296 F. Supp. 3d 166
D.C. Cir.2018Background
- Ferring's Prepopik (fixed-combination colon cleanser) contains sodium picosulfate, magnesium oxide, and anhydrous citric acid; Ferring sought 5-year NCE exclusivity for the sodium picosulfate component.
- FDA originally treated sodium picosulfate as containing the active moiety picosulfate (not previously approved) but denied 5-year exclusivity in 2012 under an interpretation barring fixed-combinations containing any previously approved active moiety; it granted 3 years instead.
- After Ferring challenged the agency interpretation, the district court in a reconsideration granted summary judgment to Ferring and remanded to FDA for proceedings not inconsistent with the court’s opinion (finding FDA’s original interpretation arbitrary and capricious in some respects).
- On remand the FDA re-examined sodium picosulfate’s chemistry and concluded the active moiety is BPHM (after excluding salts/esters), a moiety present in previously approved drugs, and thus denied 5-year NCE exclusivity.
- Ferring moved to enforce the prior judgment, arguing law-of-the-case, judicial estoppel, retroactive rulemaking/due process, and arbitrary and capricious action; the court denied the motion, holding these challenges inappropriate on an enforcement motion and that FDA’s change was not barred.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDA’s change on the identity of the active moiety violates the court's prior order (law of the case) | FDA previously agreed picosulfate was the active moiety; court relied on that shared understanding, so FDA cannot relitigate | The court never decided the moiety identity; issue was not addressed and is within agency competence on remand | Law-of-the-case inapplicable; court never decided moiety identity and remand allowed agency reconsideration |
| Whether FDA is judicially estopped from reversing its earlier position on the moiety | FDA maintained an earlier, contrary position throughout regulatory process and litigation; reversal is unfair | FDA did not persuade the court of the earlier position; change appears inadvertent and not tactically motivated | Judicial estoppel does not apply: FDA’s earlier position was not adopted by the court and change may be inadvertent |
| Whether FDA’s remand decision constituted improper retroactive rulemaking or violated due process | Reinterpretation of "ester" to encompass sulfur appendages is new, retroactive, and deprived Ferring of notice/hearing | Agency replies these are merits issues for an APA challenge, not an enforcement motion; remand permitted reconsideration | Procedural/merits claims not resolved on enforcement motion; such APA challenges must be raised separately |
| Whether FDA’s remand action was arbitrary and capricious | Late chemical analysis and unexplained shift in approach are arbitrary and capricious | Agency performed additional scientific analysis within its expertise and may reach same result on permissible grounds after remand | Court declined to decide arbitrary-and-capricious claim on enforcement motion; agency may be reviewed in separate APA action |
Key Cases Cited
- Chevron U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837 (1984) (framework for reviewing agency statutory interpretations)
- Heartland Reg'l Med. Ctr. v. Leavitt, 415 F.3d 24 (D.C. Cir. 2005) (limits of motions to enforce remand results; merits of post-remand agency action belong in separate APA suit)
- New Hampshire v. Maine, 532 U.S. 742 (2001) (judicial estoppel factors)
- Fed. Election Comm'n v. Akins, 524 U.S. 11 (1998) (agencies on remand may reach same result for different permissible reasons)
- A.L. Pharma, Inc. v. Shalala, 62 F.3d 1484 (D.C. Cir. 1995) (deference to agency scientific judgments)