May 27, 2015
On May 19, the Food and Drug Administration (FDA) released a proposed rule that will enable more detailed data collection on antibiotic use in livestock production in the United States. This rule would require drug companies to obtain and report estimates of sales by major food producing species – namely cattle, chickens, turkeys, and pigs. The additional information from drug companies is intended to allow the FDA to help ensure the proper use of these medically important antibiotics.
Annual reporting of distribution and sales by these antibiotic drug companies has been required under Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA). This proposed rule would require sales and distribution information by individual animal species as compared to the current rule that simply requires a summary prepared by the FDA based on data submitted by drug companies. The rule also requires the FDA to publish its annual report of antibiotic sales and distribution information by December 31 of the following year, which is a more stringent deadline.
Antimicrobials, or antibiotics, have been widely used in animal agriculture to treat disease in an animal or a group of animals, prevent disease, and to promote growth. The Union of Concerned Scientists estimates that 70 percent of all antimicrobials in the US are used as feed or water additives for pigs, poultry and cattle for the non-therapeutic purposes of growth promotion and prophylactic disease prevention.
There has also been recent action in the House on antibiotic use in animal food production in addition to this proposed FDA rule. Representative Louise Slaughter (D-NY) has reintroduced the Delivering Anti-microbial Transparency in Animals (DATA) Act. This bill would also require drug companies to submit annual reports that specify antibiotic sales by animal species and would require identification of the reason for antibiotic use.
Representative Slaughter has stressed the importance of this data to allow for independent verification of the phase out of antimicrobial growth promoters which the FDA requested under Voluntary Guidance 213. Rep. Slaughter introduced similar legislation in the House in early 2013, which followed several other attempts in both the House and the Senate to pass legislation restricting antibiotic use for healthy animals.
All written comments for the FDA proposed rule must be received on or before August 18, 2015.