Normal view

There are new articles available, click to refresh the page.
Before yesterdayMain stream

EPA, state lawmakers could consider regulating abortion pills as pollutants in 2026

22 December 2025 at 10:25
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)

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 TexasWisconsin 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 IdahoIndianaIowaKansasNorth 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.

This story was originally produced by News From The States, which is part of States Newsroom, a nonprofit news network which includes Wisconsin Examiner, and is supported by grants and a coalition of donors as a 501c(3) public charity.

Abortion patients most often rely on independent clinics, but more closed in 2025, report shows

11 December 2025 at 11:00
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) 

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. 

This story was originally produced by News From The States, which is part of States Newsroom, a nonprofit news network which includes Wisconsin Examiner, and is supported by grants and a coalition of donors as a 501c(3) public charity.

Leaders of 2 major anti-abortion groups call for Trump’s FDA chief to be fired

9 December 2025 at 16:51
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)

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. 

Trump left contraceptives to rot — and women paid the price 

8 December 2025 at 11:00
Drawing of female reproductive system with judge's gavel and stethoscope

Getty Images

As a practicing OB-GYN in Wisconsin, I see firsthand how many of my patients rely on contraception to protect their health, manage painful conditions, and plan their futures. When a woman sits across from me in the exam room, she’s not thinking about politics. She’s thinking about how to survive her work day without severe cramps, how to manage her bleeding so she can attend class without mishap, or how to avoid threatening her life with another high-risk pregnancy. 

These situations are only a few of the reasons why the news about abandoned U.S.–funded contraceptives overseas is so alarming. This action blatantly reflects the same disregard for women’s health that now shapes national policy. And that disregard lands directly on women’s bodies. 

Under the Trump administration, the U.S. government ordered the destruction of nearly $10 million worth of U.S.–funded contraceptives, based on the false claim that birth control is an “abortifacient.” This claim is absolutely nonsensical. Contraception doesn’t end a pregnancy — it prevents one. Unfortunately, ideology, and not medicine, guided that decision, leaving lifesaving, taxpayerfunded medicine stalled in warehouses instead of reaching women who need it. 

The full picture is even more disturbing. Several days ago, a new report found that the Trump administration left 20 of 24 U.S.–funded contraceptive shipments to waste away in Belgian warehouses. These were fully paid-for, taxpayer-funded supplies — IUDs, implants, pills, and other reproductive health essentials — intended for women in 13 countries. This is simply appalling. 

And if you think that kind of extremism stops at the water’s edge, think again. 

Back home, I see the fallout of the same ideology driving national attacks on contraception and women. 

Already, there are over 300,000 women of reproductive age in Wisconsin in need of contraception, and attacks are making this gap even worse. 

And these gaps carry real health risks, because contraception does more than prevent pregnancy — it treats endometriosis, PCOS, severe bleeding and anemia, and it reduces the risk of reproductive cancers

Rural clinics that once offered contraception and family-planning visits have declined in number, a trend worsened by federal policy shifts that weaken the reproductive-health safety net and leave too many women without reliable nearby options for care.

And now, with health-insurance costs already skyrocketing for many families — and monthly bills set to jump even higher if those tax credits expire — the ACA’s no-cost contraception guarantee slips further out of reach. Road block after road block after road block. 

Fortunately, Wisconsin has leaders who understand the stakes. 

Sen. Tammy Baldwin’s leadership on the “Right to Contraception Act” reflects a truth every OBGYN knows: contraception saves lives. Contraception reduces maternal deaths, prevents unintended pregnancies, treats reproductive-health conditions, and empowers women to build stable lives. Baldwin fights to protect contraception — what Wisconsin women rely on every day — not because it’s politically convenient, but because she understands it’s a medical necessity. 

U.S. Rep. Mark Pocan co-sponsored the “Saving Lives and Taxpayer Dollars Act” — legislation designed to stop exactly what we’re seeing in Belgium. The bill requires that U.S.–funded food and medical supplies – like the contraception sitting in Brussels at this moment – reach the people they were purchased for, instead of being left to rot or destroyed for ideological reasons. In Washington, where too many have decided contraception is a cultural wedge rather than essential health care, Pocan’s voice matters. 

