Biden lawyers ask Supreme Court to maintain access for abortion pill mifepristone

WASHINGTON − President Joe Biden's administration on Friday asked the Supreme Court to step into the monthslong legal battle over the abortion pill mifepristone, arguing that the justices should overturn an appeals court decision from last month that would impose significant restrictions on access to the drug.

A federal appeals court in Louisiana said on Aug. 16 that it would limit access to mifepristone, ruling that the Food and Drug Administration had overstepped its authority with a series of actions that made it far easier for Americans to obtain the drug, such as allowing prescriptions to be filled by mail. But the ruling from the U.S. Court of Appeals for the 5th Circuit was put on hold as both sides prepared to resolve the matter at the nation's highest court.

The administration's appeal on Friday was the latest step in what has turned into a lengthy legal drama over the drug, which has taken on added significance as conservative states banned abortion in response to the Supreme Court's decision last year to overturn Roe v. Wade. Medication abortion accounts for about half of all U.S. abortions.

"Study after study has shown that when mifepristone is taken in accordance with its approved conditions of use, serious adverse events are exceedingly rare," U.S. Solicitor General Elizabeth Prelogar told the Supreme Court in an appeal filed Friday.

The logic of the 5th Circuit's "unprecedented decision," she wrote, "would threaten to severely disrupt the pharmaceutical industry and prevent FDA from fulfilling its statutory responsibilities according to its scientific judgment."

The Supreme Court will likely take several months to decide whether to grant the case. In the meantime, mifepristone will remain available as it was before the court case began.

A patient prepares to take the first of two combination pills, mifepristone, for a medication abortion during a visit to a clinic in Kansas City, Kansas.
A patient prepares to take the first of two combination pills, mifepristone, for a medication abortion during a visit to a clinic in Kansas City, Kansas.

The 5th Circuit's decision dismissed a part of the lawsuit that challenged the FDA's underlying approval of the drug at all. It also allowed the FDA's approval in 2019 of a generic version of the drug to stand.

But the court blocked a move by the FDA in 2021 to allow the drugs to be dispensed through the mail. The appeals court also ruled against FDA decisions in 2016 to let pregnant people take the drug three weeks longer into a pregnancy and to let pharmacists prescribe the drug instead of just doctors.

At issue: Appeals court backs limits on access to abortion pill mifepristone, ruling against Biden's FDA

“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it," the court wrote. “It failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person."

Critics noted how unusual it is for federal courts to weigh into drug approval decisions by the FDA. A wide swath of government agencies and outside experts have said the drug is safer than common drugs such as Tylenol and Viagra. But the anti-abortion groups challenging the drug questioned those studies and argued that the FDA didn't follow its own protocols and ignored contrary data as it expedited the drug's approval.

The case has already been to the Supreme Court once before, on the emergency docket. In April, a majority allowed full access to mifepristone while the case played out in lower courts, maintaining the status quo from before the lawsuit was filed. That short-term "stay," which doesn't necessarily signal how the court will rule on the underlying merits of the case, will not lift until the appeal to the Supreme Court is resolved.

This article originally appeared on USA TODAY: Biden appeals abortion pill mifepristone ruling to Supreme Court