Court Orders FDA To Evaluate Safety of Agricultural Antibiotics

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A new court decision will send the U.S. Food and Drug Administration back in time to 1977. The decision, which was handed down Thursday by New York Magistrate Judge Theodore H. Katz, requires the FDA to follow through on hearings it initiated 35 years ago regarding the safety and appropriateness of certain low-level antibiotics used in animal feed. Labelled "growth promoters," these antibiotics -- among them penicillin and tetracyclines -- are criticized by concerned scientists, environmentalists, and others as promoting the evolution of antibiotic-resistant "superbugs."

Wired's Maryn McKenna reports that the FDA's hearings to determine the safety and legality of "growth promoters" were never held, largely due to high-level congressional opposition. Judge Katz's order will compel the FDA to take action on its own safety findings by withdrawing approval for most non-therapeutic uses of penicillin and tetracyclines in animal feed, unless the industry can prove in public hearings that those drug uses are safe. The ruling also makes clear that future nonbinding guidance from FDA will not excuse the Agency from its obligation to hold hearings on whether to withdraw approval for antibiotics covered by the decision. Provided the order is not overturned on appeal, it will end the administration's current policy allowing voluntary self-regulation in the agricultural pharmaceuticals industry.

Under the ruling, the FDA's notice of proposed withdrawals may be updated to reflect current data and concerns.

From the order's Overview:

    For over thiry years, the FDA has taken the position that the widespread use of certain antibiotics in livestock for purposes other than disease treatment poses a threat to human health. In 1977, the FDA issued notices announcing its intent to withdraw approval of the use of certain antibiotics in livestock for the purposes of growth promotion and feed efficiency, which the agency had found had not been proven to be safe.

    In the intervening years, the scientific evidence of the risks to human health from the widespread use of antibiotics in livestock has grown, and there is no evidence that the FDA has changed its position that such uses are not shown to be safe.

Plaintiffs in the suit include the Natural Resources Defense Council, the Center for Science in the Public Interest (CSPI), Food Animal Concerns Trust (FACT), Public Citizen, and the Union of Concerned Scientists (UCS). They are celebrating the court's decision as a significant victory for their cause. Avinash Kar, a health attorney with the NRDC, issued this statement:

    For over 35 years ago, FDA has sat idly on the sidelines largely letting the livestock industry police itself. In that time, the overuse of antibiotics in healthy animals has skyrocketed – contributing to the rise of antibiotic-resistant bacteria that endanger human health. Today, we take a long overdue step toward ensuring that we preserve these life-saving medicines for those who need them most – people.

    These drugs are intended to cure disease, not fatten pigs and chickens.

The Court noted the limits of its decision: "the Court is not ordering a particular outcome as to the final issuance of a withdrawal order," reads the decision. It merely requires the FDA to hold the aforementioned hearings, which will give drug sponsors the opportunity to try to prove their products are safe. "If, at the hearing, the drug sponsors fail to show that use of the drugs is safe, the Commissioner must issue a withdrawal order," the order continues, "... If the drug sponsors demonstrate that the subtherapeutic use of penicillin and/or tetracyclines is safe, then the Commissioner cannot withdraw approval."

Still, the plaintiffs are enthusiastic about the decision. “After decades of delay, the FDA will finally have to address this long-standing threat to the public,” said Richard Wood, executive director for FACT. “This is a great victory for public health and a great chance to make American farms move in a more healthy direction.”

If you really want to, you can read the entire 55-page text of yesterday's order below:

Opinion and order granting summary judgment re growth promoter antibiotics

[Via Wired]

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