Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 56 of 67 PageID 4478
In September 2000, FDA abandoned its safety proposals and acquiesced to the objections of the Population Council and Danco. Despite its “serious reservations” about mifepristone’s safety, FDA approved a regimen that relied on a self-certification that a prescribing physician has the ability to diagnose ectopic pregnancies. Id. at 51, 62; see also ECF No. 1-28 at 21 (“[W]e concluded that there was no need for special certification programs or additional restrictions.”). FDA later released the applicant entirely from its Phase 4 duties — twelve years after the 1996 commitment. ECF Nos. 1-24 at 6, 1-28 at 32; see also 21 C.F.R. § 314.510 (“Approval under this section will be subject to the requirement that the applicant study the drug further, to verify and describe its clinical benefit, where there is uncertainty … of the observed clinical benefit to ultimate outcome. Postmarketing studies would usually be studies already underway.”) (emphasis added).
FDA must refuse to approve a drug if the agency determines there is “insufficient information to determine whether such drug is safe for use” or a “lack of substantial evidence that the drug will have the effect it purports or is represented to have” under the conditions of use in the proposed label. 21 U.S.C. § 355(d)(4)–(5); see also 21 C.F.R. § 314.125(b). FDA is therefore required to deny an NDA if it makes the exact findings FDA made in its 2000 review. “[A]n agency’s decision to change course may be arbitrary and capricious if the agency ignores or countermands its earlier factual findings without reasoned explanation for doing so.” F.C.C. v. Fox Television Stations, Inc., 556 U.S. 502, 537 (2009). The agency must ordinarily “display awareness that it is changing position,” and “must show that there are good reasons for the new policy.” Id. at 515. And “if the agency’s decision was in any material way influenced by political concerns it should not be upheld.” Earth Island Inst. v. Hogarth, 494 F.3d 757, 768 (9th Cir. 2007). FDA’s only acknowledgments of its prior proposals were that “FDA and the applicant were not always in
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