Proposed new rules for veterinary oversight of antimicrobials in animal agriculture attracted a mix of comments and questions as representatives of the FDA and USDA/APHIS held a public meeting on the subject in Fort Collins, Colorado.
The agency’s initiative for judicious use of medically important antimicrobials in medicated feed or drinking water of food-producing animals establishes a framework for phasing out production uses of antimicrobials important in treating humans, and phasing in veterinary oversight of the remaining therapeutic uses of such drugs.
Following introductions, two FDA veterinarians, Bill Flynn, DVM, MS, and Craig Lewis, DVM, MPH, DAVCPM, led off with an overview of the plans, particularly Draft Guidance 213, introduced in April 2012. This proposal sets a three-year timeframe implementing veterinary oversight of antimicrobials in feed and water and streamlining of the Veterinary Feed Directive (VFD), which provides the framework through which veterinarians oversee the use of drugs added to feed for therapeutic purposes. Under the Draft Guidance, a range of drugs currently available over the counter would fall under the VFD.
One key change is that currently a veterinarian must file a VFD order for a specific quantity of medicated feed for an identified group of animals. The proposed rule would allow a veterinarian to file a VFD for a standing order lasting up to six months, with an estimate of the number of animals receiving the medication over the prescribed time period. This, FDA maintains, will allow greater flexibility for veterinarians and their clients.
Next, Dave Dargatz, DVM, PhD, with Veterinary Services at USDA/APHIS outlined the availability of food-animal veterinarians in the United States. A common concern over the proposed rules is the lack of access some livestock producers have to veterinary services. Dargatz showed data from several studies, indicating patches scattered around the country where veterinarians are in short supply or where veterinarian numbers are low relative to livestock populations in the area. Dargatz says more research is needed though, to determine the impact of the proposed rules on producers in those areas.
Next, Christine Hoang, DVM, MPH, CPH, assistant director of the Division of Scientific Activities of the American Veterinary Medical Association (AVMA), discussed the role of veterinarians in food-animal antimicrobial use. Hoang focused on the Veterinarian, client, patient relationship (VCPR), which she says is integrated throughout AVMA and FDA policies on drug use. Currently, the VFD requires a valid 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. Among about 40 participants in the meeting, at least half were veterinarians from private practice, government, academia and industry. Producers and producer associations also were represented and provided comments. One consumer-oriented group, the Center for Science in the Public Interest, sent a representative. The comments and discussion generally were cordial and supportive of FDA’s efforts, but stakeholders did voice concerns and requests for clarification on a number of points.
Following is a summary of concerns participants expressed during the public comment period:
Veterinary Feed Directive
- Need to clarify the length of expiration date and refill policy.
- Need to clarify rules regarding VFDs for on-farm versus commercial feed manufacturing.
- Some veterinarians believe an electronic system with standardized VFD forms would streamline the process.
- The change to basing VFD orders on the number of animals versus the volume of feed could add some complexity for veterinarians.
- Several questioned how the proposed rules would be enforced fairly and equally.
- Some comments indicated a need for training and education for veterinarians who have not filed VFD orders in the past.
General impacts of the changes
- Many concerns related to the potential increase in paperwork as more products fall under veterinary oversight.
- 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.
- As noted earlier, producers in some areas lack easy access to veterinary services.
- Some expressed concern that the added requirements will cause some small distributors and feed manufacturers to stop carrying affected products, resulting in loss of availability to producers.
- Veterinarian, client, patient relationship issues
- Some participants favored FDA’s intention to modify the VCPR provisions in the VFD, others believed those provisions should be more strict.
- Need more clarity on definitions of the uses of antimicrobials for prevention, control and treatment of disease.