Prove They’re Safe Or Stop Using Them: Court Orders Major FDA Action on Antibiotics in Livestock Feed
Intensity over the issue of antibiotic use in animal feed has been heating up over just how much the government should intervene. And a recent ruling by a federal court has crystallized the severity, ordering the FDA to take further action in efforts to protect public health from the repercussions of excessive antibiotic use. The overuse of antibiotics has led to a growing number of antibiotic-resistant pathogens and concerns about effective use of the drugs to treat serious human health issues.
According to a statement from the Natural Resources Defense Council, the court wrote of its decision:
“[T]he statutory scheme requires the Agency to ensure the safety and effectiveness of all drugs sold in interstate commerce, and, if an approved drug is not shown to be safe or effective, the Agency must begin withdrawal proceedings. The Agency has forsaken these obligations in the name of a proposed voluntary program, Guidance # 209, and acted contrary to the statutory language.
. . .
[FDA] must evaluate the safety risks of the petitioned drugs and either make the finding that the drugs are not shown to be safe or provide a reasoned explanation as to why the Agency is refusing to make such a finding.”
The decision comes on the heels of a court order in April that will force the FDA to withdraw the approval of the nontherapeutic use of certain antibiotics in animal feed unless there’s conclusive evidence that the drugs are safe. The court’s most recent ruling also included specific instructions that the FDA must reexamine its decision that denied two Citizen Petitions filed on the issue with the FDA in 1999 and 2005.
“As the court points out, FDA has recognized but stopped just short of making formal findings that the nontherapeutic use of antibiotics in livestock production poses a risk to human health,” said NRDC attorney Jen Sorenson in a statement. “By forcing the agency to grapple with the science, the court’s order paves the way for a ban on these dangerous drug uses.”
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Image: eutrophication&hypoxia
