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The Supreme Court began a high-stakes legal fight that might end with a ruling on the future of the most popular drug for medication abortions and its accessibility, including through the mail.
The Biden administration and the pharmaceutical company Danco defended several FDA decisions that made the mifepristone pill more widely available and usable in their appeals, which the court has agreed to take into account. Danco is the company that makes Mifeprex under that brand name.
Early in the new year, the justices will conduct oral arguments; by June 30th, they are expected to have rendered a verdict. The final decision could have a crucial impact on the 2024 presidential election as abortion has become a lightning rod issue among voters, the Washington Examiner noted.
The Biden administration released a statement praising the Supreme Court for taking on the case. White House Press Secretary Karine Jean-Pierre stated that the lower court ruling that is now being reviewed “threatens to undermine the FDA’s scientific independent judgment and would reimpose outdated restrictions on access to safe and effective abortion medication.”
Danco has stated its continued confidence in the “safety and effectiveness” of Mifeprex, which will continue to be available as usual under the current FDA regulations until the Supreme Court reviews the matter.
According to the company’s statement, “Decades of real-world experience in millions of patients and extensive safety and effectiveness data from clinical trials well supported the FDA actions at issue.”
With its conservative majority of 6-3, the Supreme Court has shown its animosity toward abortion rights in the past, most recently by overturning the historic Roe v. Wade decision that protected the right to an abortion. However, before this latest round of litigation began in April, the court had already blocked a judge’s decision that would have rendered the drug’s FDA approval null and void.
Although this case brought into question the court’s promise last year to defer to state and federal abortion policy, it does not directly address the right to abortion; rather, it focuses on various legal concerns regarding the FDA’s drug approval process.
The Supreme Court has rejected an appeal that brought up the FDA’s initial 2000 approval of the drug, so that decision is no longer in question.
Rather, the court will look at subsequent FDA actions that eased pill access beginning in 2016, such as the initial 2021 decision that allowed pill delivery by mail, which was finalized earlier this year.
Additional decisions from 2016 are being reviewed, which decreased the number of in-person visits for patients from three to one and extended the window of opportunity to use mifepristone to terminate pregnancies from seven to ten weeks. The FDA also changed the dosage schedule in 2016 after determining that a reduced amount of mifepristone was enough.
If the court determines that the challengers lack the necessary legal standing to sue, it could also dismiss the case.
The Supreme Court is not considering the 2019 FDA approval of GenBioPro’s generic version of the medicine.
Decisions made by the FDA after 2016 should be halted, according to the 5th U.S. Circuit Court of Appeals in New Orleans, which stated in August that the actions “were taken without sufficient consideration of the effects those changes would have on patients.” The court rejected the petitioners’ arguments that sought to reverse the drug’s initial approval and the subsequent authorization of the generic version.
Subsequently, the Supreme Court received appeals from both parties.
The current dispute over the medicine stems from a lawsuit that the rivals brought in November 2022. They assert that the drug’s subsequent decisions that expand access were also flawed, partly due to the FDA’s failure to consider women’s safety concerns during approval in 2000.
U.S. District Judge Matthew Kacsmaryk of Texas issued a broad ruling in April nullifying the drug’s initial approval by the FDA, which was over 20 years ago. Following the Supreme Court’s decision to halt the implementation of that decision pending further litigation, the appeals court reduced the scope of Kacsmaryk’s ruling to encompass only the changes made after 2016.
The two medications that make up the FDA-approved medication abortion regimen are misoprostol, which causes contractions, and mifepristone, which blocks the hormone progesterone. The Guttmacher Institute surveyed women who had abortions to find out that the pill is the method of choice for the vast majority of these procedures in the United States.
Since the Supreme Court’s decision to overturn Roe v. Wade has prompted conservative states to pass strict regulations that restrict or prohibit abortion entirely, the availability of medication abortion, particularly via mail, has assumed paramount importance. Guttmacher reports that fourteen states have outright banned abortion.
