NEW YORK – A federal appeals court ruled that the Food and Drug Administration (FDA) is not required to withdraw approval for animal drugs the agency itself deems unsafe. The ruling reverses a lower court decision.
The National Resources Defense Council (NRDC) and other public advocacy groups sued the FDA and the Dept. of Health and Human Services in May 2011 in an effort to force the agencies to ban the use of some antibiotics in food animals. The groups also sought to force FDA to hold hearings on a petition to withdraw approval of such drugs.
The US Court of Appeals for the Second Circuit ruled 2-1 in favor of the FDA and HHS. Judges Gerald Lynch and Katherine Forrest found in favor of the defendants, while Chief Judge Robert Katzmann dissented in a separate opinion.
In their ruling
, Lynch and Forrest said “Our survey of the text, the context, the regulations, and the background legal principles leave us firmly persuaded that Congress has not required the FDA to hold hearings whenever FDA officials have scientific concerns about the safety of animal drug usage, that the FDA retains the discretion to institute or terminate proceedings to withdraw approval of animal drugs by issuing or withdrawing NOOHs [Notices of Opportunity for a Hearing], and that the statutory mandate contained in § 360b(e)(1) applies to limit the FDA’s remedial discretion by requiring withdrawal of approval of animal drugs or particular uses of such drugs only when the FDA has made a final determination, after notice and hearing, that the drug could pose a threat to human health and safety.”
The court sent the case back to district court with instructions to deny the plaintiffs’ motion for summary judgment, grant the defendants’ motion for summary judgment and dismiss the action.
“As previous court rulings made clear, FDA has failed to follow its own scientific evidence and stop this practice. Unfortunately, today’s Appeals Court decision effectively gives FDA a free pass to ignore the science when it is politically inconvenient,” said Jen Sorenson, NRDC attorney. “We will evaluate all our legal options, and we will continue to push to end the dangerous and unnecessary use of antibiotics on animals that are not sick through every avenue available to us.”
In his dissent, Katzmann said “Today’s decision allows the FDA to openly declare that a particular animal drug is unsafe, but then refuse to withdraw approval of that drug. It also gives the agency discretion to effectively ignore a public petition asking it to withdraw approval from an unsafe drug. I do not believe the statutory scheme can be read to permit those results, and I must therefore respectfully dissent.”