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Legal Experts on What's Next for Mifepristone

— Case returns to Fifth Circuit Court, then what?

MedpageToday
A close up photo of the US Supreme Court building in Washington, DC.

Legal experts clashed on the significance of last week's Supreme Court decision to allow the continued sale of mifepristone (Mifeprex) while the case plays out in lower courts, and also disagreed on what the decision says about the high court's views on the widely used abortion medication.

"Overall, the Supreme Court remains highly conservative and highly aggressive in pushing a conservative agenda. I don't see that changing," wrote Lawrence O. Gostin, JD, director of the O'Neill Institute for National and Global Health Law at Georgetown University in Washington, D.C., in an email to app.

"But by staying an injunction against mifepristone, the majority of the court still won't undermine the authority of the FDA to make scientific determinations about a drug's safety and efficacy," he added.

In contrast, Erik Baptist, JD, senior counsel at Alliance Defending Freedom (ADF) -- the group representing the plaintiffs in the case -- characterized the high court's ruling as nothing more than "standard operating procedure ... as it gives the court sufficient time to consider the parties' arguments before ruling."

On Friday, the court granted an "emergency stay" , allowing the appeals process to be heard. Justice Samuel Alito, who authored the Dobbs opinion overturning Roe v. Wade last June, and Justice Clarence Thomas, voted to let lower-court restrictions take effect.

The case has now been fast-tracked at the Fifth Circuit Court of Appeals, where it is slated to be heard on May 17.

In a , Jennifer Dalven, JD, director of the ACLU Reproductive Freedom Project, argued that abortion rights activists "aren't out of the woods by any means."

"This case, which should have been laughed out of court from the very start, will continue on. And as this baseless lawsuit shows, extremists will use every trick in the book to try to ban abortion nationwide," she said. "Their efforts to prevent us from making our own decisions about whether to have a child are deeply unpopular, and we'll keep doing everything in our power to work toward a world where everyone can actually make these decisions for themselves."

Medication abortions account for more than half of all abortions nationwide. Part of a two-drug combination with misoprostol, mifepristone is the most commonly used medication for abortion. While misoprostol alone is safe and effective, it is not as effective as the two-drug regimen. The drugs are also commonly used in managing miscarriages.

According to studies and postmarketing data, the two-drug protocol successfully terminates pregnancies of the time, with major complications occurring in of cases and deaths in fewer than of cases.

Had the Supreme Court not extended the stay, the Fifth Circuit Court's order would have gone into effect, banning the distribution of mifepristone through the mail, rolling back the gestational limits for providing mifepristone from 10 weeks to 7 weeks, reinstating rules around required physician visits, and suspending the approval of generic mifepristone, which accounts for two-thirds of the available supply of the drug.

In addition to not undercutting the FDA's authority, the high court justices also likely took into account the plaintiffs' "weak position" in the case, Gostin said. "They are anti-abortion activists that really aren't harmed by the use of mifepristone and don't have standing, according to well-established Supreme Court precedents."

The Fifth Circuit Court's order said that the plaintiffs in the case -- the Alliance for Hippocratic Medicine and other anti-abortion physicians -- could challenge the FDA's 2016 risk evaluation and mitigation strategy (REMS) program and subsequent agency actions, including the 2019 approval of GenBioPro's generic mifepristone, and a 2021 REMS update that made the drug permanently available by mail.

In Gostin's view, the appeals court is likely to issue a similar ruling, keeping mifepristone on the market, but deciding against the FDA's "post-2016 decisions" that expanded access to mifepristone.

Baptist, for his part, argued that "the facts of the case clearly show that the FDA repeatedly violated the law to approve these drugs and remove important safeguards, despite the substantial evidence of the harms women and girls who undergo this dangerous drug regimen could suffer."

While Baptist did not say whether he thought the Fifth Circuit court's decision might change after a full review, he said the ADF is looking forward to "presenting these facts to the Fifth Circuit."

According to James Bopp Jr., JD, general counsel for the National Right to Life Committee, because the Supreme Court said that its stay would be "resolved on appeal," any decision by the Fifth Circuit Court would not immediately take effect.

"The general view on these matters is that the status quo should be maintained until the appeal is over ... What the stay does is maintains the status quo," Bopp said. In other words, access to mifepristone would remain unchanged until after the case is heard in the Fifth Circuit Court and returns to the Supreme Court, at which point the justices would either render a decision or refuse to take the case.

Gostin noted that it's "all but certain" the case will return to the Supreme Court in the fall, where it will be decided quickly, given the "convenient off-ramp" that the plaintiffs' lack of standing creates.

"I think they will take that off-ramp and never decide fully on the merits of the case ... my guess is the court will split 7-2, but ultimately rule in favor of science and the FDA," he said.

Bopp, on the other hand, does not view last week's vote as predictive of any future decisions. The court had only 2 days to consider the merits of the case, which typically takes months, he said.

The opposition filed its brief last Wednesday and judges will usually read both briefs together, so as not to give the views of one or the other a "head start," he explained. "We don't have an opinion by eight of the nine justices ... there's really not too much you can read into this."

Baptist agreed, noting that "as other scholars have observed, the decision may have been 5-4 because not all of the justices identified how they voted."

"I thought the reasoning of the court was very strong when it held that the Biden administration's removal of physicians' supervision was not justified by any evidence or studies," Bopp said. "I would be optimistic that the Supreme Court would agree that the abortion drug should be removed from the market because the FDA improperly and illegally approved it."

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    Shannon Firth has been reporting on health policy as app's Washington correspondent since 2014. She is also a member of the site's Enterprise & Investigative Reporting team.