As the end-of-year deadline for pharma companies to revise the labels of antibiotics they market to food producers rapidly approaches, the FDA is moving on to the next phase of its multifaceted effort to combat the rise of drug-resistant superbugs. On September 12, the agency put out a call for the public’s input on so-called medically important antimicrobials--drugs that are used to combat bacterial infections in people but that are also widely relied upon in food production.
Specifically, the FDA is concerned about medically important antibiotics that are added to animal feed or water to address at least one therapeutic indication--but that don’t have a defined duration of use, according to a statement from the agency. About 32% of antibiotics that are subject to the FDA’s new rules fall into that category. The FDA is asking the public for suggestions on how it should establish appropriate durations of use for those products.
The FDA is particularly interested in gathering information on when livestock and poultry are most vulnerable to the diseases that are treated with medically important antimicrobials, what treatment methods could help farmers to use the drugs in a more judicious manner, and how the labels of drugs that don’t include a suggested duration of treatment might be revised. The agency began taking comments on September 14 and will continue accepting them for 90 days.
“Today’s action furthers the FDA’s overall efforts to ensure medically important antimicrobials are used in food animals only for health purposes,” the agency said in the statement.
The FDA’s efforts to rein in antibiotics use in food production have hit some rough patches of late. In June, the agency released a progress report revealing that only one drug label has been revised to reflect new regulations requiring that antibiotics can only be used to combat infections in food animals and not for nonmedical uses like growth promotion. Four antibiotics have been shifted from over-the-counter to prescription status and 41 have been withdrawn from the market, but there are still hundreds of products being marketed in ways that will no longer be compliant as of the start of next year.
After Stephen Ostroff took over as the FDA’s new deputy commissioner for foods and veterinary medicine early this year, he vowed publicly to clarify the role of antibiotics in food production. Pharma companies, for example, will need to collect sales data on the drugs and estimate percentage of revenues by species.
The FDA’s new initiative to further refine the labels of animal antibiotics comes at a time when all of the world’s pharma regulators are under pressure to help lessen the spread of superbugs. On September 21, the United Nations' General Assembly will take on the topic of antibiotics resistance for the first time during a one-day meeting that will include input from animal health leaders like Zoetis ($ZTS), Merck ($MRK) and Eli Lilly ($LLY).
- here’s the FDA's statement
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