On January 3, the Biden Administration took additional steps to ease access to FDA-approved abortion medication in the United States, further wading into the legal and political chaos that has sprung up in the wake of the decision by the Supreme Court in the case of Dobbs v. Jackson Women’s Health Organization.
FDA Modification of Mifepristone REMS
On January 3, the FDA updated the prescribing and label information and Risk Evaluation and Mitigation Strategy (REMS) for mifepristone—the first of two pills taken in the medication abortion (MAB) regimen—to make two significant changes that could help expand access to MAB throughout the United States.
First, FDA removed the requirement that mifepristone be dispensed to patients in person in a clinic, medical office or hospital. Since 2020, FDA had not largely been enforcing the in-person dispensing requirement (either in response to the court-imposed injunction in the case of ACOG v. FDA, or as an exercise of the agency’s own enforcement discretion in response to the COVID-19 pandemic). However, by law, to delete such a requirement from the REMS required that the MAB manufacturers submit an application to FDA seeking approval for such a change. On January 3, FDA approved the modification, and under the revised REMS, patients may obtain a prescription from their certified health care provider, either by telemedicine or remote visits or in person.
Second, FDA removed the requirement in the REMS that had prevented retail pharmacies from dispensing MAB. Until the January 3 modification, MAB could only be dispensed by certain mail-order pharmacies or by certified doctors or clinics. Under the newly revised 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 Medications
On 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.