U.S. Health and Human Services Secretary Robert F. Kennedy Jr., shown here in September, cited a white paper funded and self-published without peer review by anti-abortion groups as grounds for federal scrutiny of a key abortion medication’s safety. (Photo by Andrew Harnik/Getty Images)

The U.S. Food and Drug Administration is facing increasing pressure from abortion opponents and advocates over how it regulates a drug that has become central to abortion access since Roe v. Wade was overturned three years ago.

Abortion medication manufacturers, health care providers and state attorneys general have continued to petition and sue the agency to loosen regulations for mifepristone, a key abortion drug. At the same time, anti-abortion policy leaders have successfully lobbied the Trump administration — on the basis of a self-published white paper funded by anti-abortion groups — to review mifepristone’s safety again and consider reviving old restrictions.

On Thursday, Nov. 13, the American Civil Liberties Union sued the FDA under a federal public records law for refusing to disclose the parameters of its new review, as well as communications with outside groups. 

Abortion opponents have called on the FDA to ban telehealth abortion, which has allowed abortion rates to rise slightly nationally despite state bans. A shift in mifepristone regulation could dramatically change abortion access throughout the country, and health advocates and litigators on both sides of this dispute are closely watching how the agency justifies any changes. 

Abortion-rights advocates have also seized on a recent federal ruling from a Trump-appointed judge, which orders the FDA to justify its 2023 decision to maintain restrictions on the abortion pill and argues the agency excluded from its review, without explanation, a wealth of research and evidence that it previously accepted.

Reproductive health legal experts say the action could prevent the anti-abortion white paper from being the main thing the agency considers before modifying its policy. 

“This is where the debate, both in the courts and the FDA, is taking place, around how it is considering evidence, making sure it is reviewing valid evidence and not junk evidence, and getting really reasoned explanations based in that evidence, as opposed to politics or ideology,” said Diana Kasdan, the legal and policy director for the Center on Reproductive Health, Law, and Policy at the University of California, Los Angeles School of Law. 

Where reproductive health legal experts say the abortion pill has been over-regulated for a drug with a high safety record, anti-abortion attorneys, like senior counsel Erik Baptist of the Christian-right powerhouse Alliance Defending Freedom, have been arguing that the drug’s risks are exacerbated by its increased availability. The law firm, which was integral to the overturning of Roe v. Wade, is also representing a Louisiana woman in an abortion medication lawsuit against the FDA. 

“The FDA’s actions have created an even more unsafe environment for women,” Baptist said. 
“We expect the Trump administration to zealously appeal this dangerous decision.”

‘It’s the same data set, essentially’

Putting pressure on FDA’s review team are national anti-abortion policy groups like Americans United for Life, one of several groups that criticized the agency for approving a new generic version of mifepristone this fall. The group is part of a coalition that helped produce and, at the end of April, publicize the white paper on mifepristone’s safety, which U.S. Health and Human Services Secretary Robert F. Kennedy Jr. soon after cited as the basis for ordering a new review of the drug. 

The Ethics and Public Policy Center’s self-published paper analyzed a commercially available data set of all-payer health insurance claims from 2017 through 2023 and found an 11% rate of severe adverse events — 22 times higher than the less than 0.5% rate that’s on the label for mifepristone. Reproductive health researchers have criticized the paper’s broad classification of serious adverse events while noting it also reports low rates of the most serious side effects associated with medication abortion, like sepsis (0.1%), transfusion (0.15%), and hospitalization related to the abortion (0.66%). Meanwhile more than 100 peer-reviewed studies have found low rates of serious adverse effects, including for abortion medication provided through telehealth.

The paper, which has also been cited by lawmakers like U.S. Sen. Josh Hawley of Missouri, did not go through a scientific peer review, and the Ethics and Public Policy Center would not disclose the exact data set used. Spokesperson Hunter Estes previously told States Newsroom the group was not legally permitted to provide the data set but that the paper’s description of it should be enough to replicate the study.  

