Are State Attorneys General expanding their reach in this Post-Dobbs world? On February 1, 2023, twenty state Attorneys General signed letters to both CVS and Walgreens warning the giant retail pharmacies against mailing medications that could potentially be used to induce abortions. These letters are most notable for the legal posture they assume. The state Attorneys General penning this letter are purporting to emphasize enforcement of federal law (18 U.S.C. § 1461), not the state law of the respective states these Attorneys General represent. Press reports state that CVS and Walgreens plan only to distribute abortion-inducing medications where it is legal to do so. Nevertheless, these warning letters assert that each Attorney General has the right to enforce federal law—typically the purview of federal prosecutors—against any retail pharmacy that mails abortion-producing medications within, to, or from jurisdictions that are less restrictive with respect to abortions.18 U.S.C. § 1461 (mailing obscene or crime-inciting matter), the proverbial hammer cited in the two warning letters, criminalizes using the mail to send any medicine, among other things, for the purposes of “producing” an abortion. Perhaps acknowledging the atypical nature of a state Attorney General attempting to invoke a federal criminal statute, the twenty state Attorneys General here cross-reference a federal anti-racketeering statute, known as the Racketeer Influenced and Corr

s implementation and compliance with the REMS.In the wake of the recent REMS modification, at least two major pharmacy retail chains — Walgreens and CVS Health — have stated that they will seek certification to allow for dispensing mifepristone.It is yet to be determined the precise impact the modified REMS will have on access to mifepristone in states where medical termination of a pregnancy has been made illegal. Per FDA, the Agency is coordinating with the US Department of Justice (DOJ) “and others across the government” on such legal issues, and “[a]ny questions regarding preemption of state law should be directed to [DOJ].”Mailing Mifepristone and MisoprostolIn a related development, on December 23, 2022, the US Department of Justice (DOJ) Office of Legal Counsel (OLC) published a memorandum opinion for the General Counsel of the US Postal Service (USPS) regarding the mailing of mifepristone and misoprostol. The opinion was issued by OLC in response to USPS’ inquiry as to whether 18 U.S.C. § 1461 — originally enacted as part of the Comstock Act — prohibits the mailing of either mifepristone or misoprostol. Under the Act, “[e]very article or thing designed, adapted, or intended for producing abortion” and “[e]very article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion” is “declared to be nonmailable matter and [may] not be conveyed in the mails or delivered from any post office or by any letter carrier.” Nonetheless, OLC concluded that 18 U.S.C. § 1461 does not prohibit the mailing of either mifepristone or misoprostol “where the sender lacks the intent that the recipient of the drugs will use them unlawfully.” OLC explained that “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.”Meanwhile, 20 attorneys general issued letters to CVS and Walgreens warning against m

As those in the reproductive health space scramble to keep up with the ever-changing landscape of mifepristone (Mifeprex) access, it seems that every party must have their say.The last three months have seen updates from two federal agencies, five separate letters collectively signed by over 40 state attorneys general, announcements from two major pharmacy chains, at least one proclamation via tweet by a state governor, and further movement in the Texas case challenging FDA’s approval of mifepristone. In the end, the state of mifepristone access remains unclear.As we previously reported here, the US Department of Justice (DOJ) Office of Legal Counsel (OLC) published a memorandum opinion on December 23, 2022, for the General Counsel of the US Postal Service regarding the mailing of mifepristone and misoprostol — used together to end an early pregnancy. OLC concluded that 18 U.S.C. § 1461 — originally enacted as part of the Comstock Act — does not prohibit the mailing of either mifepristone or misoprostol “where the sender lacks the intent that the recipient of the drugs will use them unlawfully.” Per OLC, “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.”Less than two weeks later, on January 3, 2023, the US Food and Drug Administration (FDA) approved modifications to the mifepristone Risk Evaluation and Mitigation Strategy (REMS). Among other things, the modified REMS allows for any pharmacy — including retail pharmacies — to become certified to dispense mifepristone so long as the pharmacy meets certain requirements. In the wake of the REMS modifications, Walgreens and CVS Health announced that they would seek certification to dispense mifepristone.Twenty attorneys general subsequently issued letters (the February 1, 2023 Letters) to CVS and Walgreens warning agains

