regulation occurs in an environment where people in the agency tasked with the particular area attempt to work with the science. But, as the process moves further up the regulatory hierarchy, science is replaced by politics in the form of legislative committees that hold regulatory agency purse strings, and politically appointed commissioners more responsive to public opinion and political pressure, which are often influenced by the news media.
Changes in feed antimicrobial use are likely, and our industry must be actively engaged in the discussion of what form increased veterinary oversight of feed antimicrobials might take. After all, we'll be living with the results.
Mike Apley, DVM, Ph.D., is a professor in clinical sciences at Kansas State University in Manhattan.