New Jersey recently banded together with three other states to request that the United States Food and Drug Administration lift all existing restrictions on mifepristone, better known as the abortion pill.
The citizen petition filed June 5 by New Jersey Attorney General Matthew Platkin and the attorneys general of California, Massachusetts, and New York argues the federal requirements for mifepristone are unnecessary, costly, and delay care, particularly in rural and medically underserved areas.
“We will never waver in our commitment to preserving reproductive freedom—and that includes ensuring access to mifepristone," Platkin said in a statement sent to NJ Advance Media.
“Mifepristone is safe, and it saves lives. Yet it has more federal restrictions on it than other drugs that pose a much higher risk to patients,” Platkin said.
Platkin and his fellow petitioners are asking that the FDA remove its requirements for mifepristone — specifically, the prescriber certification, pharmacy certification, and patient agreement form. Alternatively, they request that the FDA not enforce the requirements in their respective states.
What is mifepristone?
Since the FDA approved mifepristone in 2000, it has been used as part of a two-drug-regimen for early-stage abortions and miscarriage management. The medication, which comes in pill form, can be taken in pregnancies up to ten weeks, according to the Federal Food and Drug Administration.
Use of the drug has quickly grown over the past two decades. In 2023, mifepristone was used in 63% of all abortions, according to data from the Guttmacher Institute.
In January 2023, the FDA permanently removed a requirement that mifepristone had to be dispensed in person and let pharmacies dispense mifepristone directly to patients with a prescription from a certified prescriber.
In New Jersey, residents can get prescriptions for medication abortion through online telehealth appointments or have pills mailed to them, according to the state website. The pills are also available at clinics like Planned Parenthood, which has been stockpiling its own supply for years.
How does the FDA restrict mifepristone?
Mifepristone is one of 71 drugs part of the Risk Evaluation and Mitigation Strategy program. The drug safety program is required for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks, according to the FDA website.
But Platkin and the attorneys general of California, Massachusetts, and New York argue that the safety and efficacy of mifepristone is well-established. They’re not the only ones seeking to lift these regulations.
Last year, nearly a dozen professional medical associations — including the American College of Obstetricians and Gynecologists, the American Medical Association, the National Association of Nurse Practitioners in Women’s Health and the Society of General Internal Medicine — collectively asked the FDA to remove the mifepristone REMS program.
In a joint statement, the medical organizations said “the REMS requirements do nothing to enhance the safety of an already safe drug; instead, they impose administrative burdens, exacerbate health inequities, and lead to delays in care.”
Studies have found that medication abortion successfully terminates the pregnancy nearly 100% of the time, with less than a 1% risk of major complications.
As of Dec. 31, 2024, the FDA has received 36 reports of deaths in patients associated with mifepristone since the product was approved, according to the FDA website.
“These restrictions have no medical or scientific basis, and they actively impede doctors from caring for their patients and deny reproductive rights to women across this country. We urge the FDA to do the right thing and remove these burdensome restrictions from mifepristone,” Platkin said in a statement sent to NJ Advance Media.
Platkin and his fellow petitioners also claim the FDA regulations put providers at risk, specifically the requirements for prescriber and pharmacy certification. The petition explains that certified providers are named on both national and local lists of certified abortion providers.
“The dangers associated with being a ‘certified’ abortion provider are all the more prevalent now given the number of states that have criminalized abortion and are seeking to punish providers who have facilitated medication abortions for patients who reside in other states,” the petition states.
As of Dec. 20, 2024, 12 states banned abortion entirely, and 10 states had limits based on the gestational age of the fetus, according to KFF, formerly known as the Kaiser Family Foundation, an independent nonprofit focused on health policy.
Why is New Jersey doing this now?
The action follows a recent request by Y.S. Health and Human Services Secretary Robert F. Kennedy Jr. for FDA Commissioner Martin Makary to review the latest data on mifepristone.
“Commissioner Makary will ensure gold standard science is used while incorporating practical, common-sense considerations to its regulatory processes,” an HHS spokesperson told NJ Advance Media.
The decision to review mifepristone was condemned by abortion-rights groups as a precursor for an outright ban on abortion.
“This review is not grounded in new data or real safety concerns—it’s driven by Project 2025-aligned groups and right-wing politicians who want to ban abortion nationwide,“ said Mini Timmaraju, president and chief executive officer of Reproductive Freedom for All, a nonprofit that lobbies for reproductive rights.
“We are now one step closer to the Trump administration’s ultimate goal of a national abortion ban,” said Timmaraju in a press release.
But other groups, such as the anti-abortion nonprofit New Jersey Right to Life, have shown support for the complete review of mifepristone.
“The FDA’s decision to review the safety of the abortion pill comes in response to studies revealing severe adverse effects experienced by many women—including sepsis, infection, hemorrhaging, and other serious medical complications within 45 days of taking the drug," said Executive Director Marie Tasy in a press release.
“Women deserve leaders who advocate for their health and safety, not activist attorneys general who use their office to advance the agenda of the abortion industry,” said Tasy.
What else is New Jersey doing to protect medication abortion?
New Jersey is one of a handful of states that has begun stockpiling mifepristone, fearing it could be restricted on the federal level.
In January, Gov. Phil Murphy’s administration said the New Jersey Department of Health will work closely with clinics that provide abortions to begin collecting at least a six-month strategic reserve of mifepristone, the first of two drugs in the medication abortion process.
The governor’s office said the stockpiling investment is part of a more than $50 million investment in reproductive health services in 2025.
There is also a legislative effort in New Jersey to cover out-of-pocket costs for abortion services.
The average out-of-pocket cost for medication abortion ranges anywhere from around $500 to $1,000 depending on how far along the pregnancy is, according to research published in the Journal of Health Affairs.
Stories by Jackie Roman
Thank you for relying on us to provide the journalism you can trust. Please consider supporting NJ.com with a subscription.
Jackie Roman may be reached at jroman@njadvancemedia.com.