Neurelis Inc. v. Califf
Civil Action No. 2024-1576
D.D.C.Mar 19, 2025Background
- Neurelis, Inc. sued the FDA, alleging the agency violated the Orphan Drug Act (ODA) by approving Aquestive Therapeutics, Inc.'s Libervant during Neurelis's period of market exclusivity for its own drug, Valtoco.
- The court agreed with Neurelis, found the FDA acted outside its statutory authority, and vacated Libervant's approval.
- Aquestive sought a stay of the order pending appeal, arguing for "remand without vacatur" instead of immediate vacatur, citing potential harm to patients and procedural fairness.
- The FDA took no position on the stay but rejected the argument that remand without vacatur was appropriate, stating there was no clinical superiority claim in the record before the lawsuit.
- Neurelis opposed the stay, contending remand without vacatur was legally unavailable due to a fundamental misreading of the agency’s authority and that clinical superiority was not legally or factually established.
- The court denied Aquestive’s motion for a stay but allowed a short stay until March 28, 2025, to allow an expedited appeal to the D.C. Circuit.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the FDA violated the ODA by approving Libervant during Valtoco’s exclusivity period | Neurelis: FDA lacked authority for approval under ODA | Aquestive: No defense on merits at this stage; focused on remedial order | Court: FDA acted ultra vires; approval vacated |
| Remedy – Should the court remand without vacatur? | Neurelis: Not legally available when agency exceeded authority | Aquestive: Remand without vacatur proper; FDA could consider clinical superiority | Court: Remand without vacatur not justified; error not curable |
| Harm and Disruption from Vacatur | Neurelis: Not a relevant factor when agency lacked authority | Aquestive: Vacatur harms patients and company | Court: Disruption not a basis when agency exceeds statutory authority |
| Stay Pending Appeal | Neurelis: Opposes; no basis for stay | Aquestive: Requests stay to seek appellate relief | Court: Stay denied, except briefly to permit expedited D.C. Circuit appeal |
Key Cases Cited
- Nken v. Holder, 556 U.S. 418 (2009) (explains standards for stays pending appeal and judicial discretion)
- Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7 (2008) (sets preliminary injunction factors including likelihood of success and public interest)
- Wash. Metro. Area Transit Comm’n v. Holiday Tours, Inc., 559 F.2d 841 (D.C. Cir. 1977) (adopts sliding scale for preliminary relief in D.C. Circuit)
- Allied-Signal, Inc. v. U.S. Nuclear Regul. Comm’n, 988 F.2d 146 (D.C. Cir. 1993) (sets standards for vacatur versus remand in administrative law)
- Comcast Corp. v. FCC, 579 F.3d 1 (D.C. Cir. 2009) (discusses disruptive consequences when considering vacatur)