Since the Supreme Court’s Dobbs decision, abortion pills have been a powerful tool for people to safely end a pregnancy on their own at home in the 14 states that have banned abortion. Abortion opponents and supporters are deeply invested in either cutting off or expanding access to the pills, and that tension has triggered a wave of legal challenges that could determine the future of medication abortion in the U.S.
“Back in the pre-Roe era, abortion was all done via procedure, which meant that if you could control the gatekeepers — the providers — then you could stop abortion in your state or stop a lot of it,” says Greer Donley, an associate professor at the University of Pittsburgh School of Law. “But now pills travel across borders all the time. It makes abortion really hard to control.”
Three cases stand before the courts so far. An anti-abortion lawsuit in Texas could have the devastating effect of banning medication abortion nationwide as soon as the case is fully briefed on February 10. The other two suits, filed in North Carolina and West Virginia in late January, could have the opposite effect by dramatically expanding access even in states where abortion is currently illegal.
Medication abortion accounted for 54 percent of abortions in the U.S. even before the end of Roe, and the chaotic legal landscape left in its wake has caused widespread confusion. About half of adults in the U.S. — including 41 percent of women of reproductive age — are unsure whether medication abortion is legal in their state, according to a new survey by the Kaiser Family Foundation. “Both sides understand the power of abortion pills,” Donley says, so these legal fights are likely only the beginning.
The case that could ban abortion pills nationwide.
In late November, the conservative Christian legal group Alliance Defending Freedom sued the FDA and the Department of Health and Human Services in federal court in Texas on behalf of a collective of anti-abortion activists. The suit seeks to reverse the FDA’s approval of mifepristone, the pill that helps end pregnancy by blocking the hormone progesterone. Misoprostol, the second step in the medication-abortion regime, causes contractions that help expel the uterus’ contents. The drug is approved for stomach ulcers but used off-label for a wide-range of gynecological purposes including inducing labor and miscarriage management.
The FDA approved mifepristone for abortion care in 2000, and the statute of limitations to sue the agency over approval of a new medication is six years — making the lawsuit 16 years too late. While the argument underpinning the lawsuit is that the FDA exceeded its regulatory authority and had to “disavow science” in the approval process, the opposite is true. A 2008 report by the Government Accountability Office found that the FDA properly used its authority in approving and having oversight over mifepristone. If anything, there’s even more research now that supports medication abortion’s safety, says Nicole Huberfeld, a public-health law expert and professor at Boston University.
“We could point to the opioid crisis and say that there might be reasons to reconsider how certain opioids have been approved over time because the evidence is that they are harmful in certain ways,” she says. “On the other hand, with mifepristone, the gathered evidence over time has been that it is even safer than initially understood and more effective for the purpose for which it is approved, i.e., it can be used for a longer period of time and still result in a safe abortion.”
Medication abortion is between 95 percent and 99 percent effective as well as extremely safe with less than 0.4 percent of patients experiencing serious complications that require hospitalization. In other words, taking Tylenol or Viagra is riskier than using abortion pills. “The way that it is being framed by the Alliance Defending Freedom, the Alliance for Hippocratic Medicine, and the other groups is that this is not a safe drug, but that is just untrue,” Huberfeld says of the plaintiffs’ argument. “Their position is that no abortion is morally safe or good because they are coming at this from a religious perspective. But that is different from the FDA’s task, which is to decide whether a drug is, based on scientific evidence, safe and efficacious for the purpose for which it is created.”
The lawsuit also argues that mailing abortion pills is illegal under a federal criminal statute that was originally part of the anti-obscenity Comstock Act, which dates back to 1873 — and which banned contraception well before women even won the right to vote. (The Department of Justice disagrees with the plaintiffs’ interpretation.) “It’s batshit crazy. Literally, if it had been presented in virtually any other courtroom, it would have been thrown out,” says Kirsten Moore, director of the EMAA Project, which seeks to expand access to medication abortion.
