March 21, 2023

Court Rules FDA Doesn’t Need to Hold Hearings on Antibiotic Use

In a serious blow to those concerned about antibiotic use in farm animals, the U.S. Second Circuit Court of Appeals in New York ruled on Thursday, July 24, 2014 that the FDA does not have to hold hearings on the safety of feeding antibiotics to farm animals at sub therapeutic levels. Two years ago, two courts ruled that the FDA is required to hold those hearings to force the industry to prove that this particular use of antibiotics is safe.

GavelsThe appeal would have forced the FDA to end the use of penicillin and tetracyclines, two classes of antibiotics that are critical to human health, in animal feed. There is overwhelming scientific evidence linking this misuse of drugs in food animals to rising antibiotic resistance in many pathogenic bacteria. At least 20,000 people in the United States die every year from antibiotic-resistant infections, and that number is expected to increase.

Dr. Keeve Nachman, researcher at Johns Hopkins Center for a Livable Future, said in a statement, “penicillin and tetracyclines are necessary and commonly-prescribed antibiotics used to treat a variety of infections in people. If they lose their effectiveness, many infections that used to be easily treatable will become farm more dangerous and costly to treat.”

“This decision allows dangerous practices known to threaten human health to continue,” said Avinash Kar, attorney with Natural Resources Defense Council’s health program. “Adding antibiotics to farm animals’ feed, day after day, is not what the doctor ordered and should not be allowed.”

This decision means that the FDA doesn’t have to consider banning this off-label use of antibiotics in farm animals. Judge Robert Katzmann wrote a dissent to the decision, saying, “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.”

The groups that filed the appeal include the Center for Science in the Public Interest, Public Citizen, Natural Resources Defense Council, Food Animal Concerns Trust, and the Union of Concerned Scientists.


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