Olympia, Wash. — In the conversation about reducing use of antimicrobial drugs on American livestock, the focus has shifted from why to how.

That’s generally how the discussion went this week, at least, during the second of five meetings scheduled by the U.S. Food and Drug Administration (FDA) around the country to hear comments on its call for veterinarians to oversee most antimicrobial drug use in ranch and farm animals.

“If we can make something work that does not create a big burden or enormous cost to the industry — we’ll just have to roll up our sleeves and work together,” said Jack Field, executive vice president of the Washington Cattlemen’s Association.

The FDA’s proposal to require prescriptions or “veterinary feed directives” (VFDs) for a variety of antibiotics given to livestock is one of multiple steps the agency said it is pursuing to stem the rise of drug resistance in pathogens.

In livestock, the agency is targeting two aspects of antimicrobial use: First, it plans to curtail feeding of antimicrobial drugs to promote animals’ growth. Second, it plans to require a veterinarian’s authorization before giving animals certain antibiotics to prevent or treat medical conditions.

The targeted drugs are those that are important in human medicine. They come under any of seven classes: animoglycosides, lincosamides, macrolides, penicillins, streptogramins, sulfonamides and tetracyclines.

Dr. Craig Lewis, an FDA veterinary medical officer, estimated that dozens of drugs fall into the affected classes. Those that are given to animals in their feed will require a VFD, while those given to animals in their water will require a prescription.

Lewis said drugs in classes for which no versions exist for human patients, such as ionophores, will remain available without veterinary authorization and may be used for the purpose of making animals grow faster — a phenomenon he described as something of “a miracle use of the drugs.”

“You essentially feed the animal this antibiotic in food, and they eat less food and grow more,” he explained.

Public health officials particularly are concerned about this type of use because it applies typically to large groups of animals, heightening the opportunities for drug resistance to develop in pathogens exposed to those drugs, said Dr. Bill Flynn, deputy director for science policy at the FDA Center for Veterinary Medicine.

Flynn pointed out that injectable forms of the antibiotics will remain available over the counter. “Right now, our focus is on feed and water products,” he said.

While livestock producers historically have had over-the-counter access to a variety of antimicrobial drugs for therapeutic and production purposes alike, the shift to requiring veterinary oversight has been underway for decades.

Flynn said the agency has since the late 1980s required prescriptions or VFDs on new antimicrobial drugs. And since the early 2000s, he said, “we’ve been formally assessing every new product for animal use for ... the risk of resistance development. What we’re doing now is a look back at older products that have been on the market prior to the assessment process.”

The agency plans to publish final guidance on veterinary oversight before the end of the year, allowing drug makers three years to revise product labels to reflect the changes. For now, the revisions are voluntary.

Asked in an interview what happens if all manufacturers of the targeted antibiotics don’t comply voluntarily, Lewis hinted that the action could become mandatory. “After those three years (of transition), all options are on the table,” he said.


The veterinary pharmaceutical industry as a whole has supported the plan since it first was announced last spring. A statement provided Tuesday by the Animal Health Institute, a trade group for animal drug makers, reiterated that support, noting: “The careful, judicious use of antibiotics to address animal disease and disease threats to keep food animals healthy is an important link in the food safety chain. Healthy animals produce safe and healthful food.”

Active support from AHI and other influential players in the veterinary establishment, including the American Veterinary Medical Association (AVMA), represents a shift from a few years ago, when the industry and profession tended to downplay the scope of antibiotic use in livestock and its potential contribution to drug resistance in pathogens.

With major parties now agreeing that the concept of restricting antibiotic use is sound, the central question is how to execute the plan. A chief concern is that a significant number of livestock producers don’t have a veterinarian — either because none practices in the vicinity or because they choose to forgo the expense, or both.

Ed Field, executive director of the Washington Cattle Feeders Association, told the FDA panel Tuesday that producers, especially those with small operations, often rely on someone other than a veterinarian for medical advice and medicine.

“Some producers don’t have the desire, funding or whereabouts to consult with a veterinarian,” Field said. “I’m on the feedlot. A lot of them come to me, because we’re the experts at treating cattle, and say, ‘I’ve got (an animal with) a snotty nose, what do I do?’ I might give them a syringe of medication.”

Another common scenario involving an apparently minor illness, he said, is that a producer will ask the advice of employees at a feed store that carries medication. “Something like that, if that’s going to require that a small producer has a relationship with a veterinarian, that’s not going to happen,” he said.

Washington rancher Rick Nelson testified to the need for producers to watch their expenses. “If I have an orphan calf I need to give medicated milk replacer, the calf’s worth $50 and it costs me $150 to have a veterinarian see the calf, well, you know what’s going to happen,” Nelson said.

Veterinarians have concerns about expenses, as well. Dr. Fred Gingrich, a mixed animal practitioner in Ohio, told the VIN News Service in a telephone interview that if veterinary oversight means physically examining every affected animal, that would be prohibitively inefficient and expensive.

