U.S. Food and Drug Administration Commissioner Martin Makary’s deeply rooted belief in data-based decision making could be put to the test after a new study found that mifepristone, the drug responsible for more than half of the nation’s abortions, is more dangerous than previously known.
Makary told PBS’ Amna Nawaz at Semafor’s World Economy Summit over the weekend that “I have no plans to take action on mifepristone.” He did, however, hint that “here is an ongoing set of data that is coming into the FDA on mifepristone” that could change the agency’s position on the pill.
“So, 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 continued.
Four days later, a new study showed that the rate of life-threatening complications due to mifepristone is at least 22 times higher than what the FDA and Danco Laboratories, the manufacturer of the drug, indicate on its label.
The researchers at the Ethics and Public Policy Center, who successfully completed the “largest known study of the abortion pill,” emphasized that the “FDA should reinstate the original patient safety protocols that were required when mifepristone was first approved.”
The study’s conclusion also noted the FDA should “further investigate the harm this drug causes to women and, based on objective safety criteria, reconsider its approval altogether.”
“Women deserve better than the abortion pill,” the researchers wrote.
The same day the study was published, Sen. Josh Hawley, R-Mo., sent a letter to Makary urging the FDA head to “follow this new data and take all appropriate action to restore critical safeguards on the use of mifepristone.”
“The time to act is now,” he wrote, noting that the “health and safety of American women depend on it.”
This isn’t the first time Makary has encountered questions about the status of mifepristone under his leadership
During the FDA chief’s confirmation hearing, Republican senators repeatedly demanded to know whether Makary would consider reevaluating mifepristone’s approval status and the expansions made by the Obama and Biden administration. Committee on Health, Education, Labor, and Pensions Chairman Bill Cassidy explicitly asked Makary to restore abortion pill safeguards such as requiring an in-person visit to obtain a mifepristone prescription.
Makary repeatedly claimed he would look at the data and go from there.
The Federalist pressed the FDA over whether its chief has plans to review the new study’s findings and “take action,” per his recent comments.
An FDA spokeswoman did not directly answer The Federalist’s questions, but claimed the agency 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,” she continued. “With a steadfast focus on protecting consumers, the FDA applies a balanced, science-based approach while incorporating practical, common-sense considerations to its regulatory processes.”
Jordan Boyd is a staff writer at The Federalist and producer of The Federalist Radio Hour. Her work has also been featured in The Daily Wire, Fox News, and RealClearPolitics. Jordan graduated from Baylor University where she majored in political science and minored in journalism. Follow her on X @jordanboydtx.
