Coalition challenges federal requirements on mifepristone, citing 25-year safety record and barriers to care in rural and underserved communities
NEW JERSEY – New Jersey Attorney General Matthew J. Platkin has joined with the attorneys general of California, Massachusetts, and New York in filing a formal petition urging the U.S. Food and Drug Administration (FDA) to eliminate what they describe as medically unnecessary restrictions on the abortion medication mifepristone.
The petition, submitted as the FDA undertakes a full review of mifepristone’s labeling requirements, asks the agency to fully revoke its Risk Evaluation and Mitigation Strategy (REMS) program for the drug. Mifepristone, first approved by the FDA in 2000, is widely used in combination with misoprostol for medication abortions and early miscarriage care. More than 7.5 million people in the U.S. have used it, and according to medical authorities, serious complications are extremely rare.
“We will never waver in our support for reproductive freedom, and we will not stand by while the Trump Administration threatens access to essential reproductive health care. Access to mifepristone saves lives and is critical for reproductive choice. That’s why we will continue to fight to ensure that New Jerseyans can continue to access mifepristone,” said Attorney General Platkin. “Federal restrictions on mifepristone are burdensome impediments to reproductive choice and are not based in science or medicine. The FDA has an opportunity to do the right thing and to eliminate barriers to access to this critical medication. I am proud to file this petition and to call on the FDA to make mifepristone more accessible for women across the country.”
Currently, mifepristone is subject to a REMS program typically reserved for drugs with significant safety risks. Under this program, providers must obtain special certification, patients must sign a declaration of intent to terminate a pregnancy—even when being treated for miscarriage—and pharmacies must adhere to complex certification and tracking rules.
Attorney General Platkin and the coalition argue these restrictions are not evidence-based, citing a contrast with other medications—such as opioids, blood thinners, and certain hormone treatments—that carry greater health risks but face fewer regulatory barriers.
The petition underscores the impact of these restrictions on access to reproductive and miscarriage care, especially in rural and underserved areas. Data show that just 1% of medication abortions occur in primary care settings, while nearly 90% of U.S. counties lack an abortion provider.
The coalition also points to recent incidents in which pharmacies faced intimidation and legal confusion for attempting to stock mifepristone. For instance, Walgreens ultimately chose not to dispense the drug in 20 states following coordinated pressure campaigns, despite abortion remaining legal in several of those jurisdictions.
According to federal law, REMS requirements must be designed to mitigate specific serious risks without being “unduly burdensome.”
The petition contends that the mifepristone REMS fails this legal standard and adds unjustified administrative strain on health systems, obstructing patient care during critical moments such as miscarriage management in emergency settings.
As an alternative to full repeal, the attorneys general are asking the FDA to exercise enforcement discretion and suspend REMS requirements within their states—where abortion remains legal, regulated, and accessible.
The petition is filed under the FDA’s rulemaking authority, which allows individuals and public officials to request changes to agency regulations. The agency is expected to weigh this petition during its current review, directed by U.S. Health and Human Services Secretary Robert F. Kennedy, Jr.
For residents of New Jersey and surrounding areas, the outcome of this petition could significantly impact how and where medication abortion and miscarriage care are accessed, particularly in primary care and pharmacy settings.
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