“I cannot economically justify getting in my truck and driving for an hour for a guy who has 10 cows,” Gingrich said. “I’m there 15 minutes, and I drive an hour back. I bill him for 15 minutes of my time, and it took up two hours and 15 minutes.”

Gingrich said the situation potentially will inject tension between veterinarians and their clients. “There will be producers who are pissed off that the veterinarian will not prescribe something over the telephone,” he said. “It pits producers against veterinarians; cattle are in the middle of it.”

At the FDA meeting, one speaker suggested that veterinarians might see the new requirement as a moneymaking opportunity.

In response, Dr. Fred Muller, a cattleman, bovine veterinarian and Northwest director of the American Association of Bovine Practitioners, said he and his organization favor the action, but not because of the income it may generate. “Our real intention in supporting some of these changes is to make sure we still have access to these products and access to these tools to help producers and livestock," he said. " … Our goal is to protect these products so we have them (for use in the future).”

In a similar vein, responding to questions about how much livestock antibiotic use contributes to the overall drug resistance problem, Lewis of the FDA said: "Every single use of these (antimicrobial products) can contribute to antimicrobial resistance. So the use of your hand sanitizer here can make it harder to treat your calves, and the use of milk replacer to your calf can make it tougher to treat your kids. They’re all interrelated."

Muller expressed confidence that the veterinary oversight system can work. “We will adapt to the situation, and I think we’re very capable of providing those services,” he said.

The key, Muller said, is in allowing veterinarians flexibility and discretion. Veterinarians should, for example, be able to treat patients as groups and classes as well as individuals.

“If you were to say we had to write a VFD for every group of cattle that entered a feedlot, it would cripple the work we do,” Muller said. “ … We understand the groups, which are being weaned, which are moving into feed pens; we understand the risks (for each). I think it’s more than reasonable that we’re (having) to write VFDs for that farm and for specific classes of animals … but I don’t think I should need to write a VFD every month when we wean a group of cows and move them out to a feed pen. The process doesn’t change from group to group that gets weaned and moved out to the yard.”

FDA officials are in the process of amending existing rules for VFDs, which allow for orders to be written only for specifically identified animals. One proposed change is to allow veterinarians to issue standing orders good for up to six months, limited by an approximate number of specified animals.

By setting a six-month time frame, Flynn said, the agency is “kind of forcing the issue that minimally, the vet and producer have to discuss the issue every six months.”

Lewis said in an interview that exactly what constitutes appropriate veterinary oversight is something the FDA will look to professional groups such as the AVMA to characterize. After all, he pointed out, the FDA doesn’t regulate veterinarians; states do, through professional licensing boards and through practice statutes. In turn, many states look to the AVMA for guidance on their practice acts. 

Dr. Christine Hoang, assistant director of the AVMA Scientific Activities Division, said the association has updated its Model Practice Act several times during the past year in part to address the antimicrobial veterinary oversight issue.

“It allows for more flexible practice for a large animal veterinarian,” said Hoang, speaking as a panelist at the gathering. Changes she cited include:

• Allowing for “patient” to mean a group of animals, not necessarily only individuals.
• Allowing for a veterinarian to visit the “operation” where an animal is managed, not necessarily the “premises” where the animal is located.
• Allowing “sufficient knowledge” of a patient to be supplemented through consultation with a producer, consideration of local disease epidemiology and a review of health records.

Hoang said the AVMA also is incorporating into its Principles of Veterinary Ethics a statement that absent a valid veterinarian-client-patient relationship, “veterinarians should not be prescribing any sort of drug, and that would include antimicrobials. We do believe veterinarians should be involved in the process when antimicrobials are used.”

Types of questions and suggestions from veterinarians to producers that the FDA hopes to engender generally, Flynn said, are: “Is this really the right drug to be using in this instance? Is this how we should be using it? Maybe there are some changes you can be making in management practices to prevent the need to use these products.”

He said, “We’re putting a fair amount on the veterinarian to take on, but it’s something that veterinarians are trained to do.”

Three more outreach meetings are scheduled as follows:

• May 8: The Natural Resource Research Center, USDA Animal and Plant Health & Inspection Service, Veterinary Services, Centers for Epidemiology & Animal Health, 2150 Centre Ave. (Building B, Gray’s Peak Conference Rooms A & B), Fort Collins, Colo.
• May 21,  Best Western Ramkota Hotel & Conference Center (Amphitheater II), 920 West Sioux Ave., Pierre, S.D.
• June 4, Texas A&M University (Memorial Student Center, Room 2406A), Joe Routt Boulevard and Houston Street, College Station, Texas.

Plan details are posted online. The FDA will accept written comments for 60 days following the final meeting. Comments may be submitted electronically or by mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane Room 1061, Rockville, Md. 20852. Comments should reference Docket No. FDA-2012-N-1046.