Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 26 of 67 PageID 4448
certain healthcare settings”).[1] The statute also provides other “elements to assure safe use” of dangerous drugs. 21 U.S.C. § 355-1(f)(1), (3). The Secretary must publicly explain “how such elements will mitigate the observed safety risk.” 21 U.S.C. § 355-1(f)(2). The Secretary must also consider whether the elements would “be unduly burdensome on patient access to the drug” and must “minimize the burden on the health care delivery system.” Id. Additionally, the elements “shall include [one] or more goals to mitigate a specific serious risk listed in the labeling of the drug.” 21 U.S.C. § 355-1(f)(3). And as the Court will later explain, federal law prohibits the mailing of chemical abortion drugs. Thus, unlike in Heckler, there is “law to apply” to FDA’s decision. See Texas v. Biden, 20 F.4th at 982 (“[T]he executive cannot look at a statute, recognize that the statute is telling it to enforce the law in a particular way or against a particular entity, and tell Congress to pound sand.”). And even if Defendants have significant discretion in how they administer Section 355-1, that does not mean all related actions are immune to judicial review under Section 701(a)(2) of the APA.
In sum, Defendants cannot shield their decisions from judicial review merely by characterizing the challenged action as exercising “enforcement discretion.” ECF No. 28 at 15; see also Texas v. Biden, 20 F.4th at 987 (“The Government is still engaged in enforcement — even if it chooses to do so in a way that ignores the statute. That’s obviously not nonenforcement.”); id. at 985 (“Heckler cannot apply to agency actions that qualify as rules under 5 U.S.C. § 551(4).”); Heckler, 470 U.S. at 833 n.4 (a decision to consciously and expressly adopt a general policy that is “so extreme as to amount to abdication of its statutory responsibilities” is not “committed to agency discretion”) (emphasis added). Furthermore, the suggestion that FDA has full discretion
- ↑ See also Frequently Asked Questions (FAQS) about REMS, FDA (Jan. 26, 2018), https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/frequently-asked-questions-faqs-about-rems (“A REMS is required to ensure the drug is administered only in a health care facility with personnel trained to manage severe allergic reactions and immediate access to necessary treatments and equipment to managing such events.”).
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