But the case is being heard by Judge Matthew Kacsmaryk, a Trump appointee with a track record of opposing LGBTQ+ rights, birth control, and abortion. While it would be unprecedented, legal experts believe it’s within the realm of possibility that Kacsmaryk will side with the plaintiffs. “It’s really hard to wrap my head around the fact that this one judge in Texas might actually suspend access to an FDA-approved drug that has been around for 20-plus years,” Moore says.
If Kacsmaryk issues an injunction requiring that the federal government pull mifepristone from the market immediately, that will impact patients across the country regardless of whether abortion remains legal in their state. While misoprostol on its own also safely terminates a pregnancy, it has generally been considered a less effective method than the two-step regime.
The odds of such a decision being reversed are not ideal. An appeal would go to the Fifth U.S. Circuit Court of Appeals, one of the most conservative courts in the nation, and could ultimately land before the conservative supermajority in the Supreme Court. “This case is serious for a lot of reasons,” Donley says. “It really proves the truth that, with Roe gone, no one’s safe.”
The cases that could chip away at abortion bans.
Although filed separately, the lawsuits in West Virginia and North Carolina have the same core argument: The states’ restrictions on abortion are in direct conflict with the set of rules the FDA carefully crafted for medication abortion. Therefore, the suits argue, federal approval of medication abortion supersedes the states’ laws, and the use of abortion pills should be allowed. These preemptive lawsuits are the antithesis of the anti-abortion challenge in Texas.
“If the cases were to be successful and replicated in other states as well, then it could be the key to restoring access to at least early abortion,” Donley says, ”which would have pretty huge implications because most abortions in this country are done in the first ten weeks.”
GenBioPro, one of two American manufacturers of mifepristone, brought the lawsuit in West Virginia to restore access to the drug nationwide. The plaintiff argues that, beyond federal law preempting the state’s abortion ban, such restrictions limit the company’s ability to do business there.
Abortion remains legal but is heavily restricted in North Carolina, a state that has become a critical point of access for patients all over the South. Dr. Amy Bryant, an abortion provider at the University of North Carolina, has sued the state, arguing that its restrictions on medication abortion go way beyond the FDA’s regulations — including that pills “may be provided only in person, only by a physician, and only in a specially certified facility after state-mandated counseling, a 72-hour waiting period, and (in certain circumstances) an ultrasound.” There is some precedent for courts deciding that federal law prevents states from further regulating specific drugs. In 2014, the drug company Zogenix sued Massachusetts over its ban on the opioid drug Zohydro ER because of concerns that the drug could lead to addiction or overdose. A federal court ruled that the FDA “endorsed Zohydro ER’s safety and effectiveness when it approved the drug,” which meant that while Massachusetts could issue regulations, they had to be in line with federal law.
The fact that the FDA has included mifepristone in its Risk Evaluation and Mitigation System, or REMS, strengthens the preemptive lawsuits. The safety program is “for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.” Although leading health organizations have argued mifespristone’s inclusion is medically unnecessary because of its safety record, Donley and her colleagues David S. Cohen and Rachel Rebouché say the inclusion could be beneficial in court. “State laws that overregulate medication abortion rest on scientific conclusions that are directly at odds with those that Congress required the FDA to make when issuing a REMS,” they write in a new research article.
It’s unclear whether the courts will agree. While Texas abortion opponents found a sympathetic judge to hear their case, the preemptive lawsuits could face an uphill battle. Legal experts have theorized that a conservative court could say West Virginia is banning an action — abortion itself — and therefore is not targeting mifepristone, the drug. Whether Kacsmaryk issues a nationwide injunction will also affect the other cases. In that scenario, both lawsuits would be put on hold pending a final appeal in the Texas case, further dragging out the legal battle over abortion pills. “What we are witnessing is the natural or inevitable chaos, confusion, and conflict that has arisen in the wake of the Supreme Court reversing a major constitutional right,” Huberfeld says.