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On Tuesday, the U.S. Supreme Court will hear arguments in a case that has the potential to upend access to mifepristone, a common abortion-inducing drug. This is the first major abortion case the high court has heard since the overturn of Roe v. Wade in 2022.
The case was first filed in Amarillo, where conservative federal Judge Matthew Kacsmaryk sided nearly a year ago with anti-abortion groups seeking to move mifepristone off the market. Subsequently, the Supreme Court froze any changes to the drug’s legal status until it had a chance to hear the case.
The Alliance for Hippocratic Medicine, an organization of anti-abortion doctors, filed the initial lawsuit in November 2022, saying the U.S. Food and Drug Administration did not properly vet the safety of mifepristone before approving it in 2000 or loosening restrictions in 2016 and 2022.
In their filings, the FDA and Danco Laboratories, which produces mifepristone, point to decades of overwhelming evidence that shows the safety and efficacy of mifepristone. They also argue that the Alliance for Hippocratic Medicine has no legal standing to bring this suit, as its members have not been impacted by the drug’s approval.
The next frontier
When the U.S. Supreme Court overturned Roe v. Wade in June 2022, Justice Samuel Alito indicated his hope that allowing states to set their own abortion laws might remove the need for the high court to weigh in on the issue time and time again.
“Far from bringing about a national settlement of the abortion issue, Roe and Casey have enflamed debate and deepened division,” Alito wrote, referring to two landmark abortion rulings from 1973 and 1992, respectively. “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”
But less than two years later, the abortion issue is once again before the nine justices. While the question in this case is less fundamental than in the 2022 case that overturned Roe, the ruling would have widespread repercussions for abortion access nationwide.
Medication abortion, in which a combination of mifepristone and misoprostol are taken to terminate a pregnancy up to 10 weeks, is the most common abortion method in the United States. It is lower risk than a surgical procedure, and while patients can take just misoprostol alone, the two-drug regimen has been shown to be more effective and lower risk.
With abortion banned or significantly restricted in more than a dozen states, access to mifepristone has become the new focal point for both sides of the abortion fight. While it is illegal to mail abortion-inducing medication in Texas, international providers and out-of-state groups are still finding ways to get the pills to the people.
Timeline of the case
This is exactly what anti-abortion groups have been fighting against, almost since mifepristone was approved back in 2000. Initially, some of these groups filed a citizen petition challenging the approval in 2002. The FDA did not respond until 2016, rejecting the petition on the same day it announced new guidelines allowing the medication to be used through 10 weeks of pregnancy, instead of the original seven.
In 2019, the FDA approved a generic version of mifepristone, and then in January, after easing some requirements during the pandemic, the agency permanently lifted the in-person dispensing requirement, allowing the medication to be prescribed through telehealth appointments, dispensed at retail pharmacies and sent through the mail.
The anti-abortion groups argue that all of this was improper, starting with the 2000 approval. Last April, Kacsmaryk agreed, issuing an opinion laced with anti-abortion rhetoric, calling abortion providers “abortionists” and describing the medical procedure as “starv[ing] the unborn human until death.”
“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”
Kacsmaryk’s ruling would have revoked mifepristone’s approval and taken it off the market in the United States. But before it could go into effect, the 5th U.S. Circuit Court of Appeals intervened, allowing mifepristone to stay on the market but undoing some of the newer regulations allowing for the provision of generic mifepristone and telemedicine prescribing. That’s when the Supreme Court stepped in and said nothing would change about mifepristone’s regulations until the case was resolved.
This case has raised concerns across the pharmaceutical industry, far beyond the question of abortion access.
“This is the first time a judge has unilaterally, against the FDA’s objections, removed a drug from the market,” Greer Donley, a University of Pittsburgh law professor who studies FDA law, told The Texas Tribune in April. “A judge who has … no scientific expertise, overruling the agency that has a ton of scientific expertise.”
In his ruling, Kacsmaryk also raised the specter of a 150-year-old zombie law, the Comstock Act, which prohibits using the U.S. postal service to mail anything related to abortion. The law remains on the books, but has not been enforced for decades. Anti-abortion groups would like to see the Comstock Act used to regulate the mailing of abortion medication, but legal experts warn it could have much wider implications, potentially halting the mailing of anything medical.
The 5th Circuit upheld Kacsmaryk’s interpretation of the Comstock Act, leaving that as yet another area of unsettled law for the Supreme Court to weigh in on.
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