Supreme Court of the United States · Official docket →
Vanda Pharmaceuticals, Inc. v. Food and Drug Administration, et al.
Paid petition · United States Court of Appeals for the District of Columbia Circuit, No. 23-5200 · judgment December 17, 2024
Before the decision, about 2× the 4.1% base rate. The model weighted this up for counsel who has won certiorari before, a D.C. Circuit decision below, and a business petitioner.
Questions presented
Congress enacted the Fast Track program to speed the development and approval of certain novel therapies. It required FDA to designate “a new drug” as a “fast track product” if “it is intended * * * for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.” 21 U.S.C. § 356(b)(1). The questions presented are:
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Whether FDA has acted contrary to the statutory mandate by substituting an evaluation of the potential of a sponsor’s current drug development program for an assessment of “a new drug[’s]” own inherent “potential to address unmet medical needs.”
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Whether an approach to statutory interpretation that upholds an agency construction so long as it is “reasonable” and “consistent with” the statute’s “goal” (App., infra, 17a) unlawfully departs from the Court’s instructions in Loper Bright Enterprises v. Raimondo, 603 U.S. 369, 400-401 (2024).
Counsel of record
For petitioner
Paul Whitfield Hughes
McDermott Will & Emery
For respondent
D. John Sauer
Solicitor General
Proceedings
- Nov 17 2025Petition DENIED.
- Oct 29 2025DISTRIBUTED for Conference of 11/14/2025.
- Oct 28 2025Reply of petitioner Vanda Pharmaceuticals, Inc. filed. (Distributed)
- Oct 15 2025Brief of respondents Federal Respondents in opposition filed.
- Sep 04 2025Motion to extend the time to file a response is granted and the time is further extended to and including October 15, 2025.
- Sep 03 2025Motion to extend the time to file a response from September 15, 2025 to October 15, 2025, submitted to The Clerk.
- Jul 25 2025Motion to extend the time to file a response is granted and the time is extended to and including September 15, 2025.
- Jul 24 2025Motion to extend the time to file a response from August 15, 2025 to September 15, 2025, submitted to The Clerk.
- Jul 16 2025Response Requested. (Due August 15, 2025)
- Jun 25 2025DISTRIBUTED for Conference of 9/29/2025.
- Jun 20 2025Waiver of right of respondent Federal Respondents to respond filed.
- May 16 2025Petition for a writ of certiorari filed. (Response due June 20, 2025)
- Mar 12 2025Application (24A871) granted by The Chief Justice extending the time to file until May 16, 2025.
- Mar 07 2025Application (24A871) to extend the time to file a petition for a writ of certiorari from March 17, 2025 to May 16, 2025, submitted to The Chief Justice.