Feed yards, dairies and the veterinarians and nutritionists who serve them soon will face significant changes in the ways they use medicated feeds. Over the next three years, the FDA will implement new policies, phasing out the use of medically important antimicrobials for non-therapeutic uses in animals and requiring more veterinary oversight for therapeutic uses of those products delivered in feed.
FDA initiated its judicious-use efforts in 2010, by issuing Draft Guidance 209, which was finalized in 2012. Also in 2012, the agency issued Draft Guidance 213, which provides details on the implementation of Guidance 209.
To summarize the issues and outline the proposed changes, the FDA’s Center for Veterinary Medicine and the American Academy of Veterinary Pharmacology and Therapeutics held a workshop on May 22-23 in Potomac, Md. FDA veterinarian Craig Lewis, DVM, MPH, DAVCPM, described some of the changes veterinarians can expect to see.
Lewis said FDA intends to finalize Guidance 213 this year. Within three years of finalization, FDA expects drug manufacturers to specify their intended changes to labels of affected drugs. Also this year, FDA plans to issue its proposal for streamlining the Veterinary Feed Directive (VFD) process and bringing affected drugs under the VFD. That proposal will be subject to a public comment period, but FDA hopes to move toward finalization and implementation within the same three-year timeframe as for implementation of Guidance 213. Under the draft guidance, a range of drugs currently available over the counter would fall under the VFD if used in feed or water. These include: aminoglycosides, lincosamides, macrolides, penicillins, streptogramins, sulfonamides and tetracyclines.
Also under the proposed guidance, companies will voluntarily remove production claims such as for growth promotion or feed efficiency. Companies will have the option to pursue new therapeutic label claims for products currently fed for performance purposes. To hear and discuss concerns over the changes, FDA and USDA held a series of public meetings during May and June at locations around the country. During one of those meetings in
Fort Collins, Colo., Dave Dargatz, DVM, PhD, with Veterinary Services at USDA’s Animal and Plant Health Inspection Service, presented data indicating patches scattered around the country where veterinarians are in short supply.
Next, Christine Hoang, DVM, MPH, CPH, assistant director of the Division of Scientific Activities of the American Veterinary Medical Association, said that the current VFD requires an established veterinarian-client-patient relationship (VCPR). The proposed streamlining would modify that requirement, allowing certified veterinarians with familiarity with a livestock operation to file a VFD order on behalf of the operation. Following some questions and discussion on the presentations, FDA opened the meeting for an official comment period. Following is a summary of concerns participants expressed: Need to clarify the length of expiration date and refill policy for the VFD.
• Some veterinarians believe an electronic system with standardized VFD forms would streamline the process.
• A change basing VFD orders on the number of animals versus the volume of feed could add some complexity for veterinarians.
• Some comments indicated a need for training and education for veterinarians who have not filed VFD orders in the past.
• Many concerns were related to the potential increase in paperwork.
• Several participants suggested a need for framework of specific goals for the program and a system for evaluating the costs and quantifiable benefits or impacts of the rules.
• Producers in some areas lack easy access to veterinary services.
• Some expressed concern that the added requirements will cause small distributors and feed manufacturers to stop carrying affected products, resulting in loss of availability to producers.
• Some participants favored FDA’s intention to modify the VCPR provisions in the VFD; others believed those provisions should be stricter.
• Several called for more clarity on definitions of the uses of antimicrobials for prevention, control and treatment of disease.