US domestic antimicrobial sales drop 33 percent on FDA restrictions

19 Dec 2018 --- US domestic sales and distribution of all medically important antimicrobials intended for use in food-producing animals decreased by 33 percent between years 2016 and 2017, according to a new US Food and Drug Administration (FDA) report. The “2017 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals” also shows that domestic sales and distribution of all medically important antimicrobials decreased 41 percent since 2015 (peak year of sales/distribution) and decreased 28 percent since the first year of reported sales in 2009.

While sales data do not necessarily reflect actual antimicrobial use, the reduction in sales volume observed in 2016 and 2017 is an important indicator that ongoing efforts to support antimicrobial stewardship are having a significant impact, the agency reports.

The data summarized in the 2017 Sales/Distribution report is collated from estimates of antimicrobial animal drug product sales for that year provided by the drug manufacturers and can’t be substituted for actual usage data. For example, veterinarians and animal producers may purchase antimicrobial drugs, but never actually administer them to animals, or they may administer the drugs in later years, the agency stressed.

In a statement from FDA Commissioner Scott Gottlieb, M.D. on the findings, he noted: “While I’m very pleased with the results of the report, and the efforts by all of our stakeholders thus far to improve antimicrobial stewardship, our work isn’t yet done when it comes to fighting antimicrobial resistance.”

“CVM’s five-year action plan, unveiled in September, outlines additional steps that the FDA intends to take to continue fostering our momentum in antimicrobial stewardship across veterinary settings,” he added. “The plan involves a broad set of actions intended to combat antimicrobial resistance and preserve the effectiveness of antimicrobial drugs. This includes, for example, applying a risk-based approach to evaluate new and currently approved antimicrobial products for animals. It also calls for further collaboration with key stakeholders to support stewardship of these products and facilitates the collection of data on resistance and antimicrobial use to monitor the effectiveness of this action plan in slowing the development of resistance,” he explained.

The items outlined in the action plan will be initiated in phases over the next five fiscal years (2019-2023). “This phased approach will allow for adjustments to be made based on critical, science-based analysis, public health impact, feedback from stakeholders and resource availability. Down the road, we will continue to engage our stakeholders and the public as we develop and implement strategies for addressing individual actions and goals identified in this plan,” said Gottlieb.

Gottlieb noted that this action plan is an integral piece to the agency’s 2019 Strategic Approach for Combating AMR in both veterinary and human health care settings, including efforts to facilitate product development to ensure a robust pipeline of safe and effective treatments that can combat resistant organisms. 

The consumer lobby group, the Center for Science in the Public Interest (CSPI) welcomed the findings. “The US ban on using antibiotics for growth promotion and restrictions on over-the-counter use went into full effect in January 2017,” read a statement from CSPI President Dr. Peter G. Lurie. “Now, we are seeing the striking results that those changes have had on our food production system. The new sales data are encouraging, and show that progressive steps driven by the FDA, industry, and consumer demand can be effective in bringing about real change,” he added.

Lurie noted that the highest percentage drop in sales was in chicken, while the largest overall amount of sales remains in cattle and swine. “Further progress on antibiotics use in cattle and swine may be achievable and could have a critical impact in fighting the threat of antibiotic resistance,” Lurie stressed. “While good news, the new FDA data show continuing areas for improvement. Sales of injectable, oral, and intramammary antibiotics, while low, have increased slightly over the past year. Some of these products are still available over-the-counter without a prescription. The FDA has promised to bring these products under veterinary oversight and should act swiftly to implement that change,” he added.

The CSPI also stressed that the FDA has also not yet fulfilled its pledge to publish figures that account for animal weight. “This information will be vital to understanding how antibiotics are used in our food system and should be published without further delay,” Lurie concluded.