Regulatory Focus™ > News Articles > Group Sues FDA, Seeking 'Confidential Information' About Antibiotic Prescribing Data

Group Sues FDA, Seeking 'Confidential Information' About Antibiotic Prescribing Data

Posted 06 December 2012

A consumer advocacy group has filed a lawsuit against the US Food and Drug Administration (FDA) for withholding data regarding the use and sale of antibiotics used in food-producing animals, saying the denial of its Freedom of Information Act (FOIA) request for the information was "unlawful."

The group, the Government Accountability Project (GAP), which bills itself as a whistleblower protection organization, said it objects to FDA withholding certain data reported to it each year by pharmaceutical companies.

Under the Animal Drug User Fee Act (ADUFA), later updated by the Animal Generic Drug User Fee Act (AGDUFA) of 2008, FDA has the authority to require sponsors to submit to it annual reports regarding the sale, distribution, and active ingredients in antimicrobial products intended for good-producing animals. The rule is intended to make sure the agency has sufficient information to detail the scope of prescribing, which can be crucial in determining whether certain drugs are being over- or improperly used and might pose a threat by promoting antibiotic-resistant strains of bacteria.

Both pieces of legislation are due for renewal in the coming year.

In two recent Federal Register notices, FDA said it is actually looking to collect even more data from sponsors, including sales and distribution data for "antimicrobial animal drug products that are approved and labeled for more than one food-producing animal species, an estimate of the amount of each active antimicrobial ingredient sold or distributed for use in each approved food-producing animal species."

"Specifically, comments should address how sponsors can both practically and accurately provide separate sales and distribution information for each species," FDA explained in its 27 July Federal Register notice. The comment period for that proposed rule recently ended.

The problem, writes GAP, is that the collected data is largely kept secret from the public, which it argues would stand to benefit the most from the agency being transparent with its data. GAP, acting on behalf of the Johns Hopkins Center for a Livable Future, made a FOIA request for the documents back in February 2011. That request was ultimately denied, and the group said it has since "exhausted all other steps to get the information, short of litigation."

FDA, according to GAP, denied its request on the basis of it containing "confidential commercial information"-a reason often used by FDA when certain data, such as confidential manufacturing or pricing information, is collected.

Under AGDUFA, FDA is specifically allowed to "make summaries of the information reported under this paragraph publicly available." A caveat under Title I, Section 105(1)(E)(ii) of the law, however, adds that "the data shall be reported in a manner consistent with protecting both national security and confidential business information."

The definition of "confidential business information," then, is likely to be the main source of debate between FDA and GAP.

"The FDA frequently claims that documents sought through the FOIA process contain 'confidential commercial information,'" wrote Jeff Gulley, Food & Public Health Counsel for GAP, in a statement. "When tested in court, however, these claims frequently don't hold up. This response by FDA is a violation of FOIA and a wrongful withholding of agency records."

"The agency's job is to protect the public's health, not industry secrets," added Amanda Hitt, Food Integrity Campaign director for GAP.

FDA does not, as a rule, comment on pending or ongoing litigation.


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