Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (N.D. Texas 2023).pdf/31

From Wikisource
Jump to navigation Jump to search
This page has been proofread, but needs to be validated.

Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 31 of 67 PageID 4453

progress.”[1] He also criticized States’ efforts to impose restrictions on mifepristone because such efforts “have stoked confusion, sowed fear, and may prevent patients from accessing safe and effective FDA-approved medication.”[2] Thus, it is unlikely FDA would reverse course on its “mail-order” abortion regimen. ECF No. 7 at 7. Defendants’ position on the Comstock Act in this litigation only confirms that fact. See ECF No. 28 at 38 (“Plaintiffs misconstrue the Comstock Act.”).[3]

e. The Comstock Act was raised with Sufficient Clarity

Finally, the Comstock Act issue was “raised with sufficient clarity.” Ross, 976 F.3d at 942. This is because: (1) the 2019 Petition requested FDA to retain the in-person requirement for dispensing of chemical abortion drugs; and (2) the Comstock Act issue was also raised by the United States Postal Service and the Department of Health & Human Services on July 1, 2022, “[i]n the wake of” Dobbs.[4] The Office of Legal Counsel specifically mentioned FDA’s regimen for chemical abortion drugs when concluding “the mere mailing of such drugs to a particular jurisdiction is an insufficient basis for concluding that the sender intends them to be used unlawfully.” OLC Memo at *1. This shows not only that the issue was raised with sufficient clarity, but also the futility of raising the issue before the agency. Therefore, Plaintiffs’ failure to exhaust their claims does not preclude judicial review.


  1. Memorandum on Further Efforts to Protect Access to Reproductive Healthcare Services, The White House (Jan. 22, 2023), https://www.whitehouse.gov/briefing-room/presidential-actions/2023/01/22/memorandum-on-further-efforts-to-protect-access-to-reproductive-healthcare-services/.
  2. Id.
  3. The D.C. Circuit has hinted that the futility doctrine is ordinarily predicated on the “worthlessness of an argument before an agency that has rejected it in the past” rather than the likelihood that “the agency would reject it in the future.” Tesoro Refin. & Mktg. Co. v. FERC, 552 F.3d 868, 874 (D.C. Cir. 2009). But in this case, there is no principled distinction between the two scenarios. Defendants do not even pretend the agency might have accepted Plaintiffs’ arguments. Other cases may involve uncertainty about future agency rejection, but it is not this case.
  4. See Application of the Comstock Act to the Mailing of Prescription Drugs That Can Be Used for Abortions, 2022 WL 18273906 (O.L.C. Dec. 23, 2022) (“OLC Memo”).

31