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Veterinarians such as Dr. Fred Gingrich, a practitioner in Ohio, are apt to become busier as a federal rule takes effect this fall that requires ranchers to consult veterinarians before giving antibiotics in animal feed.

A years-long effort by the federal government to slow the evolution of drug resistance in disease-causing microbes will pass a milestone on the veterinary side this fall.

The U.S. Food and Drug Administration in June put the final wording to a rule designed to stem the indiscriminate use in certain food animals of medically important antibiotics and other drugs important to human medicine. The rule, called the Veterinary Feed Directive, or VFD, takes effect on Oct. 1.

Underlying the rule is the principle that veterinarians should oversee or be consulted in the use of medically important antimicrobial drugs in food animals.

To help explain the upcoming change, its context and associated programs coming from the FDA, the VIN News Service prepared these questions and answers on the topic:

What exactly is the Veterinary Feed Directive?

Historically, a number of antibiotics used in livestock feed to promote growth, as well as to prevent, control and treat disease, have been available over the counter (OTC) to ranchers.

Dr. William Flynn, deputy director for science policy at the FDA’s Center for Veterinary Medicine, said that a key aspect of the agency’s strategy for preserving the efficacy of important antimicrobial drugs “is to eliminate the use of antibiotics for production or growth promotion. The goal is to limit medically important antibiotics to uses specific to animal medical health needs.”

Toward that end, the FDA asked drug manufacturers to voluntarily relabel certain antibiotics that had been available OTC such that they will require a written VFD from a veterinarian. Manufacturers agreed to these label changes, which means the antibiotics will require written authorization similar to a prescription.

Technically, a VFD is not a prescription because the law regards drugs in feed in a category separate from prescription drugs. “This category was created to provide veterinary supervision without invoking state pharmacy laws for prescription drugs that were unworkable for the distribution of medicated feed,” the FDA explains.

The affected drugs are those that fall in any of these seven classes: animoglycosides, lincosamides, macrolides, penicillins, streptogramins, sulfonamides and tetracyclines. The rule also gives the FDA the flexibility to add new drugs that are deemed medically important.

What happens on Oct. 1 when the rule kicks in?

Practices won’t change overnight. The FDA is allowing a transition period of more than a year for the more than 280 affected drugs coming to the marketplace with new labels.

“That rule itself doesn’t trigger these products switching over from OTC to VFD,” Flynn said.

It’s not just a matter of changing labels. The FDA wants “to make sure the necessary information is out there so veterinarians and producers can be better prepared,” Flynn said.

The transition should be completed by December 2016.

What about regions where veterinary services are hard to come by?

The FDA is acutely aware of the impact on ranchers as well as veterinarians. Requiring authorization for products previously bought OTC raises “real issues for certain producers in certain parts of the country,” Flynn said, acknowledging that ranchers in some regions have limited access to regular veterinary services.

One accommodation the agency made that it hopes will help was adjusting the requirement for a valid Veterinary Client Patient Relationship, or VCPR. Rather than going with a single federal definition of a VCPR, the regulation allows producers potentially to come under VCPRs as defined in their respective states.

In theory, placing the responsibility for defining and regulating the maintenance of a VCPR at the state level will allow regulators to adjust the VCPR definition to meet local needs and regional practice styles.

However, this alternative is not available automatically. FDA spokeswoman Megan Bensette explained by email: "The FDA is working with each state to review their VCPR requirements (to) determine whether they include the key elements of the federally defined VCPR. These key elements (are) that the veterinarian: engage with the client (the producer) to assume responsibility for making clinical judgments about the patient’s health; have sufficient knowledge of the patient by virtue of patient examination and/or visits to the facility where the patient is managed; and provide for any necessary follow-up evaluation or care.”

Bensette said that “in states where the FDA determines that no applicable or appropriate state VCPR requirements exist, veterinarians will still need to issue VFD orders in compliance with federally defined VCPR requirements.”

