Attorney General Bonta Continues the Fight to Expand Patient Access to Medication Abortion

OAKLAND – California Attorney General Rob Bonta today, alongside the attorneys general of Massachusetts, New York, and New Jersey, filed a petition with the U.S. Food and Drug Administration (FDA) requesting that FDA eliminate unnecessary restrictions on the abortion medication mifepristone by removing the Mifepristone Risk Evaluation and Mitigation Strategy Program (REMS program) including the Prescriber Certification, Pharmacy Certification, and Patient Agreement form. Barring removal of the REMS program, the attorneys general ask that FDA exercise its discretion to not enforce the requirements of the REMS program within four Petitioner States, leaving regulation of mifepristone to the states – thereby minimizing unnecessary, duplicative, and burdensome requirements and maximizing access to this critical medication.

Mifepristone is a safe and effective medication prescribed to patients who need critical, time-sensitive reproductive care, including abortions and treatment of miscarriages. Studies show that medication abortion allows people to get reproductive care as early as possible when it is safest, least expensive, and least invasive. It plays an important role in reducing barriers and promoting equitable access to healthcare, particularly for those who live in rural and underserved communities. 

“For decades, medication abortion has been recognized not only as effective, but so safe that it presents lower risks of serious complications than taking Tylenol or getting a colonoscopy,” said Attorney General Bonta. “The medication is a lifeline for millions of women who need access to time-sensitive, critical healthcare – especially low-income women and those who live in rural and underserved areas. Its 25-year safety record is backed by science and cannot be erased at the whim of the Trump Administration. We’re calling on the FDA to reverse course and maintain broad access to mifepristone. Far from making America healthier, restricting mifepristone’s availability through unnecessary barriers for prescribers, pharmacies, and patients only harms patients and our healthcare system.”

On May 14, 2025, Robert F. Kennedy, Jr., Secretary of Health and Human Services (HHS), testified before the Senate Health, Education, Labor and Pensions Committee that he had ordered FDA administrator Martin Makary to conduct a “complete review” of mifepristone and its labeling requirements, even though mifepristone has proven extraordinarily safe. Since its approval in 2000, approximately 7.5 million Americans have safely used the medication. Mifepristone is even on the World Health Organization’s core list of essential, life-saving medicines.

Despite its safety record, FDA has subjected mifepristone to a REMS program designed for drugs with known, serious risks. The current REMS program involves three burdensome requirements: (1) Prescriber certification, which deters clinicians from prescribing the medication by requiring their names be added to national and local abortion provider lists, raising serious safety and legal concerns; (2) Patient agreement forms, which all patients must sign – even those being treated for miscarriage – attesting they intend to “end [their] pregnancy”; and (3) Pharmacy certification, which imposes complex tracking, shipping, and reporting burdens that dissuade pharmacies from carrying mifepristone.

In the petition, the attorneys general emphasize that these restrictions stand in stark contrast to the FDA’s treatment of far riskier medications. Drugs like opioids, blood thinners, and even other formulations of mifepristone used to treat illnesses like Cushing’s syndrome are not subject to such restrictive REMS programs. FDA-approved drugs for cosmetic procedures and erectile dysfunction, despite well-known risks for serious complications, also face fewer barriers than mifepristone.

Under federal law, REMS requirements must mitigate a specific serious risk and cannot be “unduly burdensome” on patients or health care delivery systems. Attorney General Bonta and the coalition argue that the current mifepristone REMS fails to meet that standard. The Petitioner States already have in place robust state laws that ensure safe prescribing, rigorous informed consent, and professional accountability. The FDA is also specifically directed to account for access in rural areas and to minimize unnecessary burdens on the health care system, criteria that the mifepristone REMS does not meet. 

In the petition, the attorneys general argue that the current mifepristone REMS:

• Is medically unjustified: Mifepristone has an extensive safety record established over 25 years, and its safety has remained stable even as restrictions on its use have been lessened over that period. The medication has been safely used by more than 7.5 million women and serious adverse events have been, in the FDA’s own words, “extremely rare,” and no deaths have ever been definitively attributed to the drug. It further interferes with the practice of medicine by imposing unnecessary restrictions on physicians’ ability to provide the best options for patients within the context of their own unique health concerns.
• Is burdensome on patient access: These REMS requirements significantly impede access to care, especially in rural and underserved communities. The vast administrative burden associated with REMS requirements has kept mifepristone out of most family medicine practices and primary care settings, despite its low risk and ease of use. Many primary care and family medicine physicians report viewing the complex process as “not worth the effort.” As a result, medication abortion is largely limited to specialized settings, with only one percent of such abortions occurring at primary care facilities. Meanwhile, nearly 90 percent of U.S. counties lack a single abortion provider.
• Places undue strain on the nation’s entire health system: Emergency rooms often cannot prescribe mifepristone due to certification hurdles, despite being critical for patients experiencing miscarriages. Pharmacies also struggle to meet the administrative burdens brought on by certification requirements, and some have even faced coordinated pressure campaigns and threats simply for attempting to stock the medication. For example, when Walgreens announced plans to seek certification, it was met with intimidation and ultimately declined to dispense the drug in 20 states, including several where abortion remains legal.

Attorney General Bonta and the coalition assert that in light of mifepristone’s strong safety record and essential role in abortion and miscarriage care, the current REMS program is both scientifically and legally indefensible. The attorneys general ask FDA to fully eliminate the mifepristone REMS program, including prescriber, pharmacy, and patient certification requirements.

Alternatively, the States argue that the FDA should exercise enforcement discretion and cease applying REMS elements in California, Massachusetts, New York, and New Jersey — states where abortion is legal and safe, and health care is highly regulated. Trump claimed he would leave abortion to the States — that is precisely what the four states are requesting.

A copy of the petition is available here.