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.
This lawsuit comes after FDA’s failure to respond properly to GAP’s Freedom of Information Act (FOIA) request to the agency, which sought data concerning the amount of antibiotics sold for use in food animals in 2009, classified by animal type and dosage information.
Every year, nearly 30 million pounds of antibiotics – 80 percent of the total antibiotics sold in the United States – are sold for use in food animals. The misuse of antibiotics in industrial animal agriculture drives the development of antibiotic-resistant bacteria that have made human illnesses more dangerous and difficult to treat. Instead of enforcing stricter regulations or providing vital information to the public on this issue, FDA has asked companies to reduce certain uses of antibiotics voluntarily, allowing rampant misuse to continue.
The complaint can be accessed here.