gulatory and legal changes as both federal and state governments adapt to the evolving landscape. The Jenner & Block Post-Dobbs Task Force continues to monitor this changing area.Footnotes[1] Medication Abortion Now Accounts for More Than Half of All US Abortions, The Guttmacher Institute, Feb. 24, 2022, https://www.guttmacher.org/article/2022/02/medication-abortion-now-accounts-more-half-all-us-abortions. [2] All. for Hippocratic Med. et al v. F.D.A. et al, No. 2:22-cv-00223-Z, 2022 WL 17091784 (N.D. Tex. 2022). Plaintiffs have also filed a motion for preliminary injunction, which is currently pending. [3] Id. at 111. [4] Medication Abortion, The Guttmacher Institute, https://www.guttmacher.org/state-policy/explore/medication-abortion. [5] Matthew Perrone, The FDA just finalized a Biden rule change to make abortion pills much more widely available at pharmacies nationwide, Fortune, Jan. 4, 2023, https://fortune.com/2023/01/04/fda-abortion-pills-rule-change-pharmacies-mail-order/. [6] 18 U.S.C. § 1461. [7] Application of the Comstock Act to the Mailing of Prescription Drugs That Can Be Used for Abortions, 46 Op. O.L.C. ___ at 16 (Dec. 23, 2022) (“Application of the Comstock Act”), available at https://www.justice.gov/olc/opinion/file/1560596/download. [8] 18 U.S.C. § 1461. [9] Application of the Comstock Act, at 1. [10] Application of the Comstock Act, at 1-2. [11] Id. at 3. [12] Id. at 5. [13] Application of the Comstock Act, at 5. [14] See Bours v. United States, 299 F. 960 (7th Cir. 1915); Youngs Rubber Corp. v. C.I. Lee & Co., 45 F.2d 103 (2d Cir. 1930); Davis v. United States, 62 F.2d 473 (6th Circ. 1933); United States v. One Package, 86 F.2d 737 (2d Cir. 1936); United States v. Nicholas, 97 F.2d 510 (2d Cir. 1938); Consumers Union of United States, Inc. v. Walker, 145 F.2d 33, 33 (D.C. Cir. 1944). [15] Application of the Comstock Act, at 13-14. [16] Id. at 15-16. [17] Id. at 16. [18] Id. at 17. [19] Id. [20] Application of the Comstock Act, at 18-20. [21] Id. at 17. [22] Id.

OVERRULED in part by United States v. Sturm, 672 F.3d 891 (10th Cir. 2012).United States v. McDowell, 498 F.3d 308 (5th Cir. 2007)The defendant was charged with aiding and abetting a violation of 18 U.S.C. § 1461, mailing obscene material using the U.S. Postal Service. Though the obscene material was, in fact, mailed, there was in sufficient evidence that the defendant was aware that the mails were being used or that he aided and abetted the offense with the knowledge that the mails were being used to distribute the obscene videos.

