FDA Sued After Withholding Animal Antibiotics Data

WASHINGTON The Government Accountability Project (GAP) contends the U.S. Food and Drug Administration (FDA) has unlawfully withheld data pertaining to the sale of antibiotics for use in food animals.

The Washington, D.C.-based non-profit advocacy organization recently filed a lawsuit against FDA in the U.S. District Court for the District of Columbia following a request for information under the Freedom of Information Act (FOIA). 

On Feb. 10, 2011, the GAP submitted its FOIA request, asking FDA for different types of information, including data relating to the amount of antibiotics sold for use in food animals in 2009 specifying the type of animal, container size, strength and form of dosage. FDA furnished certain educational and outreach materials that GAP requested, but later revealed it wouldn't provide the other data, citing an exemption under FOIA, according to the lawsuit.

GAP alleges the FOIA exemption doesn't apply and that FDA should be required to produce the documents. "The information sought by GAP does not concern, and disclosure of the information would not reveal, any commercially valuable plan, formula, process, or device used for the making, preparing, compounding, or processing of any trade commodities," the advocacy group declared in the complaint that asks for declaratory and injunctive relief.  

Tamara Ward, an FDA spokeswoman, said the agency doesn't comment on pending litigation.

GAP submitted its FOIA request in order to obtain detailed information beyond annual summaries that the Secretary of Health and Human Services publishes pursuant to the Animal Drug User Fee Act as amended in 2008.

Organizations such as GAP have expressed concerns that the millions of pounds of antibiotics sold for use in food animals is leading to resistant bacteria that can pass to humans through food or direct contact with the animals.

"How can we truly know the extent to which these drugs are causing harm if we can't even access information," asked GAP Food Integrity Campaign Director Amanda Hitt, in a statement Dec. 5. "The agency's job is to protect the public's health, not industry secrets."