On December 5, 2012, the Government Accountability Project (GAP) filed suit in U.S. District Court against FDA in response to the agency’s refusal to provide detailed information regarding the amount of antibiotics being sold for use in food-producing animals in the United States. FDA collects this data under the Animal Drug User Fee Act (ADUFA).
ADUFA requires manufacturers of certain antimicrobial animal drugs to submit a report that includes the amount of each antimicrobial active ingredient and the target animals for which it is labeled. GAP filed a Freedom of Information Act (FOIA) request in February 2011 in order to obtain this data. However, FOIA allows federal agencies to withhold certain “trade secrets and commercial or financial information.”
On June 9, 2011, FDA denied the request on grounds that it concerned confidential commercial information. On its website, GAP states that its concern stems from “the misuse of antibiotics in industrial animal agriculture [that] drives the development of antibiotic-resistant bacteria that have made human illnesses more dangerous and difficult to treat.” In the GAP complaint, the organization argues that the information is aggregate data and therefore does not fall under the exemptions described in FOIA. The court’s decision could greatly impact how FDA responds to FOIA requests in the future.
In an interesting side note, on July 27, 2012, FDA published an advance notice of proposed rulemaking seeking comments regarding potential changes to the regulations that govern what data must be submitted for antimicrobial animal drugs. Specifically, the agency may amend to require the submission of additional sales and distribution information, including an estimate of the amount of each antimicrobial sold or distributed for use in each approved food-producing animal species. The comment period was to end September 26, 2012, and was subsequently extended to November 26, 2012. No additional related notices have been published by FDA since the end of the comment period.
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