Case: 23-10362 Document: 543-1 Page: 82 Date Filed: 08/16/2023
The FDA also points to its 2011 Risk Evaluation and Mitigation Strategy, arguing that this too re-approved mifepristone and cured any defects in its 2000 approval. It did not. To the contrary, the 2011 REMS letter made clear that the agency continued to rely on Subpart H for its approval of mifepristone—that it “is approved under the provisions of 21 CFR 314.520 (Subpart H).” FDA Supplemental Approval Letter to Danco Labs at 1. Moreover, the letter only approved the Risk Evaluation and Mitigation Strategy proposed in Danco’s 2008 Supplemental Application—it did not re-approve the drug apart from Subpart H. In fact, the letter recognized the need for continued compliance with the conditions “required by” Subpart H. Id. at 2 (citing 21 C.F.R. § 314.550). *** For these reasons, I would find that Plaintiffs are likely to succeed on the merits of their challenge to the 2000 approval. Plaintiffs also satisfy the remaining factors for equitable relief. The harm to Plaintiffs is irreparable. No relief at law can adequately address Plaintiffs’ conscience injuries. See BST Holdings, L.L.C. v. OSHA, 17 F.4th 604, 618 (5th Cir. 2021). Nor can money damages remedy the destruction of life. Cf. Amoco Production Co. v. Village of Gambell, 480 U.S. 531, 545 (1987). The balance of equities and public interest also favor Plaintiffs. Plaintiffs seek to vindicate the “national policy of discountenancing abortion as inimical to the national life,” as reflected in Congressional enactments including the Comstock Act. Bours v. United States, 229 F. 960, 964 (7th Cir. 1915). See 18 U.S.C. § 1461; id. § 1462. Cf. 19 U.S.C. § 1305(a).
IV.
With respect to the FDA’s 2016 and 2021 revisions, I agree with the majority’s thoughtful analysis explaining how the FDA “entirely failed to consider an important aspect of the problem” in 2016 and “offered an
82
