Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 59 of 67 PageID 4481
drugs for use under the conditions prescribed, recommended, or suggested in the proposed labeling.” ECF No. 7 at 24.
For similar reasons as the 2000 Approval, the Court agrees. Unlike the crucial studies FDA relied upon to extend the maximum gestational age, change the dosing regimen, and authorize a repeat dose of misoprostol, the labeling approved by FDA in 2016 did not require: (1) an ultrasound; (2) an in-person follow-up exam; or (3) the ability of abortionists to personally perform a surgical abortion if necessary. Id. Simply put, FDA built on its already-suspect 2000 Approval by removing even more restrictions related to chemical abortion drugs that were present during the final phase of the investigation. And it did so by relying on studies that included the very conditions FDA refused to adopt.[1] None of the studies compared the safety of the changes against the then-current regimen, nor under the labeled conditions of use. Moreover, FDA shirked any responsibility for the consequences of its actions by eliminating any requirement that non-fatal adverse events be reported. Thus, FDA took its chemical abortion regimen — which had already culminated in thousands of adverse events suffered by women and girls — and removed what little restrictions protected these women and girls, systematically ensuring that almost all new adverse events would go unreported or underreported.
Defendants aver that “Plaintiffs point to no statutory provision requiring the conditions of use in a drug’s approved labeling to duplicate the protocol requirements used in the studies supporting its approval.” ECF No. 28 at 32. “The [FFDCA] thus requires FDA to apply its scientific expertise in determining whether a drug has been shown to be safe and effective under particular conditions of use, and the application of that expertise is owed substantial deference.” Id. But FDA does not have unfettered discretion to approve dangerous drugs under substantially
- ↑ See ECF No. 1-35.
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