U.S. Reps. Henry Waxman (D-Calif.) and Louise Slaughter (D-N.Y.) recently introduced legislation (H.R. 820) that would require drug manufacturers “to provide better information on the amount and use of antibiotics and other antimicrobials given to animals raised for human consumption,” according to a February 26, 2013, press release. The Delivering Antimicrobial Transparency in Animals (DATA) Act would also compel, “for the first time, large-scale producers of poultry, swine, and livestock to report data on the medicated feeds provided to their animals.”

Under the DATA Act, drug manufacturers would report to the Food and Drug Administration (FDA) on how their products are used “by determining (or estimating) the amounts of their drugs used in each food-producing animal for which they are approved.” In addition to general data about their antibiotic use, livestock producers administering medicated feed under a Veterinary Feed Directive would submit “detailed information” about “the quantities, dosages and duration of time the medicated feeds were provided to the animals.” The DATA Act would also direct the (i) Department of Health and Human Services to collaborate with the U.S. Department of Agriculture to improve data collection activities; (ii) FDA to finalize “its guidance to drug sponsors wishing to comply with [the agency’s] recommendations for judicious use of medically important antibiotics and other antimicrobials in animals”; and (iii) Government Accountability Office to evaluate FDA’s data collection efforts as well as its success in reducing the “injudicious use of antimicrobials in animals.”

“The widespread use of antibiotics in animals is a vital public health issue,” said Waxman. “We need to learn more about how these drugs are being used. With this information, scientists will be able to better pinpoint the relationship between the routine use of antibiotics in animals and the development of dangerous resistant bugs that can harm humans. This knowledge will inform scientists and Congress and start us down the path to sensible regulation.”

Meanwhile, the Institute for Agriculture and Trade Policy and 34 other groups have signed a February 26, 2013, letter asking the Senate Committee on Health, Education, Labor and Pensions to reauthorize and update the Animal Drug User Fee Act (ADUFA), which currently provides for data collection and reporting related to the use of antimicrobials in animals. In particular, the coalition has asked that the committee revise ADUFA to require (i) feed manufacturers to report medicated feed sales to FDA “by the antibiotic used, by animal species, and by indication (purpose of use) when available,” and (ii) FDA to better summarize these data for the public, in part by reporting all available information on antibiotic sales in food-producing animals and by tracking “the response of drug manufacturers to FDA’s voluntary plan so that Congress and the public can evaluate its effects on sales of antibiotics for use in food animal production.”

“[FDA’s] response to the threat has been to propose recommendations (Guidance for Industry #213) that encourage industry to voluntarily phase-out the marketing of antibiotics to speed up animal growth and to also voluntarily phase out the over-the-counter marketing of antibiotics,” concludes the letter, which calls on Congress to help curb animal antibiotic use. “This guidance does not require action and has no mechanism to track the adoption of these recommendations or to evaluate their effects on antibiotic use and resistance, nor does it address the routine feeding of antibiotics to food animals to keep them from getting sick in overcrowded, unsanitary, and high-stress conditions.”