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FDA faces lawsuit over food animal antibiotics data

By Rod Addy , 11-Dec-2012

The Government Accountability Project (GAP) is suing the US Food & Drug Administration (FDA) for withholding data on the sale of antibiotics for use in food animals.

GAP is concerned that misuse of antibiotics in industrial animal agriculture is fostering the development of antibiotic-resistant strains of bacteria that then threaten human health.

The lawsuit follows the FDA’s failure to satisfy adequately GAP’s Freedom of Information Act (FOIA) request to deliver information concerning the amount of antibiotics sold for use in food animals in 2009.

GAP claims to have made every attempt to secure the relevant details since February 2011, short of litigation, and was eventually told the requested data was “confidential commercial information”.

‘Confidential’

"The FDA frequently claims that documents sought through the FOIA process contain 'confidential commercial information," said Jeff Gulley, GAP Food & Public Health Counsel.

"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."

Keeve Nachman, director of the Farming for the Future program at Johns Hopkins Centre for a Liveable Future (CLF), which has served as a scientific adviser to GAP on the request and lawsuit, said: "These data will help public health researchers decipher how the industry's antibiotic use erodes the effectiveness of these life-saving drugs.”

In April this year a study, conducted by the CLF and Arizona State’s Biodesign Institute, was published claiming banned drugs had been found in eight out of 12 multi-state feather meal samples. The CLF researchers called on the FDA to monitor what drugs were going into animal feed.

Basic information

Drug companies are required to report basic information about antibiotic sales to the FDA under the Animal Drug User Fee Act (ADUFA).

Such 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.

FDA publicly releases a limited summary of ADUFA data each year, but withholds almost all of what companies report, GAP claims.

The FDA has 30 days to respond to the lawsuit, which was filed on December 5.

The FDA was unavailable for comment at the time FoodProductionDaily.com was published.

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