Americans United for Life CEO John Mize said he hopes to see the paper peer-reviewed in the near future. But he said the coalition has for now achieved its goal of convincing the FDA to look at the same insurance claims data set analyzed by the Ethics and Public Policy Center and then do its own analysis.

“What we’ve been told is the FDA is doing their own internal analysis of the EPPC data,” Mize said. “It’s to be seen what the FDA does with methodology. That’s the important component, because the data is the data. It’s the same data set, essentially.”

HHS did not respond to questions about its ongoing mifepristone review or the federal judge’s recent order to review all of the safety data, instead directing States Newsroom to an Oct. 2 post on X from Kennedy defending both the FDA’s review of mifepristone and its approval of a second generic version. 

“Recent studies already point to serious risks when mifepristone is used without proper medical oversight,” Kennedy posted. “@US_FDA only approved a second generic mifepristone tablet because federal law requires approval when an application proves the generic is identical to the brand-name drug.”

But if the FDA’s review ultimately draws different scientific conclusions than the anti-abortion movement, Mize said his side won’t stop pursuing challenges to the drug. 

“If it comes out that it’s not nearly as dangerous as what EPPC is reporting, and the data appears to be quality and not skewed by politics, then personally, I might take a different perspective,” Mize said. “But I am still fairly confident that a drug that induces abortion at home without clinical oversight is probably something that needs a little bit more scrutiny. … We might continue to fine tune methodology and look at pursuing other avenues of peer review.”

Politicized science 

Anti-abortion policy and legal advocates have been lobbying for tighter restrictions on mifepristone since the drug was first approved in 2000, and especially since the FDA started dropping restrictions, such as allowing the regimen to be used until 10 weeks’ gestation instead of seven in 2016. After Roe v. Wade was overturned, the FDA under President Joe Biden’s administration permanently dropped the in-person dispensing requirement, allowing people to obtain the abortion pill via telehealth and through the mail. 

But the FDA maintained other regulations, as part of the drug’s Risk Evaluation and Mitigation Strategy, such as requiring prescribers, pharmacists and patients to sign forms agreeing to meet certain qualifications and acknowledging the drug’s common side effects, like heavy bleeding and nausea, and potential severe risks, like infection. Abortion providers have argued that some of the rules are unnecessary and burdensome.

Of the more than 20,000 prescription drug products approved by the FDA, less than 100 have REMS, and many of those are injectables with serious side effects like coma and death. In a quarter century, the FDA has reported 36 deaths associated with, but not necessarily caused by, mifepristone.

U.S. District Judge Jill Otake on Oct. 30 ordered the FDA to review all the relevant safety data on mifepristone, ruling that the agency erred years ago when it failed to justify maintaining strict rules on the drug despite a strong safety record after 25 years on the market. One week later, the U.S. Senate Democratic Caucus sent a letter to Kennedy and FDA Commissioner Martin Makary demanding the ongoing mifepristone review be based on science and evidence. 

“That court order reinforces that, in conducting this new review, FDA may not cherry-pick junk science serving an anti-abortion agenda, but must instead look at the full body of evidence both confirming mifepristone’s safety and underscoring the harms of the FDA’s onerous restrictions,” reads the letter obtained by NOTUS. The senators ask HHS to respond by Nov. 28, to questions about the evidence being considered and the methodology.

Anti-abortion research groups also produced new studies for their first legal attempt to reinstate restrictions on mifepristone in a lawsuit filed in 2022. The plaintiffs persuaded a Trump-appointed district court judge to order the FDA to change its policy on the basis of studies funded by the anti-abortion movement that were later retracted by the journal’s publisher because of their methodology. The U.S. Supreme Court rejected the case, not on the merits but because plaintiffs did not have proper standing. The high court is expected to consider similar questions again, as at least seven mifepristone-focused lawsuits work their way through the lower courts.