2:22-cv-00223-Z (N.D. Tex. Jan. 13, 2023) [“Opposition Brief”]. [9] Misoprostol has been approved by the FDA only for the prevention and treatment of gastric ulcers. Its use for abortion, miscarriage treatment or other pregnancy-related purposes is all considered “off label.” See Sarah McCammon, Why an ulcer drug could be the last option for many abortion patients, NPR, February 24, 2023, available at: https://www.npr.org/2023/02/24/1159075709/abortion-drug-mifepristone-misoprotol-texas-case [10] 21 C.F.R. §§ 314.500–314.560. [11] See 21 C.F.R. § 314.520. [12] See Opposition Brief at 3–7. [13] Plaintiffs’ Brief in Support of Their Motion for Preliminary Injunction at 25, Alliance for Hippocratic Medicine v. US. Food & Drug Administration, No. 2:22-cv-00223-Z (N.D. Tex. Nov. 18, 2022) [“Preliminary Injunction Brief”]. [14] See Complaint at 111, Alliance for Hippocratic Medicine v. US. Food & Drug Administration, No. 2:22-cv-00223-Z (N.D. Tex. Nov. 18, 2022) [“Complaint”] (“Declare that 18 US.C. § 1461 and 18 US.C. § 1462 prohibit the FDA from approving a new drug application or a supplemental new drug application that fails to limit distribution of chemical abortion drugs in accordance with these laws.”). [15] Id. at 15 [16] See 21 US.C. § 355(a), (b). [17] Preliminary Injunction Brief at 19. [18] 18 US.C. § 1641 prohibits the mailing or delivery by any letter carrier of “[e]very article or thing designed, adapted, or intended for producing abortion” and “[e]very article, instrument, substance, drug, medicine, or thing, which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion.” And 18 US.C. § 1462 forbids the use of “any express company or other common carrier” to transport chemical abortion drugs “in interstate or foreign commerce.” [19] Opposition Brief at 9–14. [20] Id. [21] Id. at 16 (citing 28 US.C. § 2401(a)). [22] Id. at 22–23. [23] Id. at 26. [24] Id. at 28–29. [25] Id. at 31. [26] Paxton Supports Efforts to Stop FDA

d REMS, pharmacies may now become certified to dispense MAB upon receiving a prescription from a certified prescriber if they meet certain requirements and abide by the other aspects of the REMS. As of January 4, 2023, at least one major pharmacy chain indicated it would take steps to seek certification.Although both actions by FDA could enhance access to MAB, given the many state laws that have been enacted in the wake of Dobbs banning abortion (both MAB and surgical) outright or severely limiting MAB, it is unclear how much of an impact these changes will have, particularly in states that have acted to ban or limit all forms of abortion. As we previously discussed, there is limited precedent or guidance on whether state-based bans of MAB are pre-empted by FDA’s label and REMS.Department of Justice Opinion on Mailing of Abortion MedicationsOn January 3, the Office of Legal Counsel (OLC) in the Department of Justice (DOJ) issued a formal legal opinion concluding that the Comstock Act (18 U.S.C. § 1461), a nearly 150-year-old law designed to thwart “vice” through the use of the mail, does not prohibit the mailing, or the delivery or receipt by mail, of medications used to perform abortions if the sender lacks the intent that such drugs will be illegally used. The opinion notes that “those sending or delivering mifepristone and misoprostol typically will lack complete knowledge of how the recipients intend to use them and whether that use is unlawful under relevant law” and provides examples of potential legal uses of such drugs, even in states that have acted to limit or ban abortion in the wake of Dobbs. The opinion is limited to OLC’s views on the application of the Comstock Act to the mailing or delivery of MAB and does not address the application of state or local laws criminalizing such activities, or other federal laws.

See also United States v. Sanchez-Mata, 925 F.2d 1166 (9th Cir. 1991) and United States v. Estrada-Macias, 218 F.3d 1064 (9th Cir. 2000). United States v. McDowell, 498 F.3d 308 (5th Cir. 2007) The defendant was charged with aiding and abetting a violation of 18 U.S.C. § 1461, mailing obscene material using the U.S. Postal Service. Though the obscene material was, in fact, mailed, there was in sufficient evidence that the defendant was aware that the mails werebeing used or that he aided and abetted the offense with the knowledge that the mails were being used to distribute the obscene videos.

” Fox, 2012 U.S. LEXIS 4661 at *8. In the ensuing years, FCC modified its policy and in 2001, issued Industry Guidance on Commission’s Case Law Interpreting 18 U.S.C. §1461 and enforcement policies regarding broadcast indecency. 16 FCC Rcd. 7999.