United States: New Year Brings New Guidance Related To Medication Abortion

Medication abortions represent more than half of all abortions that take place in the United States, accounting for over 53% of procedures in 2020.¹ Though individual state laws regarding medication abortion vary, at least some online services have continued to ship medication to states where their use is prohibited.

In response, anti-abortion advocates have taken various steps to restrict access to these drugs. In November 2022, anti-abortion groups took aim at medication abortions by filing a challenge in federal court to the Food and Drug Administration's (FDA) 2002 approval of mifepristone, the most commonly used prescription medication to facilitate abortion, alleging the FDA approved the medication under an expedited review process that put women's health and safety at risk.² Among other relief, plaintiffs seek a declaration that the Comstock Act prohibits the mailing of abortion medication.³

At the same time, multiple individual states made efforts to ban or restrict the use of medication to facilitate abortions in 2022 by requiring a physician to provide medication abortion, requiring the physical presence of the prescribing clinician, or having an explicit ban on the use of telemedicine for medication abortion.⁴ Additionally, the Attorney General of Alabama recently announced that he would prosecute women in Alabama who take abortion medication under an existing state law aimed at protecting children from endangerment due to chemical exposure from drugs, although he has since walked back that statement, saying he intended to target providers, not patients. A coalition of conservative groups, including the Heritage Foundation and Susan B. Anthony Pro-Life America, recently sent a letter to the House majority with a list of demands, including that the House override the FDA's (prior) ruling that abortion medication can be mailed to patients.

In contrast, the Biden Administration committed to increasing medication abortion access by removing the requirement that women pick up the medication in person.⁵ In the first week of 2023, barriers fell on access to medication on multiple other fronts with the release of a Department of Justice Office of Legal Counsel opinion addressing Comstock Act liability and an FDA decision that relaxes restrictions around abortion medication.

Department of Justice Addresses Comstock Act Liability

Post-Dobbs, proponents of abortion access have faced uncertainty about potential liability related to the provision of medication abortions. The Comstock Act, a federal law enacted in 1873, labels "every 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, or for any indecent or immoral purpose" as "nonmailable matter" that USPS may not lawfully deliver and makes it a felony to knowingly mail such items (a separate section of the Comstock Act imposes similar prohibitions on other mail carriers, such as FedEx and UPS).⁶ Under Roe, these provisions had no force.⁷ But following Dobbs, the Comstock Act presented a new issue for mail carriers who might inadvertently carry abortion medication into states where its use has been criminalized. At the request of the United States Postal Service (USPS), the Justice Department's Office of Legal Counsel (OLC) analyzed whether the Comstock Act of 1873⁸ prohibits the mailing of mifepristone and misoprostol, the two prescription medications that are commonly used to terminate pregnancies.⁹

In a 21-page opinion, made public on January 3, 2023, the OLC determined that "section 1461 does not prohibit the mailing, or the delivery or receipt by mail, of mifepristone or misoprostol where the sender lacks the intent that the recipient of the drugs will use them unlawfully."¹⁰ An OLC opinion is controlling within the Executive Branch.

The OLC detailed the long history of the Comstock Act, a law that was originally put in place to prevent materials deemed as "vice" from being transmitted in the mail.¹¹ OLC explained that over the years since the law was originally passed, Congress and the Judiciary, as well as USPS, reached a common understanding of the scope of section 1461 and what it prohibited.¹² Notably, by the middle of the 20th century, "the well-established, consensus interpretation was that none of the Comstock Act provisions, including section 1461, prohibits a sender from conveying such items where the sender does not intend that they be used unlawfully."¹³ OLC illustrated this point with a litany of federal court case law-ranging from 1915 to 1994-all supporting the proposition that section 1461 did not preclude mailing information about abortion or contraception or materials that may be used for abortions or contraception if sent with lawful intentions.¹⁴

