Arizona leads push to remove federal restrictions on most common abortion pill

Over a dozen Democrat-led states with abortion protections, including Arizona, are calling on the Trump administration to remove federal regulations on the most commonly used abortion pill and make it easier for women to obtain it from their family doctor. 

In a 55-page citizen petition sent to the U.S. Food and Drug Administration on Wednesday, Arizona Attorney General Kris Mayes, along with Pennsylvania Gov. Josh Shapiro and the attorneys general for 14 other states, told the federal agency that preserving restrictions around how abortion pill mifepristone is dispensed would dramatically impact the ability of clinicians to prescribe it and women to access it. 

In a written statement announcing the petition, Mayes, who ran on a campaign to protect abortion access, denounced the movement to narrow women’s reproductive health care options. 

“Women in Arizona have used Mifepristone safely and effectively for more than two decades. The FDA is folding to anti-abortion politicians and activists,” she said. “The FDA should immediately remove these unnecessary restrictions and allow Arizonans to access the reproductive health care they have a right to.”

The petition comes as the FDA, at the direction of Health and Human Services Secretary Robert F. Kennedy Jr., is reviewing mifepristone — despite 25 years of agency approval and hundreds of clinical trials that repeatedly confirmed the drug’s safety and effectiveness. 

While more than a dozen states protect abortion access in some form or enshrine the procedure in their state Constitution following the fall of Roe v. Wade, including the Grand Canyon State, narrowing FDA approval of mifepristone would function as a backdoor abortion ban. The pill, which is part of a two-drug regimen, makes up the vast majority of medication abortions nationwide, and accounts for around 60% of total procedures. 

At stake: FDA policies around mifepristone prescriptions, dispensing

Last year, a coalition of anti-abortion doctors and medical groups sought to convince the U.S. Supreme Court to rescind the federal government’s approval of mifepristone and roll back policies that expanded access to it in 2016. The justices ultimately threw out that lawsuit, but now the focus among abortion foes has shifted to lobbying the FDA to enforce strict limits on who can prescribe the pill and when it can be dispensed that were softened under the Obama and Biden administrations. 

Some drugs are approved with Risk Evaluation and Mitigation Strategies, also called REMS, in place to ensure the FDA can monitor, prevent and manage the “severity of adverse health events” associated with those drugs. Under the REMS governing mifepristone, pharmacies must meet a certification process to dispense the drug, medical professionals seeking to prescribe it must be certified to do so and patients must fill out a special acknowledgement form. 

In 2023, the Biden administration dropped a requirement that mifepristone be dispensed to patients in-person. Reproductive rights advocates fear that the Trump administration could seek to restore that restriction or tighten the existing regulations in ways that could further deter women and physicians from asking for and providing mifepristone. 

Earlier this month, 20 Republican attorneys general wrote a letter to the FDA asking the agency to do just that. 

Dems: REMS do nothing but make it harder to access abortion pill 

In their longshot request, the Democrat states argued that mifepristone shouldn’t be limited by its existing REMS because it has been repeatedly proven to be safe, the requirements reduce the willingness of physicians and patients to prescribe and ask for the drug, and their health care systems are already sufficiently regulated. 

The attorneys general urged the FDA to either entirely scrap the REMS around mifepristone or at least decide not to enforce them in their states. The group pointed out that their lawmakers or constituencies elected to protect abortion after Roe was overturned, and guaranteeing access to mifepristone is a key part of respecting that choice. 

In Arizona, the mifepristone drug regimen was used for 99.7% of women who opted for a medication abortion in 2023 to terminate a pregnancy or manage a miscarriage. That same year, about 59% of all procedures were medication abortions. Surgical abortions are more invasive and expensive, and are often out of reach for low-income or rural women. 

As proof that the REMS around mifepristone are unnecessary, the states pointed to both anecdotal evidence from local physicians and a recent article published in the Journal of the American Medical Association that concluded the policies make no difference for patient safety. 

The authors noted that the certification for clinicians hoping to prescribe mifepristone is nothing more than a self-attestation that they are skilled in caring for patients with an early pregnancy. Despite how easy that standard is to meet, however, the authors found that 1 in 10 OB-GYNs are hesitant to fill it out, because of fear that the form could later be made public and they could be identified as abortion providers. 

Instead of protecting patients, the physician certification narrows the pool of people who are authorized to prescribe mifepristone. In addition, the certification requirements for pharmacies to be allowed to dispense mifepristone are so burdensome that, even in states where abortion is legal, there are few pharmacies willing to undergo the process. Together, the prescriber certification form and the pharmacy certification process only serve to make it more difficult for women to obtain a medication abortion. 

“Forcing patients to go to ‘specially certified’ providers, as opposed to their primary care or family physicians, can require patients to travel long distances, disrupts continuity of care, stigmatizes routine health care , and discourages patients from making the best health care choices for themselves and their families,” the Democratic attorneys general wrote.

Likewise, the patient acknowledgement form women are required to fill out doesn’t serve a clear safety purpose. Instead, it runs the risk of misinforming patients or even causing them emotional harm, according to the states. A Pennsylvania doctor surveyed for the citizen petition noted that it is based on science from 2016, and said it could undermine the patient-clinician relationship to have the provider explain the procedure one way, only to be immediately disputed by outdated information on the mandatory acknowledgement form. 

Filling out the form is a required step for women seeking to use mifepristone to end a pregnancy, as well as for women who are dealing with a miscarriage, and yet the language is the same in both situations. That can cause unnecessary pain for many women, according to doctors quoted in the citizen petition.

“As one Oregon physician explained, ‘I have had patients who were already undergoing the traumatizing experience of a miscarriage, become deeply upset, confused, or distressed at having to sign a form about medication abortion’ attesting that they are deciding to voluntarily terminate their pregnancy,” reads the petition. 

The states argued that their own health care systems are sufficiently regulated to justify eliminating the REMS governing mifepristone. Arizona’s medical boards and licensure requirements ensure that medical professionals, clinics and pharmacies are qualified and up to code. And multiple state laws regulate how physicians can dispense medication, and penalize violations. 

Adding REMS to how mifepristone is prescribed isn’t just overkill, according to the states, but nonsensical. Decades of research has proven that the drug is safe; it shouldn’t be placed in the same kind of regulatory category as riskier medications. Since the drug first earned FDA approval in 2000 through December 2024, only 36 deaths have been reported out of 7.5 million uses, and the agency has acknowledged that no evidence could link mifepristone to those deaths.  

“As one physician explained, ‘REMS are generally only placed on dangerous drugs like opioids and the existence of the REMS, coupled with the provider certification, creates a disincentive to prescribe a very safe medication,’” wrote the attorneys general. 

On top of failing to benefit patients or the health care system in any way, the REMS around mifepristone use also likely violate federal law, the states argued. The Federal Food, Drug and Cosmetic Act, which gives the FDA the power to issue regulations, strictly limits the passage of safety policies to situations where they reduce the risk of a “serious adverse drug experience” and prohibits regulations that are “unduly burdensome” on patient access — especially in rural areas. The states argued that the REMS around mifepristone don’t succeed in reducing any safety risk, and the drug itself doesn’t present a significant danger, and concluded that the regulations should be eliminated. 

“The current regulatory requirements for prescribing and dispensing mifepristone – requiring patients to sign an agreement form and providers and pharmacies to obtain special certification — are unrelated to any ‘specific risk’ of the drug, let alone required to mitigate any perceived risk,” they wrote.