The women I see in my exam room aren’t looking for a political fight. They’re looking for care that lets them stay healthy, stay safe, and stay in control of their lives — something contraception makes possible every day. 

Jeopardizing contraception — whether through wasteful negligence abroad or political interference here at home — is harmful, cruel and simply unjust. 

We in Wisconsin cannot afford to look the other way. We need leaders who will defend the right to contraception, not undermine it. 

The stakes are simple: either we protect access to basic health care, or we allow ideology to decide who gets care — and who doesn’t. 

For the women in my clinic — and for women everywhere — contraception is essential care that strengthens their health and safeguards their freedom.

GET THE MORNING HEADLINES.

Privacy concerns linger in reproductive health care despite HIPAA lawsuit’s dismissal

5 December 2025 at 11:00
A Biden-era protection for reproductive and gender affirming health care information was upended by a federal judge in Texas in June. Despite several lawsuits, key privacy rules for medical records remain, but some experts say they aren’t sufficient. (Photo by Dave Whitney / Getty Images)

A Biden-era protection for reproductive and gender affirming health care information was upended by a federal judge in Texas in June. Despite several lawsuits, key privacy rules for medical records remain, but some experts say they aren’t sufficient. (Photo by Dave Whitney / Getty Images)

The four lawsuits at the center of a Republican-led effort to ensure law enforcement can access reproductive health records are now mostly resolved, after attorneys for Texas Attorney General Ken Paxton agreed last week to dismiss the last remaining suit challenging the legality of a foundational health privacy rule.

Paxton filed the lawsuit in September 2024 arguing that Democratic President Joe Biden’s administration illegally created a rule under the Health Insurance Portability and Accountability Act barring certain reproductive health care information from being disclosed if a procedure such as abortion was obtained in a state where it is legal.

The federal HIPAA law is meant to protect patient information generally, especially when that information travels between providers. It contains exceptions for information that can be disclosed to investigators, who can subpoena records from other states. 

Ashley Kurzweil, senior policy analyst for reproductive health and rights at the National Partnership for Women & Families, said the dual threat that Paxton’s lawsuit presented was alarming on a much wider scale than just reproductive health care, so it is a relief that the case is dismissed. Overturning key privacy protections from 2000 that formed the basis of the Biden-era rule could have thrown the entire health care system into chaos, she said.

“We are thrilled that the 2000 privacy rule is still in effect. It is hugely important that it is still in place,” Kurzweil said. “However, (it) provides insufficient safeguards for reproductive health care information when it comes to the broader landscape of increased criminalization risk that people are facing.”

The 2024 rule specifically relating to reproductive and gender-affirming health care information was nullified in June by U.S. District Judge Matthew Kacsmaryk. His ruling came in a Texas-based case filed by a clinician in a small town who said the rule created a conflict with her responsibility to report child abuse, because she considers abortion and gender-affirming health care to be child abuse.

Without those 2024 protections, doctors can choose whether to report patients to law enforcement, Kurzeil said, and some might also be discouraged from offering reproductive health care altogether to minimize legal risks.  

States Newsroom reported more than 400 people were charged with pregnancy-related crimes in the two years after the U.S. Supreme Court’s Dobbs decision, according to data from the nonprofit Pregnancy Justice. 

One of those people was Brittany Watts, an Ohio woman who went to the hospital with miscarriage complications and waited for hours without receiving help. After miscarrying at home and returning to the hospital, staff called the police, accusing her of abuse of a corpse. A grand jury declined to indict her, and Watts is now suing the hospital

In nine of the 400 cases, pregnant people were accused of researching or attempting to obtain an abortion.

Advocacy group dropped effort to appeal Texas ruling

The case before Kacsmaryk is the only one of the four that resulted in a ruling. Although it was filed in the last few months of the Biden administration, the bulk of the case was litigated under Republican President Donald Trump’s Department of Justice.

Repealing the rule was a directive in Project 2025, the conservative blueprint published by the Heritage Foundation. Several prominent anti-abortion organizations were part of the panel that drafted Project 2025, and many of the people involved in writing the 900-page document now work for the Trump administration.

Democracy Forward, a nonprofit legal organization, represented Doctors for America and the cities of Columbus, Ohio, and Madison, Wisconsin, in an attempt to intervene in the case because they did not expect the government to defend the rule. If they were allowed to intervene, they could appeal Kacsmaryk’s opinion striking down the rule regardless of the Trump administration’s decision.

Their attempts were denied by Kacsmaryk, and while the organization did initially appeal that decision, the attorneys dropped the effort in September, saying in a court filing that “the resources of the parties and the courts would be best conserved by dismissing this appeal.”

In a statement to States Newsroom, a spokesperson for Democracy Forward said they will continue to pursue every tool available to defend reproductive rights from political interference and anti-abortion extremists.

The other two cases are in Missouri and Tennessee, where Republican attorneys general also challenged the 2024 reproductive health care-specific rule. The Missouri case was dismissed in September, because Kacsmaryk’s decision had a nationwide effect, and the Tennessee attorney general asked the court to dismiss their case for the same reason. The judge in that case has not yet granted the motion.

map visualization

Shield laws help, but federal backstop would address more situations

Texas and Louisiana have recently launched investigations into out-of-state doctors who, through telehealth, prescribed and mailed abortion medication to patients in their states where abortion is outlawed.

Texas officials have repeatedly investigated and attempted to prosecute people for either leaving the state to seek abortion care or for prescribing abortion medication from a different state. At the end of October, a New York judge dismissed a civil case brought by Paxton seeking $100,000 in damages from a provider the AG said prescribed abortion pills to a woman in the Dallas area, according to The Texas Tribune. Officials in Louisiana attempted to extradite the same New York doctor on criminal charges related to an abortion medication prescription for a pregnant minor. That case was also rejected.

Those attempts were some of the first that tested shield laws implemented by 18 states, including New York. Four others have executive orders from Democratic governors saying they won’t comply with extradition requests for investigations into reproductive health care.

Texas has also passed a law allowing people to seek at least $100,000 in damages if someone they impregnated or someone they’re related to received abortion pills by mail from another state. That law took effect Thursday, Dec. 4.

Kurzweil said those shield laws are a vital help to patients seeking care, but the addition of a federal protective rule would be ideal.

“The two in tandem would be much more fulsome and would address gaps that come up,” she said.

This story was originally produced by News From The States, which is part of States Newsroom, a nonprofit news network which includes Wisconsin Examiner, and is supported by grants and a coalition of donors as a 501c(3) public charity.

Anti-abortion groups, lawmakers push feds for more permanent ‘defunding’ of Planned Parenthood

26 November 2025 at 11:15
The Planned Parenthood clinic in New Orleans was open for over 40 years but stopped seeing patients at the end of September after federal Medicaid funding cuts. Abortion opponents are looking for more ways to pull funds from the organization, despite legal abortion care making up a small portion of the services affiliated health centers provide. (Photo by Greg LaRose/Louisiana Illuminator) 

The Planned Parenthood clinic in New Orleans was open for over 40 years but stopped seeing patients at the end of September after federal Medicaid funding cuts. Abortion opponents are looking for more ways to pull funds from the organization, despite legal abortion care making up a small portion of the services affiliated health centers provide. (Photo by Greg LaRose/Louisiana Illuminator) 

Anti-abortion organizations and Republican elected officials are searching for more ways to prevent Planned Parenthood from receiving federal resources after congressional Republicans successfully cut off federal Medicaid funding until at least July 2026.

Letters written by activist organizations and Republican elected officials show stated goals of barring Planned Parenthood health centers from receiving federal money of any kind and pulling them from the 340B drug pricing program. With it, Title X-funded centers can receive significant discounts on prescription drugs, allowing the purchase of more medications and the ability to reach more patients.

Anti-abortion activists also expect proposals for further restrictions on Planned Parenthood’s access to Medicaid in health care legislation in early 2026.

In July, Republican members of the House and Senate passed a sweeping budget reconciliation bill that included a one-year provision barring clinics from receiving federal Medicaid reimbursement if they offer abortion services and billed Medicaid more than $800,000 in fiscal year 2023. The rule largely affects Planned Parenthood because of the high dollar amount, but some large independent clinics have also been affected.

Since then, more than 20 Planned Parenthood clinics nationwide have closed their doors, many of which did not provide abortion services. Others have laid off staff, including in Ohio. Maine Family Planning, the state’s largest reproductive health care provider, also offered primary care services at three of its 18 clinics but discontinued those services at the end of October because of the funding loss.

Katie Rodihan, director of state advocacy communications for Planned Parenthood Action Fund, said in a statement that those actions would make medication more expensive and take away access to birth control, testing and treatment for sexually transmitted infections, and cancer screenings.

“These anti-abortion lawmakers are so hellbent on shutting down Planned Parenthood that they’re willing to sacrifice your health care,” Rodihan said. “No matter what attack anti-abortion groups and politicians launch, Planned Parenthood Action Fund will always be ready to fight back for patients.” 

Opposition to the organization receiving federal funding is rooted in a belief that its main purpose is to provide abortion care, when in fact abortion makes up about 4% of the services Planned Parenthood clinics provide nationwide, according to the most recent annual report. But anti-abortion groups and many Republican lawmakers object to federal dollars being associated with legal abortion care in any way, even if it’s not directly paying for the procedure except in limited circumstances under the law.

In late September, Oklahoma Republican Gov. Kevin Stitt sent a letter to the administrator of the federal Health Resources and Services Administration, a division of the U.S. Department of Health and Human Services, asking that the agency revoke Planned Parenthood’s 340B drug pricing eligibility and reject any future requests for that designation. The letter is also signed by the Republican governors of Alabama, Arkansas, Indiana, Iowa, Louisiana, Ohio, Tennessee, Utah, West Virginia and Wyoming.

Several Republican-led states, including Ohio and Indiana, have also recently tried to cut Planned Parenthood off of state Medicaid funding.  

“States across the country are acting to ensure taxpayer dollars are not used to fund or promote abortions, and in turn, these clinics are seeking roundabout ways to maintain their funding,” Stitt wrote. “Even if Planned Parenthood affiliates with pro-life laws refrain from using federal funds for abortion, the organization’s national infrastructure still benefits, enabling abortion expansion in states where abortion is legal … .”  

Instead, Stitt suggested that money be allocated to community health centers and rural hospitals.

The letter was sent five days before the government shutdown started on Oct. 1, and no action has been taken by the agency so far since reopening on Nov. 12.

Argument traces back to COVID loans

Students for Life of America, an anti-abortion group with more than 2,000 student chapters nationwide, is leading the effort to pressure Republican President Donald Trump and his administration to disqualify Planned Parenthood as a vendor with the federal government. Called “debarment,” the administrative process usually applies to vendors accused of wrongdoing — such as fraud, embezzlement, failure to perform or tax evasion — and is determined by  the U.S. General Services Administration.

A vendor who is debarred cannot receive federal money of any kind for a period of three years. There is also a lesser penalty of suspension, which lasts up to 12 months.

Kristi Hamrick, Students for Life’s vice president of media and policy, told States Newsroom that members started discussing the idea toward the end of Trump’s first term, but since it involves a long administrative process, there wasn’t enough time to pursue it before Democratic President Joe Biden took office.

Students for Life sent a letter to the U.S. Small Business Administration on Oct. 22, along with a letter to the president’s office signed by more than 50 other anti-abortion groups, encouraging them to start the process of debarment. There has not been a response from the small business agency so far, Hamrick said, but employees only returned to work recently following the 43-day shutdown.  

The letter to Trump is signed by other well-known anti-abortion organizations, including Susan B. Anthony Pro-Life America, Family Policy Alliance, Americans United for Life, Family Research Council and National Right to Life.

Along with allegations of financial fraud, the letter to the Small Business Administration accuses Planned Parenthood of a host of other violations, and mentions lawsuits filed against the organization led by Republican attorneys general in states like Missouri and Texas.   

Hamrick said the letter went to the agency because Republican U.S. Sens. Rand Paul of Kentucky, and Joni Ernst of Iowa wrote a letter of their own in March about alleged fraud committed by Planned Parenthood. They wrote that many of its affiliates — which are independent nonprofit organizations — applied for and received Paycheck Protection Program loans of about $120 million during the COVID pandemic.

The two senators said Planned Parenthood was not eligible for the loans because organizations with more than 500 employees were excluded. Planned Parenthood argued the national organization and the regional affiliates are separate — the affiliates applied individually — and guidance for the loans was later updated by the Biden administration to allow them. Most of the loans were forgiven.

Other entities were also accused of abusing the intent of the Paycheck Protection Program, including Catholic Charities USA, a humanitarian aid arm of the Catholic church with more than 3,000 employees. The Associated Press reported the organization and its member agencies received about 110 loans worth up to $220 million, which were forgiven.

Hamrick said Republicans in Congress should keep up their efforts to bar Planned Parenthood from Medicaid reimbursements, but there’s more that can be done.

“We won’t have to keep voting on whether or not Planned Parenthood can be funded in any one program, such as Medicaid, if they’re not eligible to be funded at all,” Hamrick said.

States still heavily affected by cuts

Hamrick said she hopes to see Republican lawmakers extend the Medicaid cuts for 10 years or more this time around, because this first round of cuts didn’t yield any “dire consequences.”

Dr. Chelsea Daniels, a member of the Committee to Protect Health Care’s Reproductive Freedom Task Force, disagrees. She moved out of Florida two months ago, where she worked in Miami for Planned Parenthood of Florida, and where she tried to help pass an amendment that would have enshrined a right to abortion into the state constitution. Although 57% of voters approved it, 60% is required by Florida law.

That demoralizing loss on top of many days where she had to tell people she legally couldn’t help them became too much. Florida has a six-week abortion ban, with exceptions for rape, incest, fatal fetal abnormalities and human trafficking. But Daniels said she routinely saw sexual assault victims who weren’t able to get an abortion regardless of any documentation they presented.

“Florida honestly just kind of pulverized me. I felt ground up by the end of it,” Daniels said.

She moved to California, and now practices as a family planning physician at Planned Parenthood of Orange and San Bernardino Counties. In her first week of employment there, the affiliate announced it would close its primary care practice because of the Medicaid cuts, laying off 77 staffers and sending 13,000 patients across seven clinics looking elsewhere for basic care such as treatment for high blood pressure, vaccines, annual wellness exams and diabetes management. The final day of service will be Dec. 10.

Daniels wasn’t part of the layoffs, but she said that loss of care for so many patients is devastating.

“I left Florida for good reason, but the state of the country writ large is not good,” Daniels said. “And I don’t think our federal government cares. They think it’s just collateral damage and punishment for anyone who’s ever been associated with Planned Parenthood.”

This story was originally produced by News From The States, which is part of States Newsroom, a nonprofit news network which includes Wisconsin Examiner, and is supported by grants and a coalition of donors as a 501c(3) public charity.

Why a state Senate bill to redefine abortion will hurt, not help, patients and doctors

24 November 2025 at 11:15

Health care providers march for abortion rights at a Madison rally in October 2022. (Photo by Baylor Spears/Wisconsin Examiner)

The Wisconsin State Senate passed SB 553 on Tuesday, Nov. 18, in their last floor session of the year. This bill, purportedly written to define abortion, is actually a covert attempt to exclude abortion from the broader scope of reproductive healthcare. 

Anti-abortion legislators pushing this bill are attempting to play to their religious base who voted them into office to promote an anti-abortion agenda. This is a failing strategy, however, when we’ve seen in countless elections around the country that abortion access is a winning issue, including in Wisconsin. 

The bigger problem, though, is how proponents of the bill are describing it as a way to allow physicians to safely provide care and clarify abortion restrictions, by excluding medical procedures intended to save a person’s life, such as C-sections, the removal of dead embryos, and treatment for ectopic pregnancy, to name a few, from the definition of “abortion.”

Lawmakers are misleading people into thinking that this bill will further define the nuances of care that physicians provide and actually allow, rather than restrict, the provision of care. 

This could not be farther from the truth. We have too many examples nationwide of physicians practicing in states hostile to reproductive rights who are unsure about what care is legal to provide, ultimately leading to unnecessary delays in caring for pregnant people. It is telling that physicians who provide miscarriage and abortion care were not called on to write the text of this legislation. 

Nationally, we have already seen pregnant people die preventable deaths while waiting for essential care for early pregnancy complications because lawmakers stirred confusion and meddled in healthcare decisions. This bill will amplify those dangers in our state, where 13.2 people out of 100,000 die in pregnancy, childbirth, or 42 days after termination of a pregnancy. A study by researchers at the University of Washington and Massachusetts General Hospital showed that these trends, across race, have been worsening in Wisconsin since 2010. 

Black birthing people in Wisconsin account for a disproportionate amount of the disparities in maternal mortality. Adding these racial and systemic inequities to a bill that will delay care for folks across the board, it’s nearly guaranteed that certain groups will have a greater share of these poor outcomes.

As a family medicine and obstetrics physician, I care for folks across the entire spectrum of pregnancy — including miscarriage and abortion. I want to emphasize the similarities in those two scenarios and how they significantly overlap. 

The procedure performed for abortion is identical to the procedure performed for a miscarriage. When a person has a miscarriage or an abortion in the first trimester, generally, a procedure called a “manual vacuum aspiration” or “MVA” can be performed to remove the pregnancy contents. For miscarriages or abortions that occur later in pregnancy, the procedure involves dilating the cervix and removing the pregnancy via a procedure called a dilation and curettage (D&C) or dilation and evacuation (D&E), based on gestational age. 

Additionally, when managing a miscarriage with medications, physicians use mifepristone and misoprostol — medications that lawmakers and anti-abortion activists are actively seeking to restrict because they’re used identically in first-trimester abortions. 

That is the underlying, root issue here: amplifying and reinforcing stigma and criminalization around abortion. 

Carving out the definition of abortion doesn’t actually create medical clarity for providers; instead, it creates a stigmatizing health care space where patients have to disclose and justify why they need certain essential health care. People deserve care and compassion, not judgment or punishment. 

Whether due to miscarriage, abortion, or self-managed abortion, pregnancy loss is not a crime. People should not fear jail time for getting the health care they need. SB 553 aims to differentiate abortion based on intent — a dystopian concept where politicians are in the private space of a doctor’s office. Wisconsinites currently have an opportunity to combat this stigma and call out politicians who are actively harming patients and the patient/provider relationship. 

In my practice already I have seen patients who are hesitant to disclose their pregnancy history for fear that sharing a history of needing abortion care could get them in trouble. Imagine how that influences future decisions to engage with health care providers around miscarriage, abortion and pregnancy complications. 

Wisconsin already heavily regulates how medications for miscarriage are prescribed, including a mandatory in-person dispensing requirement. Those of us who offer this care should not need to feel we must pit our medical expertise against legal jargon when it comes to providing normal, essential care. We need people to be able to trust their health care providers, and we need politicians to stop making laws that pigeonhole physicians into even narrower definitions of care. 

Now that this dangerous bill has been passed in the Senate, it will next head to the Assembly before ultimately landing on Gov. Tony Evers’ desk. In his seven years in office Evers has consistently vetoed anti-abortion legislation, and he has vowed to veto any bill that would limit access to abortion, including SB 553. 

As a physician, it’s devastating to rely on a single individual to preserve my ability to practice safe and necessary health care for countless people and families across the state without political interference. 

There is no other type of health care that is regulated in the unique, stigmatizing, harmful way that abortion care is. Our state politicians need to understand that health care decisions should remain between a patient and their trusted provider. SB 553 ignores that and should not become law. 

GET THE MORNING HEADLINES.

Mifepristone on trial: Where lawsuits about a key abortion medication stand

23 November 2025 at 16:05
Federal regulations around mifepristone, which has provided abortion access across the United States, are being challenged in multiple lawsuits from opposing directions. (Getty Images)

Federal regulations around mifepristone, which has provided abortion access across the United States, are being challenged in multiple lawsuits from opposing directions. (Getty Images)

Despite its strong safety record, the abortion and miscarriage drug mifepristone has been taken to court in several conflicting lawsuits, where some plaintiffs argue the drug should be easier to access, and others say it should be more restricted. 

Testing the shields logo

The medication, sometimes prescribed through telehealth and sent to patients by mail, has provided abortion access across the United States and become a prime target for abortion opponents. 