The OLC concluded that Congress ratified this judicial understanding with various amendments to the Comstock Act, as well as legislating "regarding the FDA's treatment of mifepristone in a manner consistent with the understanding that the Comstock Act does not categorically prohibit the covered modes of conveying abortion-inducing drugs."¹⁵ USPS has long followed the judicial and congressional understanding of the Comstock Act as a result.¹⁶

The OLC noted that it has long been understood-indeed, before the Supreme Court's decisions in Griswold v. Connecticut and Roe v. Wade-that section 1461 and other related provisions of the Comstock Act do not prohibit the mailing of articles intended to produce abortion if the sender lacked the intent that those items to be used unlawfully.¹⁷ With that backdrop informing its decision, the OLC determined that section 1461 does not prohibit the mailing of medication for abortions where the sender does not intend that the medication be used unlawfully.¹⁸

The OLC went on to articulate the manifold circumstances in which a sender of these medications would typically lack an intent that they be used unlawfully. OLC explained that recipients in all 50 states may in some circumstances lawfully use mifepristone and misoprostol to induce an abortion,¹⁹ such as, where applicable given state law, abortions performed before the gestational age at which abortion are prohibited, abortions to save the life of the mother, abortions in the context of rape or incest or where there are fetal anomalies, abortions in which the patient ingests the medication in a different state in which it is legal, and use of the medication for purposes other than inducing abortion.²⁰ Because of these circumstances, and the fact that "those sending or delivering mifepristone and misoprostol typically will lack complete knowledge of how the recipients intend to use them,²¹ OLC concluded that even if a mail carrier knows that a package contains such medication or even that the medication will be used to facilitate an abortion, that is not sufficient to conclude that section 1461 has been violated.²² OLC noted that "USPS could not reasonably assume that the drugs are nonmailable simply because they are being sent into a jurisdiction that significantly restricts abortion."²³

The OLC also noted that this analysis would apply equally to other abortion-related prohibitions under the Comstock Act, such as 18 U.S.C. § 1462, that impose similar restrictions on other common carriers, such as FedEx or UPS.²⁴ The OLC did not address whether the mailing of mifepristone or misoprostol might violate other federal laws than the Comstock Act.²⁵

Food and Drug Administration Increases Access to Abortion Medication

On January 3, 2023, the same day as OLC's opinion was released, the FDA announced on its website that abortion medication can now be offered at retail pharmacies.²⁶ This move relaxed some of the restrictions around mifepristone, which had previously only been allowed to be distributed through certain specified mail-order pharmacies or doctors or clinics which had undergone a certification process.²⁷ Under the new rule set by the FDA, any pharmacy that agrees to accept prescriptions for mifepristone and to follow certain other criteria can offer the medication in-store and by mail.²⁸ The FDA also officially removed the requirement that patients obtain mifepristone in person from a health provider as well.²⁹ Honeybee Health, a California-based online pharmacy, became the first to be officially certified to dispense medication under the new requirements on January 3, 2023. Walgreens and CVS both announced on January 4, 2023 that they planned to offer abortion pills under the new requirements as well, though they have not completed the certification process at present.

Looking Ahead

Facing a divided Congress, the Executive Branch continues to use all of the tools at its disposal to protect abortion access for Americans. Together, these recent changes provide clarity on federal liability for mailing abortion medication and increase access to that medication. That said, risks remain around the distribution of medication abortion. For instance, OLC's opinion does not alter existing state law, including state criminal law that in some states like Texas,³⁰ impose lower knowledge requirements than the Comstock Act.

It is also not certain that these changes will be permanent, as courts could take up the matter or a future Republican administration could seek to revisit these decisions. The OLC opinion is being criticized by commentators on the right, who argue that the opinion mischaracterizes case law and legislative history. Moreover, as already noted above, FDA's approval of mifepristone is currently being challenged in federal court, with a preliminary injunction pending that could halt the use of the medication nationwide. The FDA regulatory change has also received criticism from commentators on the left, who are frustrated at the remaining certification hurdles to more widespread access, and commentators on the right, who argue the medication is not safe and carries too many risks to be dispensed at pharmacies.

The medication abortion space likely will continue to see regulatory 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.

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