WASHINGTON (CN) — The maker of a popular abortion pill asked the Supreme Court on Friday to review an appellate ruling issued this summer limiting the use of the drug nationwide.
Danco Laboratories said the Fifth Circuit’s ruling on the drug presents serious questions on constitutional and statutory limitations of judicial review.
“For the women and teenage girls, health care providers, and States that depend on FDA’s actions to ensure safe and effective reproductive health care is available, this case matters tremendously,” Jessica Ellsworth, an attorney with Hogan Lovells representing the drugmaker, wrote in the petition. “And for the pharmaceutical and biotechnology industry, permitting judicial second-guessing of FDA’s scientific evaluations of data will have a wildly destabilizing effect.”
For over two decades, millions of Americans have utilized mifepristone in abortion care. The drug — which blocks the hormone progesterone — is used with misoprostol to end a pregnancy.
The Federal Drug Administration first approved mifepristone’s use to terminate pregnancy through seven weeks gestation in 2000. In 2016, the agency extended its use up to 10 weeks gestation. The 2016 update also reduced the number of visits required to receive mifepristone from three to one.
Although they do not actually prescribe mifepristone themselves, the Alliance for Hippocratic Medicine, a group of conservative Christian doctors, sued the government, claiming mifepristone’s approval caused them harm.
The anti-abortion organization was formed after the high court’s historic ruling striking down Roe v. Wade. Although the group is Tennessee-based, it was incorporated in Amarillo, Texas, where federal courts assign cases based on geographic location. Filing the suit in Amarillo virtually guaranteed the case landed on the docket of U.S. District Judge Matthew Kacsmaryk.
Alliance for Hippocratic Medicine doctors claim they could be forced to treat patients with adverse reactions to mifepristone. If one of those patients came to the workplace of one of these doctors and the doctor had to help them, the Alliance for Hippocratic Medicine says its doctors would be forced to conduct a procedure that violates their beliefs.
Mifepristone’s safety record rivals common over-the-counter medications like ibuprofen and acetaminophen. For every million people who take the drug, only five die from its use. In comparison, the maternal mortality rate in the United States was 39.2 deaths per 100,000 live births in 2021, according to the U.S. Centers for Disease Control and Prevention.
The doctors claim mifepristone’s two-decade-old approval under Subpart H — an accelerated approval process for new drugs treating serious or life-threatening illnesses — created safety hazards that persist today. The Alliance for Hippocratic Medicine claims pregnancy should not have been considered a serious or life-threatening illness. The process was first used for drugs to treat HIV/AIDS. Mifepristone’s approval still took over four years and included dispensing requirements.
After the suit landed on his docket in the Northern District of Texas, Kacsmaryk, a Trump appointee, moved to take mifepristone off the shelves nationwide. A panel on the Fifth Circuit upheld the majority of the ruling, setting off a battle on the Supreme Court’s emergency docket.
After Justice Samuel Alito temporarily paused Kacsmaryk’s ruling to allow the court to consider the case, the full court blocked new restrictions on the medication. Justice Clarence Thomas would not have allowed the pause. Alito penned a dissent to the grants.
The justices’ ruling allows mifepristone to be administered without restrictions until the appeals process is complete.
In August, the Fifth Circuit partially sided with the doctors, ruling to restrict mifepristone’s use. The appeals court found that the FDA violated the Administrative Procedure Act in 2021 when it allowed mifepristone to be dispensed through the mail instead of requiring people to take the medication in a clinic.
The court also took issue with the 2016 changes to mifepristone’s prescription. According to the panel, the FDA improperly loosened safeguards by allowing nonphysicians to prescribe the drug and removing the required in-person follow-up appointments.
Danco says the Fifth Circuit erred in finding standing where there is none.
“Respondents — associations of doctors who are opposed to abortion and do not prescribe mifepristone — are not themselves ‘the object of the government action or inaction [they] challenge,’” Ellsworth wrote.
The drugmaker said the court’s attempt to link the doctor’s claims that they’d been harmed by a medication they do not administer by assuming that there was a probability that one of the hundreds of members of the group could be forced at some time to provide care they did not agree with went too far. Danco said this type of standing argument was already rejected by the court in Summers v. Earth Island Inst.
“Six circuits have flatly rejected what the Fifth Circuit sanctioned here, reasoning that an assertion some members of a large group will inevitably be affected by a regulation — without clear allegations regarding ‘who these members are or how exactly the [regulation] will harm them individually’ — ‘trends too closely to the statistical probability theory of associational standing rejected in Summers,’” Ellsworth wrote.
Danco also claims the Fifth Circuit’s merits decision diverges from precedent.
“Judicial review under the APA asks whether an agency acted ‘within a zone of reasonableness,’ does not permit a court to ‘substitute its own policy judgment for that of the agency,’ does not require an agency to incant ‘magic words,’ and permits an agency to make ‘predictive judgments,’” Ellsworth wrote. “Here, even the limited set of materials available at this stage includes hundreds of pages of careful, detailed, scientific analysis bearing on FDA’s decisions in 2016 and 2021.”
The Biden administration is also expected to file a petition in the case for the court’s review.Follow @KelseyReichmann
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