Animal Pharmaceutical Companies Commit To FDA's Antibiotic Guidance

AHI member companies say they will align with FDA's December announcement to phase out use of medically important antibiotics for growth promotion

Published on: Mar 12, 2014

The Animal Health Institute and its member companies on Tuesday announced a commitment to adhere to a proposed FDA guidance that would phase out use of medically important antimicrobials for growth promotion in food animals.

Under the policy, which was announced in December, veterinary oversight of the use of therapeutic antimicrobials will also be phased in. FDA anticipates the process will take about three years.

AHI was joined by the Generic Animal Drug Alliance in providing the FDA a written commitment to align affected products with the policy. The FDA had asked affected companies to provide feedback on the guidance within 90 days of its announcement.

AHI member companies say they will align with FDAs December announcement to phase out use of medically important antibiotics for growth promotion
AHI member companies say they will align with FDA's December announcement to phase out use of medically important antibiotics for growth promotion

"By working cooperatively with stakeholders, FDA has achieved a significant change in the way antibiotics are to be used in animal agriculture that we believe will avoid unintended consequences," AHI President and CEO Alexander Mathews commented.

The AHI represents several animal pharmaceutical companies, including Merck, Merial, Zoetis, Novartis and others.

Related: Veterinarian Addresses Proposed Antibiotic Changes

FDA still must issue a final rule on proposed changes to the veterinary feed directive. If implemented, medically important antibiotics will only be used in food animals under the direction of a veterinarian when there is a specific disease challenge.

"We understand that consumers have concerns about medically important antibiotics being used to promote growth," said Mathews. "We hope this change in regulation and control will increase consumer confidence and lead to a more productive discussion about animal welfare, sustainability and public health."

Flawed plan?
One group, the Cornucopia Institute, has argued against the directive, claiming that it would disadvantage smaller producers, and companies profiting from antibiotic sales will ignore the FDA's proposal, if it is realized.

Rebecca Thistlethwaite, a farm policy analyst with The Cornucopia Institute, said in a February commentary that the new plan increased veterinary oversight will also present problems with veterinary availability.

"While that move seems reasonable in many ways, similar to requiring a doctor’s prescription to obtain antibiotics for humans, it may disproportionately disadvantage small farmers who don’t have a regular relationship with a veterinarian," Cornucopia said in its statement regarding the policy.

The American Veterinary Medical Association, however, said that greater veterinary oversight of the use of antimicrobials on the farm is a benefit to human and animal health, and supports the policy.