University of Pittsburgh law professor Greer Donley said that to meet the FDA’s policy on approving new drug regulations, the agency will need more than one or two outlier studies as justification. 

“To survive arbitrary and capricious review, they have to provide a reasoned decision that’s based on the facts, and if the facts taken as a whole suggest that this is a safe and effective drug, even though there’s one new paper out there that suggests it’s maybe a little less safe than it was before, they’re going to have to justify why that one paper outweighs the 50 papers on the other side that were published in peer-reviewed journals,” Donley said. “I don’t know how they could explain that.”

Donley has studied mifepristone regulation closely and said she watched the science around the medication become increasingly politicized, much more than other drugs. While controversial medicine, like gender-affirming care, involve drugs with multiple purposes, mifepristone was approved for the explicit purpose of ending a pregnancy. 

The FDA’s medication abortion regimen involves another drug, misoprostol, which was approved to treat ulcers, and is used off-label for abortions and miscarriages. It has not faced the same scrutiny as mifepristone. Abortion providers have said they would likely pivot to a misoprostol-only regimen if mifepristone were to become much harder to access, which it has even for miscarriages in states that have banned abortion entirely, like Kentucky and Louisiana.

Mifepristone manufacturer Danco Laboratories last year confirmed ongoing efforts to add miscarriage management as an approved use to its drug label. Were that to happen, it could be a game changer for access, Greer said.  

“It actually would be a pretty huge deal if they added it,” she said. “Because all of these attacks against mifepristone for abortion, even if they succeed, then mifepristone would theoretically remain on the market for miscarriage care, and then it could be used off-label for abortion.”

Read the latest on legal cases over mifepristone winding their way through the courts. 

Tomorrow, a look at efforts to both reinforce and crack shield laws across the country.

Hope Broussard, 20, sought care at a Planned Parenthood in Washington in 2023 when her IUD became lodged in her cervix and the clinics in her hometown of Sandpoint, Idaho, weren’t able to help. She now lives in Pullman, Washington. (Photo by Geoff Crimmins for States Newsroom)

Fifth in a five-part series. 

Hope Broussard’s intrauterine device should have brought relief from her severe periods. But at 17, it started causing debilitating pain.

At the Sandpoint, Idaho, clinic where the device was implanted, providers suspected it was embedded in her uterine wall, but lacked the ultrasound equipment to make a diagnosis.

Homeless with no insurance after her mother kicked her out, Broussard couldn’t enroll in Medicaid as a minor without a parent’s involvement. The women’s clinics in Sandpoint couldn’t help. Hospital bills were out of the question.

“The only people that were able to help me were Planned Parenthood,” Broussard said.

She sought care across the border in Washington, at the Spokane Planned Parenthood, where an ultrasound showed the IUD was coiled around her cervix. A specialist carefully removed it in a follow-up appointment and she paid $20 for everything because it was all she could afford.

“It really was my saving grace at the time,” said Broussard, who moved from Idaho to Pullman, Washington, in part because of that experience of being unable to access health care locally. “I have no idea what I would’ve done if I didn’t have that option available to me.”

Broussard is one of more than 2 million people nationwide who used Planned Parenthood for health care between 2023 and 2024, according to the national organization’s annual report. But how many people will be able to afford and access care is changing after a new federal provision prohibits some organizations that provide abortions from receiving Medicaid payments for at least a year. Nationally, Planned Parenthood estimates it could lose $700 million from Title X and Medicaid cuts, forcing affiliates to close some clinics, curtail services and stop accepting Medicaid patients.

Many Republican lawmakers and anti-abortion groups celebrated the provision passed by Congress in July that essentially targeted Planned Parenthood clinics nationwide for “defunding” because abortion care is part of clinical services in many states where access is mostly legal. Federal Medicaid dollars cannot be used to pay for abortions except in limited circumstances, and abortion care makes up a small percentage of overall care provided by clinics. Still, conservatives argue the mere association with any such clinics is equivalent to funding all abortion. 

“Planned Parenthood’s desperate ploy for our tax dollars only underscores why the One Big Beautiful Bill is such a historic win,” said Susan B. Anthony Pro-Life America President Marjorie Dannenfelser in a July statement. “It halted, for the first time, over half a billion taxpayer dollars from propping up the corrupt abortion industry.”

Democratic-led states are in troubleshooting mode 

In response, elected officials in some Democratic-led states, including Washington, Hawaii, Colorado and Massachusetts have publicly pledged to backfill the funding needed to allow Planned Parenthood clinics to keep accepting Medicaid and other low-income patients. In July, Washington Gov. Bob Ferguson committed to filling the $11 million gap Planned Parenthood expected to see.

Many states don’t begin their legislative sessions until January, so some of the plans aren’t official yet and still need to make it through the legislative process or the details of allocation are still in progress. That means clinics either have to absorb the costs for now with the promise of reimbursement, or change their payment options and services for the time being. For example Hawaii is moving to sliding-scale fees for some Medicaid patients, and in Maine, a major independent clinic is making changes to its services. 

Idaho’s border with Washington and Oregon is a point of contention among lawmakers across state lines, where the political views could hardly be more polarized between the hard-line conservatives in Idaho and progressive politics in the other two states. But for the people who need abortion care, or even a basic ultrasound, like Broussard, clinics in places like Spokane and Ontario, Oregon, are some of the last options available. 

Oregon lawmakers are also brainstorming ways that the state can provide reimbursement to Planned Parenthood for lost funding. Clinics across the state billed Medicaid nearly $17 million for services in 2024, according to the Oregon Capital Chronicle. 

Courtney Normand, the Washington state director for Planned Parenthood Alliance Advocates, said this latest move from Congress is adding to challenges from the first Trump administration when there were other cuts, along with health care system pressures from the COVID-19 pandemic, and the impact of increasing patient volumes after the U.S. Supreme Court’s Dobbs decision that upended federal abortion rights protections.

“It feels like the hits have just kept on coming in Washington, and that’s why access, affordability and stable funding is our key concern,” Normand said. 

Brita Lund, the health center manager at a Planned Parenthood in Seattle, worries about having to turn away patients if the federal Medicaid cuts and other strains on the health care system become too much to bear. She already feels like she spends too much time grilling a patient about their personal details at an appointment so the staff can find a way to get the treatment paid for by a specific pocket of funding. 

“Who is going to help these people if we’re not going to help them? I want someone to give me that answer,” Lund said. “It literally keeps me up at night.” 

While Washington state is known for being one of the most openly accessible for sexual and reproductive health, a budget crisis led legislators to cut 55% of the funding to the Abortion Access Project, about $8.5 million. Normand said it’s hard to know exactly why legislators made the decision, but some regretted it and are trying to find a solution for the upcoming session. Ferguson pledged to restore the funding as well. 

‘I know the state is supportive, it’s just about what their capacity is’

In Hawaii, Title X cuts from the Trump administration earlier this year amounted to about $2.1 million, said Jen Wilbur, Hawaii state director for Planned Parenthood Alliance Advocates. The state legislature acted quickly in April to approve a new $6 million family planning fund to offset that loss over the next two years, with $3 million specifically allocated to Planned Parenthood clinics. What the funding program will look like exactly is still to be determined, Wilbur said. The needs vary by island, and an assessment of what those needs are is underway.  

Hawaii has trended slightly more conservative than other blue states in recent elections, Wilbur said, but support from lawmakers still feels strong. She and other advocates are trying to game plan in the event that the federal government restricts access to mifepristone through the mail, which would severely affect access for the islands. 

But Wilbur worries about the long-term sustainability of the funding in a small state that already has many challenges with high cost of living, difficulty retaining providers and navigating the unknown. 

“We don’t even know how many more cuts are coming, so is any state really going to be able to sustain this going forward? I don’t know,” Wilbur said. “I know the state is supportive, it’s just about what their capacity is.” 

Short-term state fixes in Maine, Massachusetts 

New England, considered a hub for abortion access and low-cost reproductive health services, has been especially impacted by the federal Medicaid rule. It affects not only Planned Parenthood affiliates, but also two nonprofit health networks that offer wide-ranging health services primarily to Medicaid patients: Health Imperatives in Massachusetts and Maine Family Planning, which, like Planned Parenthood, has sued over the new policy. 

Maine’s legislature this summer appropriated about $6 million for family planning funding, to go to organizations like Planned Parenthood of Northern New England and Maine Family Planning, the largest reproductive health provider in the state with 18 clinics compared to Planned Parenthood’s four. But as Maine Morning Star reports, the temporary relief does not fully meet both organizations’ deficits, and Maine Family Planning this week announced it will end primary care services in Ellsworth, Houlton and Presque Isle at the end of October.

Still, both Maine Family Planning and Planned Parenthood of Northern New England say they will continue to see Medicaid patients free of charge for reproductive health and family planning services. 

Massachusetts Democratic Gov. Maura Healey also announced the state would deliver $2 million to Planned Parenthood League of Massachusetts, which is one of the co-plaintiffs in Planned Parenthood’s lawsuit against the federal government.

“We want the people of Massachusetts to know that if you need reproductive health care services, you should continue to seek this care,” Healey said in a news release. 

Massachusetts has been a leader in policy promoting access to reproductive health including abortions, which is legal in the state up to 24 weeks of pregnancy with exceptions for significant fetal abnormalities and the pregnant person’s health.  

But access to broad reproductive health care even in a city like Boston remains limited, especially for people living in poverty, said Dominique Lee, president and CEO of Planned Parenthood League of Massachusetts.

Lee told States Newsroom that making a primary care or OB-GYN appointment in the Boston area can mean having to wait 60 days, while Planned Parenthoods typically have same-day appointments. She noted that the communities with the least access to low-cost reproductive health services are concentrated in central and western Massachusetts, where Planned Parenthood has three clinics.

Lee said she is grateful for the $2 million in state funding, which she calls “short-term relief.” Because Medicaid funding represented about a quarter of her organization’s revenue, Lee said it is like a business losing its biggest customer. Her goal now is to figure out how the affiliate can sustain long term. She said they are brainstorming other revenue streams like offering vasectomies.

“We have gotten really good at contingency planning,” Lee said. “But it would be great to have a business model that is sustainable, that can withstand all of these attacks, and not have to worry about it. That would be a dream.”

The affiliate’s website notes that patients can no longer use their MassHealth or Medicaid Managed plans for care at Planned Parenthood clinics but says they are still seeing “all patients.”

Health Imperatives, which operates seven clinics in southern Massachusetts, is also looking at operations.

Health Imperatives CEO Julia Kehoe said the $19 million nonprofit serves about 23,000 people annually and offers social and psychiatric services to vulnerable populations. About 40% of what Health Imperatives does is offer low-cost sexual and reproductive health services for about 10,000 patients annually, Kehoe said. For now, they are continuing to see the same amount of patients and are working with the state government for funding help. 

But she said the organization is also looking at private funding because they are determined to continue seeing Massachusetts’ poorest residents, many of whom experience food insecurity in places like Nantucket, which is one of the nation’s wealthiest towns but where the main safety net for those who are not wealthy is a single Health Imperatives clinic. 

“I would never, ever make the decision to not see Medicaid patients,” Kehoe said. “We exist to provide services to people who fall through the cracks of mainstream systems of care. So we’re going to prioritize people who are on Medicaid or people who don’t have insurance. What I would do is, rather than further health disparities and wealth disparities in one of the most expensive states in the country, I would have fewer clinics.”

Correction: This article has been corrected to reflect that elected officials in Maine have not yet pledged to support family planning clinics with backfilled funding. The state passed a bill last session that provided family planning funding that was already needed before the congressional bill cut Medicaid funding.