The final rule does not specifically address how ranchers in areas lacking veterinary services should deal with the problem.

Dr. Fred Gingrich, an Ohio dairy practitioner, is concerned. “It is very common in some areas of the country for very small farmers not to have a veterinarian,” he said. “What are they going to do? In some cases, the veterinarian is going to be met with requests for a VFD from non-clients.”

What are the implications for veterinarians?

“For veterinarians, (the rule means) a big change, too,” said Flynn. “It means taking on additional responsibility in terms of oversight of these products.” Of course, the responsibility is part of the intent behind the VFD ruling, he said, as the goal is to make the veterinarian an intrinsic part of the decision-making process to medicate livestock.

Gingrich sees one potential pitfall for veterinarians as they learn the rules around issuing VFDs. In treating livestock illnesses, veterinarians often prescribe drugs for uses other than those specified on the label, a permitted practice known as extralabel drug use.

However, it is illegal to use feed-grade antibiotics for anything other than the label indication, Gingrich pointed out. “Vets need to be careful about doing something illegal out of lack of knowledge,” he cautioned.

For practitioners, Gingrich believes the biggest impact will be learning how to write a VFD. The FDA draft guidance document describing the VFD process is 20 pages long; instructions on writing and filing a VFD take roughly eight of those pages.

Gingrich — who generally favors placing all livestock antibiotic use under veterinary supervision but questions whether the VFD rule will significantly decrease the overall amount of antibiotics used on livestock — noted that veterinarians will need to figure out reasonable charges to requests for VFDs.

“It’s a service,” he said. “So veterinarians are going to have to determine how to charge appropriately, because it could take a lot of time and be burdensome.”

How did this all begin?

The VFD is one aspect of a government strategy to prevent the overuse in animals of antibiotics that are important to human medicine. The strategy, called the Judicious Antimicrobial Use Program, is outlined in two FDA documents.

1. “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals Guidance for Industry #209” issued in 2012 lays out the rationale for restricting the use of targeted drugs in livestock. GFI #209, as it’s called for short, provides historical background on the subject dating to the 1960s, and articulates the agency’s goal of limiting medically important antimicrobial drugs to medically necessary uses in animals and ensuring that those drugs are used only under veterinary oversight or consultation.
2. “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209 Guidance for Industry #213” issued in 2013 explains why the agency aims to crack down on administration of targeted drugs in feed and water: “Because antibiotics in feed or water are typically administered to herds or flocks of food-producing animals, in-feed or in-water antibiotic use leads to an increased risk of selecting for resistance.”

The guidance calls for:

• Voluntary revision of the FDA-approved use conditions on the labels of medically important antibiotics to remove production indications, such as increased rate of weight gain and improved feed efficiency.
• Phasing in veterinary oversight of the remaining therapeutic uses of medically important antibiotics in feed or water by changing the OTC status of the drugs.

What’s next?

In March, the White House released a National Action Plan for Combating Antibiotic-Resistant Bacteria. Among other things, the 62-page document lays out goals for the Judicious Antimicrobial Use Program in coming years.

• “Within three years: FDA, in partnership with animal drug sponsors, will complete all changes recommended by GFI #213 and GFI #209. Once these changes are complete, growth promotion uses of medically important antibiotics will no longer be permitted, and the use of medically important antibiotics in the feed or water of food-producing animals will require veterinary oversight.”
• “Within five years: FDA, in partnership with USDA and the animal agricultural industry, will evaluate and report on the impact of GFI #213 by analyzing data on antibiotic use, including total sales of antibiotics in animal agriculture and types and prevalence of antibiotic-resistance among selected food-borne pathogens and commensals isolated from retail meat and farm animals.”

Some states are beginning to tighten regulations around antibiotic use in livestock even further. In California, for example, a proposed bill, SB 27, would eliminate OTC antibiotic use altogether in that state as of January 2018. It also would require veterinarians graduating after 2018 to complete a course in judicious antimicrobial use every four years to maintain their California veterinary license.