957 F.3d 254
D.C. Cir.2020Background
- PMRS submitted an NDA (Jan 2017) for an immediate‑release oxycodone labeled as an “Abuse Deterrent Formulation (ADF)” and claimed certain inactive ingredients (including a dye) and formulation properties would deter injection and other abuse routes.
- FDA issued a complete response letter: PMRS provided no substantial evidence that the dye or formulation would deter intravenous or nasal abuse, and some studies showed the drug could be manipulated into an injectable solution.
- PMRS requested an administrative hearing instead of resubmitting; it argued the drug’s acute‑pain indication and lower dosing would reduce abuse and criticized FDA’s 2015 Guidance on abuse‑deterrent opioids.
- FDA issued a denial order (Oct 2018), concluding PMRS’s proposed labeling was false or misleading under 21 U.S.C. § 355(d)(7), refused to consider belated label revisions submitted after the hearing request, and denied the hearing as unnecessary.
- PMRS sought judicial review under 21 U.S.C. § 355(h); the D.C. Circuit denied the petition, upholding FDA’s statutory interpretation, substantive denial, and refusal to grant a hearing.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDA may deny an NDA solely because proposed labeling is false or misleading under § 355(d)(7) | The statute’s sentence referencing “clauses (1) through (6)” shows § 355(d)(7) cannot by itself support denial | The numbering mismatch is a scrivener’s error; the statute’s text, structure, and context show § 355(d)(7) is a sufficient ground for denial | Court: FDA may deny an NDA on § 355(d)(7); reading the statute as permitting such denial corrects an apparent scrivener’s error |
| Whether FDA’s denial was arbitrary and capricious (APA) | FDA ignored material facts (conditions of use like indication and dosing) and misapplied the law; evidence of lower dosing/acute indication should have been dispositive | FDA reasonably found no substantial, reliable evidence that the formulation had abuse‑deterrent physical/chemical properties; deference to agency scientific judgment | Court: Denial was reasonable and adequately explained; agency did not act arbitrarily or capriciously |
| Whether FDA abused its discretion by denying PMRS a hearing | A hearing was needed to challenge FDA’s approach and to let PMRS show its indication/dosing evidence could support approval | No genuine and substantial factual issue was raised that could change the outcome; late label revisions were untimely; policy objections are not appropriate at an NDA hearing | Court: Denial of hearing was within FDA’s discretion; no determinative factual dispute warranted a hearing |
| Whether FDA treated its 2015 Guidance as binding law | FDA required Category 1–3 studies without notice‑and‑comment rulemaking, thus treating guidance as binding | FDA did not rely solely on the Guidance; it denied the NDA for absence of any substantial evidence supporting the label | Court: Rejected PMRS’s claim; denial rested on lack of any substantial evidence, not on treating the Guidance as binding |
Key Cases Cited
- Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983) (arbitrary and capricious standard requires reasoned explanation)
- Rempfer v. Sharfstein, 583 F.3d 860 (D.C. Cir. 2009) (courts give deference to FDA scientific judgments)
- Cytori Therapeutics, Inc. v. FDA, 715 F.3d 922 (D.C. Cir. 2013) (avoid second‑guessing agency scientific determinations)
- United States v. Palmer, 854 F.3d 39 (D.C. Cir. 2017) (correcting a clear scrivener’s error in statutory text is permissible)
- Lamie v. U.S. Tr., 540 U.S. 526 (2004) (courts cannot judicially amend statutes to supply omitted language)
- John D. Copanos & Sons, Inc. v. FDA, 854 F.2d 510 (D.C. Cir. 1988) (hearing granted only where a genuine and substantial factual dispute could affect the outcome)
- Nat’l Corn Growers Ass’n v. EPA, 613 F.3d 266 (D.C. Cir. 2010) (deferential review of agency decision denying a hearing)