Supreme Court preserves abortion drug approval as legal case plays out

The US Supreme Court has preserved access to a widely used abortion drug while legal challenges against mifepristone’s government approval continue, marking the court’s first major decision on abortion rights in the year after a constitutional right to abortion care was revoked.

The decision from the nation’s high court on 21 April will maintain the US Food and Drug Administration’s approval of the drug, which is used in more than half of all abortions in the US, after a federal judge in Texas struck it down in a ruling that would have profound and potentially dangerous consequences for millions of Americans if allowed to go into effect.

Mifepristone will remain legal and accessible, with the FDA’s approval intact. The case now returns to the Fifth Circuit Court of Appeals in Louisiana, where both parties will have a chance to file briefs. The case will be argued before a three-judge panel on 17 May.

Conservative Justices Samuel Alito and Clarence Thomas dissented.

Abortion providers and abortion rights advocates feared that a ruling that preserves a decision from US District Judge Matthew Kacsmaryk in Texas would effectively allow a single judge, with a history of anti-abortion activism, to determine reproductive healthcare decisions for millions of Americans – not only in states where abortion already faces severe restrictions but also in states where access to care is legally protected.

A ruling that strip’s the FDA’s regulatory authority could also invite similar activist- and partisan-driven challenges to other drugs at the centre of right-wing attacks, including Covid-19 vaccines, birth control, HIV medication and hormones and other drugs used for gender-affirming healthcare.

“If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks,” President Joe Biden said in a statement earlier this month.

The Supreme Court’s decision on Friday, hours before its self-imposed midnight deadline, means that the FDA’s 23-year-old approval of the drug will remain in place while the high-profile challenge mounted by an anti-abortion activist group continues in the lower court.

Mifepristone was first approved for use by the US Food and Drug Administration in most cases up to 10 weeks of pregnancy in 2000. A vast majority of abortions occur within the first nine weeks of pregnancy. From 2019 through 2020, nearly 93 per cent of all abortions were performed before the 13th week, according to the US Centers for Disease Control and Prevention.

More than 5 million women have used mifepristone to end their pregnancies since the FDA’s approval in 2000.

Mifepristone is also used to treat miscarriages. Roughly 10 per cent of clinically recognized pregnancies end in miscarriages, according to the American College of Obstetricians and Gynecologists.

Major medical groups and research from hundreds of studies over the last two decades have confirmed the overwhelming safety and efficacy of the drug. Studies show it is as safe to use as common over-the-counter pain relievers like ibuprofen and acetaminophen, and the protocol for medication abortion is used in more than 60 other countries.

The American College of Obstetricians and Gynecologists and the American Medical Association also signed a brief in the case opposing the challenge from anti-abortion groups.

The decision arrives nearly one year after the Supreme Court’s conservative supermajority decision in Dobbs v Jackson Women’s Health Organization, which revoked a constitutional right to abortion care, and triggered a wave of state-level anti-abortion laws and restrictions.

In the months that followed, more than a dozen states effectively outlawed abortion care for most pregnancies, and more than a dozen others have imposed restrictions on abortion drugs.

“The Supreme Court’s decision is a huge relief, but we’re not out of the woods yet,” said Nancy Northup, president and CEO of the Center for Reproductive Rights.

“The lower court ruling out of Texas has zero basis in fact or law – and yet it has sowed chaos, confusion and panic for patients and providers across the country, including those in states with strong protections for abortion rights,” she added. “That crisis was not resolved today.”

Jennifer Dalven, director of the ACLU Reproductive Freedom Project, welcomed the Supreme Court’s decision, adding that “it is frightening to think that Americans came within hours of losing access to a medication that is used in most abortions in this country and has been used for decades by millions of people to safely end a pregnancy or treat a miscarriage.”

“Patients shouldn’t have to monitor Twitter to see whether they can get the care they need,” she added.

In November, the right-wing legal group Alliance Defending Freedom filed a lawsuit against the FDA in US District Court in Amarillo, Texas on behalf of a group of anti-abortion activists that incorporated as the Alliance for Hippocratic Medicine that same month with an address in Amarillo.

The legal challenge was widely derided as an attempt to “shop” for a judge who would deliver a sympathetic ruling, with an appeals process that would land in a similarly sympathetic appeals court in Louisiana.

The Alliance Defending Freedom also led the challenge at the Supreme Court that ultimately struck down Roe v Wade.

Erik Baptist, senior counsel for Alliance Defending Freedom, said in a statement after the Supreme Court’s decision that the FDA “must answer for the damage it has caused” to women’s health, a claim dismissed by major health organisations and 20 years of research.

President Biden said his administration “will continue to fight politically driven attacks on women’s health” and renewed his demand that Congress codify the protections for abortion care affirmed by Roe v Wade into law.

That is increasingly unlikely in a Republican-dominated House of Representatives, which has proposed several anti-abortion measures.

“But let’s be clear – the American people must continue to use their vote as their voice, and elect a Congress who will pass a law restoring the protections of Roe v Wade,” Mr Biden said.

Vice President Kamala Harris, who has led efforts at the White House on reproductive healthcare in aftermath of Roe, said in a statement that the administration will “continue to fight to protect a woman’s freedom to make decisions about her own body and access to reproductive health care, including medication abortion.”

“No one should stand between a woman and her doctor,” she added.