Animal Drug Companies Fulfill Commitment to Change Antibiotic Labels
Requiring veterinary oversight and eliminating ‘growth promotion’ uses are important steps forward in ensuring responsible use of antibiotics in food animals
The successful implementation of this guidance marks a fundamental shift in how antibiotics can be given to animals in the U.S.
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This analysis piece was updated on Jan. 4, 2017.
The Food and Drug Administration announced an important milestone today in efforts to ensure that antibiotics are used responsibly in food animals.
The agency said that all affected companies have voluntarily complied with Guidance for Industry #213 that called for them to make two key modifications to the labels of medically important antibiotics used in these animals by Jan. 1:
- Change the marketing status of antibiotics administered via animal feed and water so that use of these drugs now requires the oversight of a licensed veterinarian and are no longer available over the counter.
- Remove “growth promotion” indications, meaning it will no longer be legal to give antibiotics to healthy animals for the purpose of “enhancing feed efficiency”—or gaining weight.
The successful implementation of this guidance marks a fundamental shift in how antibiotics can be given to animals in the U.S. and is indicative of the growing consensus that antibiotics should be used only when necessary and appropriate to protect animal health. Still, more work remains to be done and Pew looks forward to working with FDA on the next steps the agency identified in its announcement.
Pew commends FDA for its leadership on this issue and the animal drug companies for fulfilling their commitment. Their collective action will help advance the global effort to slow the emergence of drug-resistant bacteria and preserve the effectiveness of these lifesaving drugs. And the collaboration between the companies and FDA offers an encouraging example of how stakeholders can work together to effect change that serves the public interest.
Karin Hoelzer is a senior officer on The Pew Charitable Trusts’ safe food and antibiotic resistance projects and is a veterinarian by training.
Analysis shows more than 1 in 3 labels will not fully meet judicious use standards after implementation of FDA policy