On May 19, 2015, the Food and Drug Administration (“FDA”) proposed a rule requiring animal drug manufacturers to track drug sales by species. Currently, manufacturers must track only total sales by drug class in accordance with the Animal Drug User Fee Amendments.
Total sales by drug class, however, does not provide direct data on which species are being given which drugs. The FDA wants to fix this data deficiency in order to better understand the antibiotic-resistant bacteria that forms in animals and then transfers to humans. It is hoped that the collection of antibiotic-use data by species will reveal trends or patterns in resistance.
To increase the effectiveness of the collected data, the proposed rule also requires the FDA to issue its annual report on animal antibiotic data by December 31 of the following year.
The FDA will accept public comments on the proposed rule for 90 days following its publication in the Federal Register. Read the FDA news release, “FDA proposes rule to collect antimicrobial sales and distribution data by animal species”, that describes the proposed rule.
US Representative Louise Slaughter from New York had previously introduced in the US Congress the Delivering Antimicrobial Transparency in Animals Act. The bill would require heightened reporting of antibiotic use by animals and public dissemination of that information.
Congresswoman Slaughter, the only microbiologist in Congress, commented in a news release, titled “Congresswoman Louise Slaughter Reacts to Proposed Rule from FDA on Antibiotic Use in Livestock,” that the FDA’s proposed rule should but does not require reporting the reason for antibiotic use.