By Andrew Chung
(Reuters) -A 2023 judicial decision that would curb access to the abortion pill threatens to disrupt the authority of the Food and Drug Administration (FDA) and harm the American healthcare system, President Joe Biden’s administration told the U.S. Supreme Court on Tuesday, urging the justices to reverse the ruling.
The Justice Department filed a written brief outlining its main arguments to preserve broad access to the pill, called mifepristone, in its appeal of an August decision by the New Orleans-based 5th U.S. Circuit Court of Appeals that barred telemedicine prescriptions and shipments by mail of the drug.
The justices decided in December to hear the mifepristone case but have not yet announced the date for oral arguments. The pill’s manufacturer, Danco Laboratories, also filed a written brief on Tuesday in its appeal of the 5th Circuit ruling, similarly raising concerns about undermining FDA authority.
The Justice Department said in its filing that the 5th Circuit’s decision represented the first time any court has second-guessed the FDA’s expertise on safety to restrict access to an approved drug.
The 5th Circuit’s ruling “threatens profound harms to the government, the healthcare system, patients and the public” and would “upend the regulatory regime for mifepristone,” with disruptive consequences for the FDA, the pill’s manufacturers and women who need access to the drug, the administration added.
Mifepristone is taken with another drug called misoprostol to perform medication abortion, which accounts for more than half of all U.S. abortions.
The legal challenge to the pill was brought in Texas by anti-abortion groups and doctors. The 5th Circuit’s decision is currently on hold pending the outcome of the Supreme Court appeal.
The Supreme Court, which has a 6-3 conservative majority, ended its recognition of a constitutional right to abortion in 2022 in a ruling overturning the 1973 Roe v. Wade precedent.
The mifepristone case could jeopardize the authority of the FDA, the federal agency that signs off on the safety of food products, drugs and medical devices.
Danco’s brief said the 5th Circuit’s decision “threatens to destabilize the pharmaceutical industry, which relies both on FDA’s ability to make predictive judgments and on courts not second-guessing those scientific judgments.”
The FDA, which gave regulatory approval to mifepristone in 2000, has called the drug safe and effective as demonstrated over its decades of use by millions of American women, with adverse effects on them exceedingly rare.
The Supreme Court’s eventual ruling in the case is expected by the end of June – in the middle of a presidential race in which Biden, a Democrat, is campaigning for re-election.
Biden and Vice President Kamala Harris have taken aim at Republicans and former U.S. President Donald Trump for curbs on abortion rights, a galvanizing issue for Democrats that they hope will boost enthusiasm among their base, attract independent voters and increase turnout in November’s U.S. election.
Women in America face a new “cruel reality” because of laws restricting abortion, Biden said on Monday, the 51st anniversary of Roe v. Wade, which had legalized abortion nationwide until it was overturned by the Supreme Court.
Trump, the frontrunner for the Republican nomination to challenge Biden, appointed three members of the court, all of whom voted to overturn Roe.
Besides medication abortion, mifepristone has other uses including management of miscarriages.
Anti-abortion groups led by the Alliance for Hippocratic Medicine and four anti-abortion doctors sued the FDA in 2022. The challengers, represented by the Alliance Defending Freedom, a conservative religious rights group, contend that the FDA has harmed women’s health by illegally removing safeguards on what they call a dangerous drug.
The 5th Circuit’s decision rolled back FDA actions that had made the drug easier to access in recent years, including a 2021 action during the Biden administration allowing the pill to be prescribed remotely and sent by mail, instead of requiring an in-person doctor visit, and a 2016 action under Democratic former President Barack Obama to allow mifepristone to be used to 10 weeks of pregnancy, up from seven.
Since the 2022 Supreme Court decision, at least 14 U.S. states have put in place outright abortion bans while many others prohibit abortion after a certain duration of pregnancy.
(Reporting by Andrew Chung in New York; Editing by Will Dunham)
