Antibiotic Changes: 18 months and counting

By the end of 2016, the U.S. Food and Drug Administration will implement a new policy aimed at on-farm use of antibiotics in food-animal production. The agency’s goal is to work with the production sector to eliminate the use of medically important (to human illness) antibiotics for growth promotion and to bring therapeutic use – to treat, control or prevent specific disease – under veterinary oversight. Pork producers should be taking steps now to prepare for the changes.

“Antibiotics aren’t going away, but on-farm use will change. Producers should sit down with their veterinarians to discuss how to apply veterinary feed directives and other herd-health strategies.”                     – Jennifer Koeman, DVM, Pork Checkoff“That sounds like a long way off, but producers need to start getting ready,” said Jennifer Koeman, DVM, Pork Checkoff’s director of producer and public health. “Antibiotics aren’t going away, but on-farm use will change. Producers should sit down with their veterinarians to discuss how to apply veterinary feed directives (VFDs) and other herd-health strategies.”

At the centerpiece of FDA’s policy are 283 products that will be added to the VFD list, said Bill Flynn, DVM, deputy director for science policy at FDA’s Center for Veterinary Medicine. Over-the-counter sales of these products will be eliminated, and their use will require veterinary oversight and diagnosis for a specific animal health condition. Producers will need a VFD to gain access to the affected feed-based antibiotics and a prescription for water-based products.

“The action focuses on antibiotics approved prior to 2003 and the need to bring them up to today’s standard,” Flynn said. “It’s a very substantial change to the landscape of products that will be handled under the VFD framework. We’re talking about individual products, combinations, generics – products that have been around for 40 years.”

FDA is relying on stakeholder collaboration (drug companies, veterinarians, producers and the feed milling sector)  to move the action forward. All 26 companies that market drugs to the pork industry have provided a written commitment to make product and label changes, removing production claims and requiring veterinary oversight by the December 2016 deadline.

The National Pork Board, the National Pork Producers Council (NPPC) and American Association of Swine Veterinarians (AASV) are working to help producers and veterinarians implement FDA’s directive.

Record Keeping is Critical
Producers, veterinarians and feed processors will need to be especially diligent in keeping records.

Record Keeping Is Critical

Producers, veterinarians and feed processors will need to be especially diligent in keeping records associated with VFDs and prescription antibiotic use once the new policy rule goes into effect. Fortunately, records associated with Pork Quality Assurance® Plus (PQA Plus®) certification already have this covered.

“But producers don’t always keep all of the data today that will be required in the future, so improving on that will be a priority,” said Liz Wagstrom, DVM, chief veterinarian with NPPC. “There also will be interest in measuring how FDA’s policy is impacting antibiotic usage on the farm.  That will be an ongoing discussion – what to measure, whom to collect data from and how to analyze and report it.”

Meanwhile, Flynn added that FDA plans to release progress reports on its Judicious Use Strategy every six months (likely in June and December).

 

Veterinary Oversight, Research Priorities Are Key

The reality of FDA’s proposed changes is that producers will have to have more interaction with veterinarians. However, that’s a net positive on many levels.

“Maintaining a close working relationship with a veterinarian who is knowledgeable about pork production can benefit producers in many ways,” said Harry Snelson, DVM, communications director for AASV. “Judicious use of antibiotics is just one part of an overall herd-health management plan. Veterinarians can help design herd-health and production plans that strive to decrease disease, enhance performance and produce safe, wholesome pork for the global market.”

Chris Hodges Quote about AntibioticsAside from increasing veterinary interaction, the quest for responsible antibiotic use involves honing research priorities. Earlier this spring, the White House released a five-year, $1.2 billion action plan to address antibiotic resistance, including human and animal applications, and to guide public health and healthcare professionals. The plan cited additional research and the development of new antibiotics, therapies and vaccines among its goals.

The pork industry welcomes this approach to the antibiotics issue. “Our industry pledges to go beyond simply complying with federal guidance,” said Chris Hodges, National Pork Board chief executive officer. “U.S. pig farmers are committed to continuous improvements to produce safe, wholesome pork in a socially responsible way. Antibiotics are just one piece of a much broader plan that our farmers use to keep their animals healthy.”

For decades, the pork industry has been a leader in directing and funding antibiotic research, from the causes and transmission of antibiotic resistance to identifying alternative products or practices to help minimize antibiotic use. The Pork Checkoff also shares related information and research with U.S. retailers and foodservice companies.

“Collaboration across our industry, from the farms to the dinner table is critical,” Hodges said. “Sharing information underscores the safeguards already in place for antibiotic use in pork production and illustrates our focus on improving pork’s safety, quality and nutritional value, a priority on which producers, retailers and consumers can all agree.”

FDA Moves Forward on Antibiotic Guidance

The U.S. Food and Drug Administration (FDA) is taking a new approach on the judicious use of medically important (to treat human illness) antibiotics in food-animal production. It involves voluntary cooperation by all sectors. Here’s a snapshot of FDA’s time line to implement these changes.

Guidance 209: In 2010, FDA outlined its intent and recommendations regarding growth promotion uses of medically important antibiotics in food-animal production. This action applies to both feed-grade and water-based antibiotics. FDA also specified that veterinarian oversight will increase for the remaining therapeutic applications (prevention, treatment and control) of medically important antibiotics.

Guidance 213: On Dec. 11, 2013, FDA initiated a three-year transition process to complete its food-animal antibiotic strategy. This action requests animal-health companies to outline intentions to voluntarily remove any production/growth-promotion uses from product labels of medically important antibiotics. The guidance also eliminates over-the-counter status of these medications and increases veterinary oversight for on-farm therapeutic use by requiring a veterinarian feed directive (VFD) for feed applications and a prescription for water treatments. December 2016 is the deadline for this guidance to be completed and implementation to begin.

Proposed VFD Rule: On March 12, 2013, FDA concluded the comment period on its proposed VFD rule. According to the agency, the final rule outlining specific details of the VFD process for feed-grade antibiotics and the regulatory foundation is expected to be released sometime this spring (2015).

Compounds Not Included: Antibiotics of interest to pork producers that will not be affected by FDA’s new policy include bacitracin, tiamulin, carbadox, bambermycin and narasin. For a list of affected products, go to http://www.pork.org/antibiotics.