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FDA seeks more data on antimicrobial sales for food-producing animals
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To obtain a clearer picture of antimicrobial use in food-producing animals in the United States, the FDA has proposed a rule that would require animal drug sponsors to provide estimated sales data of these drugs for cattle, swine, chickens and turkeys, according to a press release.
“The additional data would improve understanding of how antimicrobials are sold or distributed for use in major food-producing animals and help the FDA further target its efforts to ensure judicious use of medically important antimicrobials,” the release said.
Current rules in the Animal Drug User Fee Amendments of 2008 require antimicrobial drug sponsors to report antimicrobial drug sales intended for use in food-producing animals, including antibiotics, to the FDA but do not require specifics broken down by animal. The FDA said it prepares a report for the public based on the information it receives.
“Consistent with data collection objectives outlined in the administration’s National Strategy for Combating Antibiotic-Resistant Bacteria, this proposed rule is a step toward providing more detailed information to the FDA and the public on changes in antimicrobial sales and distribution over time. We plan further actions to complete the task,” Michael R. Taylor, JD, FDA’s deputy commissioner for foods and medicine, said in the release.
At this time, the FDA said it can only mandate data collection on antimicrobial sales and distribution, which may have limited value.
“While adding species-specific information will help provide a fuller picture, more detailed information is needed about on-farm use practices to adequately understand links between usage patterns and trends in resistance,” the FDA said.
On May 20, the agency began accepting public comments on the proposal for 90 days, Megan Bensette, MPH, FDA health communication specialist, told Infectious Disease News. She said no date has been set for a final ruling, which “would be important in supporting efforts such as the National Antimicrobial Resistance Monitoring System (NARMS), a surveillance program that tracks trends related to antimicrobial resistance in food-producing animals and humans. Specifically, this information could inform the agency’s risk assessment when evaluating animal drugs to be used in food-producing animals.”
The Obama administration’s 2016 fiscal year budget proposal lists more than $1.2 billion in federal funding toward combating antibiotic resistance. This includes $77 million to the Agriculture Department for antibiotic research and surveillance and $47 million to the FDA for the evaluation of novel antibacterial treatments for patients and antibiotic stewardship in animal agriculture, according to information provided by the White House. – by David Jwanier
Perspective
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Herbert L. DuPont, MD
Efforts to reduce foodborne illness in this country are important. President Barack Obama has been particularly interested in the safety of our food, supporting a number of programs listed in this article. Antibiotic resistance is a growing problem that needs attention as new drugs are not in the pipeline that could offer hope for management of infections caused by these strains.
Antimicrobials used in food-producing animals do contribute to antibiotic-resistant Salmonella and Campylobacter and possibly gram-negative coliforms. It is particularly important to remove from animal use antibiotics in common use in humans. While these efforts are underway, an even more pressing need is to develop programs to improve use of antibiotics in humans. Almost certainly inappropriate use of antibiotics in people is more important to the problem of antimicrobial resistance in human infections than use of antibiotics in animals. Both programs need immediate attention.
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