With an updated number of 283 drugs added to the new Veterinary Feed Directive (VFD) program, nutritionists that currently rely on antimicrobial drugs for improving feed efficiency for production uses in food-animals may need to reformulate feeds to meet the regulations in 2016. But nutritionists aren’t the only ones that will be adapting to the proposed changes. A host of new VFD products and regulations are set to affect the industry as a whole — especially feed mills, veterinarians and producers.
The three major changes to the current VFD program include increasing the number of VFD drugs from two to 283 — these drugs will be approved accordingly for different uses such as to combat a variety of diseases in more than one species. Another major change is the amount of regulation, e.g. feed mill licensing for formulating and distributing VFD medicated feed. Last but not least are the proposed changes requested from the agriculture community to streamline the paperwork for an easier and more efficient administrative process.
What drugs are considered VFD drugs?
According to the FDA Center for Veterinary Medicine, drugs that are VFD products are used in livestock feed. They are reviewed by the Center for Veterinary Medicine and are approved for use with a VFD in livestock feed for specific reasons. For example, proposed VFD drugs such as penicillin will be available for use in livestock feed for specific reasons like preventing a disease. In conjunction with listing the approved uses or reasons for administering a drug, VFD drugs also list the approved dosage amounts that can be used in medicated feed.
The overall industry goal for the proposed VFD is to increase veterinary oversight on what drugs are used in feed, and for what reasons. This will also inadvertently limit the use of antimicrobial drugs in feed for increasing the rate of gain in food-producing-animals. Ultimately, the Food and Drug Administration (FDA) hopes that this will prevent bacteria from building a resistance to antibiotics — a goal that is widely accepted in the industry.
Antimicrobial classes that are proposed VFD drugs include aminoglycosides, lincosamides, macrolides, penicillins, streptogramins, sulfonamides and tetracyclines.
The three main changes
Here’s a list of the three areas to watch in the coming year:
1) 283 Over-the-counter drugs set to become VFD drugs
The proposed VFD will put veterinarians in charge of prescribing 283 different drugs. This is a jump from the current VFD program that is in place. “In 1997, when the VFD was started, there were only a few medications that were approved,” says Dr. Christine Hoang American Veterinary Medical Association assistant director in scientific activities. “The process was also very cumbersome with a lot of paperwork.”
With an increase of drugs added to the VFD program, Hoang says it’s imperative to streamline the process to make it as appropriate and efficient as possible.
“The most important thing to know is that even though the transition is difficult, we are working with all the stakeholders so that the transition is smooth, and veterinarians will have oversight of these products,” Hoang says.
In June 2014, AVMA held a VFD summit at their headquarters with representatives from every species and commodities group to gather feedback for the FDA regarding the proposed changes. “We had a lot of good responses,” says Hoang, “all of the stakeholders and the FDA are working together very well.”
2) Proposed regulation changes to feed mill licensing
Richard Sellers, American Feed Industry Association (AFIA) senior vice president of legislative and regulatory affairs, says that there are a lot of proposed regulation changes and new VFD drugs for the industry to adapt to using. “All of these changes are going to go into place in 2016,” says Sellers, adding that there may be a honeymoon period of a few months to help the industry adapt after the new VFD regulations are approved.
The current regulation reads that VFD drugs need to go through a category II feed mill to use a Type A medicated article drug — the most concentrated animal drug product that is used as a component to either manufacture another Type A medicated article, an intermediate Type B medicated feed or a formulation Type C medicated feed. However, the proposed rule removes the regulation that requires feed mills be either category I or category II to process feed. Whether or not feed mills will need a category I or a category II license will depend on FDA approval.
3) Electronic paperwork and e-signatures to streamline administration process
Sellers says that there are proposed changes to the VFD process that will streamline the process and make it more effective. “The current VFD requires two years of record keeping, while other record keeping is only required for one year,” he says. “We would like to see the proposed change for one year of record keeping to go into place.”
Other proposed changes include how the VFD order is delivered to the feed mill. The current VFD process requires a veterinarian to provide the producer with the original prescription and to deliver a paper copy to the feed mill within five days of writing the prescription. However, a proposed change would allow the veterinarian to fill out a form online using their e-signature. The form would then be sent electronically to the feed mill.
FDA encourages the agriculture industry to comment on the VFD
While the agriculture industry is supportive of the proposed VFD, there are still details and concerns that need to be worked out before regulations go into place in 2016. Some of these concerns include the industry’s ability to provide enough large animal vets to authorize VFDs and the type of training — if any — needed for these veterinarians to write VFDs. There are also concerns on how much, and how the medicated feed will be stored at feed mills. The FDA encourages comments from the industry regarding details and concerns. Industry members are also encouraged to keep in contact with industry organizations such as the AVMA, and AFIA through sessions and webinars.