The U.S. Food and Drug Administration’s (FDA) 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) Wednesday.
Drug companies are required to report basic information about antibiotic sales to the FDA under the Animal Drug User Fee Act (ADUFA). The information reported 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, 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, using tools like the National Antimicrobial Monitoring System, for example, to monitor resistance among foodborne pathogens. The agency says it needs more data to track resistance issues.
FDA publicly releases a limited summary of ADUFA data each year, but withholds almost all of what companies report, according to GAP.
This lawsuit comes after FDA failed to respond “properly” to a Freedom of Information Act (FOIA) request filed by 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.
According to the group, Johns Hopkins Center for a Livable Future (CLF) at the Johns Hopkins Bloomberg School of Public Health reached out for help obtaining these data almost two years ago.
“These data will help public health researchers decipher how the industry’s antibiotic use erodes the effectiveness of these life-saving drugs,” said Keeve Nachman, Ph.D., director of the Farming for the Future program at CLF, which has served as a scientific adviser to GAP on the request and lawsuit.
GAP said they 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,” according to the group.
“The FDA frequently claims that documents sought through the FOIA process contain ‘confidential commercial information,’” said Jeff Gulley, who serves as Counsel to the group. “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.”