FDA NewsPerspective

FDA requests changes in antibiotic use in food-producing animals

The FDA has proposed a plan to phase out the overuse of antimicrobial drugs in livestock to reduce antimicrobial resistance in animals and humans. The plan also would bring therapeutic uses of antimicrobials in animals under veterinary oversight.

The agency is asking animal pharmaceutical companies to voluntarily remove FDA-approved indications for use in food-producing animals on drug labels and discontinue over-the-counter sales of these drugs. Companies should notify the FDA of their willingness to conform to the new guidelines in the next 3 months and would then have 3 years to comply.

“Implementing this strategy is an important step forward in addressing antimicrobial resistance,” Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, said in a press release. “Based on outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort.”

Michael R. Taylor, JD 

Michael Taylor

In addition, the agency is proposing a change in regulations pertaining to veterinary feed directive (VFD) drugs, or medically important drugs approved for use in food-producing animals that require authorization from a licensed veterinarian to dispense. The proposed rule relaxes administrative requirements for the distribution and use of VFD drugs, which would help veterinarians more effectively provide services to food animal producers.

“This action promotes the judicious use of important antimicrobials to protect public health while ensuring that sick and at-risk animals receive the therapy they need,” Bernadette Dunham, DVM, PhD, director of the FDA’s Center for Veterinary Medicine, said in the release. “We realize that these steps represent changes for veterinarians and animal producers, and we have been working — and will continue to work — to make this transition as seamless as possible.”

The proposed VFD rule is open for public comment. To submit comments, visit www.regulations.gov and insert docket FDA-2010-N-0155.

The FDA has proposed a plan to phase out the overuse of antimicrobial drugs in livestock to reduce antimicrobial resistance in animals and humans. The plan also would bring therapeutic uses of antimicrobials in animals under veterinary oversight.

The agency is asking animal pharmaceutical companies to voluntarily remove FDA-approved indications for use in food-producing animals on drug labels and discontinue over-the-counter sales of these drugs. Companies should notify the FDA of their willingness to conform to the new guidelines in the next 3 months and would then have 3 years to comply.

“Implementing this strategy is an important step forward in addressing antimicrobial resistance,” Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, said in a press release. “Based on outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort.”

Michael R. Taylor, JD 

Michael Taylor

In addition, the agency is proposing a change in regulations pertaining to veterinary feed directive (VFD) drugs, or medically important drugs approved for use in food-producing animals that require authorization from a licensed veterinarian to dispense. The proposed rule relaxes administrative requirements for the distribution and use of VFD drugs, which would help veterinarians more effectively provide services to food animal producers.

“This action promotes the judicious use of important antimicrobials to protect public health while ensuring that sick and at-risk animals receive the therapy they need,” Bernadette Dunham, DVM, PhD, director of the FDA’s Center for Veterinary Medicine, said in the release. “We realize that these steps represent changes for veterinarians and animal producers, and we have been working — and will continue to work — to make this transition as seamless as possible.”

The proposed VFD rule is open for public comment. To submit comments, visit www.regulations.gov and insert docket FDA-2010-N-0155.

    Perspective
    Jason Newland, MD

    Jason Newland

    The FDA’s plan to curb the overuse of antimicrobials in animals is needed, and it’s been needed for years. The question is: Will the plan be good enough? The FDA first tried to reduce inappropriate antibiotic use in the animal industry back in 1977 without success. I’m glad the agency released additional guidance in 2013, but I’m nervous that it might not be effective.

    There are two problems that I see with the guidance. First, the FDA is expecting drug companies to voluntarily remove the use of antibiotics for production purposes, in other words, growth promotion. The 1977 guidelines also were voluntary, and nothing happened. The agency is reassuring us that companies will comply with the guidance, but then the companies will have 3 years to comply. The second problem with the guidance is that it shouldn’t take 3 years, when this has been a problem for almost 70 years.

    Another important issue is the veterinary feed directive (VFD). Currently antibiotics can be placed in feed without a veterinarian’s prescription because they are not designated as VFD drugs. A new amendment to the VFD would classify antibiotics as VFD drugs, therefore requiring a veterinarian’s script in order to have an antibiotic included in an animal’s feed. While I am happy that antibiotics will now be included as VFD drugs, experience tells us that people are going to figure out how to get antibiotics. Are we going to see veterinarians who don’t think that the use of antibiotics is a problem and say, “Yeah, I’ll give you some antibiotics to help your animals,” — whether those animals are really sick or not? I’m nervous about the work-arounds, and I’m concerned that we will continue with the status quo of overuse of antibiotics for growth promotion.

    We need to recognize that every area in which we use antibiotics will affect resistance, whether it’s the agricultural industry or human medicine. Appropriate antibiotic use will prolong the use of these important therapeutic drugs.

    Is this going to cost food producers more? Yes, it probably will cost more. But they still should be able to produce the same amount of food without the use of antibiotics — it just might not be as quick.

    We all have to be more aware of the issue. All of us need to be aware that there is excess use of antibiotics in the animal  industry and that will impact human health.  I would encourage people to be cognizant of the meats they buy and support those companies that raise their animals without the use of antibiotics.

    • Jason Newland, MD, MEd
    • Medical director of patient safety and systems reliability
      Children's Mercy Hospital, Kansas City

    Disclosures: Newland received an antimicrobial stewardship grant from Pfizer.