The Food and Drug Administration is leaving the door open to reimposing restrictions on access to the abortion pill mifepristone, following calls from anti-abortion advocates and conservative leaders for the agency to reconsider its decades-old approval of the medication.
Sen. Josh Hawley, a staunch anti-abortion ally, wrote Monday to the FDA’s commissioner, Marty Makary, demanding that the agency “take all appropriate action to restore critical safeguards on the use of mifepristone” following the release of a study on the drug from the conservative Ethics and Public Policy Center.
Asked if the FDA would consider Hawley’s request, an agency spokesperson said: “The FDA is committed to safeguarding public health by ensuring the safety, efficacy, and quality of the products it regulates. The agency rigorously evaluates the latest scientific data, leveraging gold standard science to make informed decisions.”
The spokesperson then referred NOTUS to a comment Makary made at a Semafor event last week where he said, “There is an ongoing set of data,” on mifepristone.
“If the data suggests something or tells us that there’s a real signal, we can’t promise we’re not going to act on that data,” Makary said.
The study from the Ethics and Public Policy Center, which was not peer-reviewed, says nearly 11% of women “experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion.”
Mifepristone is endorsed and considered safe and effective by major medical organizations including the American Medical Association and the American College of Obstetricians and Gynecologists.
The Biden administration during the COVID-19 pandemic eliminated in-person prescribing requirements, which allowed abortion pills to be accessed via mail. Anti-abortion advocates have since called for the in-person requirement to be brought back since the availability of the pills online effectively circumvents state abortion bans.
“The time to act is now. It is time to revisit and restore the FDA’s longstanding safety measures governing mifepristone,” Hawley wrote.
The Trump administration has yet to take a definitive position on abortion pills. Health and Human Services Secretary Robert F. Kennedy Jr. said during his Senate confirmation hearings that President Donald Trump asked him to “study the safety of mifepristone” and that Trump “has not yet taken a stand on how to regulate it.”
In an unusual move, the Justice Department recently took steps to essentially halt key federal cases that could reimpose restrictions on abortion pills. Legal experts and abortion-rights advocates expressed concern that the administration’s decision to pause these challenges could mean government officials are interested in modifying regulations on abortion pills.
Hawley is asking Makary to respond to the letter by May 15.
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Oriana González is a reporter at NOTUS.