Placing Animal Drugs under Veterinarian Oversight: Questions and Answers with Michael Taylor and William Flynn
The Food and Drug Administration has been working for several years to limit the use of antimicrobial medications in food-producing animals to appropriate medical needs and to place such use under the supervision of a veterinarian.
Michael Taylor, Former FDA Deputy Commissioner for Foods and Veterinary Medicine
William Flynn, DVM, MS, Deputy Director for Science Policy in FDA's Center for Veterinary Medicine
Antimicrobial drugs, which include bacteria-fighting antibiotics, have been added to the feed of cattle, hogs, poultry and other animals for production (as opposed to animal health) purposes, such as to help them gain weight faster. The problem is that all use of antimicrobials, in humans and animals alike, generally contributes to the development of antimicrobial-resistant bacteria, considered a global threat to public health. Drug-resistant strains of bacteria could be fatal if they enter the human body through uncooked or improperly cooked food and the medicines created to combat them are rendered ineffective.
FDA is implementing a plan to eliminate all animal production uses of “medically important” antimicrobials – ones used to treat human disease – by the end of 2016 and bring remaining animal health uses that meet FDA’s “judicious use” principles under veterinary supervision. On June 2, 2015, the FDA announced display in the Federal Register of the Veterinary Feed Directive (VFD) final rule, an important part of the agency’s strategy to promote judicious use of antimicrobials in animals that enter the food supply.
Michael Taylor, Former FDA deputy commissioner for Foods and Veterinary Medicine, and William Flynn, DVM, MS, deputy director for science policy in FDA’s Center for Veterinary Medicine (CVM), explain the role this new rule will have in advancing the agency’s efforts to ensure that the remaining uses of antimicrobial drugs in food-producing animals are under veterinarian oversight.
What does the VFD rule do exactly? How important is this?
How will the FDA hold veterinarians accountable for ensuring that medically important antimicrobials are used judiciously?
What could happen if a veterinarian does not comply?
Will there be inspections to check on compliance, as with other FDA regulations?
What about medically important antimicrobial drugs that are used on an ongoing basis as a preventive measure? Will such use be allowed under this new rule?
You’ve said that collecting more data about antimicrobial drug use in food-producing animals is a priority. Why?
The FDA’s judicious use strategy doesn’t require animal drug manufacturers to transition their products to veterinarian oversight until December 2016. Why is the FDA releasing this rule now?
Q: What does the VFD rule do exactly? How important is this?
Taylor: We’re enhancing the framework for veterinary oversight of the use of antimicrobial medications in feed when they are necessary to protect the health of the animal. This is an important advancement in the larger FDA initiative to fight antimicrobial resistance. According to the Centers for Disease Control and Prevention (CDC), in the United States alone, at least 2 million people become infected annually with bacteria that are resistant to antibiotics. And at least 23,000 people die each year as a result of these infections. The non-therapeutic use of antimicrobial drugs in animals that enter the food supply contributes to this problem.
Flynn: What we’re calling the “judicious use” of these medically important antimicrobial medications in food producing animals requires the oversight of a licensed veterinarian, given the benefit of that individual’s scientific and clinical training. The VFD final rule provides veterinarians in all states with consistent standards (key elements) for authorizing the use of these drugs in feed when they are needed for specific animal health purposes. The rule also updates recordkeeping requirements and takes advantage of electronic tools to make the VFD process more efficient and flexible.
Q: How will the FDA hold veterinarians accountable for ensuring that medically important antimicrobials are used judiciously?
Taylor: The VFD final rule requires veterinarians issuing orders authorizing the use of these medically important antimicrobials in animal feed to do so within the context of a veterinarian-client-patient- relationship (VCPR), and specifies the key elements that define a VCPR. Among these key elements is the expectation that veterinarians have sufficient knowledge of the animals for which they are authorizing the use of a VFD drug. FDA believes that “sufficient knowledge” is obtained through animal examination and/or visits to the facility where the animals are raised. Of course, this means providing some flexibility to account for the wide variety of circumstances that veterinarians encounter, such as managing disease outbreaks in large herds or flocks where an examination of all affected individual animals would not be physically possible.
Flynn: Most states have a set of VCPR requirements and, under the VFD final rule, veterinarians will be required to follow appropriate state requirements. In states where the FDA determines that no applicable and appropriate state VCPR requirements exist, veterinarians must follow federal VCPR requirements. The agency is working with each state to review their VCPR requirements and determine if they are consistent with federal standards.
