Animal Growth Steroid Challenge Dismissed

     SAN FRANCISCO (CN) – A federal judge has dismissed a lawsuit claiming the U.S. Food and Drug Administration failed to follow federal law in approving drugs used to boost animal growth rates.
     The Center for Food Safety, Center for Biological Diversity and the Sierra Club sued the FDA and its commissioner Margaret Hamburg in November 2014, claiming the agency avoided applying required National Environmental Policy Act analysis to at least 10 new animal drug applications containing ractopamine hydrochloride.
     The center describes the drug as a “controversial feed additive banned or restricted in dozens of nations, including all of the European Union and China.”
     “Scientists have linked ractopamine exposure to numerous adverse health events in humans and animals, including abnormal heartbeat, aggression, hyperactivity, collapse and even death,” according to the 26-page complaint.
     Zachary Marker, attorney for the Center for Food Safety, told Courthouse News on Thursday that although ractopamine is not a “steroid” per se, it does posses similar characteristics and that it is used in combination with known steroids.
     “Ractopamine is a beta agonist, but performs similarly to steroids because it increases metabolism, which allows the conversion of feed into muscle faster,” he explained. “We have challenged, I think, a total of 19 [FDA] approvals of drugs that are a combination of ractopamine and steroids, like melengestrol. Some of the combos involve antibiotics, like tylosin, and even the FDA says overuse is a partial cause for at least some of the antibiotic resistance we have seen.”
     Marker said the lawsuit in part challenges the FDA’s pattern of “rubber stamping” ractopamine drug combinations based on prior environmental impact statements and environmental analysis. He said the FDA fails to account for the vast changes in the industry between the time the analysis is conducted and eventual approval.
     “Some of the analysis goes back to 2001. But the approval wasn’t until 2008, so in those seven years a lot of things have changed,” he said. “Some of these combination drugs that were approved within the last couple years are relying on environmental analysis going as far back as 1995 and they are using a categorical exclusion to avoid the environmental review process. So we are saying on these most recent approvals, the agency is required to take into consideration that circumstances have changed and must update their analysis.”
     Intervenor defendant and drug manufacturer Elanco Animal Health moved to dismiss the complaint in June for failure to exhaust administrative remedies.
     U.S. District Judge Yvonne Gonzalez Rogers granted the motion on Nov. 5.
     “Plaintiff failed to exhaust their NEPA challenges pursuant to APA and therefore may not yet bring this action in this court,” she said in a 16-page order.
     In that order, Rogers suggested that a stay “pending exhaustion would allow the court to monitor the progress of administrative review.”
     Marker said that under this direction, the plaintiffs would be required to file a citizen petition under the FDA’s Food, Drug and Cosmetic Act and that they do not want to pursue that particular course because it would result in a long delay in achieving a remedy.
     “Our point of view is that this is not what NEPA is meant to do,” he explained. “When the analysis was done, it was done confidential, so advocates and the public didn’t see the environmental analysis until after approval was made – which turns NEPA on its head. The judge suggested she would stay the case pending the petition. We fundamentally disagree with the judge’s ruling in that sense and don’t believe we should file a citizen petition.”
     Marker laid out how he believes the case could proceed if his clients decided to follow Roger’s suggestion and file a citizen petition with the FDA.     
     “In our experience with citizen petitions in the past, it can be a long drawn out process,” he said. “They are required to give a response to our petition within 180 days, where the agency’s tentative response is informing petitioners they need more time to review the petition as we sit around and wait. Then, after some time period, maybe two years or more, after they still haven’t acted we would then have to file a lawsuit based on them not responding within the required time. Then you go into litigation over that, not even over what you are alleging in the citizen petition.”
     Considering the possible long delay, the plaintiffs decided to forego Rogers’ suggestion in lieu of taking another possible tact.
     The parties submitted a joint statement yesterday, asking the court not to stay the case pending exhaustion.
     “We filed a statement with the court saying we don’t believe that this is the proper avenue to address our concerns, so Judge Rogers didn’t order the stay and dismissed the case as final judgment.”
     Rogers issued her order yesterday based on the parties’ joint statement, granting Elanco’s motion to dismiss for failure to exhaust administrative remedies.
     Jennifer Corbett-Dooren of the FDA’s Office of Media Affairs did not immediately return a request for comment.

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