A group of ongoing federal lawsuits challenges the U.S. Food and Drug Administration’s 2023 decision to maintain special requirements for the abortion pill, with a federal court in Washington upholding the FDA’s decision, a federal court in Hawaii asking the FDA to justify its decision, and a court in Virginia still to rule. Yet another lawsuit, filed Nov. 13 by the American Civil Liberties Union, challenges the FDA under the Freedom of Information Act, alleging the agency has, without giving a reason, refused to disclose the parameters of its mifepristone review and related communications with outside groups. 

For more information and updates on pending mifepristone cases, visit the Mifepristone Litigation and Federal Action Tracker from the Center on Reproductive Health, Law, and Policy at the University of California, Los Angeles.

Heidi Purcell et al. v. Robert F. Kennedy Jr. et al.

  • Court: U.S. District Court for the District of Hawaii
  • Claims: Originally named Chelius v. Wright and filed Oct. 3, 2017, by the American Civil Liberties Union on behalf of a family doctor and several medical associations, this lawsuit challenges the FDA’s mifepristone restrictions as unduly burdensome and arbitrarily restrictive, in violation of the Administrative Procedure Act.
  • Stakes: This case could determine whether the FDA can continue requiring special certifications for patients and providers, which plaintiffs argue deter and delay care, and present privacy risks for patients and providers post-Roe. If plaintiffs succeed, mifepristone could become easier to dispense and access throughout the country.
  • Status: On Oct. 30, Judge Jill Otake, nominated by Republican President Donald Trump, ruled the FDA did not properly justify its 2023 decision or consider all of the evidence when it decided to maintain current restrictions on mifepristone. She ordered the agency to reconsider its decision. Plaintiffs did not seek to vacate the regulations in its lawsuit, so for now they remain in place pending the outcome of the FDA’s review and response to the court. A joint status report from plaintiffs and defendants on how the case should proceed is due Dec. 4.

Whole Woman’s Health Alliance et al. v. U.S. Food and Drug Administration et al. 

  • Court: U.S. District Court for the Western District of Virginia
  • Claims: On May 8, 2023, abortion providers in Virginia, Montana, and Kansas challenged the FDA’s mifepristone rules as unduly burdensome and arbitrarily restrictive, similar to the claims in Purcell v. Kennedy.
  • Stakes: If plaintiffs succeed in this case, mifepristone could become easier to dispense and access.
  • Status: U.S. District Judge Robert S. Ballou, nominated by Democratic President Joe Biden, heard oral arguments on the motions for summary judgment in May but has not yet issued a decision.

Washington et al. v. FDA et al.

  • Court: U.S. District Court for the Eastern District of Washington
  • Claims: On Feb. 23, 2023, Washington and initially 11 other states challenged the FDA’s mifepristone regulations as burdensome and unnecessary.
  • Stakes: Expanding mifepristone access was on the line in this case.
  • Status: Terminated. Judge Thomas O. Rice, nominated by former Democratic President Barack Obama, ruled this summer that the FDA’s review and decision regarding the mifepristone restrictions was reasonable, not arbitrary or capricious.  

American Civil Liberties Union v. FDA

  • Court: U.S. District Court for the District of Maryland
  • Claims: On Nov. 13, 2025, the ACLU sued the FDA arguing it has not complied with the Freedom of Information Act. The nonprofit law firm in August sought  expedited records around the parameters of the FDA’s ongoing review of mifepristone and communications with outside groups. The ACLU alleges the agency has failed to provide a determination regarding the request.
  • Stakes: Records released as part of this lawsuit could bring transparency to HHS’ review of the abortion pill.
  • Status: The government has not yet filed a brief in response to the lawsuit, which has been assigned to Magistrate Judge Timothy J. Sullivan. 

 

Another group of lawsuits challenge state abortion pill restrictions, arguing that federal law, which allows medication abortions to be prescribed via telehealth and by the mail up to 10 weeks’ gestation, supersedes state laws.

GenBioPro v. Kristina Raynes et al.

  • Court: U.S. Court of Appeals for the Fourth Circuit (on appeal from U.S. District Court for the Southern District of West Virginia)
  • Claims: In 2023, mifepristone generic manufacturer GenBioPro sued West Virginia after the state criminalized abortion and explicitly banned prescription of mifepristone by telemedicine. The company argued federal law preempts West Virginia law and that Congress authorized only the FDA to impose restrictions on access to mifepristone.
  • Stakes: A ruling in plaintiffs’ favor could have made abortion drugs easier to access in a state that has cut off access to pregnancy termination in most circumstances.
  • Status: Terminated. District court Judge Robert C. Chambers, nominated by former Democratic President Bill Clinton, found in 2023 that the Food and Drug Administration Amendments Act did not preempt West Virginia’s abortion regulation. The U.S. Court of Appeals for the Fourth Circuit affirmed the lower court’s decision in July

Amy Bryant v. Timothy Moore et al.

