Supreme Court to decide whether to restrict abortion drug nationwide

By Devan Cole and Ariane de Vogue, CNN

(CNN) — The Supreme Court said Wednesday it will consider whether to restrict access to a widely used abortion drug — even in states where the procedure is still allowed.

The case concerns the drug mifepristone that — when coupled with another drug — is one of the most common abortion methods in the United States.

The decision means the conservative-leaning court will again wade into the abortion debate after overturning Roe v. Wade last year, altering the landscape of abortion rights nationwide and triggering more than half the states to outlaw or severely restrict the procedure.

The new case could be decided by July, inserting the Supreme Court into the middle of the presidential election, where abortion access is once again a key issue.

For now, mifepristone remains available and not subject to restrictions the lower courts have said should be imposed on its use. The high court determined in April that access to the drug would remain unchanged until the appeals process finishes.

The Biden administration and a manufacturer of the drug are asking the justices to reverse a federal appeals court decision that, if allowed to go into effect, would restrict access to the drug. At the same time, groups and doctors that oppose abortion want the justices to go even further than a conservative federal appeals court did and hold that the initial 2000 approval of the drug was also unlawful.

The White House said that the government will continue to support the US Food and Drug Administration’s “safe and effective” approval and regulation of the drug.

“As the Department of Justice continues defending the FDA’s actions before the Supreme Court, President Biden and Vice President Harris remain firmly committed to defending women’s ability to access reproductive care,” White House press secretary Karine Jean Pierre said in a statement.

Erin Hawley, an attorney with the conservative Alliance Defending Freedom, which is representing the abortion pill challengers, urged the justices to agree with the lower-court decisions restricting access to the drug when they eventually decide the case.

“Every court so far has agreed that the FDA acted unlawfully in removing common-sense safeguards for women and authorizing dangerous mail-order abortions. We urge the Supreme Court to do the same,” Hawley said.

Behind the challenge

Central to the dispute is the scope of the US Food and Drug Administration’s authority to regulate mifepristone, a drug that the medical community has deemed safe and effective. It has been used by millions of women across the country in the more than two decades it’s been on the market.

The drug was initially approved by the FDA in 2000, but in 2016, 2019 and 2021, the FDA put in place modifications that would make the drug more easily accessible. Those modifications were related to issues such as dosing and in person dispensing requirements. The changes also allowed the drug to be taken later in pregnancy.

Challengers – including doctors and groups who oppose abortion – argue that the FDA did not do enough to study the safety implications of the drug when it approved its use and made it more easily accessible in subsequent years.

The legal volleying jumpstarted this spring, when US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, issued a ruling that would have a halted the FDA’s 2000 approval of the drug.

The judge said that the FDA failed to consider “the intense psychological trauma and post-traumatic stress women often experience from chemical abortion.” The term “chemical abortion,” which is preferred by abortion opponents, was repeatedly invoked by the judge in his ruling, as was “abortionist” and “unborn human.”

Kacsmaryk also suggested that the FDA’s data was downplaying the frequency with which the drug was being mistakenly administered to someone who had an ectopic pregnancy, i.e. a pregnancy outside the cavity of the uterus. He repeated the challengers’ accusations that the FDA’s approval process had been the subject of improper political pressure.

At the 5th US Circuit Court of Appeals, the conservative court backtracked somewhat, saying that while it was too late for the challengers to mount a case against the initial 2000 approval of the drug and left in place the 2019 approval of a generic version of the drug, it would block changes made in 2016 and 2021 that made the drug more easily accessible.

“Because the drug could not safely be approved without restrictions, the agency conditioned its approval on numerous safeguards,” Erin Hawley, of the conservative Alliance Defending Freedom, told the justices in court papers. “Yet in 2016, FDA stripped away many of the safeguards, failing to explain why it was proper to eliminate them without a study showing their cumulative safety.”

Though the justices on Wednesday agreed to consider an appeals court decision that restricted access to the drug, they declined a separate appeal by the abortion foes to consider if the FDA’s 2000 approval of the drug was unlawful.

“The denial of the cross-petition may seem technical, but it’s a strong sign that the Court is focused only on what the Biden administration and Danco laboratories are challenging – the lower courts’ conclusion that the plaintiffs could bring this case in the first place,” said Steve Vladeck, CNN Supreme Court analyst and professor at the University of Texas School of Law.

“That makes it far less likely that the court will reach the merits of whether the FDA has acted lawfully in first approving and then expanding access to mifepristone, and far more likely that the case will be resolved on procedural grounds that won’t have any direct effect on access to mifepristone going forward,” he added.

In September, Solicitor General Elizabeth Prelogar appealed the decision to the Supreme Court, arguing in legal briefs that “more than half of American women who choose to terminate their pregnancies rely on mifepristone to do so” and that “study after study has shown that when mifepristone is taken in accordance with its approved conditions of use, serious adverse events are exceedingly rare.”

Prelogar said that if the lower court decision is allowed to take effect it would “up-end the regulatory regime for mifepristone, with damaging consequences for women seeking lawful abortions and a healthcare system that relies on the availability of the drug under the current conditions of use.”

She said the “unprecedented decision” would also “threaten to severely disrupt the pharmaceutical industry and prevent FDA from fulfilling its statutory responsibilities according to its scientific judgment.

Jessica L. Ellsworth, a lawyer for Danco Laboratories, a manufacturer of the drug and an intervenor in the case, told the justices in court papers that “for the women and teenage girls, health care providers and States that depend on FDA’s actions to ensure safe and effective reproductive health care is available, this case matters tremendously.”

She said the court should take up the dispute because it “affects the availability of a drug with lawful uses in States across the country” and “raises questions about whether a single federal court can limit abortion access in the States that protect it.”

The 5th Circuit decision “destabilizes” the pharmaceutical and biotechnology industries “by questioning when scientific studies – accepted by FDA – are sufficient to support conditions of use,” Ellsworth added.

This story has been updated with additional details.

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