Washington — The Supreme Court is scheduled to meet on Tuesday to listen to arguments in a case concerning a commonly used abortion pill and recent actions by the Food and Drug Administration to simplify the process of obtaining the medication.
At the heart of the legal dispute lies the pill mifepristone, which is used in conjunction with another drug to end an early pregnancy. Approved by the FDA in 2000, over 5 million patients have taken mifepristone, as per the agency, and studies referenced in court documents have demonstrated its safety and effectiveness.
In recent times, the FDA has taken several measures to enhance accessibility to mifepristone, such as permitting it to be taken up to 10 weeks into pregnancy and enabling it to be delivered by mail without requiring an in-person doctor’s visit. These actions, carried out in 2016 and 2021, have come under legal scrutiny after a group of anti-abortion rights doctors and medical associations alleged that the FDA breached the law by easing the regulations.
The Supreme Court is set to review a ruling from a federal appeals court that declared the agency’s actions as illegal. A decision reversing these changes would jeopardize access to mifepristone nationwide, even in states with laws supporting abortion rights.
Access to mifepristone has remained unaffected while the legal proceedings in the case are ongoing, since the Supreme Court issued an order last April maintaining its availability. This relief will persist until the Supreme Court delivers its decision, expected by the end of June.
Arguments in the case are being held less than two years after the Supreme Court decided in June 2022 to revoke the constitutional right to abortion and return the issue to the states. Another case that the justices will consider within the next month involves whether federal law mandates emergency room doctors in states that prohibit abortion to carry out the procedure on pregnant patients facing life-threatening situations.
The court’s deliberation also follows recent findings indicating an increase in medication abortions in the U.S. since the Supreme Court overturned Roe v. Wade.
A study published in the medical journal JAMA on Monday revealed that the number of self-managed abortions using pills rose in the six months after the high court overturned Roe. Research from the Guttmacher Institute, an organization supporting abortion rights, published last week indicated that medication abortions made up 63% of all abortions within the U.S. healthcare system in 2023, up from 53% in 2020.
The dispute over mifepristone
The challenge to the FDA’s initiatives regarding mifepristone was filed in November 2022 — more than 20 years after the drug became available in the U.S. — by a group of medical associations opposed to abortion rights. Filed in federal district court in Texas, the groups, led by the Alliance for Hippocratic Medicine, contested the FDA’s initial 2000 approval and its recent changes in 2016 and 2021.
As part of these measures, the FDA permitted mifepristone to be taken up to 10 weeks into a pregnancy, reduced the required in-person visits from three to one, allowed more healthcare providers to prescribe the drug, and eliminated the in-person prescription mandate.
The organizations, represented by the conservative legal group Alliance Defending Freedom, argued that the FDA lacked the authority to approve mifepristone for sale and did not adequately assess the drug’s safety and effectiveness.
The federal judge overseeing the case, U.S. District Judge Matthew Kacsmaryk, concurred that the FDA’s 2000 approval and subsequent actions were likely illegal. He halted the FDA’s initial step allowing the drug to be sold in the U.S.
However, Kacsmaryk postponed his ruling for a week, and both a federal appeals court and the Supreme Court intervened. Ultimately, the Supreme Court preserved access to mifepristone while legal proceedings continued.
Several months later, the U.S. Court of Appeals for the 5th Circuit upheld the FDA’s 2000 approval of the abortion pill but stated that the agency violated the law with its recent changes. Nevertheless, the appeals court’s decision is overridden by the Supreme Court’s previous April 2023 order safeguarding access.
The Justice Department and Danco Laboratories, the manufacturer of Mifeprex (the brand-name version of mifepristone), requested the Supreme Court to review the 5th Circuit’s decision, and the court agreed to do so in December.
The arguments in the case
In their plea to reverse the appeals court’s ruling, the Biden administration has contended that the medical associations and their physician members have not demonstrated any potential harm caused by the FDA’s actions, and that the alleged injuries cannot be linked to the FDA’s relaxation of mifepristone regulations.
The doctors contesting the changes do not prescribe the drug and have not identified any instances where a member was compelled to complete an abortion for a woman arriving at an emergency room with an ongoing pregnancy, Solicitor General Elizabeth Prelogar informed the court in legal documents.
On the other hand, lawyers for the medical groups, represented by the Alliance Defending Freedom, argued that their members object not only to abortion but also to being part of the process.
“The FDA has spent years directing women harmed by abortion drugs to emergency rooms. Many of them have sought treatment from the respondent doctors,” the attorneys wrote. “Now that the FDA is being held accountable for the harm caused, the agency cannot claim that the treatment option it directed is somehow speculative.”
If the Supreme Court agrees with the Justice Department that the doctors lack the proper grounds to sue in federal court, it would dismiss the case without deciding whether the FDA acted within legal bounds when altering the rules for mifepristone usage.
However, if the justices delve into the legal issues raised in the case, the Justice Department and Danco have urged the court to affirm that the FDA’s 2016 and 2021 actions were legal.
The agency relied on a “substantial body of medical evidence” on mifepristone’s use over decades when it decided that the 2016 changes would be safe, Prelogar noted. In any case, she stated that the district court was mistaken in questioning the determinations that Congress empowered the FDA to make.
“To the government’s knowledge, this case represents the first instance where any court has restricted access to an FDA-approved drug by second-guessing the FDA’s expert judgment on the conditions required to ensure the drug’s safe use,” Prelogar mentioned.
Pharmaceutical companies and former heads of the FDA have cautioned the court that upholding the 5th Circuit’s decision could undermine the agency’s drug approval process and lead to ongoing legal challenges against its approval decisions.
“The lower court’s approach, if upheld, would enable courts to substitute their lay analysis for the FDA’s scientific expertise and overturn the agency’s approval and conditions of use for drugs — even after they have been on the market for decades,” a group of former commissioners and acting commissioners communicated to the court in a brief.
“The resulting uncertainty would jeopardize the incentives for drug companies to invest the time and resources required to develop new drugs and ultimately impede patients’ access to vital treatments that prevent suffering and save lives,” they added.
Furthermore, a group of pharmaceutical companies and executives emphasized the importance of drug companies being able to rely on the courts to respect the FDA’s scientific judgments.
“If a court can overturn those judgments many years later through a process lacking scientific rigor, the resulting uncertainty will create unacceptable risks and undermine the incentives for investment regardless of the drug in question,” they highlighted in a brief. “This, in turn, will ultimately harm patients.”
Conversely, lawyers for the medical associations and their members opposing abortion rights argued that the FDA failed to provide a “satisfactory explanation” for its decision to eliminate the in-person dispensing requirement and criticized the studies the agency relied upon as “deeply problematic.”
The removal of the in-person visit requirement in 2021 eliminated the opportunity for healthcare workers to screen for ectopic pregnancies and other conditions, the associations contended. In 2016, the FDA removed “interconnected safeguards without studies” examining the changes holistically, they continued.
The group Americans United for Life, supporting the Alliance for Hippocratic Medicine, alleged that the FDA has promoted access to abortion pills without medical supervision, leading to increased health and safety risks for women and interfering with their care.
The Battle Over Abortion
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