FDA seeks limited antibiotic phase out

Rockville, Md. — The Food and Drug Administration's (FDA) proposal to phase out antibiotic use in food animals unless there is medical necessity drew comments from interested veterinary groups.

FDA's proposed guidance, titled "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals," calls for a phase out of antimicrobial use for growth promotion in food animals. The document reiterates the benefits of therapeutic uses of antibiotics in food animals as means of protecting animal health and safeguarding human health.

In July, the American Association of Bovine Practitioners (AABP) and Academy of Veterinary Consultants (AVC) released a statement regarding FDA's proposal calling on the agency to fight antibiotic resistance through analysis of all available data.

"The AABP and AVC welcome the opportunity to collaborate with the FDA-CVM on the principles identified in the draft guidance…The issues of drug availability for maintaining good animal health, as well as veterinary oversight/consultation for such uses, have been priorities for AABP and AVC members for many years.

"Although the AABP and AVC do not agree that the weight of the scientific evidence supports the phasing out of all production indications, we are committed to supporting changes that measurably and positively impact the critical issue of antimicrobial resistance. The AABP and AVC recognize the importance of antimicrobial resistance and wish to participate in aggressively addressing resistance concerns; however, the organizations remain committed to regulation based on data-based analysis rather than expert consensus. It is imperative that the collaborators approach the issue of production enhancement uses of antimicrobials with the realization that the standards and practices established for these uses will serve as a precedent for evaluating disease prevention, control and therapeutic uses."

AVMA was also quick to release a preliminary statement on the issue, and promises that detailed comments on this issue will follow.

"The American Veterinary Medical Association (AVMA) is pleased that the FDA is committed to working with the veterinary profession to address antimicrobial resistance concerns," Dr. W. Ron DeHaven, AVMA's chief executive officer, states. "Veterinarians are essential to any discussion regarding the importance of disease control and prevention. We look forward to reviewing and commenting on the draft guidance."

The FDA guidance document is open to public comment for the next 60 days and can be found online at fda.gov.

In March, AVMA representatives lobbied lawmakers against passage of broad antibiotic bans currently under review at the federal level, like the Preservation of Antibiotics for Medical Treatment Act (PAMTA).

FDA's new guidance document acknowledges the veterinary profession's efforts in calling for judicious use of antimicrobial drugs as a method to stave off antimicrobial resistance, but states that "additional steps are needed."

The draft document proposes to limit antimicrobial use in food animals unless such drugs are medically necessary and administered by oversight or in consultation with a veterinarian, FDA reports.

"Using medically important antimicrobial drugs as judiciously as possible is key to minimizing resistance development and preserving the effectiveness of these drugs as therapies for humans and animals," says Bernadette Dunham, DVM, PhD, director of FDA's Center for Veterinary Medicine. "FDA is committed to working with animal drug sponsors, the veterinary and public health communities, the animal agriculture community, and all other interested stakeholders in developing a practical strategy to address antimicrobial resistance concerns that is protective of both human and animal health."