On January 3, 2023, the U.S. Food & Drug Administration (FDA) modified the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program to remove the in-person dispensing requirement and allow dispensing of mifepristone at certified retail pharmacies. FDA announced this forthcoming modification in December 2021 and, as we predicted, the process took approximately one year. Below we discuss the modified REMS and recent related legal developments.
Removing the In-Person Dispensing Requirement
Until recently, healthcare providers were required to dispense mifepristone in person, greatly limiting access to the drug. As discussed in our prior post, FDA was enjoined from enforcing this requirement from July 13, 2020 until January 12, 2021, when the injunction was vacated by the Supreme Court. On April 12, 2021, FDA issued a guidance document stating its intent to exercise enforcement discretion with respect to in-person dispensing of mifepristone during the COVID-19 pandemic. This became an especially relevant issue in light of the 2022 Supreme Court ruling in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade. The new ability of states to set their own policies protecting or banning abortion without any federal standard created a new focus on medication abortion, which accounts for over half of all abortions performed in the United States. Implementation of FDA’s policy change took approximately one year and, on January 3, 2023, FDA announced the modification of the REMS to remove the in-person dispensing requirement.
When FDA issued the modified REMS, it also denied two related citizen petitions:
- The first petition from Students for Life of America requested that FDA reinstate the Mifepristone REMS to its 2011 form (i.e., reinstatement of the in-person requirement and other restrictions), but FDA found the petition did not include new data to support the argument and denied the petition.
- The second petition from American College of Obstetricians and Gynecologists requested that FDA ask the drug sponsor to file a supplemental new drug application (sNDA) for a miscarriage management indication and exercise its enforcement discretion to allow the use of mifepristone for miscarriage management without complying with the REMS. FDA denied the petition and determined that an sNDA or a different new drug application would need to be submitted with data to support a finding of safety and effectiveness. FDA also determined that a request for enforcement discretion is not an appropriate use of a citizen petition.
Certified Retail Pharmacies May Dispense Mifepristone
The modified Mifepristone REMS allows both mail-order and brick-and-mortar retail pharmacies to dispense the drug under certain conditions. In order to become a certified pharmacy, the pharmacy must complete the “Pharmacy Agreement Form,” a single-page document containing approximately 20 conditions, including:
- Maintaining comprehensive records relevant to all processes, procedures, prescribers, and recipients of the drug;
- Training all relevant staff on the Mifepristone REMS;
- Complying with mifepristone sponsor audits; and
- Verifying each mifepristone shipment as well as the prescriber’s certification status.
Uncertainties Surround Application of State Laws Banning or Otherwise Restricting Abortion
As discussed above, a key development prior to FDA’s recent modification of the Mifepristone REMS was the U.S. Supreme Court’s decision in Dobbs, which allows states to restrict a person’s right to an abortion. This decision resulted in approximately 12 states to date completely banning abortion with very limited exceptions for medical emergencies and many other states implementing various restrictions on abortion, including prohibitions on the provision of abortion-inducing drugs and abortion-related equipment. As of now, there is no clear answer whether these states can restrict the prescription of mifepristone. Further, FDA stated that “questions regarding preemption of state law [concerning mifepristone availability] should be directed to the DOJ.”
One such example of an agency referring a mifepristone legal question to the U.S. Department of Justice (DOJ) is found in the July 2022 query from the U.S. Postal Service as to whether, in light of the Dobbs decision, mailing mifepristone is a violation of 18 U.S.C. Section 1461[1]. DOJ issued a memorandum on this question finding it is not a violation of Section 1461 for a pharmacy to ship mifepristone to states where the local law may otherwise prohibit its use, so long as the pharmacy lacks the intent that the recipient will use the drug unlawfully.[2] DOJ further noted that “the mere mailing of [mifepristone] to a particular jurisdiction is an insufficient basis for concluding that the sender intends them to be used unlawfully.” However, this memorandum likely does not prevent state authorities from bringing criminal charges against such pharmacies under state criminal laws.
Plaintiffs Challenge FDA’s Approval of Mifepristone
The Alliance for Hippocratic Medicine and other anti-abortion medical groups are challenging FDA’s treatment of abortion-inducing drugs in the Amarillo Division of the Northern District of Texas. In the suit, plaintiffs allege two primary challenges. First, plaintiffs claim that mifepristone is not safe and effective, and therefore the court should grant a preliminary injunction and order the FDA to withdraw or suspend the approval of Mifeprex and the generic mifepristone. If this request is granted, it would drastically limit the availability of the drug, as marketing or distribution of the unapproved article would likely violate the Food, Drug, and Cosmetic Act. Second, plaintiffs also request that the Court order FDA to reimplement the in-person dispensing requirement. If FDA reinstates the in-person dispensing requirement, access to the drug will be greatly limited, as some populations may not be able to receive the drug absent telehealth prescriptions and retail dispensing.
MoFo’s FDA + Healthcare Regulatory and Compliance practice works seamlessly with our Investigations + White Collar Defense, Global Ethics + Compliance, Life Sciences Transactions + Licensing, Privacy + Data Security, and Appellate practice groups to ensure that life sciences companies can navigate the many difficult legal issues that have arisen in light of the challenging federal and state requirements. Please subscribe and follow our Life Sciences Blog, as we continue to update the industry on new developments in compliance, especially with respect to the ongoing mifepristone litigation and other regulatory and state law developments surrounding abortion and abortion-inducing drugs.
Kai Mindick, a Law Clerk in our Austin office, contributed to the writing of this post.
[1] Section 1461 states 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,” to be “nonmailable matter” that may not lawfully be delivered from any post office or by letter carrier. 18 U.S.C. § 1461.
[2] The Comstock Act declares that articles intended to produce abortion may not be lawfully delivered by the U.S. Post Office. 18 U.S.C. § 1461. However, as the DOJ memorandum notes, courts have long held that the Comstock Act is to be construed narrowly, and courts routinely interpret the Act as only prohibiting items that are unlawful, whereas here there are many lawful uses of mifepristone.