PHILADELPHIA – A Horsham-based supplier of pharmaceutical services alleges a federal agency failed to timely respond to its petition regarding the approval of a drug.
Pharmaceutical Manufacturing Research Services Inc. filed a complaint for writ in the nature of mandamus relief on Aug. 4 in the U.S. District Court for the Eastern District of Pennsylvania against United States Food and Drug Administration, Commissioner of Food and Drugs Scott Gottlieb, M.D., and U.S. Department of Health and Human Services Secretary Thomas E. Price, M.D.
According to the complaint, the plaintiff alleges that Gottlieb and the FDA failed to promptly respond to its petition for stay of action in violation of the Administrative Procedure Act and the Mandamus Act. The suit states the plaintiff was a request for the FDA to stay the effective date of the approval of Inspirion Delivery Services LLC's drug application for Roxybond.
The plaintiff alleges it was "forced to submit the petition for stay to prevent another mislabeled and dangerous opioid from entering the market while the FDA considers the life-and-death-issues raised in PMRS's various submissions," the suit states.
The plaintiff seeks injunction against the defendants to provide a response, award court costs to the plaintiff and any further relief the court grants. It is represented by Natalie S. Watson of McCarter & English, LLP in East Brunswick, New Jersey.
U.S. District Court for the Eastern District of Pennsylvania case number 2:17-cv-03507-LDD