Key Takeaways:

  • The Biden administration started off 2023 with two announcements intended to protect and facilitate access to medication abortion, now the most common method of terminating a pregnancy.
  • The Food and Drug Administration (FDA) issued a policy change that would now allow certified retail pharmacies to dispense medication abortion.
  • The Department of Justice (DOJ) released a legal opinion concluding that a particular federal statute does not prohibit the mailing of medication abortion if the sender does not have the intent and knowledge that the medication will be used unlawfully by the recipient.
  • The impact of these announcements, however, will vary depending on the particular state at issue, as neither the FDA policy change nor the DOJ opinion precludes states from enforcing their own restrictive abortion laws, including laws that criminalize certain activities relating to the procurement and provision of abortion services, and laws that prohibit retail pharmacies in the relevant state from dispensing medication abortion.

In the first week of 2023, the Biden administration announced two actions centered on expanding access to medication abortion. The first involves a policy change by the FDA regarding the ability of retail pharmacies to dispense these drugs. The second involves a legal opinion by the DOJ regarding the permissibility of mailing medication abortion under a particular federal law.

Following the Supreme Court's decision in Dobbs v. Jackson Women's Health Organization, which overturned Roe v. Wade and found that the U.S. Constitution does not confer a right to abortion, the status and availability of medication abortion has been in the spotlight. This is particularly important for individuals who live in states with restrictive abortion laws, as medication abortion is now the most common method of terminating a pregnancy in the United States.

Access to medication abortion in a post-Roe landscape also raises a variety of legal questions for other stakeholders, such as pharmacies willing to dispense the medications to patients, as well as entities involved in the distribution and mailing of these medications. The Biden administration's announcements last week are intended to address some of the legal concerns that have been raised, particularly surrounding federal enforcement. However, it should be noted that states with restrictive abortion laws generally maintain wide latitude to enforce their own laws surrounding these issues.

FDA Policy on the Ability of Retail Pharmacies to Dispense Medication Abortion

On January 3, 2023, the FDA relaxed certain restrictions on the distribution of mifepristone, a medication abortion drug that is approved for use in a regimen with misoprostol to end an intrauterine pregnancy through 10 weeks gestation (70 days or less since the first day of a patient's last menstrual period). Mifestripone is subject to a Risk Evaluation and Mitigation Strategy (REMS), which is a regulatory tool used by the FDA to manage safety issues with select drugs when the benefits of offering the drug outweigh its risks, provided that specified elements to assure safe use are implemented and followed.

The previous REMS for mifepristone required, among other things, that (1) the drug be dispensed only in certain health care settings (specifically clinics, medical offices, and hospitals); (2) prescribing providers be certified and qualified and that they sign a "Prescriber Agreement Form"; and (3) patients are counseled on risks and benefits and that they sign a "Patient Agreement Form."1

The Biden administration had temporarily eased a number of in-person restrictions in response to the COVID-19 public health emergency (PHE), partially in response to a separate case brought by abortion rights supporters to enjoin the Trump administration from enforcing the in-person requirements. The FDA announced in an April 2021 letter to the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine that it would forego enforcing the in-person dispensing requirements and would permit mail-order dispensing following a telehealth consultation by a certified provider during the COVID-19 PHE.2

The following December, the Agency decided that the COVID enforcement policy pertaining to the above mifepristone REMS requirements should be made permanent.3 The agency directed the drug's sponsors to submit proposals to revise the shared system REMS to permit the drug to be dispensed by certified licensed health care providers and pharmacies (including retail pharmacies) and require that pharmacies that dispense the drug be certified accordingly.4 The sponsors subsequently prepared a proposed REMS modification and submitted it to their respective applications. The FDA approved the application supplements on January 3, 2023, permanently removing the in-person dispensing requirements.5

Pharmacies that intend to become certified to dispense mifepristone are required to complete a Pharmacy Agreement Form. By signing this form, the pharmacy agrees to put processes and procedures in place to ensure compliance with various requirements, including verifying that the prescriber is certified, ensuring that the patient receives the drug within an appropriate time period, tracking and verifying the receipt of each shipment of the drug, and various reporting and recordkeeping requirements. Within days of the FDA's approval of the updated REMS, major retail pharmacies, including CVS and Walgreens, announced their intent to become certified.

