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FDA to require data on drugs used in food animals

Manufacturers and distributors will now be required to file annual reports on who the drugs are sold to, how much is bought and what animals they will be used in.

By Stephen Feller
FDA to require data on drugs used in food animals
The FDA's new rule requiring reports on antimicrobial drugs sold for use in food-producing animals is expected to help the agency find more and better ways to reduce their use. Photo by Iakov Kalinin/Shutterstock

BETHESDA, Md., May 12 (UPI) -- The U.S. Food and Drug Administration announced it has finalized a rule requiring much more detailed information on antimicrobial drugs distributed for use in food-producing animals, an effort to reduce bacterial resistance to medicines widely depended on for human health.

Manufacturers of antimicrobial drugs will now be required to submit detailed information on who the drugs are sold to, how much they buy and what their use will be, in addition to the estimates of overall sales and distribution of the drugs for food production already required by the FDA.

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Farmers have used the drugs to prevent infection in animals, as well as to encourage growth, though their widespread use for decades has resulted in resistance, with antibiotics used in humans being ineffective against bacteria they are meant to kill.

Although companies have said in recent years they would reduce levels of the drugs used in animals, a 2015 FDA report found the amount of drugs sold to farmers actually increased by four percent from 2013 to 2014 and by 22 percent between 2009 and 2014.

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While the new rule will not outlaw or act to reduce levels of drugs used in animals, it will allow the agency to better track and understand what is being done, which officials expect to help deal with the problem in the future.

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"This information will further enhance FDA's ongoing activities related to slowing the development of antimicrobial resistance to help ensure that safe and effective antimicrobial new animal drugs will remain available for use in human and animal medicine," Dr. William Flynn, deputy director for science policy in the FDA's Center for Veterinary Medicine, said in a press release.

The new rule, published in the Federal Register on May 11, will require each sponsor -- either manufacturer or distribution company -- to submit an annual report to the FDA listing amounts of each ingredient in a drug product sold or distributed for use in food-producing animals.

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The rule also enhances requirements that companies submit information on drugs sold for specific food-producing species, including cattle, swine, chickens and turkeys, as well as the relationship between sales levels and reports of antimicrobial drug resistance.

The FDA has been working to eliminate use of the antimicrobial drugs in farming since at least 2013, when it began implementing a plan to phase out the practice.

As statistics collected by the agency have shown, the effort has been a failure, suggesting better understanding of how, why, when and in which animals specific drugs are being used could better focus efforts to curtail treating animals with them.

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