WASHINGTON (CN) — A popular abortion pill will remain free of any new restrictions until this weekend after the Supreme Court entered an extension Wednesday to a previous stay.
Justice Samuel Alito had originally given the court until midnight Wednesday to decide whether to take emergency action on a Fifth Circuit ruling that would have changed how abortion pills are administered across the country. His latest orders, awarded to both the federal government and to the drugmaker Danco Laboratories, extend stay until Friday at 11:59 p.m. EDT.
Danco's mifepristone — one of two drugs used in medication abortions — is at the center of the battle that health care advocates call a direct threat to reproductive health care access brought on by the reversal on the federal right to abortion last year. It’s been two decades since mifepristone was approved by the Food and Drug Administration, but the drug could be taken off the shelves nationwide if its challengers get their way.
“Across decades, the agency has stripped away every meaningful and necessary safeguard on chemical abortion, demonstrating callous disregard for women’s well-being, unborn life, and statutory limits,” John Bursch, an attorney with the Alliance for Defending Freedom, declared in a recent brief.
Bursch represents the Alliance for Hippocratic Medicine, an advocacy group that sued in Texas last year to halt mifepristone’s FDA approval. Although no doctors who belongs to the alliance has ever prescribed mifepristone, they argue that the approval of the drug harms them because there’s a chance that a patient who suffers an adverse reaction after taking mifepristone later seeks treatment from one of their members.
Mifepristone has been used by over 5 million people since its approval in 2000. Adverse reactions to the drug are considered rare. The FDA says only 5 out of every million to take the drug have died from its use. This safety record is similar to those of ibuprofen and acetaminophen and beats other common medications like penicillin and the erectile-dysfunction drug Viagra.
“Today, more than half of women in this country who choose to terminate their pregnancies rely on mifepristone to do so,” U.S. Solicitor General Elizabeth Prelogar wrote in brief before the court. “And study after study has shown that when mifepristone is taken in accordance with its approved conditions of use, serious adverse events are ‘exceedingly rare.’”
Despite its safety record, U.S. District Judge Matthew Kacsmaryk ordered the drug pulled from shelves nationwide. Before his appointment to the Amarillo division of the Northern District of Texas, Kacsmaryk served as legal counsel to a conservative legal advocacy group. Among multiple controversial rulings that the Trump appointee has handed down in the last four years is a ruling that labeled birth control access under Title X unconstitutional. The Alliance for Hippocratic Medicine was incorporated in Kacsmaryk’s jurisdiction only three months after the Supreme Court overturned Roe v. Wade.
In entering his injunction against mifepristone this month, Kacsmaryk resurrected an 1873 law prohibiting “obscene” material from being sent through the mail. The Comstock Act bans sending pornographic literature, contraceptives and early abortion-inducing substances through the mail.
“Plaintiffs are within the zone of interests of the Comstock Act,” Kacsmaryk wrote. “This statute ‘indicates a national policy of discountenancing abortion as inimical to the national life.’”
The district court ruling paused mifepristone’s FDA approval from 2000 as well as subsequent approvals starting in 2016 that altered how the drug is prescribed and distributed. Abortion seekers once had to schedule three doctor visits and have the medication administered by a provider to utilize mifepristone. The FDA loosened these requirements based on continued evidence of the efficacy and safety of the drug.
“FDA has maintained that scientific judgment across five presidential administrations, and it has modified the original conditions of mifepristone’s approval as decades of experience have conclusively demonstrated the drug’s safety,” Prelogar wrote. “Public health authorities around the world have likewise approved mifepristone, and the World Health Organization has included it on a list of ‘Essential Medicines.’”
As the parties appeal Kacsmaryk’s ruling, the Fifth Circuit opted last week to order a partial stay. All three Republican-appointed judges said the FDA's 2000 approval of mifepristone should remain active for now, but the panel upheld the pause on the subsequent approvals, meaning that the drug would only be available with restrictions.
The Biden administration and Danco Laboratories asked the Supreme Court for emergency relief, saying that the partial stay still means that any mifepristone on the market would have to be relabeled — a process that could take months.
“If allowed to take effect, the lower courts’ orders would upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA’s ability to implement its statutory authority,” Prelogar wrote.
Under the appeals court ruling the generic version of mifepristone would be completely removed from the market. GenBioPro, which makes the generic drug, said it supplies two-thirds of the pill taken nationwide. Over 50% of abortions in the U.S. use mifepristone.
Danco Laboratories was not deterred by the court’s delay, saying it was glad the justices were carefully considering its application.
“We are grateful the court is taking the time necessary to evaluate our client’s request for a stay pending appeal, rather than rushing to judgment in this complex and important case,” Ellsworth said in a statement. “This case has enormous stakes for our client, Danco, as well as for providers, for the biopharmaceutical industry, for women, and for health care systems.”
The Justice Department declined to comment on the extension entered Wednesday by Alito. The Alliance for Defending Freedom did not immediately respond to requests for comment.
Follow @KelseyReichmann
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