Pharmaceutical Manufacturing Research Services, Inc. v. Food and Drug Administration

In reaction to the opioid crisis, the Food and Drug Administration (FDA) (defendant) issued a guide in 2015 that provided standards that clinical studies must satisfy in order to establish a drug’s abuse-deterrent properties. Pursuant to these standards, a manufacturer was required to articulate the methodology of executing the studies, the methodology for interpreting the studies’ results, and the influence of the data on the drug’s label. In January 2017, Pharmaceutical Manufacturing Research Services, Inc. (PMRS) (plaintiff) sought approval from the FDA for a drug with alleged abuse-deterrent characteristics. In response, the FDA forwarded a letter to PMRS in November 2017 denying approval for the drug based on a lack of evidence sufficient to show the alleged abuse-deterrent properties. The FDA, in investigating PMRS’s claim, relied on PMRS’s data, from which it determined that PMRS incorrectly claimed that dyeing the drug an unpleasing color would discourage abusers from intravenous injection of a solution derived from the drug. The FDA further established the ease with which prospective abusers could extricate chemicals from the drug to prepare a solution for injection. PMRS rejected the methodology employed by the FDA in assessing the abuse-deterrence properties of PMRS’s drug. Instead of bringing its application in line with FDA standards, PMRS sought an application hearing. In October 2018, on grounds of the drug’s false or misleading label, the FDA denied PMRS’s hearing request. Thereafter, PMRS alleged that the FDA’s denial constituted an abuse of discretion. PMRS filed a petition for review of the FDA’s order rejecting PMRS’s new-drug application.