The Supreme Court will hear oral arguments in a case that could impact prescription and use of the abortion pill mifepristone in the US.
The Alliance Defending Freedom sued the FDA in 2022, alleging it improperly removed safety restrictions for political reasons, endangering women’s health.
The FDA “chose politics over science and approved chemical abortion drugs for use in the United States,” the Alliance Defending Freedom (ADF) stated.
A lower court blocked FDA actions from 2016 onward expanding mifepristone use, but the FDA and manufacturer appealed.
“The U.S. Food and Drug Administration (FDA) — the federal agency responsible for ensuring the safety of drugs that Americans take — has betrayed women and girls,” Erik Baptist, senior counsel with the ADF, stated.
“Women should have the ongoing care of a doctor when taking high risk drugs. But in recent years, the FDA has recklessly removed nearly every safeguard the agency previously considered necessary for abortion drugs, including in-person doctor visits to check for ectopic pregnancies, severe bleeding, and life-threatening infections,” Baptist added. “Without question, the FDA’s actions made taking high-risk abortion drugs less safe for women.”
The Supreme Court will review whether the FDA violated administrative law in loosening restrictions, allowing earlier gestational use and telemedicine/mail prescriptions without evidence of continued safety.
A decision could shape regulation of medication abortions as their availability has increased, now comprising over 60% of abortions according to recent data.
“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” the panel opinion read.
“It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those ‘major’ and ‘interrelated’ changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events,” the opinion added. “And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”
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