Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 27 of 67 PageID 4449
under Section 355-1 to not require any REMS for dangerous drugs would likely present nondelegation problems even under a modest view of that doctrine. See, e.g., Gundy v. United States, 139 S. Ct. 2116, 2123 (2019). So too the notion that FDA could exercise its non-enforcement discretion in violation of other federal laws. Therefore, FDA’s decision to not enforce the in-person dispensing requirement is reviewable because the decision is not committed to agency discretion by law.
- 3. Plaintiffs’ Failure to Exhaust Certain Claims is Excusable
Plaintiffs allege FDA’s 2021 Decision to dispense mifepristone through the mail did not acknowledge or address federal criminal laws that “expressly prohibit[] such downstream distribution.” ECF No. 7 at 26. Defendants maintain Plaintiffs’ argument is unexhausted because they failed to present it at any stage of any administrative proceeding. ECF No. 28 at 38. Similarly, Plaintiffs have not exhausted their challenge to FDA’s approval of the supplemental NDA for generic mifepristone. Id. at 26. These failures to exhaust claims do not preclude judicial review.
“The general rule of nonreviewability is not absolute.” Myron v. Martin, 670 F.2d 49, 52 (5th Cir. 1982). To begin, exhaustion is not required where the agency action is “in excess of” the agency’s authority. Id. And a court will review for the first time “a particular challenge to an agency’s decision which was not raised during the agency proceedings” where the agency action is “likely to result in individual injustice” or is “contrary to an important public policy extending beyond the rights of the individual litigants.” Id.; see also Mathews v. Eldridge, 424 U.S. 319, 330 (1976) (“[C]ases may arise where a claimant’s interest in having a particular issue resolved promptly is so great that deference to the agency’s judgment is inappropriate.”); Abbott Laboratories v. Gardner, 387 U.S. 136, 149 (1967) (injunctive remedies applied to administrative determinations should evaluate “both the fitness of the issues for judicial decision and the hardship
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