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FDA’s 2000 Approval. Growth Energy, 5 F.4th at 21. FDA’s 2016 decision to relax many of the REMS was issued in response to Danco’s supplemental application requesting as much. See PI App. 615–52. And FDA’s 2021 Petition Denial was issued in response to plaintiffs’ 2019 Citizen Petition asking FDA to “restore” the pre-2016 REMS—not revoke or reconsider FDA’s underlying 2000 Approval. See PI App. 667–93. Therefore neither of the “relevant proposals” prompted FDA to reopen and reconsider its 2000 Approval. Pub. Citizen, 901 F.2d at 150.
That said, the district court correctly noted that FDA nevertheless “undertook a full review of the Mifepristone REMS Program” when it reviewed plaintiffs’ 2019 Citizen Petition—even though the plaintiffs only asked FDA to restore the pre-2016 status quo ante. See PI App. 735–76; FDA Add. 22. In FDA’s words:
In 2021, FDA also undertook a full review of the Mifepristone REMS Program. In conducting this review, FDA reviewed multiple different sources of information, including published literature, safety information submitted to the Agency during the COVID-19 PHE, FDA Adverse Event Reporting System (FAERS) reports, the first REMS assessment report for the Mifepristone REMS Program, and information provided by advocacy groups, individuals, and the Plaintiffs in ongoing litigation, as well as information submitted by the sponsors of the NDA and the ANDA[.]
PI App. 735. And after conducting this unrequested “full review” of the REMS Program, FDA (inter alia) added two modifications to the REMS Program that plaintiffs never even mentioned in their 2019 Citizen Petition, including “a requirement that pharmacies that dispense the drug be specially certified.” PI App. 736; see also id. at 735 n.11 (acknowledging that “this was not raised in your Petition”). All of this suggests FDA went back to the beginning, including its very first REMS report, and conducted an
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