Arizona Attorney General Kris Mayes is joining a multi-state lawsuit against the Food and Drug Administration, claiming that the federal regulations on a drug used for medication abortions make it excessively difficult to access.
Mifepristone, the drug in question, is part of a medical regimen approved by the FDA for in 2000. According to the lawsuit, it is one of 60 FDA-approved drugs restricted under Risk Evaluation & Mitigation Strategies (REMS). That means there additional barriers for medical professionals to prescribe the drug, and for patients to obtain it.
"Access to this drug allows patients to make their own private medical decisions without interference by the government or anti-abortion politicians," said Mayes. "The bottom line is that individuals should be able to make decisions about their reproductive lives without unnecessary restrictions like these."
According to the FDA, no deaths have been attributed to mifepristone during its history of use in the country. In a press release, Mayes stated REMS are intended for more dangerous or addictive drugs, such as fentanyl and high-dose sedatives.
The lawsuit alleges the REMS applied to mifepristone created an undue burden to providers and patients alike and references abortion criminalization trends among states since the Dobbs v. Jackson Women’s Health decision in 2022 effectively overturned abortion access granted by Roe v. Wade.
The FDA's website gives an explainer on the mifepristone REMS, which was recently modified:
In 2021, after conducting a review of the Mifepristone REMS Program, the FDA determined that the available data and information support modification of the REMS to reduce burden on the health care delivery system and to ensure the benefits of the product outweigh the risks.
The Mifepristone REMS Program was modified on January 3, 2023.
Some of the REMS for mifepristone include:
- Healthcare providers complete a Prescriber Agreement Form
- A Patient Agreement Form reviewed with and signed by the patient and the healthcare provider
- Only a certified prescriber, or a certified pharmacy on a prescription issued by a certified prescriber can dispense mifepristone
The full list, as well as additional information on the drug, is available on the FDA website.
Arizona joins the states of Oregon, Nevada, Delaware, Illinois, Connecticut, Colorado, Vermont, New Mexico, Michigan and Rhode Island in this lawsuit.
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Anne Simmons is the digital executive producer for KGUN 9. Anne got her start in television while still a student at the University of Arizona. Before joining KGUN, she managed multiple public access television stations in the Bay Area and has worked as a video producer in the non-profit sector. Share your story ideas and important issues with Anne by emailing anne.simmons@kgun9.com or by connecting on Instagram, Twitter or LinkedIn.
