March 4, 2021

GAP Sues FDA for Withholding Animal Drug Data

The Government Accountability Project (GAP) has sued the Food and Drug Administration (FDA) over information about how antibiotics are used in food animals. GAP is a non-profit organization in Washington D.C. that supports and litigates on behalf of whistleblowers in the private sector and the federal government. Their Food Integrity Campaign’s mission is to facilitate truth-telling and transparency in industry and government.

GavelsGAP is suing the FDA under the Freedom of Information Act, which requires the federal government to release information to the public unless the agency “demonstrates that one of the nine enumerated statutory exemptions applies,” such as trade secrets or commercial or financial information.┬áThe Animal Drug User Fee Act (ADUFA) requires sponsors of animal drugs to submit a report every year to the Secretary of Health and Human Services specifying the amount of antimicrobial active ingredients sold for use in food animals.

In February 2011, GAP asked the FDA for information about antibiotic use in food-producing animals, broken down by container size, strength, dosage form, and class of animal. After some back-and-forth, the agency denied GAP’s request, claiming the data is “confidential commercial information”. The information GAP is seeking does not reveal “any commercially valuable plan, formula, process, or device used for the making, preparing, compounding, or processing of any trade commodities”, and is not “financial information’.”

Drug companies are required to report basic information about antibiotic sales under ADUFA. The Johns Hopkins Center for a Livable Future is working with GAP for help obtaining these data. Jeff Gulley, GAP Food & Public Health Counsel, said, “The FDA frequently claims that documents sought through the FOIA process contain ‘confidential commercial information.’ 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.”

GAP Food Integrity Campaign Director Amanda Hitt said, “How can we truly know the extent to which these drugs are causing harm if we can’t even access information? The agency’s job is to protect the public’s health, not industry secrets.” Yesterday Food Poisoning Bulletin reported on the probable change in ADUFA’s reporting methods, which may keep industry’s designation of antibiotics secret.

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