The head of the Food and Drug Administration has vowed to conduct a review of the abortion pill as the drug continues to be subject to scrutiny following a new report showing a much larger share of women experience adverse effects after taking it than previously believed.
Sen. Josh Hawley, R-Mo., shared the contents of a letter he received from Food and Drug Administration Commissioner Marty Makary in an X post Monday. Makary’s letter came in response to a letter Hawley had sent Makary on April 28 expressing concern about his insistence that he had “no plans to take action” on mifepristone, referring to the abortion pill.
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“As the Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone and working with the professional career scientists at the Agency who review this data,” Makary assured Hawley. “As with all drugs, FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of early pregnancy.”
In his initial letter to Makary, Hawley cited a study from the Ethics and Public Policy Center finding that more than 10% of women who take the abortion pill experience adverse effects as an example of data that would justify action by the FDA. Examples of adverse effects experienced by women who take the abortion pill include serious complications such as hemorrhaging, infection, ectopic pregnancies, transfusion and sepsis.
The senator noted that as Makary indicated that he had no plans to change government policy when it comes to the prescribing of the abortion pill, he clarified that “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.”
The release of the Ethics and Public Policy Center report came shortly after Makary’s declaration that he was not prioritizing the abortion pill. “The time to act is now,” Hawley wrote as he requested that Makary answer a series of questions by May 15. He asked if the FDA would “restore longstanding, critical safeguards for mifepristone use,” referring to requirements that women seeking the abortion pill have an in-person visit with a doctor first, that only doctors can prescribe it and that the drug must be administered in person.
Hawley also asked what plans the FDA has to “adjust the relevant drug safety label given this new information” about the rate of adverse events that is 22 times higher than the 0.5% reported on the abortion pill’s label based on the results of clinical trials and requested additional information about the FDA’s plans to “appropriately evaluate the real-world effects of mifepristone on American women” going forward.
Makary’s letter did not specifically answer Hawley’s questions, instead noting that the use of “Mifepristone for the medical termination of early pregnancy is the subject of pending litigation,” while stressing that the “FDA generally does not comment on matters that are the subject of pending litigation and therefore is unable to provide further information at this time.”
The litigation in question involves Idaho, Kansas and Missouri challenging the dispensing requirements for the abortion pill. The states filed a lawsuit after a similar challenge to the abortion pill by doctors and medical organizations was dismissed by the United States Supreme Court on procedural grounds. The U.S. Department of Justice, under the Trump administration, has called for the case to be dismissed, alleging that the plaintiff states lack standing, as the lawsuit was filed in Texas.
Makary’s letter to Hawley comes more than two weeks after an exchange between the senator and Secretary of Health and Human Services, Robert F. Kennedy Jr., about the abortion pill during a hearing on Capitol Hill. Hawley brought up the Ethics and Public Policy Center study as he asked Kennedy if he was committed to undertaking a “top-to-bottom review” of the abortion pill.
“I’ve asked Marty Makary, who’s the director of the FDA, to do a complete review and to report back,” Kennedy responded. Kennedy described the findings of the Ethics and Public Policy Center report as “alarming.”
The Ethics and Public Policy Center report conducted an “analysis of data from an all-payer insurance claims database that includes 865,727 prescribed mifepristone-induced abortions from 2017 to 2023.” The number of cases examined by the Ethics and Public Policy Center is much larger than the 30,966 participants in the clinical trials that resulted in a 0.5% adverse effects rate.
Ryan Foley is a reporter for The Christian Post. He can be reached at: ryan.foley@christianpost.com
