07.12.2012

The U.S. Food and Drug Administration's decision to withhold agency data regarding the sale of antibiotics for use in food animals is unlawful, according to a lawsuit filed by the Government Accountability Project (GAP), a nonprofit advocacy group.
This lawsuit comes after FDA failed to respond to a Freedom of Information Act request, according to GAP. The group sought data concerning the amount of antibiotics sold for use in food animals in 2009, classified by animal type and dosage information.
Drug companies are required to report basic information about antibiotic sales to the FDA under the Animal Drug User Fee Act. The information reported includes how much of each drug is sold; whether the drugs are formulated for use in feed or water or by injection; and the animals for which each drug is approved, but not how much of each drug is given to each class of animals.
The sales data is supposed to help the agency track potential ties between usage and the increase in antibiotic resistance. FDA publicly releases a limited summary of ADUFA data each year but withholds almost all of what companies report, according to GAP. The FDA frequently claims that documents sought through the FOIA process contain ‘confidential commercial information.