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What exactly grants Federal courts jurisdiction / authority over the FDA, such that they can invalidate approval of pharmaceuticals?

This article prompts the question: https://abcnews.go.com/Health/canada-offer-access-mifepristone-abortion-drug-banned-us/story?id=98750787

2 Answers 2

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Article III of the United States Constitution vests the nation's judicial power -- which includes the authority to hear "all cases, in law and equity, arising under ... the laws of the United States" -- in the Supreme Court of the United States, and in the inferior courts established by Congress.

The federal courts therefore have authority under the Constitution to hear basically any case alleging that a federal law has been violated.

The federal district courts specifically have jurisdiction over any case in which the United States or any federal agency is a plaintiff or defendant.

But jurisdiction to hear a case is different than being empowered to grant the relief requested in a case. That authority comes from the Administrative Procedure Act, where Congress has specifically permitted judicial review of agency actions in 5 U.S.C. § 702:

A person suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action within the meaning of a relevant statute, is entitled to judicial review thereof.

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    The federal courts are also expressly granted subject matter jurisdiction over all cases to which the United States is a party, and the FDA is a subdivision or agency of the United States government.
    – ohwilleke
    Apr 22, 2023 at 19:41
  • That's correct. I think though, that the United States isn't a party to this specific case. If I'm recalling correctly, the doctors are suing the drug manufacturers rather than the FDA.
    – bdb484
    Apr 23, 2023 at 5:38
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    Nope, that was a related case I was thinking of. This one is FDA v. Alliance for Hippocratic Medicine. I've updated the answer to include this piece, as well.
    – bdb484
    Apr 23, 2023 at 17:06
  • Note that standing is also a required element of jurisdiction, and it's very debatable that the plaintiffs in the mifepristone lawsuit actually have it. The injuries that they allege seem extraordinarily tenuous and speculative to me.
    – Kevin
    Apr 23, 2023 at 18:01
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The Administrative Procedures Act grants federal courts the power to review agency actions, including approval of pharmaceuticals. See 5 U.S.C. § 706. This section gives federal courts the power to invalidate agency actions on various bases.

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