436 F.Supp.3d 256
D.D.C.2020Background
- In December 2018 FDA imposed a partial clinical hold on Vanda’s IND for tradipitant, blocking Vanda’s proposed 12‑month human trial until a 9‑month nonrodent (dog) toxicity study was completed.
- Vanda had earlier begun a 4‑week trial; FDA previously allowed up to three months total without the longer nonrodent study.
- FDA’s initial hold letter cited the regulation (21 C.F.R. § 312.23(a)(8)) and the ICH M3(R2) guidance as scientific context; FDA’s Medical Policy and Program Review Council and Office of Drug Evaluation III documented tradipitant‑specific toxicity concerns.
- After Vanda sued, FDA sought and received a voluntary remand to explain its reasoning; the agency issued a Remand Response amplifying tradipitant‑specific concerns and defending the 9‑month nonrodent study as the scientific minimum for long‑term human studies.
- Vanda argued the hold lacked an adequate scientific basis and that FDA treated the ICH guidance as a binding rule; FDA countered that the Remand Response articulated a defensible scientific basis and that the ICH guidance is nonbinding policy.
- The district court considered procedural challenges (post‑hoc rationalization, record supplementation, amicus participation) and held for FDA on summary judgment, denying Vanda’s motions and the Humane Society’s amicus request.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of FDA’s Remand Response (post‑hoc) | Remand Response mostly post‑hoc rationalization; new reasons should be excluded. | Remand Response was issued by proper decisionmakers and is an amplified articulation (or a permissible new decision) on remand. | Remand Response is part of the administrative record and may be considered; court rejects post‑hoc objection. |
| Use of ICH Guidance — legislative rule v. policy | ICH guidance was applied as a binding rule without notice‑and‑comment, violating APA. | ICH is a nonbinding guidance (general policy); FDA relied on the regulation and scientific analysis, not on a binding rule. | ICH Guidance is a general policy statement; FDA did not rely on it as a binding legislative rule; no notice‑and‑comment required. |
| Scientific sufficiency of FDA’s decision (necessity/predictiveness of 9‑month dog studies) | FDA ignored/misinterpreted studies, failed to show dog studies predict human toxicity, and acted litigation‑driven/standardless. | FDA relied on prior analyses, tradipitant‑specific adverse findings, and regulatory framework that contemplates animal data as predictive. | Court defers to agency expertise; FDA provided a rational connection between evidence and decision; decision not arbitrary or capricious. |
| Administrative record completion & amicus participation | Court should supplement/complete the record with extra documents and accept Humane Society amicus evidence. | Documents/studies were not before FDA via proper channels; amicus raises duplicative or extra‑record arguments. | Denied: record need not be supplemented; Humane Society’s amicus brief denied as duplicative or raising extra‑record material. |
Key Cases Cited
- Menkes v. U.S. Dep’t of Homeland Sec., 637 F.3d 319 (D.C. Cir. 2011) (agency explanations on remand may be considered)
- Alpharma, Inc. v. Leavitt, 460 F.3d 1 (D.C. Cir. 2006) (agency may supply amplified articulation on remand; courts must guard against post‑hoc rationalizations)
- NAACP v. Trump, 315 F. Supp. 3d 457 (D.D.C. 2018) (discussing limits on post‑hoc rationalization and remand explanations)
- Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983) (arbitrary and capricious review standard)
- Nat’l Mining Ass’n v. McCarthy, 758 F.3d 243 (D.C. Cir. 2014) (distinguishing legislative rules from policy statements)
- Baltimore Gas & Elec. Co. v. Nat. Res. Def. Council, Inc., 462 U.S. 87 (1983) (deference to agency scientific judgments)
- Coburn v. McHugh, 679 F.3d 924 (D.C. Cir. 2012) (agency explanations need not be analytically perfect to survive review)
- Petal Gas Storage, LLC v. FERC, 496 F.3d 695 (D.C. Cir. 2007) (court will not substitute its own methodology for agency's where agency's approach is reasonable)
- Genuine Parts Co. v. EPA, 890 F.3d 304 (D.C. Cir. 2018) (agency cannot ignore evidence before it)
- Shalala v. Guernsey Mem’l Hosp., 514 U.S. 87 (1995) (specific applications may be developed through adjudication rather than formal rulemaking)