CLI Submits Comments to 3 Citizen Petitions Requesting FDA Action on Mifepristone

In July to August 2025, the Charlotte Lozier Institute (CLI) submitted three comments regarding three citizen petitions submitted to the Food and Drug Administration requesting regulatory action on the abortion drug mifepristone. Below, brief summaries and links for each of these comments are provided.

• CLI Comment on Massachusetts AG et al. Citizen Petition (Submitted 7/24).

On June 6, Attorney General of Massachusetts Andrea Joy Campbell along with the AGs of California, New York, and New Jersey submitted a citizen petition to the FDA requesting that it entirely remove the current risk evaluation and mitigation strategy (REMS) program for mifepristone (brand name ‘Mifeprex’), or else exercise its discretion not to enforce aspects of the REMS. According to the FDA, the REMS for a medication “are designed to reinforce medication use behaviors and actions that support the safe use” of medications deemed to have serious safety concerns, and are intended to “focus on preventing, monitoring and/or managing a specific serious risk by informing, educating and/or reinforcing actions to reduce the frequency and/or severity of the event.” Campbell et al. argued that mifepristone does not need REMS because there are no serious risks of the drug, and that it is safe and effective. Peer-reviewed research by CLI documenting high rates of emergency room visits following mifepristone use and the prevalence of abortion coercion are also singled out for attack in the citizen petition, with claims that this research is “deeply flawed.”

In response to this citizen petition, CLI submitted a comment to the FDA on July 24 requesting that the FDA restore many of its previous safeguards for mifepristone, such as in-person prescribing, because the removal of these regulations has increased the risk women face in obtaining drug-induced abortions. CLI argues in this comment that mifepristone safety data is severely deficient and undercounts true complication rates, that unregulated access to mifepristone could increase, not lower, maternal mortality rates, that many patients have contraindications to mifepristone, that the AG’s citizen petition lacks key context for assertions made regarding mifepristone’s safety, and that the loosening of the mifepristone REMS has already placed women at risk of coercion. Additionally, CLI defends the integrity and quality of its research, explaining how the mifepristone studies criticized in the AG’s citizen petition have been critiqued and retracted for ideological, rather than scientifically sound, reasons.

• CLI Comment on ACOG et al. Citizen Petition (Submitted 7/29).

The American College of Obstetricians and Gynecologists (ACOG), along with the Society of Family Planning and the Society for Maternal-Fetal Medicine, also submitted a citizen petition to the FDA on February 4 asking that the REMS for mifepristone be removed or that the FDA “refrain from taking any action that would further reduce patient access to mifepristone and/or increase the burdens associated with prescribing or dispensing mifepristone.” Petitioners argued, among other points, that mifepristone is “extremely safe,” that the previous elimination of the in-person dispensing requirement did not impact this safety, and that the FDA’s decision to cease collecting any complications data about mifepristone apart from deaths was justified.

CLI submitted a comment on this citizen petition on July 29 making the same request and arguments mentioned above, but adapted to address some of the unique points made by ACOG et al. This included, for example, highlighting recent examples of abortion pressure and mifepristone allegedly being prescribed and sent to individuals other than the patient, as well as unpacking in greater depth the false claim that mifepristone is “as safe as Tylenol” and other drugs (a claim debunked in a recent peer-reviewed article by CLI’s Director of Life Sciences, Cameron Louttit).

• CLI Comment on GenBioPro Citizen Petition (Submitted 8/1).

On July 7, GenBioPro, manufacturer of the generic version of mifepristone, submitted a citizen petition to the FDA requesting that it refrain from taking any action that would reduce access to mifepristone or increase the burdens associated with dispensing or prescribing it, at least in the absence of “new robust scientific or clinical evidence that meets applicable statutory standards warranting such a change.” The drug manufacturer also requested that, if any regulatory change does take place, the FDA would follow appropriate procedures in executing this change. Unlike the two previous citizen petitions, GenBioPro did not ask the FDA to remove the REMS for mifepristone and did not make any claims to the effect that it is safer than other common drugs. However, they did argue that the safety and efficacy of mifepristone is “well-established” and that there is “no scientific evidence suggesting mifepristone causes harm to the environment.”

On August 1, CLI again submitted a comment in response to this citizen petition making the aforementioned request and arguments.