From a practical standpoint, this change will enable individual states to adjust the specific criteria for a VCPR to appropriately align with current veterinary practice standards, technological and medical advances, and other regional considerations. This enables veterinarians to exercise their medical judgment to more effectively provide services to food animal producers in remote geographical areas where veterinary professional resources are limited and distances are great. The change also helps facilitate veterinarians working in consultation with other animal health professionals, such as poultry pathologists and fish health biologists.
Q: What could happen if a veterinarian does not comply?
Taylor: The practice of veterinary medicine is regulated by state licensing boards, and a veterinarian’s license is at stake if they don’t uphold the codes of practice. The agency will work with states to make sure that veterinarians appropriately authorize the use of medically important antimicrobials and will also work with states to take appropriate action if violations do occur.
Flynn: If a veterinarian authorizes the use of an antimicrobial covered by this rule without complying with applicable state licensing and practice requirements, including VCPR requirements, the state may take enforcement action and the FDA may determine the resulting animal food to be adulterated or misbranded. Similarly, if the federally-defined valid VCPR standard is applicable and the veterinarian fails to comply, the FDA may act to enforce compliance.
Q: Will there be inspections to check on compliance, as with other FDA regulations?
Flynn: The FDA will be working collaboratively with the states and the veterinary community to foster understanding of the new VFD rules and promote widespread compliance. We will also engage in general surveillance, as well as inspection assignments based on potential risk to public health. The agency has access to a variety of records to assist it with risk-based inspections, including food and drug registration information, feed mill licensing information, VFD distributor notifications, and VFD distribution records maintained by drug sponsors and distributors. This information will allow the FDA to focus inspectional resources within the industry based on risk.
Q: What about medically important antimicrobial drugs that are used on an ongoing basis as a preventive measure? Will such use be allowed under this new rule?
Taylor: This is a concern that we’re working to address. There are currently products approved for therapeutic indications that have no limit on how long they can be given to the animal. In fact, there are some I think that can be given to the animal for its entire lifetime. We’re identifying these products and talking to producers to understand why they need to use them for undefined periods of time. We’re actively engaging veterinary organizations, animal producers and other stakeholders to express our position that medically important antibiotics labeled for continuous or undefined durations of use is not consistent with FDA’s judicious use principles. We’ll work with producers to identify alternative approaches to treating those diseases, and once that has happened, work with drug manufacturers to have them change their labels to meet the new needs of producers.
Q: You’ve said that collecting more data about antimicrobial drug use in food-producing animals is a priority. Why?
Flynn: It is important that we have more granular data on how these drugs are used on farms to really understand how they are being used and to ensure that they’re only used when needed. Current regulatory authority authorizes FDA to collect antimicrobial sales and distribution information. We recently issued proposed a rule that would have drug sponsors also include species-specific information (cattle, swine, chickens and turkeys) as part of the sales and distribution information they provide. Having this additional information would help provide a fuller picture. But more detailed information is needed on the species, indication, dose, and duration of use to adequately understand links between usage patterns and trends in resistance. FDA is actively engaged with the U.S. Department of Agriculture, CDC, and a wide array of stakeholders to fill this need.
Taylor: In fact, the agency intends to hold a public meeting later this summer on this topic, and we’re looking forward to gathering feedback from stakeholders.
Q: The FDA’s judicious use strategy doesn’t require animal drug manufacturers to transition their products to veterinarian oversight until December 2016. Why is the FDA releasing this rule now?
Flynn: Although deadline agreed to by the animal drug sponsors affected by FDA’s judicious use strategy isn’t until December 2016, companies are working now to transition their medically important antimicrobial drug products to a marketing status that requires veterinarian oversight. FDA released this rule now in order to allow drug manufacturers, producers and veterinarians time to become familiar with the new regulations and to give companies the time they need to make these changes without causing significantly more disruption to the animal health and agriculture industries. The FDA intends to use a phased enforcement strategy for implementation of this final rule. As over-the-counter (OTC) antimicrobial drugs used in feed transition to VFD status as part of the agency’s judicious use strategy, the agency will provide education and training to veterinarians, distributors (including feed mills), and animal producers in order to foster better understanding of the regulations.