FDA says all but one animal drug company commit to antibiotic strategy

WASHINGTON, March 26, 2014 – FDA has received positive written commitments from 25 of 26 animal drug companies in response to its request that they phase out the use of antibiotics for growth promotion in livestock, the agency announced today.

The agency’s final Guidance 213, released in December 2013, asked the companies to stop selling antimicrobial drugs for growth promotion and directs them to change many drugs from “over the counter” to a status requiring veterinary oversight and consultation.

The industry had 90 days from the guidance release date in December to respond to FDA’s requests. On March 10, the Animal Health Institute (AHI) and the Generic Animal Drug Alliance (GADA), which represent most animal drug companies, committed to the voluntary guidelines.

In a video accompanying an AHI statement on the commitment, Richard Carnevale, the institute’s vice president for regulatory, scientific and international affairs, said many companies and producers are already following FDA’s recommendations.

“Most of the antibiotics are used for treatment and control and prevention of disease, and very little [are] actually used strictly for growth promotion,” Carnevale said. FDA did not identify the company that did not respond positively to its request.

FDA introduced its voluntary guidelines amid concerns that the overuse of antibiotics in feed and water for food animals leads to antimicrobial resistance. If the drug in question is also one that is medically important, resistance means the “drug may longer be as effective in treating various illnesses or infections,” FDA says. 

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