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Food Integrity Campaign Blog

KION – FDA Sued Over Antibiotics Reporting in Food Animals

December 6, 2012

by Jon K. Brent

Washington, D.C. – A food watchdog group is claiming that the Food and Drug Administration’s decision to withhold agency data regarding the sale of antibiotics for use in food animals is unlawful. The group knows as the Government Accountability Project or GAP filed a lawsuit Wednesday in Federal Court.

GAP notes that drug companies are required to report basic information about antibiotic sales to the FDA under the Animal Drug User Fee Act or ADUFA. The information includes how much of each drug is sold; whether the drugs are formulated for use in feed, water, or by injection; and the animals for which each drug is approved. The FDA publicly releases some of ADUFA data each year, but GAP claims they withhold almost all of what companies report.

GAP alleges the FDA failed to respond properly to GAP’s Freedom of Information Act request to the agency, which sought data concerning the amount of antibiotics sold for use in food animals in 2009, classified by animal type and dosage information.

The Johns Hopkins Center for a Livable Future, an academic research center based at the Johns Hopkins Bloomberg School of Public Health, approached GAP for help obtaining the data almost two years ago. GAP made the request in February 2011, and has exhausted all other steps to get the information, short of litigation. In the end, the agency denied GAP’s request, claiming that the requested data is “confidential commercial information.”

GAP’s counsel Jeff Gulley says, “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 contends that every year, nearly 30 million pounds of antibiotics – 80 percent of the total antibiotics sold in the United States – are sold for use in food animals. They say that this misuse of antibiotics have made human illnesses more dangerous and difficult to treat. Instead of enforcing stricter regulations or providing vital information to the public on this issue, GAP says the FDA has asked companies to reduce certain uses of antibiotics voluntarily, allowing rampant misuse to continue.

Food Integrity Campaign Director Amanda Hitt says, “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.”

FDA has 30 days to respond to the lawsuit.

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