By Ismail Shakil
May 2 (Reuters) – Two drugmakers have asked the U.S. Supreme Court to restore mail-order access to mifepristone, a move that would continue to allow women access to one of the most widely used abortion methods pending ongoing legal challenges.
Danco Laboratories and GenBioPro both filed applications with the top court on Saturday, one day after an appeals court temporarily blocked deliveries, significantly curtailing access to the drug nationwide and particularly in states that have banned abortion.
The lower court’s ruling, while temporary, is the first to significantly curtail access to mifepristone in a series of lawsuits challenging the drug’s initial approval in 2000 and subsequent rules making it easier to obtain.
It also highlights the latest front in the battle over access to abortion since the Supreme Court in 2022 overturned the landmark Roe v. Wade decision that had recognized a woman’s constitutional right to an abortion.
Nearly half of U.S. states have banned or severely restricted abortion since then, driving a surge in medication abortion and spurring a series of legal battles over access to the pills.
Friday’s pause “injects immediate confusion and upheaval into highly time-sensitive medical decisions—and it forces Danco, FDA, certified Mifeprex providers, patients, and pharmacies all to guess at what is allowed and what is not,” Danco said, citing its brand-name version of the drug.
GenBioPro separately said it “firmly believes all people have a right to access safe, affordable, evidence-based health care.”
Mifepristone, which is used in about two-thirds of U.S. abortions, is part of a two-drug regimen along with misoprostol to terminate a pregnancy within the first 10 weeks.
In 2023, the U.S. Food and Drug Administration under former Democratic President Joe Biden lifted a restriction that had required mifepristone to be given in-person, saying the drug was safe and effective.
On Friday, a conservative three-judge panel of the New Orleans-based 5th U.S. Circuit Court of Appeals unanimously ruled that the Republican-led state of Louisiana was likely to prevail in its challenge to the regulation.
Louisiana had sued the FDA, saying the agency had ignored the risks of serious adverse events such as sepsis and hemorrhaging.
Restricting access to mifepristone, including through telehealth appointments with out-of-state providers, has been a top priority for Louisiana and other Republican-led states that have banned abortion.
Republican President Donald Trump’s administration has said it is examining mifepristone’s safety, but media reports have said the review has been delayed until after the November midterm elections. Republican lawmakers are also investigating the drug.
A U.S. district judge earlier in April had paused Louisiana’s lawsuit pending the administration’s review.
GenBioPro in its statement said it remains “concerned that anti-abortion special interests are attempting to undermine the US Food and Drug Administration’s regulatory authority.”
Other groups have also raised concerns.
“Our nation is once again facing a generational-defining moment for women’s healthcare,” legal organization Democracy Forward President and CEO Skye Perryman said in a statement.
“The assault on women’s health in America did not stop when we lost Dobbs,” wrote Perryman, who helped push for mail access for the drug previously as the top lawyer for the American College of Obstetricians and Gynecologists.
Both GenBioPro and Danco Laboratories intervened in Louisiana’s lawsuit to defend the FDA regulation.
Mifeprex is Danco’s only product while GenBioPro derives most of its revenue from a generic version. Evita Solutions also makes a generic version.
The Supreme Court in 2024 took up a separate challenge to the mail-order rule by medical groups and doctors, but said they lacked legal standing to sue. Missouri, Kansas and Idaho have taken over that case, which is pending.
(Reporting by Ismail Shakil and Tom Hals; Additional reporting by Susan Heavey; Editing by Franklin Paul)
Comments