Court Rejects Challenge to FDA Approval of Ammonia-Reducing Animal Drug
Yesterday the U.S. District Court for the Northern District of California granted summary judgment to FDA and drug manufacturer Elanco Animal Health, thereby rejecting a challenge to FDA’s approval of Experior, a drug intended to reduce ammonia production in feedlot cattle. See 20-cv-03703-RS (Law360 subscription required).
Plaintiffs (three advocacy groups) had challenged the approval and argued that FDA failed to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the National Environmental Policy Act (NEPA) in approving the drug.
Specifically, in regard to drug efficacy, the Court held that FDA had properly found that there was substantial evidence supporting approval of Experior for the “reduction of ammonia gas emissions per pound of live weight and hot carcass weight in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.” The conclusion was based on 5 well-controlled studies consisting of a total of 536 animals and the Court held that it was irrelevant that the mechanism of action was not well established and that FDA did not require proof of any particular environmental results.
In regard to the safety of the new animal drug, the Court held that FDA appropriately evaluated human food safety, user safety, and target animal safety and that Plaintiffs’ arguments would require the Court to inappropriately second-guess FDA’s judgment.
Finally, with regard to NEPA, the Court held that FDA’s Finding of No Significant [Environmental] Impact (FONSI) was a reasoned decision that was not inconsistent with the approval of an ammonia reducing drug.
