By 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 here and 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 2011 Preservation 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.
ADUFA II directs FDA to prepare and publish annual summaries of antimicrobial animal drugs sold or distributed for use in food-producing animals. The data are derived from information submitted by sponsors of antimicrobial new animal drugs who each year must submit to FDA a report regarding, among other things, their distribution data for antimicrobial animal drugs distributed domestically and exported for use in food-producing animals (see FDA’s annual reports here). A September 2011 GAO report, titled Agencies Have Made Limited Progress Addressing Antibiotic Use in Animals, suggests that this information is insufficient to support a meaningful analysis of the possible relationship between antimicrobial resistance and the use of medically important antibiotics in food-producing animals. In July 2012, FDA published an Advance Notice of Proposed Rulemaking requesting comments as to how the Agency might be able to obtain more detailed information about the use of antimicrobial animal drugs when the drugs are used in numerous species, including non-food producing animals (see our previous post here).
The DATA Act would also require FDA to promptly finalize a guidance document issued in April 2012 in draft form, titled New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209. The guidance is intended to provide sponsors with specific recommendations on how to supplement their approved marketing applications to align with FDA’s guidance on the judicious use of medically important antimicrobial drugs in food-producing animals.
In addition to activity on the legislative front, FDA is embroiled in litigation over the withdrawal of approval of certain uses of certain classes of antibiotics in food-producing animals. As we previously reported, the National Resources Defense Council sued FDA in 2011 and initially sought to compel the Agency, by a court-ordered deadline, to withdraw approval of all subtherapeutic uses of penicillin in animal feed and nearly all subtherapeutic uses of tetracyclines (oxytetracycline and chlortetracycline) in animal feed and to issue final responses to two Citizen Petitions relating to hearing notices FDA issued in 1977 on the Agency’s withdrawal proposals. FDA has not fared well in the litigation, which is on appeal to the U.S. Court of Appeals for the Second Circuit (Docket Nos. 12-2106 and 12-3607).