Each year, the agency publishes a summary of the information animal drug sponsors are required to report every year by the Animal Drug User Fee Act (ADUFA), but the data are only broken down by drug class. An ongoing issue for the public health community is that sales and distribution information is not directly correlated with how the drugs are actually used.
The rule FDA proposed on Tuesday would add estimates of sales by animal species — cattle, swine, chickens or turkeys. It also includes a provision requiring FDA to publish its annual summary report of antimicrobial sales and distribution information by Dec. 31 of the following year in order to make the release of data more timely.
“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,” said Michael Taylor, FDA’s deputy commissioner for foods and veterinary medicine, adding, “We plan further actions to complete the task.”
Different species are raised differently, which is why species-specific data are necessary, said Gail Hansen, senior officer of the antibiotic resistance project at The Pew Charitable Trusts.
“They’re all forward steps, and no one piece of data is going to tell us everything we need to know,” Hansen said.
FDA noted that while adding species-specific information will help provide a fuller picture of antimicrobial use, data about on-farm use by species and purpose are what’s ultimately needed for understanding the links between usage and trends in resistance.
“FDA is actively engaged with the U.S. Department of Agriculture, Centers for Disease Control and Prevention, and a wide array of stakeholders to fill this need,” the agency stated.
In reaction to FDA’s proposed rule to expand data collection, Rep. Louise Slaughter (D-NY) reintroduced her Delivering Antimicrobial Transparency in Animals Act (DATA), which would also require reporting of the reason for animal antimicrobial use.
“Knowing how much of the drugs are being used in cattle or pork or poultry will be helpful in identifying the problem areas,” Slaughter said.
Steven Roach, senior analyst for the Keep Antibiotics Working coalition, said that FDA’s proposal is weaker than Slaughter’s bill because it collects data from the drug companies rather than the farm or feed mill.
“Given the focus on antibiotic use in food production, the drug makers are likely to underestimate amounts used on farm,” Roach said. “The DATA Act actually requires large food producers to report drug use by species and indication and does not rely on estimates.”
Time is now an imperative for the ADUFA rule, Hansen said, because FDA wants to evaluate the effectiveness of Guidance for Industry #213, which bans antimicrobial use on farms for growth promotion and will be fully implemented in January 2017. It would be good to have a year of baseline data from this expanded collection, she said.
FDA told Food Safety News that while the agency will work to finalize the proposed rule as expeditiously as possible, “we cannot give a date for a final rule at this time.”
Hansen said that releasing the final rule is probably possible by the end of 2015, but that is a tight timeframe.
“Time is of the essence,” she said.
FDA is accepting public comments on the ADUFA rule for 90 days beginning on May 20.© Food Safety News