Supreme Court restricting mifepristone would be a "slippery slope" for future drugs

On Tuesday, the U.S. Supreme Court heard arguments in a case that could restrict access to mifepristone, one of two drugs used in medication abortions, nationwide.

The argument comes at a time where access to abortion across the country is under attack. Abortion is totally banned or partially banned in 21 states. At the same time, medication abortion accounts for 63% of abortions; an increase from 53% in 2020, in part due to changes that the Food and Drug Administration (FDA) made in 2016 and 2021 that removed some barriers to access mifepristone.

The FDA approved mifepristone, which has a well-established safety profile, for the medical termination of pregnancy over two decades ago. But a lawsuit filed by Alliance for Hippocratic Medicine in November 2022 has challenged the longstanding FDA approval, alleging it was based on incomplete data, and therefore, the FDA failed to protect patients.

In April 2023, a Trump-appointed judge named Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas ruled in agreement with the plaintiffs, an organization of anti-abortion activists backed by the Christian right-wing lobbying group Alliance Defending Freedom, kicking off nearly two years of litigation around access to the medication — leading to yesterday’s oral arguments.

In a medication abortion, a patient takes mifepristone, which blocks pregnancy hormones, followed by another drug called misoprostol, which causes uterine contractions. During the hearing, much of the discussion centered around questioning whether the group of anti-abortion doctors and organizations had a right to challenge the FDA’s approval of mifepristone in the first place and that there appears to be a mismatch between the claimed injury of the plaintiffs and what they are seeking in return.

As experts have told Salon previously, the initial lawsuit and Kacsmaryk’s ruling were based on “junk science.” In fact, in February the peer-reviewed science publisher Sage Journals retracted two studies that Kacsmaryk cited in the April 2023 ruling for misrepresenting data.

“Mifepristone is safe and effective,” Alexis McGill Johnson, president of the Planned Parenthood Action Fund, emphasized in a media briefing after Tuesday’s hearing. “Since its approval over two decades ago, mifepristone has been used by more than 5 million people in the U.S. to end pregnancies through abortion or to support miscarriage care.”

McGill Johnson said “we shouldn’t even be here,” noting that the Supreme Court must reject “this politically-motivated effort" to undermine the FDA’s science and research-based approval process. “The court must reject this effort to restrict access to safe and effective abortion care,” she said.

However, legal and reproductive rights experts worry that the airtime alone for this case is harmful. During arguments, concerns were raised about the so-called adverse effects of mifepristone being prescribed via telehealth and being sent by mail. However, a recent study published in Nature Medicine found that medication abortions are just as safe through telemedicine as they are when a patient goes in-person to a clinic. The researchers of the study looked at data from more than 6,000 patients who obtained abortion pills from virtual clinics in 20 states and Washington D.C. between April of 2021 and January of 2022. They found there were no serious adverse events 99.8 percent of the time, and that abortions did not require follow-up care 98 percent of the time.

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During the discussion, the justices also brought up the topic of emergency room visits after a medication abortion. As Salon previously reported, emergency room visits after having a medication abortion aren’t a reflection of mifepristone’s safety — a concern that’s been cited by the plaintiffs. For instance, medication abortion patients will sometimes go to the emergency department to make sure that the medication worked. That’s because a pregnancy test won’t be accurate for at least four to five weeks after a medication abortion.

A ruling in favor of the plaintiffs, Alliance for Hippocratic Medicine could result in eliminating access to mifepristone by telehealth and by mail and instead require in-person appointments. It would also shorten the timeframe that it could be used for in a pregnancy from 10 weeks to 7 weeks. It will also require the dosage of mifepristone in a medication abortion to increase, while decreasing misoprostol — essentially making medications and miscarriage management more miserable and less effective. As women’s health specialists and doctors have told Salon before, the effects of such restrictions will be "devastating,” and have far-reaching consequences beyond impacting reproductive health.

“SCOTUS’s decision to hear the case Alliance for Hippocratic Medicine vs. FDA has not blocked access to mifepristone during the court’s consideration of the case, but today’s arguments indicate that the justices are approaching a final ruling on this baseless case — one that could vastly impact access,” Elisa Wells, co-founder, Plan C Pills said in a media statement. “While we hope for a just ruling that would uphold the scientific authority of the Food and Drug Administration and the strong data supporting mifepristone’s safety, the current makeup of the court — and its failure in the Dobbs case to uphold abortion rights — does not bode well for a good outcome.”

At a press briefing after the hearing, Deirdre Schifeling, ACLU’s Chief Political and Advocacy Officer, emphasized a ruling that restricts the plaintiffs case would have a “slippery slope effect” on all kinds of drugs and medicine in the future from groups who have an ideological opposition to it.

“For instance, vaccines. So any group that opposes vaccines could take it upon themselves to sue the FDA and claim that those vaccines were not properly determined to be safe,” Schifeling said. “Or birth control, or gender-affirming care, you name it. Any kind of medication that some group of people have an ideological — not scientific, not medical, not legal — but ideological opposition to, could be subject to this kind of lawsuit.”

This is precisely why so many mainstream medical groups, like the American Cancer Society Cancer Action Network, American Diabetes Association, American Kidney Fund and many others have publicly opposed the lawsuit.

“It really opens the door to undermining science,” Schifeling said. “And undermining the FDA role in regulating what is safe for the American public.”

What happens next? In the next few days, the justices will likely cast tentative votes in private. Subsequently, draft opinions will be prepared and shared. It usually takes three months for the court to issue a decision. Experts believe we won’t hear about a ruling until late June of this year.