Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Apr. 12, 2023).pdf/11

 First, it appears that the individual plaintiffs and doctors in plaintiff associations have standing to challenge FDA’s actions.

To allege an injury in fact, these doctors must show they have suffered an “invasion of a legally protected interest” that is both “concrete and particularized” and “actual or imminent, not conjectural or hypothetical.” Spokeo, Inc. v. Robins, 578 U.S. 330, 339 (2016) (quotation omitted). Plaintiffs must identify specific injuries that go beyond “general averments” or “conclusory allegations.” ''Friends of the Earth, Inc. v. Laidlaw Env’t Servs. (TOC), Inc., 528 U.S. 167, 184 (2000) (quoting Lujan'', 497 U.S. at 888). Where a plaintiff seeks prospective relief and hence points to future injuries, the Supreme Court has emphasized that “threatened injury must be certainly impending to constitute injury in fact, and that allegations of possible future injury are not sufficient.” Clapper v. Amnesty Int’l USA, 568 U.S. 398, 409 (2013) (quotation omitted).

Here, FDA-approved the “Patient Agreement Form,” which is part of the REMS for mifepristone, provides: