The Biden administration helped expand access to medication abortion last week, with the US Food and Drug Administration finalizing a rule to make the pills more readily available in pharmacies. But this effort to help patients get pills to end a pregnancy could be dwarfed by a major push to restrict access to the medication from anti-abortion leaders and their Republican allies.
As lawmakers head back to state legislatures this month, many for the first time since Roe v. Wade was overturned in June, Republicans face new pressure to restrict access to the combination of abortion-inducing drugs, mifepristone and misoprostol, used typically within the first 10 to 12 weeks of a pregnancy. Medication abortion has become the most common method for ending pregnancies in the United States, partly due to its safety record, its lower cost, diminished access to in-person care, and greater opportunities for privacy.
Restricting access to the pills is not a new goal for the anti-abortion movement; the Guttmacher Institute tracked 118 medication abortion restrictions introduced last year across 22 states, and many conservative states already have laws on the books for dispensing the drugs that go beyond what the FDA requires and what leading health organizations recommend.
But efforts to crack down on abortion pills have taken on new urgency since the Dobbs v. Jackson decision. More women are finding ways to bypass abortion bans through organizations like Aid Access in Europe, pill suppliers from Mexico, and methods like mail forwarding from states where abortion is legal. While a study from the Society of Family Planning estimated that legal abortions nationwide declined by more than 10,000 in the two months following the Supreme Court’s decision, some or many of those abortions may have been replaced by pills women privately obtained and researchers couldn’t count.
“Everyone who is trafficking these pills should be in jail for trafficking,” Marjorie Dannenfelser, the president of Susan B. Anthony Pro-Life America, told the Washington Post in December. “It hasn’t happened, but that doesn’t mean it won’t.”
Some of the restrictions on medication abortion leaders are considering extend well beyond those pursued by lawmakers in previous years, when their focus was generally on banning telemedicine and adding more requirements for dispensing pills in person, like mandatory ultrasounds, waiting periods, and visits with doctors.
Anti-abortion activists are exploring new strategies, such as laws to ban websites like Aid Access and Plan C and laws to make health care providers newly liable for disposing of aborted fetal tissue. In a federal lawsuit filed in November, one religious conservative group has challenged the FDA’s approval of mifepristone writ large, alleging the agency abused its authority 23 years ago in authorizing the drug at all.
Some lawmakers are looking to test the limits of their extraterritorial powers, exploring how and whether they could punish a resident for getting an out-of-state abortion, or retaliate against providers in other states who facilitate them.
“Anti-abortion advocates are throwing the kitchen sink in an attempt to see what might work,” said Jenny Ma, a senior attorney at the Center for Reproductive Rights. “That’s the same playbook the anti-abortion movement had before Dobbs … but they’ve become emboldened.”
Sue Liebel, the director of state affairs with Susan B. Anthony Pro-Life America, told Vox she expects states to pursue “creative” strategies for enforcement, including through state health departments, boards of pharmacy, and the police. “Everyone’s trying something different,” she said. “If there’s one thing I can anticipate, in this particular year of legislative sessions, when we’re not even quite 200 days from Dobbs, I think the keyword this year is ‘variety.’ While things are a little early right now, I know it’s going to explode very soon.”
Some states have banned abortion entirely — including abortion pills — while others have banned telemedicine abortion, meaning individuals can only obtain the drugs in person from a doctor. But there are workarounds. If you live in a state like Texas, you can still order pills from Aid Access, which ships internationally to restrictive states. Or you could travel to a less restrictive state, connect with a provider there, and then pick up the pills from a discreet location. Others rely on friends, acquaintances, and activist networks in abortion-friendly areas to help them get the medication.
To crack down on these options, anti-abortion leaders are exploring new ways to ramp up enforcement of existing rules and restrictions. With poorly regulated data privacy laws, aggressive prosecutors could amass a lot of evidence if they suspect a person obtained an illegal abortion, or an abortion that would not be legal in their home state.
One proposal, which is expected to be introduced this week in Texas, would expand the ability of private citizens to bring civil lawsuits against anyone thought to have terminated a pregnancy illegally with abortion pills. This would build on a six-week abortion ban that took effect in Texas in 2021, which included the novel citizen enforcement mechanism.
John Seago, president of Texas Right to Life, told Vox they’re looking to “utilize those civil liability tools” for abortion before six weeks, and his group is working to identify examples of people who might be distributing abortion pills illegally for local prosecutors to then charge.
Seago said Texas lawmakers are also going to explore ways to hold groups with ties to abortion pill distributors “financially and criminally accountable.” Though some medication abortion providers are outside Texas and outside the United States, Seago said elected officials are looking to target entities with connections to the providers that might have subsidiaries in Texas. “If there is still an affiliation or cooperation of other entities with that pharmacy or physician dispensing the pills, then legislators can look at our law and spread out the accountability,” he said.
