Supreme Court blocks lower court decision in case on FDA approval of abortion pill

The U.S. Supreme Court on Friday blocked lower court decisions banning or limiting the FDA-approved use of the abortion pill mifepristone for the foreseeable future.

But the justices, for now, left the case in the hands of the 5th U.S. Circuit Court of Appeals, which has scheduled oral arguments in the case for May 17. However the 5th Circuit rules, the case will almost certainly end up back at the Supreme Court, with the potential for a decision in the case next term.

The court's action means that for now at least, the drug will be widely available, at least in those states where abortion is legal for up to 10 weeks into a pregnancy.

The court's action came on a vote of 7 to 2.

Dissenting were Justices Clarence Thomas and Samuel Alito.

In his dissent, Alito argued, "As narrowed by the Court of Appeals, the stay that would apply if we failed to broaden it would not remove mifepristone from the market. It would simply restore the circumstances that existed (and that the Government defended) from 2000 to 2016 under three Presidential administrations."

President Biden on Friday said that his administration will continue to defend the Food and Drug Administration's approval of mifepristone, and he called on Americans to elect lawmakers to pass a law restoring abortion rights.

"I continue to stand by FDA's evidence-based approval of mifepristone, and my Administration will continue to defend FDA's independent, expert authority to review, approve, and regulate a wide range of prescription drugs," Biden said in a statement.

"The stakes could not be higher for women across America. I will continue to fight politically-driven attacks on women's health. 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," Biden stated.

The latest legal clash over abortion began April 7 in Texas when U.S. District Judge Matthew Kacsmaryk, a onetime anti-abortion activist, imposed a nationwide ban on mifepristone, declaring that the FDA had improperly approved the drug 23 years ago. Within minutes of that decision, U.S. District Judge Thomas O. Rice in Washington state issued a contrary ruling. In a case brought by 17 states and the District of Columbia seeking to expand the use of mifepristone, Rice declared that the current FDA rules must remain in place.

On April 12, the case became even more procedurally convoluted when the 5th U.S. Circuit Court of Appeals partially pulled back on the Texas ruling from Kacsmaryk. Because the statute of limitations for challenging FDA approval of a drug had long passed, the appeals court ruled that mifepristone could continue to be used up to seven weeks into pregnancy in states where abortion is legal — this despite the fact that the FDA has approved use of the pill for up to 10 weeks into pregnancy.

In addition, the appeals court sought to roll back rules adopted since 2015 that have facilitated access to abortion pills — among them, rules that allow patients seeking an abortion to obtain the pills by mail and rules allowing telemedicine appointments with doctors. Instead, the appeals court sought to reimpose rules not in effect since 2016, such as a rule requiring three in-person appointments for anyone using the drug and a ban on the cheaper generic version of the drug.

There is little likelihood that the appeals court will substantially change its view after oral arguments in the case. Its 42-page preliminary order is based, in part, on the Comstock Act, a law that for generations has not been enforced. Enacted in 1873, the statute sought to prevent the mailing of obscene or lewd materials and to bar the mailing of any substance, article or drug used for birth control or for the purpose of "unlawful abortion."

Regardless of how the appeals court rules, though, there is certain to be an appeal from the Biden administration, on behalf of the FDA, and Danco Laboratories, maker of the leading brand of mifepristone, Mifeprex. In briefs already filed, they note that medical abortions using pills account for the majority of abortions in the U.S. today. And they cite dozens of studies and clinical trials showing that the drug is exceedingly safe for use up to 10 weeks into pregnancy.

Both the FDA and Danco assert that were the 5th Circuit's decision to become law, it would create "regulatory chaos across the country." As Danco put it in its brief, the result would be "an untenable limbo," not only for Danco, which could not legally market and distribute its drug, but for the FDA, doctors, health care systems and women, some of whom use the drug when they miscarry. [Copyright 2023 NPR]