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Wednesday, June 19, 2024 | Back issues
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FDA Defends Hoof-Dragging in Cattle Drug Case

MANHATTAN (CN) - The 2nd Circuit seemed skeptical Friday that it should not speed up a process to stop feeding low levels of antibiotics to livestock, which has been deemed unsafe since 1977.

The Food and Drug Administration first approved feeding "preventative" antibiotics in the 1950s.

It determined two decades later that "subtherapeutic" doses of penicillin and tetracyclines - at levels too low to treat disease - contributed to development of antibiotic-resistant bacteria that could be transferred to humans.

These pathogens are commonly known as "superbugs," a health issue described by the United Kingdom's chief medical officer this year as potentially posing an "apocalyptic scenario."

In the wake of the 1977 study, the FDA issued notices of opportunity for hearing, or NOOHs, a voluntary process allowing drug manufacturers to defend the safety of their products.

The manufacturers declined to participate, and the FDA declined to regulate them.

Fed up with 22 years of inaction, several nonprofits filed citizens' petitions asking the agency to follow through on the NOOHs in 1999.

Led by the Natural Resources Defense Council in 2011, the groups filed a federal complaint claiming that the FDA's failure to act, and to respond to the petitions, violated the Administrative Procedure Act and the Food and Drug Act.

U.S. Magistrate Judge Theodore Katz later blocked the FDA from trying to negate the petitions by rescinding the NOOHs.

"The FDA has not issued a single statement since the issuance of the 1977 NOOHs that undermines the original findings that the drugs have not been shown to be safe," the 55-page order stated.

Katz ordered the FDA to move forward with those hearings, issue a new set of NOOHs and issue withdrawal orders if the drug sponsors do not prove the safety of their products.

A three-judge panel of the 2nd Circuit convened Friday to decide whether, as the FDA claims, the 1977 study constitutes an agency "finding."

Judge Gerard Lynch appeared to side with the FDA.

If it were a "finding," the drug sponsors' hearing in their defense would be a "Red Queen" affair, in which "the finding comes first and the hearing comes later," he said.

Taking the counterargument, Judge Robert Katzmann noted that the FDA never contested that preventative antibiotics pose a public health issue.

Arguing for the FDA, Assistant U.S. Attorney Ellen London said the agency took "no position" officially on the safety issue.

Though "the agency's in agreement that there's a problem," it should have discretion to resolve this problem on without a court order, London insisted.

Katzmann countered that "35 years is a long time to wait for something to happen."

Picking up on this point, Lynch quipped that the FDA could threaten drug sponsors with another voluntary compliance program in another 35 years, "so, they better watch out!"

Still, Lynch peppered NRDC attorney Jennifer Sorenson about agency discretion.

"They can't deny it on the grounds of, 'We have a 100 things more important [to do] than this one'?" he asked.

Sorenson said that they need to ground their decision in the statute.

Once the FDA determined the drug unsafe, the agency triggered a process that it could not abandon arbitrarily, she argued.

U.S. District Judge Katherine Forrest, sitting on the panel by designation from the Southern District of New York, summed up that position, asking, "The train has already left the station?"

"Right," Sorenson said.

The judges ended the hearing without indicating when they will issue their decision.

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