  • Court: U.S. Court of Appeals for the Fourth Circuit (on appeal from U.S. District Court for the Middle District of North Carolina)
  • Claims: In 2023, North Carolina Dr. Amy Bryant sued her state over medication abortion restrictions, arguing the FDA’s mifepristone policy preempts state restrictions, which require in-person prescribing, dispensing and administering; prohibit providers other than physicians from prescribing mifepristone; mandate the scheduling of an in-person follow-up appointment; and require non-fatal adverse events reported to the FDA.
  • Stakes: The case could limit states’ ability to restrict medication abortion.
  • Status: Chief Judge Catherine C. Eagles, nominated by Obama, found that some restrictions were preempted by federal law but upheld other state requirements, including mandatory ultrasounds and waiting periods. The case is pending appeal.

Birthmark Doula Collective et al. v. Louisiana et al. 

  • Court: Louisiana’s 19th Judicial District Court
  • Claims: On Oct. 31, 2024, birth workers, medical professionals and a pregnant woman challenged a Louisiana law that classifies mifepristone and misoprostol as controlled dangerous substances, even though the FDA does not. They argue the classification delays access to these medications during emergencies, risking the health and safety of patients experiencing miscarriages.
  • Stakes: Drugs used for emergencies during pregnancy could become easier for providers to access if plaintiffs prevail.
  • Status: Pending in state trial court. In May, the court held a hearing on a motion to dismiss and ruled the challenge can proceed.

 

Another group of lawsuits seek to reimpose more restrictions on mifepristone and argue the FDA erred in its decision to allow abortion medication prescribed through telehealth and sent through the mail. Both cases cite anecdotes of women being coerced or drugged by partners to argue in-person visits are in the best interest of abortion patients. 

Missouri et al. v. FDA et al.

  • Court: U.S. District Court of Eastern District of Missouri
  • ClaimsOriginally filed Nov. 18, 2022 by a group of anti-abortion doctors and groups that claimed that mifepristone is highly dangerous and the FDA unlawfully loosened restrictions. The U.S. Supreme Court rejected the case last summer, determining plaintiffs did not have standing to sue and remanded it to lower courts.
  • Stakes: If plaintiffs prevail, the FDA could bar telehealth and mail delivery of medication abortion, which would curtail access throughout the country.
  • Status: The lawsuit was resurrected by attorneys general in Idaho, Kansas and Missouri. It was transferred last month from Trump appointee Matthew Kascmaryk’s court in Texas to Trump appointee Cristian Stevens’ court in Missouri. 

Louisiana et al. v. FDA et al.

  • Court: U.S. District Court for the Western District of Louisiana Lafayette Division
  • Claims: Filed Oct. 6, 2025, the state of Louisiana and resident Rosalie Markezich are suing to vacate the FDA’s 2023 decision to remove the in-person dispensing requirement. Markezich says she was coerced by a former partner to take the abortion pill, which she says he ordered in her name and received by mail.
  • Stakes: If plaintiffs prevail, the FDA could bar telehealth and mail delivery for abortion medication, which could curtail access throughout the country.
  • Status: The case is pending in district court before Trump appointee Judge David C. Joseph.

Read more about the FDA’s high-stakes abortion pill safety review.

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

This story was originally produced by News From The States, which is part of States Newsroom, a nonprofit news network which includes Wisconsin Examiner, and is supported by grants and a coalition of donors as a 501c(3) public charity.

FDA’s abortion pill safety review under growing scrutiny

23 November 2025 at 16:00
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)

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.

Testing the shields logo

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 prescriberspharmacists 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.

This story was originally produced by News From The States, which is part of States Newsroom, a nonprofit news network which includes Wisconsin Examiner, and is supported by grants and a coalition of donors as a 501c(3) public charity.

❌
❌