The case involving the abortion pill before the Supreme Court has the potential to impact more than just abortion. It could also have far-reaching consequences on the regulatory system for all medications in the United States.
A group of anti-abortion doctors and organizations filed a lawsuit against the Food and Drug Administration (F.D.A.) to restrict access to mifepristone, the first pill in the medication abortion regimen. This pill was approved by the F.D.A. in 2000 and has been used by over five million women in the U.S.
If the plaintiffs prevail and the Supreme Court rolls back or invalidates F.D.A. regulations on mifepristone, it would be unprecedented as the court has never before challenged the agency’s authority to determine drug usage conditions independently.
Experts in drug policy and numerous pharmaceutical companies are concerned about the potential implications of such a decision. They worry that it could lead to legal challenges on other drugs, particularly those that have been politically contentious like vaccines or morning-after pills. Companies fear that without F.D.A. oversight, their drug development decisions and availability could be affected.
An amicus brief filed by over 300 industry leaders and associations warned that the resulting litigation and regulatory uncertainty could disrupt drug approval processes, hinder innovation, and jeopardize patient health.
The lawsuit, filed in November 2022, aimed to reverse the approval of mifepristone. Last April, Judge Matthew J. Kacsmaryk issued a preliminary ruling to remove the medication from the market. The U.S. Court of Appeals for the Fifth Circuit later maintained the initial approval but reversed changes made by the F.D.A. in 2016 and 2021 that increased mifepristone accessibility.
If the Supreme Court supports the Fifth Circuit and enforces pre-2016 regulations on mifepristone, patients would face increased restrictions. They would no longer be able to obtain a prescription through telemedicine or receive pills by mail. Instead, they would need to get mifepristone in person from a doctor and make multiple in-person visits during the abortion process, limiting access further.
The pharmaceutical industry’s amicus brief argued that the Fifth Circuit’s approach could impede drug development and restrict patient access to evolving medical science.
The potential impact of the Supreme Court’s decision is broad and unclear, with some suggesting the F.D.A. may keep certain regulations in place while gathering more data. Additionally, providers may continue to stockpile and prescribe mifepristone regardless of the ruling.
If providers are unable to acquire mifepristone, many may resort to prescribing only misoprostol, the second drug in the abortion regimen, which is used for other conditions and widely available by prescription.
