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Judge OKs Controversial Drug in Animal Feed

SAN FRANCISCO (CN) - A federal judge dismissed two lawsuits claiming the U.S. Food and Drug Administration unlawfully approved a hazardous drug for animal feeds.

Lead plaintiff Center for Food Safety sued the FDA in one of two consolidated lawsuits in November 2014, claiming its approval violated the National Environmental Policy Act and Administrative Procedure Act.

The additive, designed to boost lean muscle growth in animals, contains the drug ractopamine hydrochloride, which is banned or restricted in dozens of countries, including European Union nations and China.

The plaintiffs say the FDA approved the drug for use in feed consumed by "an estimated one billion pigs, turkeys and cows from 2008 to 2014."

U.S. District Judge Yvonne Gonzalez Rogers dismissed the complaints on Nov. 5, finding the plaintiffs failed to exhaust administrative remedies: they did not begin by filing a petition with the FDA.

"The FDA citizen petition process is the appropriate procedural mechanism for plaintiffs to raise its contentions in the first instance, before seeking judicial review," Rogers wrote in her 16-page ruling .

The plaintiffs asked the judge in June to deny the motion to dismiss because, among other reasons, the intervenor defendant who filed the motion lacked standing.

Elanco Animal Health, an Indiana-based, global animal health company, filed the motion to dismiss for failure to exhaust administrative remedies on June 9.

Elanco , a division of Eli Lilly & Co., summarized the supplemental new drug application for the drug after the FDA approved it as a "Type A medicated article for finishing swine," under the trade name Paylean. Studies of direct human consumption of ractopamine linked it to tachycardia (fast heartbeat), tremors and raised blood pressure.

Rogers said the plaintiffs failed to articulate why Elanco must show it suffered injury from their failure to file a petition in order to bring the motion.

"The Court cannot discern any bar to Elanco bringing this motion, especially in light of FDA's (albeit tardy) agreement that plaintiffs must exhaust," Rogers wrote.

The plaintiffs also claimed the failure-to-exhaust condition did not apply in this instance because the FDA conducts its approval process in secret, denying the public and plaintiffs a meaningful opportunity to participate in the process.

The judge rejected that argument, finding the FDA mechanism for filing petitions against its already-approved decisions sufficient under the law.

"The FDA citizen petition process grants plaintiffs a meaningful opportunity to comment on the FDA approvals, and allows the FDA an opportunity to correct any mistakes it made in the approval process prior to possible judicial intervention," Rogers wrote.

FDA regulations require the agency to issue a tentative response to petitions within 180 days, but do not specify a timeframe for a final response from the agency.

The plaintiffs claimed they would suffer "irreparable harm" unless the court immediately considered its claims, but Rogers found those claims "not compelling," based on the fact that plaintiffs waited until November 2014 to challenge FDA approvals that were issued starting in 2008.

Rogers dismissed the consolidated lawsuits, but ordered both parties to show cause why the court should not stay the case pending the outcome of the plaintiff's petition.

Both parties must file a joint statement detailing their positions on whether the judge should stay the case by Nov. 19.Other plaintiffs involved in the lawsuit include the Center for Biological Diversity, the Sierra Club, United Farmworkers of America, Animal Legal Defense Fund and Humane Society of the United States

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