Description: Challenge to the U.S. Food and Drug Administration's approval of a drug intended to reduce the amount of ammonia gas released from the waste produced by cows raised for beef.
Animal Legal Defense Fund v. Azar
Filing Date Type File Action Taken Summary 02/23/2021 Order Download Motions to dismiss denied. Federal Court Allowed Challenge to FDA Approval of Cattle Drug to Proceed. The federal district court for the Northern District of California denied motions to dismiss a lawsuit challenging the Food and Drug Administration’s (FDA's) approval of a drug intended to reduce releases of ammonia gas from the waste of cattle raised for beef. The plaintiffs’ claims include that FDA failed to consider the drug’s environmental impacts, including impacts from air emissions from concentrated animal feeding operations. The court rejected arguments that the plaintiffs did not have standing or that they failed to exhaust administrative remedies. 10/29/2020 Motion to Dismiss Download Motion to dismiss for lack of Article III standing and failure to exhaust administrative remedies filed by Elanco Animal Health. 10/29/2020 Motion to Dismiss Download Motion to dismiss first amended complaint filed by federal defendants. 09/29/2020 Complaint Download First amended complaint filed. 06/04/2020 Complaint Download Complaint filed. Challenge Filed to Environmental Review for Approval of Drug to Reduce Ammonia Emissions from Cows. Three organizations filed a lawsuit in the federal district court for the Northern District of California alleging that the U.S. Food and Drug Administration (FDA) violated the Federal Food, Drug, and Cosmetic Act and the National Environmental Policy Act when it approved a drug “that allegedly results in less ammonia gas released from the waste produced by cows raised for beef.” In addition to allegations regarding the drug’s safety and effectiveness, the complaint also alleged that the environmental assessment prepared in support of the drug’s approval failed to adequately analyze whether the approval would have a significant adverse impact. The complaint alleged, among other things, that the reduction of ammonia emissions “while confining the same or greater number of cows in [concentrated animal feeding operations (CAFOs)] will do nothing to alleviate the overall air impacts of CAFOS,” including emissions of the greenhouse gases methane and nitrous oxide.