The FDA is going forward with an investigation into the safety of the abortion pill mifepristone, an initiative that could allow the Trump administration to impose restrictions on its use, The Wall Street Journal reports.
The FDA probe, which is likely to be finished by the end of the year, the WSJ said, comes as Trump faces harsh criticism from anti-abortion activists for not using his executive powers to curb access to the pill.
Mifepristone, which was used in 63% of the abortions in the U.S. in 2023, according to the Guttmacher Institute, has been on the market in the U.S. for more than a quarter century and has repeatedly been declared safe by the FDA.
In a Q&A posted on its website, the FDA said that as of April of this year it was conducting a safety study of mifepristone.
"The next steps of the mifepristone safety study will be data exploration, evaluation of data integrity, and implementation of the analyses, validation, and peer-review," it wrote, adding that it expected the probe to be completed in less than a year.
In previous studies, such as its review last year of COVID mRNA vaccines, the agency used information from its FDA Adverse Event Reporting System (FAERS) drug-safety database.
The anti-abortion movement suffered a blow last month when the U.S. Supreme Court blocked a federal appeals court ruling in Louisiana, which would have prevented mifepristone from being prescribed over the phone and sent through the mail throughout the U.S. The new ruling allows telehealth access to mifepristone to remain intact while litigation plays out in lower courts.
Last month, Kristi Hamrick, a lobbyist for Students for Life of America, told Politico that “our patience has run out.”
“The pro-life movement, like many other parts of the [Republican] coalition, made an investment in Donald Trump. We want a return on that investment,” she added.
Pro-life supporters have maintained that mifepristone—which is used along with the contraction-triggering drug misoprostol to end pregnancies up to the first 10 weeks—can cause hemorrhaging.
Meanwhile, pro-choice supporters say that pro-lifers are using safety as a last-ditch effort to limit the availability of the drug.
“The ban on mifepristone through telemedicine was never about safety. It was about controlling people’s bodies and lives,” Angel Foster, the co-founder of The Massachusetts Medication Abortion Access Project, said in a statement last month after the SCOTUS decision.
In 2021, during the coronavirus pandemic, the in-person requirement to receive mifepristone was lifted by the FDA.
In April of 2023, the Fifth Circuit Court of Appeals in Louisiana moved to prohibit the pill from being delivered by mail and restricted the time frame mifepristone could be used during pregnancy from 10 weeks to seven weeks. The ruling dovetailed with the Supreme Court’s 2022 decision to overturn the landmark case Roe v. Wade.
In an amicus brief before the SCOTUS decision, nine former FDA Commissioners said that the appeals court’s approach would “upend FDA’s gold-standard, science-based drug approval system,” and warned that the ruling “creates a roadmap for attacks on science-based drug regulatory decisions.”
Mifepristone was developed in France and approved there in 1988. The FDA signed off on the drug in 2000. It works by blocking the hormone progesterone, which is needed for a pregnancy to continue.