One-third of animal drug labels don’t meet new antibiotics rules: Report

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Tough new rules from the FDA on antibiotics used on animals go into effect next January, but there’s scant evidence that all animal health companies that are supposed to follow the rules actually will.

That’s the conclusion of a tough new report from the Pew Charitable Trusts, a Philadelphia-based public policy think tank. An analysis by the group concludes that one out of three antibiotics marketed for use in animals will not meet the FDA’s new rules of judicious use.

Those rules, contained in the FDA’s Guidance for Industry #213, require that antibiotics labels not indicate the drugs can be used for growth promotion and that they specify veterinarians must oversee the administration of them to animals used in food production. The policy is meant to drastically decrease antibiotics use on farms, which is widely believed to be a major cause of antibiotics resistance in people.

Pew reviewed the labels of 389 antibiotics that are considered “medically important,” meaning they are also used to control infections in people. Of those, 240 are subject to judicious use rules, according to an issue brief published by Pew. But more than 140 of those drugs’ labels are not fully in compliance with the FDA’s rules.

What’s more, Pew reports, 75% of the non-compliant labels are on new, branded drugs. That could mean that future generic versions of those drugs will also violate the judicious-use principals, “because the label of a generic drug has to reflect that of the pioneer drug on which it is based,” Pew explains.

Pew found several other shortcomings on antibiotics labels beyond growth-promotion claims. For example, 100 products don’t specify duration of use. And 80 labels indicate the antibiotics can be administered to animals in situations that may not qualify as judicious use, such as “prevention in times of stress” and “maintenance of weight gains.”

The FDA has issued plenty of reminders to animal drug makers about the impending implementation of new antibiotics rules. In June, the agency sent a letter to all of the companies affected, reminding them of the January deadline for the label changes. Still, the FDA itself has acknowledged there’s plenty of evidence of a widespread lack of regard for the marketing restrictions on antibiotics. Last year, the agency took random samples from 2,000 dairy farms and found traces in several of them of the antibiotic florfenicol and 11 other drugs that aren’t approved to be used in lactating dairy cows.

Pew concludes its report with tough words for the federal agency: “FDA has publicly committed to ensuring that labels follow the judicious use of antibiotics in food animals, in particular with respect to establishing appropriate durations of use,” Pew’s brief says. “The agency should go further and announce a concrete plan and timeline for making all label revision changes--regarding duration limits and other aspects of appropriate use--as quickly as possible and follow through accordingly.”

- here’s Pew’s issue brief

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