A Texas judge could soon upend what remains of abortion access across the US if he agrees to a request by far-right groups to reverse federal approval of a key drug used in medication abortion, which accounts for more than half of pregnancy terminations nationwide.
Reproductive rights advocates say the ruling could have a “devastating” impact on the already fragile abortion care landscape, severely eroded last June by the US supreme court’s decision to overturn Roe v Wade.
In November, anti-abortion activists, represented by Alliance Defending Freedom, a Christian conservative legal advocacy organization, filed suit in the northern district of Texas asking Trump-appointed Judge Matthew Kacsmaryk to require the US Food and Drug Administration to reverse its longstanding approval of mifepristone, the first in a two-step abortion pill regimen. If the group – which played a key role in Dobbs v Jackson Women’s Health, the supreme court case that ushered in Roe’s demise – is granted a nationwide injunction, as requested, the decision could apply to states where abortion remains legal.
On Thursday evening, Kacsmaryk filed an order allowing Danco Laboratories, the drug manufacturer, to file briefs defending its FDA approval. Plaintiffs have until 24 February to respond; a decision in the case could come at any time after that.
“This ruling could be devastating for abortion care,” said Andrea Miller, president of the National Institute for Reproductive Health. “Cutting off critical access to abortion medication – which is the preferred method for more than half of abortion patients in the country – would cause significant harm, especially at a time when Dobbs has made it difficult or impossible for many to get care at clinics.”
The FDA first approved the use of mifepristone, which is taken alongside the drug misoprostol during the first 10 weeks of pregnancy, for abortion care in 2000. More than 3.7 million women have used the drug since it became available in the US. Mifepristone works by blocking the pregnancy hormone progesterone, which prevents a pregnancy from growing. Taken up to two days later, misoprostol induces cramping and bleeding to empty the uterus.
The agency broadened access to abortion pills in 2021 by allowing patients to receive them by mail through telehealth rather than requiring in-person hospital or clinic visits, a rule change prompted by the Covid pandemic. The FDA widened access further when it announced in January it would allow certified retail pharmacies to dispense mifepristone, known under the brand name Mifeprex. The use of abortion medication has steadily risen over time and now comprise at least 53% of abortions in the US, making it the most common choice for pregnancy termination.
The lawsuit, filed by four physicians and anti-abortion organizations including the Alliance for Hippocratic Medicine and the American Association of Pro-Life Obstetricians and Gynecologists, claims that the FDA “exceeded its regulatory authority” by fast-tracking approval of the drug two decades ago. The groups allege that the agency erred in its legal obligations to “protect the health, safety, and welfare” of pregnant women by eliminating necessary safeguards and “ignoring” evidence of harm.
“The FDA is entrusted to protect the public from dangerous drugs but it has failed women and girls by approving these abortion pills without the basic levels of protection when evaluating for safety and effectiveness,” said Erik Baptist, Alliance Defending Freedom senior legal counsel.
In response to the suit, the FDA called the legal request to remove a pharmaceutical drug from the market “extraordinary and unprecedented” saying that withdrawing access to mifepristone would “cause significant harm” by depriving patients of a safe and effective drug that has been in use for more than 20 years.
“Plaintiffs have pointed to no case, and the government has been unable to locate any example, where a court has second-guessed FDA’s safety and efficacy determination and ordered a widely available FDA-approved drug to be removed from the market – much less an example that includes a two-decade delay,” wrote attorneys for the US justice department in a 13 January filing.
Greer Donley, associate professor at the University of Pittsburgh Law School and expert in FDA law, says the suit’s legal argument is rife with “falsehoods and mischaracterizations” of the regulatory agency’s decision-making. Donley says the FDA “rigorously” reviewed mifepristone before approving it, requesting additional clinical trials and restrictions in distribution. She points to a 55-page audit from the Government Accountability Office which found that FDA’s approval of mifepristone was consistent with its approval and oversight for other drugs.
“This drug was certainly not approved in a rush or haphazardly,” says Donley. “In fact, many argue the FDA has actually been largely overprotective and restrictive when it comes to mifepristone, so it’s a bit ironic that these onerous regulations around the drug are being used as evidence of leniency.”
As one of the most studied drugs in the world, abortion medication – in use for more than two decades in the US – is found to be safe and effective, and backed by major medical organizations including the the American Medical Association and the American College of Obstetricians and Gynecologists. It holds a safer track record than penicillin, Viagra and even Tylenol. Legal abortions have been found to be 14 times safer than childbirth.
Removing medication abortion as an option holds “terrifying potential consequences” for abortion patients across the US, says Elizabeth Nash, principal policy associate with reproductive health research group the Guttmacher Institute. The non-invasive method allows patients to terminate a pregnancy in their own homes, especially helpful if travel to clinics is out of reach. Some providers have signaled that if mifepristone is banned, they will offer misoprostol-only abortions, a safe alternative method, but one that can carry more side-effects and a slightly higher failure rate – misoprostol alone was found in a new study to be 88% effective, while the pill combination has been shown to have a success rate of 98%.
Without access to pills, patients would probably need to undergo procedural – also known as “surgical” – abortion. These procedures must be performed in-clinic and necessitate more travel, resources, time, staff and space – increasingly difficult as overburdened clinics face an influx of displaced patients. Even if the impending ruling takes a more narrow approach than pulling the drug off the market completely – for example, by blocking medication by mail, or by reinstating the in-person dispensing requirement – it would still significantly hinder access.
The suspension of an FDA-approved drug by the judiciary set not only a “troubling precedent” for other reproductive health care but have “serious and broad implications” for all pharmaceutical drugs approved by the federal agency which would see its authority severely weakened, says Donley.
Reproductive health advocates and many legal observers worry that a suit that would be “laughed out of court” in other circumstances could find a champion in Judge Matthew Kacsmaryk, a former religious liberties lawyer who has a history of attacking abortion rights and birth control. Appointed to the bench by former president Donald Trump in 2019, Kacsmaryk most recently ruled against a federal program that allows Texas teenagers to access birth control without their parents’ permission.
“It is clear that this is a very intentional and strategic decision by the plaintiffs to forum-shop for a judge that holds similar radical views,” says Donley.
If Kacsmaryk rules for the plaintiffs and the Biden administration chooses to appeal, it will contend with the fifth circuit court of appeals, one of the most conservative appellate courts in the US. From there, the case could reach the US supreme court.
The FDA lawsuit is part of a multi-front war waged by anti-abortion activists against medication abortion. While the federal agency has loosened some restrictions on mifepristone, abortion is still banned in 13 states across the US with 18 states carrying laws that limit the use of abortion drugs. As they reconvene this year, conservative statehouses across the country are ramping up proposals to further restrict abortion medication by banning the mailing of pills and making it illegal to distribute, manufacture, or prescribe, the medication, says Nash. Extreme measures introduced in Oklahoma and Arkansas would allow those who self-manage their abortions with pills to be prosecuted. Meanwhile, two lawsuits out of North Carolina and West Virginia seek to challenge those states’ restrictions on the pills, arguing that the FDA’s regulations on abortion medication should override state law.
“Opponents of reproductive freedom set their sights on shutting down abortion clinics and found success after the fall of Roe v Wade,” says Miller. “Now, they are turning their attention very intensely – and very aggressively – to medication abortion as their next battleground because they know it still provides a remaining pathway to access.”
