Ninth Circuit Likely to Remand Animal Drug Case

SAN FRANCISCO (CN) — The Ninth Circuit indicated Monday it may let the Center for Food Safety challenge the government’s decision to approve the controversial animal-growth drug ractopamine.

The Center for Food Safety, the Center for Biological Diversity and the Sierra Club sued the Food and Drug Administration in 2014, claiming that it failed to properly analyze the environmental impacts of 18 new animal drugs containing ractopamine, as required by the National Environmental Protection Act (NEPA), before approving their use.

In 2015, the groups’ case was consolidated with similar claims by the Humane Society of the United States, the United Farm Workers of America and the Animal Legal Defense Fund.

Ractopamine, a feed additive designed to increase lean muscle growth in farm animals, can cause “significant” harm when administered to them or released into the environment, according to the plaintiffs’ opening brief. It has been linked with health problems and deaths in animals and humans, and China and the European Union have either banned or restricted it. Its risks in humans include rapid heartbeat and elevated blood pressure.

“These same drugs have been banned in other countries,” U.S. District Judge Gershwin Drain said at the Monday hearing, sitting on the appeals panel by designation from the Eastern District of Michigan. “It raises a little suspicion about the effects they have on the environment.”

The plaintiffs want the ractopamine approvals vacated, the FDA ordered to conduct another NEPA analysis, and the drugs withdrawn from the market until the FDA does so.

Elanco Animal Health, which manufactures ractopamine, intervened in 2015. It then sought dismissal later, saying the plaintiffs were required to file a citizen petition challenging the approvals before they could sue.

Though U.S. District Judge Yvonne Gonzalez Rogers sided with Elanco in November 2015, she suggested staying the case while the citizen petition, and its progress, was reviewed.
Fearing a protracted delay if they filed a petition, the plaintiffs declined the stay, and Gonzalez Rogers dismissed the case that month, for failure to exhaust administrative remedies.

Seeking reversal Monday, Center for Food Safety attorney Paige Tomaselli told the Ninth Circuit that the FDA’s citizen petition regulations run afoul of the Administrative Procedure Act, and that filing a petition is not required before going to court.

Tomaselli said the FDA can require her clients to file a citizen petition only if it suspends the drug approvals while it considers the petition. But filing the petition won’t do that, she said.

“The citizen petition process will not render the underlying drug approvals inoperative, and so therefore our case was proper in front of the district court,” Tomaselli said.

“What we’re seeking is for the agency to make informed animal drug approval decisions based on adequate NEPA analyses in the first instance.”

Department of Justice attorney Jeff Beelaert argued, as he did in his answering brief, that the plaintiffs were required to notify the FDA of their concerns so the agency could address them before going to court.

“She’s saying that she wants us to engage in the NEPA process; she wants us to consider all of this information. How we do that is through the citizen petition process,” Beelaert told the panel. “The district court said, ‘How am I supposed to know what the FDA thinks of your arguments? You didn’t raise them.’

“We’re not saying that there’s no judicial review, nor are we saying that the public can’t be involved,” Beelaert added. “They can come in as a third party and raise all of the arguments that they want. They can talk about everything we should’ve considered … and the citizen petition process is the way for the agency to then take those arguments and consider them in the process. And the agency can do a whole lot of things to address their concerns, things a district court is going to have a very hard time doing if you adopt their arguments.”

Beelaert said the FDA can address the plaintiffs’ concerns by placing restrictions on drug manufacturers or withdrawing the drugs from the market, among other things.

At the end of the hearing, Senior U.S. Circuit Judge Mary Schroeder asked Tomaselli a question that indicated the panel could remand the case.

“If we were to agree with you to the extent that you shouldn’t have been required to exhaust before you brought claims in federal court, but we were to agree with the agency that they ought to have a chance to look at this because they have agency expertise, what would we do?” she asked.

Citing the plaintiffs’ fear of delay, Tomaselli said they would want the FDA to review their grievances “in short order,” and a timeline detailing when they could expect a response.

“Who would do that? The district court?” Schroeder asked. To which Tomaselli responded yes.

U.S. Circuit Judge Johnnie Rawlinson rounded out the panel.

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