Court Won’t Force Ban on Drugs in Cattle Feed

     MANHATTAN (CN) – Despite finding the practice unsafe in 1977, the Food and Drug Administration cannot be forced into a process to withdraw approval of feeding cattle low levels of antibiotics, the 2nd Circuit ruled in a split decision.
     The Natural Resources Defense Council’s attorney Jen Sorenson said in a statement that the group will “evaluate all our legal options” in the wake of the decision.
     “As previous court rulings made clear, FDA has failed to follow its own scientific evidence and stop this practice,” Sorenson wrote. “Unfortunately, today’s Appeals Court decision effectively gives FDA a free pass to ignore the science when it is politically inconvenient.”
     FDA spokeswoman Jennifer Dooren commented only that she was “pleased” with the decision and drew attention to their own alternate plan to confront the problem in the wake of litigation.
     Nearly four decades ago, the FDA determined 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.
     Last year, the United Kingdom’s chief medical officer reportedly stated that these pathogens, commonly known as “superbugs,” could pose an “apocalyptic scenario.”
     On Thursday, all three judges of a federal appeals court in Manhattan agreed that the issue posed a “serious threat to human health,” but only one of them concluded that the judiciary could do anything about it.
     The majority’s decision dismisses a case brought by the Natural Resources Defense Council three years ago to force the FDA to begin the process to withdrawal its approval of such uses of the drug in the 1950s.
     In the wake of its 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.
     Since the manufacturers declined to participate, 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.
     The National Resources Defense Council asserted in a lawsuit three years ago that the agency’s subsequent stonewalling for more than a decade violated the Administrative Procedure Act and the Food and Drug Act.
     The FDA responded by rescinding its 1997 NOOHs and claiming that this waived the basis for the lawsuit.
     Disagreeing, a federal judge noted that the agency had not issued “a single statement” contradicting its earlier findings.
     U.S. Circuit Judge Gerard Lynch and District Judge Katherine Forrest, sitting by designation, reversed that decision, in a 65-page majority opinion.
     “It is not for us to determine whether the agency has been prudent or imprudent, wise or foolish, effective or ineffective in its approach to this problem,” Lynch wrote for the majority. “Whether the agency’s long inaction in the face of the dangers highlighted in the 1977 NOOH’s represented politically inspired foot dragging or wise caution in developing a cost effective approach, it was for the agency, and not the courts, to determine how best to proceed.”
     At a hearing early last year, the FDA’s lawyers argued that the court should not decide how the agency allocates its resources.
     Doreen, the FDA spokeswoman, said that the agency decided months after that argument that it would “phase out the use of medically important antimicrobials in food-producing animals.”
     “All 26 drug sponsors” signed onto the plan since its announcement in December, she added.
     The NRDC’s staff attorney Avinash Kar criticized the plan as a “hollow gesture” in a blog post written the month of its announcement.
     “Even if the drug manufacturers stopped selling antibiotics to speed up growth, they could continue to sell them for a very similar use: to prevent diseases associated with crowded and stressful conditions on many livestock facilities,” Kar wrote. “Not only is the use very similar in nature-low doses added to the feed of a large number of animals day after day-many of the antibiotics are approved for both kinds of uses.”
     In a dissent, Judge Robert Katzmann called the FDA’s denial of the citizen’s petitions “arbitrary and capricious.”
     Despite “recognizing that antibiotic resistance presents a serious global health problem,” Katzman wrote that his colleagues seem “to accept the view that Congress gave the FDA discretion to do virtually nothing about that problem for over 30 years-and then, when it finally decided to act, to adopt a different regulatory strategy than Congress expressly provided.”
     Such a finding could have wide ramifications, he warned.
     “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,” he added. “It also gives the agency discretion to effectively ignore a public petition asking it to withdraw approval from an unsafe drug.”

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