Health Law Daily Wrap Up, GENERAL HEALTH CARE NEWS—D.D.C.: District judge declines ruling on constitutionality of presidential appointment, (Feb 4, 2026)

By David Yucht, J.D.

The court relied upon the doctrine of prudential ripeness which prevents premature adjudication.

A federal district court in the District of Columbia ruled that Vanda Pharmaceuticals’ Administrative Procedure Act (APA) claims against the FDA for its approval of a generic drug, which implicated the Appointments Clause of the federal Constitution were unripe for review. Accordingly, the court remanded the matter to the FDA to address the pharmaceutical company’s request for reconsideration (Vanda Pharmaceuticals Inc. v. FDA, No. 23-cv-2812 (CRC) (D.D.C. Jan. 28, 2026)).

Vanda Pharmaceuticals Inc. filed a complaint against the FDA, claiming the approval of a generic drug violated the APA and was issued by an improperly appointed officer. The court previously declined to dismiss the Appointments Clause claim, giving the FDA an opportunity to have a different official ratify the approval. The FDA declined to do so. Subsequently, both Vanda and the FDA moved once more for summary judgment. The court denied the renewed motions for summary judgment without prejudice, once again, on grounds of prudential ripeness and stayed the case pending the resolution of Vanda’s formal dispute resolution request and request for reconsideration.

Appointments Clause. The court denied Vanda’s summary judgment motion because its claim, based upon the Appointments Clause of the U.S. Constitution, that the president did not properly appoint the officer who approved the generic drug application was not “prudentially ripe” for consideration. The court found there was a “substantial judicial interest in deferring resolution.” Here, the FDA has the authority to give Vanda the relief it seeks, i.e., a revocation of the challenged generic approval. Federal courts are required to avoid premature adjudication of constitutional issues unless such adjudication is unavoidable. Here, the court did not wish to decide the constitutional Appointments Clause claim because if the FDA reconsiders and rules in Vanda’s favor, this constitutional question may become moot.

Additionally, if the FDA rejects Vanda’s request for re-reconsideration, Vanda could conceivably renew its APA claims. The court found that staying this matter would not cause Vanda meaningful hardship because competing with one more generic would not make a meaningful dent in Vanda’s finances. Vanda has not shown immediate and significant hardships adequate to outweigh the court’s interests in the deferral of review.

The case is No. 23-cv-2812 (CRC).

Judge: Cooper, C.

Attorneys: Sarah Patricia Hogarth (McDermott Will & Schulte LLP) for Vanda Pharmaceuticals Inc. David H. Hixson, U.S. Department of Justice, for Food and Drug Administration and Department of Health and Human Services.

Companies: Vanda Pharmaceuticals Inc.; Food and Drug Administration; Department of Health and Human Services

Cases: CaseDecisions FDCActNews GeneralNews GCNNews GenericDrugNews PrescriptionDrugNews DistrictofColumbiaNews