GAP Lawsuit Seeks FDA Data on Use of Animal Antibiotics
The Government Accountability Project (GAP) has filed a lawsuit under the
Freedom of Information Act (FOIA) against the Food and Drug Administration
(FDA), alleging that the agency has wrongfully withheld information
requested about the use of anti-microbial drugs in food-producing animals.
GAP v. FDA, No. 12-1954 (D.D.C., filed December 5, 2012). GAP
requests an order requiring FDA to make the requested information available
within 10 working days and further seeks costs and attorney’s fees.
According to the complaint, GAP sought information in February 2011
about anti-microbial drugs collected from animal-drug sponsors under 21
U.S.C. § 360b. While FDA produced, as requested, educational and outreach
materials that assist drug sponsors in fulfilling their reported duties, it withheld
(i) “FDA’s data for use of anti-microbial drugs in food-producing animals
in 2009 as broken down by container size, strength, and dosage form”; and
(ii) “FDA’s data for use of anti-microbial drugs in food-producing animals in
2009 as broken down by class of animal.” FDA relied on FOIA exemption 4 to
withhold responsive material. GAP contends that the requested information
“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.”
GAP is a non-profit organization whose mission is to “promote corporate and government accountability by protecting whistleblowers, advancing occupational free speech, and empowering citizen activists.”
