Attorney General Letitia James urges the FDA to remove unnecessary barriers and expand access to the abortion medication mifepristone

New York – In a decisive move aimed at safeguarding reproductive rights and access to critical health care, New York Attorney General Letitia James has teamed up with her counterparts from California, Massachusetts, and New Jersey to formally petition the U.S. Food and Drug Administration (FDA) to remove longstanding restrictions on the abortion medication mifepristone. The attorneys general argue that the current regulations are medically unnecessary, legally indefensible, and impose harmful obstacles to care, especially for patients in rural and underserved areas.

The petition, filed under the authority granted by the U.S. Code of Federal Regulations, comes at a pivotal moment, as the FDA undertakes a full review of its mifepristone labeling policies at the direction of U.S. Health and Human Services Secretary Robert F. Kennedy, Jr. The coalition of attorneys general sees this review as a rare and vital opportunity to push the agency toward science-based policy reforms.

“Given mifepristone’s 25-year safety record, there is simply no scientific or medical reason to subject it to such extraordinary restrictions,” said Attorney General James. “New Yorkers, and all Americans, deserve access to this safe, effective, and essential medication without burdensome, unjustified restrictions. The FDA must follow the science and lift these unnecessary barriers that put patients at risk and push providers out of care.”

Since its initial approval by the FDA in 2000, mifepristone has been used by more than 7.5 million people across the United States to end early pregnancies, most commonly in combination with another drug, misoprostol. This combination is not only the most frequent method for early abortion, but it is also the standard medical treatment for early miscarriage management.

Health experts have long affirmed the medication’s safety profile. According to both the FDA and leading medical organizations, serious complications from mifepristone are “extremely rare.” Notably, no deaths have been definitively attributed to the drug in the U.S. in its 25-year history. It is so effective and well-understood that the World Health Organization includes it on its list of essential medicines.

Despite this, mifepristone remains subject to the FDA’s Risk Evaluation and Mitigation Strategy (REMS) — a regulatory program typically reserved for drugs with significant and demonstrable risks. The REMS requirements for mifepristone include mandatory prescriber certification, patient agreement forms, and pharmacy certification — all of which the petitioners say deter clinicians, discourage pharmacies, and ultimately block patients from accessing care.

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The attorneys general argue that the REMS program imposes administrative headaches that are completely out of step with the medication’s low risk. In fact, they say the layers of red tape are driving mifepristone out of most general health care settings altogether. Most primary care doctors, they point out, avoid prescribing the medication because of the excessive process involved in becoming certified. As a result, nearly 90 percent of U.S. counties have no abortion provider, and only 1 percent of medication abortions occur in primary care clinics.

Among the most criticized requirements is the prescriber certification, which mandates clinicians be listed on national or local abortion provider directories — a requirement that can expose them to professional and personal risks. Patients, too, must sign a standardized agreement that confirms their intention to “end [their] pregnancy,” even when being treated for a miscarriage. Pharmacies must also take on additional shipping and record-keeping tasks that many find unmanageable or intimidating.

James and her colleagues point out that these burdens contrast sharply with how the FDA regulates much riskier drugs. For example, medications used for opioid dependence, blood clot prevention, and even erectile dysfunction face fewer federal hurdles. A different formulation of mifepristone — used to treat Cushing’s syndrome — is not subject to REMS at all.

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The attorneys general also highlight the chilling effect political and social pressure has had on pharmacies and health care providers who want to dispense mifepristone. After Walgreens announced in 2023 that it would seek certification to carry the medication, it was met with an onslaught of threats and harassment. Ultimately, the chain declined to dispense it in 20 states, including several where abortion is still legal.

This backlash prompted Attorney General James to write directly to Walgreens and other national pharmacy chains, urging them to uphold access to mifepristone in New York and reiterating that dispensing the drug remains legal and protected in the state.

The current REMS program, the attorneys general argue, only worsens this climate by reinforcing stigma and disincentivizing participation from otherwise willing providers. It burdens the entire health care infrastructure, from rural clinics to urban emergency rooms, many of which cannot prescribe mifepristone due to the cumbersome certification process.

Under federal law, REMS programs must directly mitigate a specific, serious health risk and cannot impose undue burdens on patients or health care systems. The coalition insists that the current REMS for mifepristone fails on both counts. With years of safety data backing the drug and strong state-level oversight already in place in places like New York, California, and Massachusetts, the attorneys general contend that continued federal restrictions are unnecessary and legally unsound.

The petition further challenges recent attempts to question mifepristone’s safety using research that has since been discredited. Several of the studies cited by anti-abortion activists have been retracted by medical journals due to flawed methodologies. Even the FDA has acknowledged that the drug’s safety profile has not changed — even after it relaxed earlier requirements, such as in-person dispensing.

This latest petition is just one part of a broader legal and advocacy strategy by Attorney General James, who has established herself as a national leader in the defense of reproductive rights. Just last month, she led a 20-state coalition calling on the U.S. Department of Health and Human Services to restore millions in federal reproductive health funds. She also recently won a lawsuit against Red Rose Rescue, an anti-abortion group that disrupted operations at New York health clinics.

Her office has filed multiple amicus briefs with the U.S. Supreme Court, advocating for access to care for Medicaid recipients, maintaining access to emergency abortion, and protecting the right of Americans to obtain mifepristone. She’s also led efforts in urging Congress to expand reproductive health services through the Access to Family Building Act.

“This is about science, this is about safety, and this is about access,” James has said in various public statements. “We cannot allow politics to interfere with people’s ability to get essential medical care.”

The FDA is now expected to consider the petition as part of its broader review process. While it is not obligated to act immediately, the agency must issue a formal response, and the petition could influence both internal policy discussions and external legal challenges that may come in the months ahead.

James and the other attorneys general are urging the FDA to fully eliminate the REMS program for mifepristone — including the requirements for provider certification, pharmacy authorization, and patient agreements. Alternatively, they ask the FDA to exercise enforcement discretion and allow exceptions for states where abortion remains legal and oversight mechanisms are already in place.

Supporters of the petition believe that lifting these restrictions would not only improve health outcomes but also send a clear message that science and patient care must come before politics.

As this issue moves through the federal review process, Attorney General James says her office will continue to fight for equitable health care access in New York and beyond. “We will not back down in our defense of reproductive freedom,” she said. “We will keep using every tool at our disposal to protect the right to choose.”