Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 58 of 67 PageID 4480
threatening adverse reactions. Due to FDA’s lax reporting requirements, the exact number is not ascertainable. But it is likely far higher than its data indicate for reasons previously mentioned. Whatever the numbers are, they likely would be considerably lower had FDA not acquiesced to the pressure to increase access to chemical abortion at the expense of women’s safety. FDA’s failure to insist on the inclusion of its proposed safety restrictions was not “the product of reasoned decisionmaking.” State Farm, 463 U.S. at 52. To hold otherwise would be “tantamount to abdicating the judiciary’s responsibility under the [APA] to set aside agency actions that are ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.’” A.L. Pharma, Inc. v. Shalala, 62 F.3d 1484, 1491 (D.C. Cir. 1995) (quoting 5 U.S.C. § 706(2)(A)). Finally, the 2000 Approval was also arbitrary and capricious because it violated Subpart H.[1]
- b. The 2016 Changes
FDA made numerous substantial changes to the chemical abortion regimen in 2016. These changes include but are not limited to: (1) eliminating the requirement for prescribers to report all nonfatal serious adverse events; (2) extending the maximum gestational age from 49 days to 70 days; (3) eliminating the requirement that administration of misoprostol occurs in-clinic; (4) removing the requirement for an in-person follow-up exam; and (5) allowing “healthcare providers” other than physicians to dispense chemical abortion drugs. ECF No. 1 at 53–54. Plaintiffs allege the 2016 Changes were also arbitrary and capricious “because none of the studies on which FDA relied were designed to evaluate the safety and effectiveness of chemical abortion
- ↑ As one scholar noted, “the agency took this route so that it could better justify imposing otherwise unauthorized restrictions on the use and distribution of the drug.” See Noah, supra note 62, at 582. And “while agency action may generally be ‘entitled to a presumption of regularity,’ here FDA itself acknowledges that its action has not been regular: it failed to respond to the Citizen Petition for years.” Bayer, 942 F. Supp. 2d at 25 (internal marks omitted). At the hearing, Defendants’ leading argument for Subpart H was that “none of it really matters” because of the FDAAA. See ECF No. 136 at 100. “This is not the argument of an agency that is confident in the legality of its actions.” ECF No. 100 at 15.
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