In October, Republican lawmakers in Oklahoma asked their state’s attorney general for a formal opinion clarifying whether self-managed abortions constitute murder under their strict abortion ban. A spokesperson for Oklahoma Attorney General John O’Connor told Vox that request is still “being evaluated.”
Susan B. Anthony Pro-Life America has been speaking with conservative governors regarding ways to restrict shipments of abortion medication. Liebel, the state affairs director, acknowledged that internet sales makes enforcement of existing rules difficult.
“But we are also aware that states have requirements for parental consent that may or may not be followed by these [online] providers,” she said, adding that they’re working to craft legislation to address this.
To crack down on medication abortion, experts anticipate more politicians will follow in the wake of Missouri lawmakers, who in 2021 and 2022 began testing the limits of restricting abortion outside their borders. Advocates expect to see more bills targeting out-of-state doctors who prescribe pills to their residents, and bills targeting those who may “aid and abet” a pregnant person in traveling out of state.
“Anti-abortion states will not be satisfied with just banning abortion in their states and are looking to flex their extraterritorial muscles,” said Lorie Chaiten, a senior staff attorney with the ACLU’s Reproductive Freedom Project.
Medication abortion in the US has long been subject to more rules and restrictions than other drugs with higher risks of death or adverse complications.
Over the objections of groups like the American Congress of Obstetricians and Gynecologists, the FDA has long had mifepristone on its Risk Evaluation and Mitigation Strategies (REMS) list, a designation used when the government determines that increased restrictions are necessary for a drug’s benefit to outweigh its risks. As a result, the FDA could require that only certified medical professionals in hospitals, medical offices, or clinics administer the pills, meaning someone couldn’t just fill a prescription at their local pharmacy.
In 2017, the ACLU sued the FDA, arguing its mifepristone restrictions were not medically justified.
In part due to pressure from the ACLU’s still-pending lawsuit, during the pandemic the FDA temporarily lifted its requirement that mifepristone be dispensed in person at a clinic or a hospital. In December 2021, the FDA announced it would permanently lift the in-person dispensal requirement, and last week the FDA officially clarified that certified pharmacies can dispense mifepristone.
While that is still more restrictive than what leading health groups recommend, advocates praised these changes as measures in the right direction toward expanding abortion access.
But for many leaders in the anti-abortion movement, these actions were cast as proof that lawmakers are “lowering medical standards” and putting women at risk. In an op-ed published last year, Kristan Hawkins, the president of Students for Life of America, laid out the case that loosening the REMS restrictions is “anti-woman and anti-science.”
Hawkins emphasized that “more than 20” women have died of complications from abortion medication since 2000. (This is out of the nearly 5 million women in the US who have taken the drugs in that period. The FDA reports a total of 4,207 “adverse events” in that time, or a rate of 0.09 percent, less than one-tenth of 1 percent; overall, legal abortion by any method was found to be 14 times less deadly than childbirth.)
Hawkins also argued that medication abortion “causes four times the complications as surgical abortion” and comes with a “risk of death that is ten times higher,” citing research from 2009 and 2006. Both studies are “outdated and rely on outdated medication abortion protocols,” Ushma Upadhyay, a professor with Advancing New Standards in Reproductive Health at the University of California San Francisco, told Vox. The 2009 study in particular, Upadhyay added, “is simply not credible or rigorous.”
Anti-abortion leaders also claim that easing up on requirements for in-person doctor visits endangers women at risk of ectopic pregnancies, and threatens the fertility of women with Rh-negative blood type. (Approximately 1 to 2 percent of all pregnancies in the US are ectopic, and 15 percent of the population has Rh-negative blood type.) In a new citizen petition Students for Life filed last month, the activists called on the FDA to return to its previous REMS standard, partly for these reasons.
“We have a long track record of working to restore the health and safety standards that the Biden Administration has stripped from Chemical Abortion Pills,” Kristi Hamrick, a spokesperson for Students for Life, told Vox in an email. “Chemical Abortion Pills lead to injury, infertility, and even death as well as exposing women to abusers who have used the drugs without women’s knowledge or consent.”
Liebel of Susan B. Anthony Pro-Life America told Vox they are encouraging state lawmakers to pass “additional health and safety standards” around the distribution of medication abortion pills, citing the loosening of the REMS rules. In addition to requiring in-person screenings, Liebel said they’re pushing for more emergency room reporting requirements, to ensure that any complications from the drugs are not miscoded as miscarriages.
“We think there’s a real public health threat there,” she said. “A lot of state laws on abortion-inducing drugs are pretty old, pretty stale, so [lawmakers] are playing a little bit of catch-up.”
Health experts say the medical concerns raised by anti-abortion activists are not backed by evidence. Unknowingly treating a patient who has an ectopic pregnancy with mifepristone and misoprostol will not harm the patient, said Upadhyay, and “there is absolutely no evidence” that Rh in the context of abortion protects against future fertility.” The American College of Obstetricians and Gynecologists maintains that medication to manage Rh-negative pregnancies should not be a barrier to the provision of medication abortion.
When it comes to safely ending pregnancies, medication abortion is over 95 percent successful, according to Guttmacher, with less than 0.4 percent of patients requiring hospitalization. The National Academies of Sciences, Engineering, and Medicine has also affirmed medication abortion as a safe method to terminate pregnancy, and concluded that there is no medical need for the drugs to be administered in the physical presence of a health care provider.
Earlier this week, Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, sent a response to Students for Life’s December petition, denying its request. She noted the anti-abortion activists had provided no “new data or evidence beyond what was provided” in a similar 2019 petition the FDA also denied.
Kirsten Moore, the director of the Expanding Medication Abortion Access project, says she’s not surprised anti-abortion activists are trying to scare the public about mifepristone, especially since most people are still not very familiar with medication abortion, let alone how reproductive systems work.
“I want policy that is grounded in evidence and data, but I don’t believe fighting it out at that level with antis, saying my fact is better than your fact, will really matter in the court of public opinion,” she told Vox. “What I know for sure is that when we just stick to the simple fact that this is an FDA-approved drug that has been in use for more than 20 years, with a complication rate of less than 0.5 percent and is a safe, non-invasive option for early abortion, people like that idea and feel comfortable with it.”
While Students for Life’s December FDA petition was recently rejected, another citizen petition the group filed in November is still pending — and this one makes a more novel demand.
As first reported by Politico, the group has asked the FDA to require any doctor who prescribes abortion pills to bag the fetal tissue as medical waste, rather than allow the remains to be flushed down the toilet. (There is no direct evidence that abortion pills contaminate water supply, and experts have dismissed the notion that flushing these drugs poses a legitimate environmental threat.) Students for Life is also working with Republican lawmakers to push bills, in state legislatures and in Congress, that would promote this new medical waste disposal requirement.
“They are shamelessly co-opting the environmental movement’s messaging for their own agenda,” said Ma, of the Center for Reproductive Rights, who raised concern about the chilling effect it may have on providers.
Similarly, in November, Alliance Defending Freedom, the religious conservative group known for defending a baker’s right to refuse to make a wedding cake for an LGBTQ couple, filed a lawsuit before a Trump-appointed judge in Texas arguing that the FDA abused its authority when it approved mifepristone 22 years ago. The plaintiffs demand the FDA withdraw its approval for mifepristone entirely.
The judge overseeing the case, Matthew Kacsmaryk, “has shown an extraordinary willingness to interpret the law creatively to benefit right-wing causes,” as Vox has previously reported. Last month, Kacsmaryk handed down a decision claiming that Title X, a federal program that funds voluntary family planning services including birth control, “violates the constitutional right of parents to direct the upbringing of their children.”
Lorie Chaiten, with the ACLU’s Reproductive Freedom Project, told Vox that with such politicized courts, the public can’t count on the case to disappear. “The lawsuit is completely and utterly baseless, and has so many procedural defects and in a normal world it goes away quickly,” she said. “But unfortunately, we may not be in a normal world.”
Activists’ goal has never been to just allow abortions to continue in Democratic-controlled areas. Rather, anti-abortion leaders are organizing to make abortion illegal and inaccessible nationwide.
To do that will require winning back the White House in 2024, especially as the Biden administration has shown willingness to use executive power to defend reproductive freedom, via agencies like the FDA, the Justice Department, the Postal Service, and Health and Human Services.
One unsettled question looming for anti-abortion activists is whether states have the legal authority to pass rules that exceed what the FDA requires, or even outright ban drugs that the FDA has approved.
Through the passage of the Federal Food, Drug, and Cosmetic Act in 1938, Congress empowered the FDA as the sole agency to approve drugs in the US. It’s responsible for reviewing a drug’s safety, weighing its risks and benefits, and regulating appropriate conditions for safe and effective use. The question is whether federal regulation of drugs would take precedence, or preempt, any state restrictions.
For now, legal scholars say it’s unclear how these questions will play out in court. Courts often grant deference to the FDA, though there are relatively few examples involving drugs. The main precedent is a 2014 case where a federal judge struck down a Massachusetts effort to restrict the opioid Zohydro, since the FDA had approved the painkiller.
As lawyers wrestle with these questions, anti-abortion advocates recognize they can bypass some of the confusion simply by gaining control over the federal government. As a result, they’re pressing Republican lawmakers who express presidential ambitions with questions about how they’d intend to crack down on medication abortion. An anti-abortion president could do things like pressure the FDA and other federal agencies to restrict access to abortion, or simply refuse to engage state preemption challenges.