The Senate Health, Education, Labor and Pensions Committee on Monday released its version of the Animal Drug User Fee Act (ADUFA) without the provisions that would have beefed up the U.S. Food and Drug Administration’s annual reporting of antibiotic sales for use in food animal production. The move disappointed health and agriculture reform advocates who lobbied for greater reporting requirements, arguing that more data would help the government track trends in usage and resistance.Laura Rogers, a project director at The Pew Charitable Trusts said, “We are extremely disappointed that the Senate committee charged with protecting our health has neglected its mission,” in a statement issued Monday.
“The nation’s public health leaders urged the committee to allow the Food and Drug Administration to collect more detailed information about the sale of antibiotics for food animal production,” said Rogers. “Antibiotic overuse in meat and poultry production is breeding superbugs that threaten human health, but we have no information that reveals in which animals and for which purposes these drugs are administered so widely. Without greater transparency, the overuse of these drugs may continue unchecked.”
Pew applauded Senators Kirsten Gillibrand (D-NY) and Dianne Feinstein (D-CA) for offering a proposal “to shine a light on the use of antibiotics on industrial farms.”
The group said it would work with the two senators to get provisions – likely including some elements of the recently-introduced DATA Act – into the final version of the bill.
Last month, a letter from a variety of health groups – including the American Public Health Association, the Center for Science in the Public Interest, and the Trust for America’s Health – sent a letter to the HELP Committee urging them to strengthen data requirements.
The letter read:
“Congress’ requiring FDA to collect and publicly report on the sale of antibiotics in food producing animals for the first time in 2008 was a great step forward. However, it has become clear in subsequent years that there are significant gaps in both the data collected and the public reporting of that data by the FDA.
Currently, no reliable information is collected on the animal species in which the drugs are actually used except in the rare case where a drug is approved for a single species. Species-specific sales data are needed to compare with species-specific resistance trends that are identified through the National Antimicrobial Resistance Monitoring System. A 2011 report by the Government Accountability Office (GAO) recognized the limitations of the current sales and distribution data collection and recommended that federal agencies collect information on use by species.
FDA’s reporting is similarly deficient. FDA does not currently publicly disclose information on antibiotic sales by method of antibiotic administration (i.e., by feed, water, or injection) although it acknowledges that group delivery of antibiotics to large numbers of animals, such as via feed or water, poses a qualitatively higher risk for antibiotic resistance. Furthermore, FDA does not disclose what information it has on purpose of use or on the amount of sales over-the-counter versus by prescription or other means. Finally, FDA does not break out information on antibiotic sales by the medical importance of the drugs.”
The groups have called for a number of specific changes to current reporting requirements – see the full letter here.
The Senate HELP Committee is set to mark up the bill on Wednesday.
