Senator Introduces Legislation to Remove FDA Approval of Mifepristone

Senator Josh Hawley (R, Missouri) introduced a bold legislative challenge on Wednesday, unveiling a bill designed to strip mifepristone (Mifeprex) of its FDA approval when used for pregnancy termination, according to The Hill.¹

“We’ve known for years that mifepristone is risky, but it’s really just in the last few years that we’ve learned that this drug is inherently dangerous, and it is inherently prone to abuse,” Hawley told The Hill. “What it means in practice is internal infections, sepsis, a trip to the emergency room, a life-threatening condition—in 11% of cases.”

This move targets a drug that has been a cornerstone of reproductive health care since its initial approval in 2000 and accounted for 63% of all US abortions in 2023. Although the bill seeks to ban the sale of the medication for abortions, it would allow continued prescriptions for Cushing syndrome—a rare disorder managed by the same drug under different branding.^1,2

For pharmacists, who were only recently integrated into the direct dispensing of this medication, the legislation represents a potential pivot in federal drug regulation and a significant shift in their professional responsibilities.

READ MORE: Pro-Life Groups Calling for Immediate Government Action on Abortion Pills

The Bill’s Basis for Removal of FDA Approval

Hawley’s primary argument hinges on safety, as he alleges that mifepristone is inherently dangerous and prone to abuse. He cited a study suggesting that 11% of cases result in serious adverse effects such as internal infections, sepsis, or life-threatening emergency room visits. He further noted reports of the drug being used by men to force abortions on women without their consent.¹

However, these claims stand in stark contrast to data from the FDA and independent researchers. The FDA currently estimates the rate of serious adverse effects at approximately 0.5%, while other studies suggest a major complication risk as low as 0.4% and a mortality rate of less than 0.001%.^1,3,4

A recent analysis from the Johns Hopkins Bloomberg School of Public Health of over 5000 pages of internal FDA documents from 2011 to 2023 found that the agency generally followed cautious and evidence-based recommendations from staff scientists, with no evidence of ideological bias in their deliberations.⁵

“Our review sheds light on the FDA’s decision-making process over a pivotal period and with respect to a drug that has long been subject to debate,” said Joanne Rosen, JD, professor at the Bloomberg School, co-director of the Bloomberg School’s Center for Law and the Public’s Health, and co-author of the analysis. “We hope our findings that the agency acted cautiously, incrementally, and with a commitment to well-grounded scientific evidence will provide reassurance to the public and serve as a model for future agency review.”

A Changing Landscape of Medication Abortion

For the pharmacy profession, the most critical regulatory development occurred in early 2023, when the FDA modified its Risk Evaluation and Mitigation Strategy (REMS) program to allow certified retail pharmacies to dispense mifepristone.^3,6

Previously, according to the FDA, the drug was subject to an in-person dispensing requirement in clinical settings. Under the current mifepristone REMS program, pharmacies must complete a certification process, ensuring they can track shipments and dispense the drug pursuant to a prescription from a certified health care provider.⁶

This change contributed to a rise in telehealth abortions, which now account for 27% of all terminations nationally.³ Pharmacists must also navigate complex clinical considerations, as mifepristone has significant contraindications with long-term corticosteroid therapy, anticoagulants, and certain medical conditions like ectopic pregnancy.^2,6

The Congressional Push to Limit Abortion Access

The legislative push comes amid a volatile period of post-Dobbs litigation and executive action. Despite abortion bans in 13 states, the total number of abortions in the US has increased, driven by interstate travel and expanded telehealth capacity.³

However, the federal government under the Trump administration is exploring several avenues to restrict access.

Beyond Hawley’s bill, Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. has directed the FDA to launch a new safety review of the drug. Additionally, there is renewed debate over the enforcement of the Comstock Act, an 1873 law that could potentially be used to ban the mailing of medication abortion supplies nationwide.⁴

As states like Texas and Louisiana pursue legal action against out-of-state providers, pharmacists find themselves at the intersection of conflicting state laws and evolving federal mandates. Although the FDA continues its own safety studies, the outcome of Hawley’s bill remains uncertain as he seeks to unify Senate Republicans behind a permanent congressional withdrawal of the drug's certification.^1,6

“Over the years, one liberal administration after another, President Obama and then President Biden, removed almost all of the safety protocols around mifepristone such that today it is almost wholly unregulated,” Hawley told The Hill.¹ “They did it because of abortion politics. They did it because they wanted to turn mifepristone into the driver of abortion on demand.”

READ MORE: Women’s Health Resource Center

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REFERENCES

1. Bolton A. Hawley introduces bill to remove FDA approval for mifepristone. The Hill. March 11, 2026. Accessed March 12, 2026. https://thehill.com/homenews/senate/5779756-hawley-fda-approval-mifepristone/

2. Mifepristone (oral route). Mayo Clinic. February 1, 2026. Accessed March 12, 2026. https://www.mayoclinic.org/drugs-supplements/mifepristone-oral-route/description/drg-20067123

3. Abortion trends before and after Dobbs. KFF. January 7, 2026. Accessed March 12, 2026. https://www.kff.org/womens-health-policy/abortion-trends-before-and-after-dobbs/

4. The intersection of state and federal policies on access to medication abortion via telehealth after Dobbs. KFF. July 24, 2025. Accessed March 12, 2026. https://www.kff.org/womens-health-policy/the-intersection-of-state-and-federal-policies-on-access-to-medication-abortion-via-telehealth-after-dobbs/

5. Study: FDA regulation of abortion drug mifepristone from 2011 to 2023 shaped by evidence and caution. Johns Hopkins Bloomberg School of Public Health. January 12, 2026. Accessed March 12, 2026. https://publichealth.jhu.edu/2026/study-fda-regulation-of-abortion-drug-mifepristone-from-2011-to-2023-shaped-by-evidence-and-caution

6. Questions and answers on mifepristone for medical termination of pregnancy through ten weeks gestation. FDA. February 2, 2026. Accessed March 12, 2026. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation