State and federal proposals to regulate and restrict medication abortion are expected to continue in 2026 as abortion opponents claim, without strong evidence, that abortion medication is dangerous to patients and the environment. (Getty Images)

Going into the fourth year without federal abortion rights protections, groups that helped overturn Roe v. Wade are focused on cutting off access to abortion pills. As multiple lawsuits over the abortion drug mifepristone unfold, state and federal proposals to regulate and restrict medication abortion are expected to continue in 2026. Abortion opponents argue that medication abortion, despite its strong safety record, is dangerous to patients and the environment.

Abortion bans are largely unpopular, but heading into a midterm election year, some lawmakers in states with strict abortion bans have already prefiled bills to add new restrictions. Here’s a look at early legislative trends emerging in abortion-related bills recently introduced or prefiled ahead of the new year.

Proposals to restrict abortion pill or study environmental effects

Over the last few years, the national anti-abortion group Students for Life of America has spread unfounded claims that mifepristone pollutes U.S. waterways and drinking water, drafted model legislation to regulate the disposal of medication abortions, and requested environmental studies at the federal and state level. 

In 2025, lawmakers in at least seven states introduced bills to create environmental restrictions for the abortion drug mifepristone or order environmental studies. Bills introduced this year in Texas, Wisconsin and Wyoming would have required testing community water systems for traces of mifepristone. 

Bills in Maine, Montana, Pennsylvania, West Virginia, Wisconsin and Wyoming would have required providers to give patients medical waste kits to collect and return the tissue following a medication abortion. Women commonly flush the tissue associated with medication abortion and miscarriages, which typically occur during the first trimester. 

These bills, except Pennsylvania’s, would have also mandated in-person dispensing of the medication and follow-ups, effectively banning telehealth abortion. 

None of these proposals passed, but they are likely to be reintroduced in 2026 as abortion opponents continue to push for environmental regulation of abortion pills, including at the federal level. 

In June, 25 congressional Republicans sent the U.S. Environmental Protection Agency a letter inquiring about potential avenues for regulating mifepristone, as the New York Times reported. And as Politico recently reported, Students For Life lobbied the agency to add mifepristone to its recently updated list of contaminants that utilities will have to track in drinking water. It’s too late to include a new drug on the list, which is updated every five years. 

But according to Politico, EPA staffers advised anti-abortion activists to use an upcoming public comment period to drum up requests that the agency include active metabolites in mifepristone. The EPA collects nationwide data on the chemicals on this list, which could be used to set future federal limits.  

Fetal wrongful death bills 

In Florida, where abortion is banned at six weeks’ gestation, lawmakers recently advanced HB 289 ahead of the 2026 session, which would allow parents to file wrongful death lawsuits for the loss of a developing fetus and to claim damages for mental pain and loss of support. Its companion bill, SB 164, filed for the third year in a row by Republican Sen. Erin Grall, faces an uphill battle in the Florida Senate, reported the Florida Phoenix, which noted that jurors could be asked to consider the salary the fetus could have earned over its life as part of damages to which parents could be entitled. 

Groups opposing the legislation as far-reaching and likely to increase liability exposure for OB-GYNs who specialize in high-risk pregnancies include the American Civil Liberties Union of Florida, the Florida Justice Reform Institute and the Doctors Company, the nation’s largest physician-owned medical malpractice carrier.

One of the bill’s leading champions, Andrew Shirvell, founder and executive director of Florida Voice for the Unborn, told state House Judiciary Committee members they should continue expanding “civil remedies afforded under Florida law to hold accountable those who continue to take the lives of unborn children illegally in our state.”

Another bill, HB 663, would allow a family member to sue someone for providing or attempting to provide an abortion up to two years after the fact with up to $100,000 in damages, even if the woman consented or if the abortion was performed in another state or country where the procedure is legal.

Attempts to overturn or skirt abortion rights ballot measures 

Even though Missouri voters in 2024 approved an amendment to protect abortion rights in the state constitution, broad access has not returned to the state. Between January and October, there were only 80 in-clinic abortion procedures in Missouri, according to state data, with an additional 79 abortions in hospitals and identified as medical emergencies.

A trial in January could determine whether Missouri’s anti-abortion laws violate the voter-approved amendment. Meanwhile, Republican lawmakers have put a new constitutional amendment on the 2026 ballot that would ban nearly all abortions in the state with limited exceptions.   

In 2023, Ohio voters approved a constitutional amendment protecting abortion rights through fetal viability, and prohibiting the state from interfering with or penalizing someone for exercising that right. But Republicans have been advancing anti-abortion bills to create restrictions that make accessing abortion more difficult without directly flouting the amendment. 

During this legislative session, which ends Dec. 31, state Sen. Kyle Koehler introduced SB 309, which could add steps to accessing medication abortion and would require doctors to deliver a state-mandated script about the dangers of mifepristone. It would also allow patients, their parents if they’re underage, or the father of the fetus  to sue if they feel the patient was uninformed when taking the pill.

In November, the Ohio House passed HB 485, which would require students in fifth through 12th grade to watch either a “Meet Baby Oliva” fetal development video created by the national anti-abortion group Live Action, or a similar video. Live Action’s video has been criticized by reproductive health advocates for not being fully medically accurate or comprehensive. Similar bills have been introduced in dozens of states this year, and have been enacted in Idaho, Indiana, Iowa, Kansas, North Dakota and Tennessee. 

Abortion records privacy

Privacy concerns around reproductive health in the post-Roe era persist nationally. Lawmakers in states that protect abortion rights continue to try to shore up medical and data privacy protections for abortion, which is almost completely illegal in more than a dozen states. 

In Indiana, where the legislative session began in December, Sen. La Keisha Jackson introduced SB 109. Under the measure, a health care provider’s report about an abortion submitted to the Indiana health department as a medical record would be confidential and not subject to disclosure as a public record. In a state lawsuit brought by two OB-GYNs from Indianapolis, an appeals court in December upheld the privacy of these records, known as terminated pregnancy reports.

In Washington state, Democratic lawmakers are still drafting legislation that would regulate license plate readers following reports that authorities in Texas searched thousands of cameras, as far as Washington and Illinois, to find a woman they believed had a self-administered medication abortion. 

Calling for forced vasectomies for convicted rapists

State abortion restrictions typically hold health providers liable, but women have been jailed or prosecuted for their pregnancy outcomes. One Democratic lawmaker in Alabama, where abortion is banned throughout pregnancy except to save the pregnant person’s life, has introduced legislation that comes with steep penalties for men convicted of rape or incest that resulted in pregnancy. 

Democratic Rep. Juandalynn Givan’s prefiled HB 46 would authorize abortion to preserve the health of the mother or if the pregnancy resulted from rape or incest. It would also require men convicted of rape or incest to pay for the abortion, and undergo either vasectomy or castration, as determined by the court. As the Alabama Reflector reported, the bill is unlikely to be considered, but for Givan it’s really about starting a broader conversation of bodily autonomy. 

“We have already set a double standard,” Givan said. “Have you seen a bill crafted that tells a man what he cannot … do with his body? You have not, outside of the standard laws that speaks to rape and incest, and we already know that that is definitely a crime.”

Anticipated federal policy decisions during Trump’s second year 

In his first year back in office, President Donald Trump rescinded many of the Biden-era policies intended to expand abortion access, including the previous administration’s interpretation that the Emergency Medical Treatment and Labor Act covers abortions necessary to save a pregnant person’s life even in a state that has banned abortion.

More major federal policy decisions around abortion are anticipated in 2026. The Food and Drug Administration agreed to review mifepristone’s safety, but abortion opponents recently called for FDA Commissioner Martin Makary to be fired, accusing him of slow-walking the review until after the midterm elections in November. 

Just a few months before that, in July, a controversial Medicaid policy effectively defunding Planned Parenthood clinics and other nonprofit clinics that provide abortions, is slated to expire. Whether Republicans will renew the funding restriction or let it lapse — allowing the nation’s largest network of reproductive health clinics to continue serving Medicaid patients for services unrelated to abortion — remains to be seen.

Abortion-rights advocate Kristin Hady helps a car navigate past protesters toward  A Preferred Women’s Health Center of Atlanta in Forest Park, Georgia, in August 2023. Independent clinics are facing fresh challenges, and at least 23 more closed this year, bringing the total to 100 since the Dobbs decision. (Photo by Ross Williams/Georgia Recorder) 

When Wisconsin Planned Parenthood clinics temporarily paused abortion services in October because of a new law halting federal Medicaid reimbursements, patients turned to the state’s two independent clinics for care. 

Demand at Affiliated Medical Services in Milwaukee quadrupled, according to clinic director Dabbie Phonekeo. 

“It happened all of a sudden. We were all scrambling to figure out what we needed to do and how we were going to accept all patients,” Phonekeo said. 

The staff secured additional funding to meet need before Wisconsin’s Planned Parenthood clinics resumed abortions, adapting under a law that bans certain reproductive health care providers from receiving federal funding until July 2026. 

“This was a reminder of why it’s so important to have independent clinics and abortion access overall,” Phonekeo said. 

At least 23 independent clinics have closed this year, according to a report released Tuesday by Abortion Care Network, compared with 12 last year.

Most were in states with abortion-rights protections, the report found. 

Independent providers face less recognition than Planned Parenthood and ongoing barriers to funding. Donations to abortion clinics and funds have waned, leading to more out-of-pocket costs for patients, States Newsroom reported last year.  

Independent clinics provide 58% of all abortions nationwide, while Planned Parenthood provides 38%, hospitals 3%, and 1% occur at physicians’ offices, according to the latest Abortion Care Network findings. 

Medication abortion, allowed during the first 10 weeks of pregnancy, has been a focus of abortion-rights advocates and opponents this year. But independent clinics are more likely to offer legal procedural abortions after that. 

More than 60% of all U.S. clinics that offer abortion care after the first trimester are independent, 85% that provide abortion at 22 weeks or later are independent, and all clinics that perform the procedure after 26 weeks are independent, according to the report. 

“While both medication and in-clinic abortion are safe and effective, people may need or prefer one method over another,” the report states. “This is especially true for patients for whom it’s not safe or feasible to terminate outside the clinic — including those experiencing intimate partner violence, minors without support at home, people experiencing homelessness, and patients who cannot take time off from work or caretaking.” 

The latest clinic closures come more than three years after the U.S. Supreme Court’s Dobbs v. Jackson Women’s Health Organization decision forced many to cease operations: 100 independent clinics closed between 2022 and 2025. 

Affiliated Medical Services in Wisconsin is one of the few independent abortion providers that was able to reopen after closing the day the nation’s highest court overturned federal abortion rights on June 24, 2022. 

The clinic reopened in March 2024 a few months after a Wisconsin judge ruled that a 19th century abortion ban was invalid, Wisconsin Examiner reported. 

Phonekeo said people were initially hesitant to book appointments at the clinic. 

“Most of our patients that we saw had asked, ‘Is this legal? Am I going to go to jail if I have an abortion today? Can we do this in Wisconsin?’ So I think a lot of patients were still afraid to be seen,” she said. 

Independent clinics could become even more significant to reproductive health care access if lawmakers permanently bar Planned Parenthood from receiving federal resources.  

Some anti-abortion groups have urged the Trump administration to disqualify Planned Parenthood as a federal vendor, States Newsroom reported in November. 

Nearly 50 Planned Parenthood clinics closed this year due to federal health officials’ cuts to Title X and Medicaid. At least 20 closed since a federal “defunding” provision that halts Medicaid funds for reproductive health care providers that offer abortion and received more than $800,000 in fiscal year 2023 took effect, according to a tally released on Nov. 12 by the national organization. 

Some of the clinics that closed did not offer abortion. And under the law, federal funding only covers abortions in extreme circumstances, so the Medicaid reimbursement ban primarily affects patients who go to Planned Parenthood for other services, like birth control, cervical cancer screening and treatment for sexually transmitted infections. 

Some independent clinics offer non-abortion care, too, but many don’t accept Medicaid, clinic directors said at a Wednesday news briefing. 

Amber Gavin is the vice president of advocacy of operations at A Woman’s Choice, an organization that has three clinics in North Carolina and one each in Florida and Virginia. She said staff members at the Charlotte location have seen an uptick in patients seeking STI testing and related services. 

Karishma Oza, chief of staff at DuPont Clinic in Washington, D.C., also said providers there have seen an increase in patients who are uninsured or underinsured since the Medicaid ban, which mostly affects Planned Parenthood, took effect. 

Phonekeo said the Wisconsin clinic hasn’t dealt with more demand for reproductive health care services beyond abortion. Still, Affiliated Medical Services offers birth control pills, IUDs, STI testing and treatment, miscarriage care and even follow-up care for medication abortion provided through online-only clinics such as Hey Jane. 

While all three clinic leaders said they don’t accept Medicaid, they offer sliding-scale payments for people who cannot afford the full cost of care. 

“We’re more than just abortion providers,” Phonekeo said. 

U.S. Sen. Josh Hawley, R-Mo., talks to reporters at the U.S. Capitol on Saturday, June 28, 2025. (Photo by Ashley Murray/States Newsroom)

WASHINGTON — Missouri U.S. Sen. Josh Hawley is ratcheting up pressure on the U.S. Food and Drug Administration to finish a study into medication abortion and to change its prescribing guidelines, sending a letter to Commissioner Marty Makary on Wednesday that the pace of the review is “totally unacceptable.”

The letter came just one day after leading anti-abortion groups called on President Donald Trump to fire Makary, following a report from Bloomberg Law that he planned to delay the agency’s review into mifepristone until past the November midterm elections. 

Hawley wrote in the two-page letter he posted to social media that it was “unclear” whether the FDA was actually conducting a review of the current prescribing guidelines and the safety of medication abortion. 

“There are more abortions in America now than when Roe was still law,” Hawley wrote, referring to the 1973 Roe v. Wade ruling from the Supreme Court, which established the constitutional right to an abortion. “And this is largely because of the chemical abortion drug and its generics, like the one you approved.”

Hawley asked Makary to reply to three questions before Dec. 15, including whether the FDA is “conducting a comprehensive safety review of mifepristone separate from the (Risk Evaluation and Mitigation Strategies) process,” if Makary delayed any safety reviews of mifepristone and if the FDA has plans to revert prescribing guidelines to require in-person dispensing. 

President Donald Trump, asked about the timeline during a roundtable at the White House, said he would find out whether the FDA was stalling. 

“I’ll find out. I’ll ask them,” Trump said. “I don’t think they’re slow walking anything, but I’ll find out.”

A spokesperson for the Department of Health and Human Services, which includes the FDA, said that “FDA’s comprehensive scientific reviews take the time necessary to get the science right, and that is what Dr. Makary is ensuring as part of the Department’s commitment to gold-standard science and evidence-based reviews.”

Second day of pressure on Makary

Hawley’s letter continued the public pressure campaign from anti-abortion organizations and lawmakers that began Tuesday when leaders at Susan B. Anthony Pro-Life America and Live Action called for Makary to be fired over the Bloomberg Law news story reporting he had delayed the review of mifepristone over political considerations related to the midterm elections.

Americans United for Life CEO John Mize released a statement after meeting with Makary, saying it “is glaringly obvious that flawed political calculations” have stalled the FDA’s review of mifepristone, but not calling for him to lose his job over it. 

Access to mifepristone

Mifepristone is one of two pharmaceuticals used in medication abortion. It is approved for up to 10 weeks gestation and can be prescribed via telehealth and shipped to patients. 

Reducing or eliminating access to mifepristone has become a linchpin of the anti-abortion movement since the U.S. Supreme Court overturned the nationwide right to an abortion in 2022. 

Anti-abortion medical organizations, represented by Alliance Defending Freedom senior counsel Erin Morrow Hawley, tried unsuccessfully to have the Supreme Court revert the prescribing guidelines for mifepristone in 2024. 

Josh Hawley and Erin Morrow Hawley are married. 

Numerous medical organizations, including the American College of Obstetricians and Gynecologists and the American Medical Association, filed briefs to the justices in that case attesting to the safety and efficacy of medication abortion. 

“The scientific evidence is overwhelming: major adverse events occur in less than 0.32% of patients,” the groups wrote. “The risk of death is almost non-existent.”

Dr. Martin Makary testifies during his confirmation hearing to lead the Food and Drug Administration before the Senate Committee on Health, Education, Labor, and Pensions Committee at the Dirksen Senate Office Building on March 06, 2025 in Washington, DC.  (Photo by Kayla Bartkowski/Getty Images)

WASHINGTON — Two of the country’s largest anti-abortion organizations want President Donald Trump to fire U.S. Food and Drug Administration Commissioner Marty Makary over access to medication abortion. 

Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, expressed frustration Tuesday that the FDA hasn’t completed a review of the prescription drug mifepristone.

“The FDA needs a new commissioner who will immediately reinstate in-person dispensing as it existed under President Trump’s first term and immediately conduct a comprehensive study,” she wrote in a statement. “Commissioner Makary is severely undermining President Trump and Vice President Vance’s pro-life credentials and their position that states should have the right to enact and enforce pro-life protections. Makary must go.”

A spokesperson for the Department of Health and Human Services, which houses the FDA, wrote in a statement that “FDA’s comprehensive scientific reviews take the time necessary to get the science right, and that is what Dr. Makary is ensuring as part of the Department’s commitment to gold-standard science and evidence-based reviews.”

White House spokesman Kush Desai wrote in an email to States Newsroom that “Makary is working diligently to ensure that Americans have the best possible, Gold Standard Science study of mifepristone.”

“The White House maintains the utmost confidence in Commissioner Makary, whose leadership at the FDA has delivered and continues to deliver one landmark victory for the American people after another, from cracking down on artificial ingredients in our food supply to conducting the first safety review of baby formula in decades,” Desai added. “Uninformed attacks against Commissioner Makary from individuals outside the Administration will not change these facts.”

FDA approval 

Mifepristone is one of two pharmaceuticals used in medication abortion. It is FDA-approved for up to 10 weeks gestation and can be prescribed via telehealth and shipped to patients remotely. 

About 63% of the abortions in 2023 were medication, as opposed to procedural, according to the Guttmacher Institute. 

The U.S. Supreme Court rejected an attempt by anti-abortion medical organizations to overturn the FDA’s current prescribing guidelines for mifepristone in 2024. 

Numerous medical organizations, including the American College of Obstetricians and Gynecologists and the American Medical Association, filed briefs to the justices in that case attesting to the safety and efficacy of medication abortion. 

“The scientific evidence is overwhelming: major adverse events occur in less than 0.32% of patients,” the groups wrote. “The risk of death is almost non-existent.”

‘No preconceived plans’

Makary testified before a Senate committee in March as part of his confirmation process that he planned to review data on mifepristone and follow the research where it led him.

“I have no preconceived plans on mifepristone policy except to take a solid, hard look at the data and to meet with the professional career scientists who have reviewed the data at the FDA,” Makary said at the time.

Lila Rose, founder of the anti-abortion group Live Action, also called for Makary to be fired, writing in a social media post that his request to delay the results of the review until after the November 2026 midterm elections, which was reported by Bloomberg Law, was unacceptable. 

“If Dr Makary will not act as head of the FDA to protect children and mothers he should be fired,” Rose wrote, later adding the administration should, “Ban the abortion pill now!”

Americans United for Life CEO John Mize released a statement after meeting with Makary, saying it “is glaringly obvious that flawed political calculations” have stalled the FDA’s review of mifepristone. 

“To avoid political backlash in the upcoming midterm elections, advisors within the Administration are acting on a false premise, that emphasizing the importance of women’s safety and direct in-person consultation with her clinician is a political liability,” Mize wrote. 

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.