Court decision pushes FDA on antibiotic use
By Sara Wyant
© Copyright Agri-Pulse Communications, Inc.
WASHINGTON, March 28, 2012 -Critics of antibiotic use in animal agriculture for growth promotion purposes praised a New York federal judge for ordering the Food and Drug Administration (FDA) to follow through on a notice it issued 35 years ago announcing an opportunity for public hearings on proposals to end routine use of penicillin and tetracycline in animal feed.
The Animal Health Institute (AHI) said the decision could delay FDA's process of eliminating subtherapeutic use of medically-important antibiotics, a process backed by animal drug makers.
“FDA has said the collaborative, stakeholder process is a more efficient way of achieving these goals than the process being forced by the court,” said Ron Phillips, vice president of legislative and public affairs of AHI. “It is unfortunate that time and resources will now be diverted to responding to the court decision.”
In a statement to Agri-Pulse, FDA said it was “studying the opinion and considering appropriate next steps.” The ruling stems from 1977 when FDA, concerned that the long-term use of antimicrobial drugs in food-producing animals posed a threat to human health, set in motion a regulatory process to discontinue the use of penicillin and tetracyclines for growth promotion and/or feed efficiency. FDA granted requests for hearings on the proposals, but never held them.
Judge Theodore Katz' ruling stems from a lawsuit brought last year by a coalition of consumer advocacy groups suing the FDA over its inaction. While the decision doesn't require the agency to ban subtherapeutic use of antibiotics, it does require the agency to complete the process it initiated in the late 70s.
“It's about time,” said Rep. Louise Slaughter, D-N.Y., chief sponsor of the Preservation of Antibiotics for Medical Treatment Act. “The FDA has been dragging its feet on this for 35 years. We've all known that this is a public health issue for quite some time . . . The evidence for ending the daily dosing of antibiotics to otherwise healthy animals is overwhelming. I'm pleased to finally see some progress and I can only hope that we see swift action from the FDA on this looming crisis,” she said.
“For more than two years, FDA has articulated a goal of eliminating subtherapeutic use and extending veterinary oversight using a collaborative, stakeholder process. The judge's opinion makes it clear that FDA's voluntary approach ‑ letting the industry police itself ‑ does not satisfy its legal obligations,” said Avinash Kar, an attorney with the Natural Resources Defense Council, the lead plaintiff in the suit.
Original story printed in March 28, 2012 Agri-Pulse Newsletter.
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