Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 25 of 67 PageID 4447
reasonably diligent in pursuing their claims. See, e.g., ECF No. 1-4 at 6 (after years of waiting for FDA to respond to the Petition, Plaintiff “called upon” FDA to issue a response in 2005 and again in 2015). And the public interest in this case militates toward resolving Plaintiffs’ claims on the merits. Accordingly, Plaintiffs’ challenges to FDA’s Pre-2021 Actions concerning chemical abortion drugs are not time-barred.
- 2. FDA’s April 2021 Decision on In-Person Dispensing Requirements is not “Committed to Agency Discretion by Law”
Defendants also argue any challenge to FDA’s decision regarding the in-person dispensing requirement is foreclosed under Heckler v. Chaney, 470 U.S. 821, 832 (1985). ECF No. 28 at 30. In Heckler, the Supreme Court held that FDA’s decision not to recommend civil or criminal enforcement action to prevent violations of the FFDCA was “committed to agency discretion by law.” 470 U.S. at 837–38; see also Texas v. Biden, 20 F.4th at 982 (“In other words, a litigant may not waltz into court, point his finger, and demand an agency investigate (or sue, or otherwise enforce against) ‘that person over there.’”). “[T]he Supreme Court and the Fifth Circuit have consistently read Heckler as sheltering one-off nonenforcement decisions rather than decisions to suspend entire statutes.” Texas v. Biden, 20 F.4th at 983. The “committed to agency discretion by law” exception to judicial review is a “very narrow exception” that applies only where “statutes are drawn in such broad terms that in a given case there is no law to apply.” Citizens to Pres. Overton Park, Inc. v. Volpe, 401 U.S. 402, 410 (1971), overruled on other grounds by Califano v. Sanders, 430 U.S. 99 (1977).
That is not the case here. The Secretary has the authority to determine that drugs with “known serious risks” may be dispensed “only in certain health care settings, such as hospitals.” See 21 U.S.C. § 355-1(f)(3)(C); Gomperts v. Azar, No. 1:19-CV-00345-DCN, 2020 WL 3963864, at *1 (D. Idaho July 13, 2020) (“[T]hese restrictions mandate that Mifeprex be dispensed only in
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