DOJ Opinion on the Mailing of Medication Abortion

Shortly after the Supreme Court overturned Roe v. Wade in June of 2022, the United States Postal Service (USPS) asked the DOJ for guidance on how to approach the mailing of medication abortion. Specifically, USPS asked the DOJ for its view on whether section 1461 of title 18 of the United States Code (the Comstock Act) prohibits the mailing of mifepristone and misoprostol, the two prescription drugs that are together commonly used to terminate pregnancies, among other purposes.

Originally enacted in 1873, the Comstock Act, provides that "[e]very article or thing designed, adapted, or intended for producing abortion," as well as "[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 a "nonmailable matter" that USPS may not lawfully deliver. The DOJ opinion6 notes, however, that over the last century, courts, Congress and USPS have settled on a narrower interpretation of the statute than a literal reading might suggest. Specifically, the "consensus interpretation" has been that the Comstock Act does not prohibit a sender from conveying such items where the sender does not intend for the items to be used unlawfully. In practice, this means the Comstock Act would not encompass the mailing of such items where the individual does not have knowledge that the items will be used unlawfully.

The DOJ then applies this framework to the mailing of medication abortion in the United States today. The DOJ notes that federal law does not prohibit the use of medication abortion. Indeed, as explained above, the FDA has determined that a regimen of mifepristone and misoprostol is safe and effective for the medical termination of early pregnancy. Furthermore, notwithstanding the significant variation in abortion laws across states, the relevant drugs – mifepristone and misoprostol – can be used lawfully to some degree in all 50 states. For example, even states with the most restrictive abortion laws still allow for abortion before a certain number of weeks of pregnancy, to save the health and/or life of the mother, and in cases of rape or incest. Furthermore, the relevant medications can be used for medical purposes other than to induce abortions, and the legality of those uses would remain unaffected by state restrictions on abortion. Thus, "USPS could not reasonably assume that the drugs are nonmailable simply because they are being sent into a jurisdiction that significantly restricts abortion. Nor would such an assumption based solely on the recipient's address be reasonable even if it is apparent that some women in a particular state are using the drugs in question in violation of state law."

Given the above, the DOJ ultimately concludes that the Comstock Act does not prohibit the mailing of medication abortion where the sender lacks the intent that the recipient will use them unlawfully, and adds that "the fact that the drugs are being mailed to a jurisdiction that significantly restricts abortion is not a sufficient basis for concluding that mailing" violates the statute. The DOJ also notes that this interpretation also applies to another federal law that encompasses express companies and common carriers, which would include FedEx and UPS.

Conclusion

The impact of the FDA policy change and the DOJ opinion will largely depend on the relevant state at issue. In states where abortion is generally legal, these recent actions will likely expand and facilitate access to medication abortion. However, in states with restrictive abortion laws, the impact is less clear. Notwithstanding the FDA policy change, pharmacies in states with near-total abortion bans and/or laws prohibiting retail pharmacies from dispensing medication abortion will likely not be able to participate. Furthermore, the DOJ opinion does not preclude states from enforcing their own laws that independently restrict the mailing of medication abortion within their jurisdiction (although the DOJ notes that the doctrine of intergovernmental immunity should preclude the application of such laws against USPS employees).

Last, it should be noted that both of these actions, the FDA policy change and the DOJ opinion, are largely non-binding, meaning that a subsequent administration could reverse course on either or both of these specific issues.

Footnotes

1 US FDA, Approval Letter for MIFEPREX, September 28, 2000, https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20687appltr.pdf.

2 Acting Commissioner Woodcock, Letter to ACOG and SMFM, April 12, 2021, available at https://twitter.com/ACOGAction/status/1381781110980501512.

3 U.S. FDA, Letter from CDER Director P. Cavazzoni to G. Chelius, Dec. 16, 2021, https://www.aclu.org/sites/default/files/field_document/fda_letter_to_chelius.pdf; U.S. FDA, Questions and Answers on Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation, https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex.

4 Id., U.S. FDA, Question and Answers on Mifepristone.

5 Approved Risk Evaluation and Mitigation Strategies (REMS), Mifepristone Shared System REMS (01/03/2023), https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_01_03_REMS_Document.pdf.

6 Department of Justice, Memorandum Opinion for The General Counsel United States Postal Service, Application of the Comstock Act to the Mailing of Prescription Drugs That Can Be Used for Abortions (Dec. 23, 2022), https://www.justice.gov/olc/opinion/file/1560596/download.

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