February 27, 2013By Kurt R. Karst –
On Tuesday, February 26th, Representatives Henry Waxman (D-CA) and Louise Slaughter (D-NY) announced the introduction of H.R. 820, the Delivering Antimicrobial Transparency in Animals Act of 2013 (“DATA Act”). Introduction of the DATA Act comes just as the U.S. Senate Committee on Health, Education, Labor, & Pensions is scheduled to hold a hearing on reauthorization of two animal drug user fee agreements – the third iteration of the Animal Drug User Fee Amendments (“ADUFA III”) (proposed statutory text and goals letter available hereand here) and the second iteration of the Animal Generic Drug User Fee Act (“AGDUFA”) (proposed statutory text and goals letter available here and here) – and several months after Rep. Waxman first announced his intention to introduce the DATA Act and after gathering input on a discussion draft of the bill. Representative Slaughter, who is a microbiologist, has shown a keen interest in antibiotic use in animal agriculture and has been a critic of FDA’s efforts to address the issue (see our previous post here). She is the author of the 2011Preservation of Antibiotics for Medical Treatment Act, which was intended to phase out the non-therapeutic use in livestock of medically important antibiotics, among other things.
The DATA Act would amend FDC Act § 512(l) to require drug manufacturers to obtain and provide to FDA enhanced information on how their antimicrobial drugs are used in the food-producing animals for which they are approved. The bill is also intended to improve the timing and quality of the data that FDA publicly releases on antimicrobial drug use in food-producing animals. According to a summary of the bill:
[T]he DATA Act will, for the first time, require large-scale producers of poultry, swine, and livestock to report data on the medicated feeds provided to their animals. The bill would require these producers to submit data to FDA detailing the type and amount of antibiotics and other antimicrobials contained in the feed they use. If the medicated feed is under a Veterinary Feed Directive (VFD), more detailed information must be provided to FDA, including the quantities, dosages, and duration of time the medicated feeds were provided to the animals.
The DATA Act would also require the HHS Secretary to coordinate with the Secretary of Agriculture to improve the collection of data and information on the use antimicrobial drugs in or on food-producing animals, and require the U.S. Government Accountability Office (“GAO”) to evaluate FDA’s antimicrobial data collection process and the Agency’s voluntary approach to reducing or eliminating injudicious use of antimicrobials in animals.
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