President Donald Trump's pick to head the U.S. Food and Drug Administration said he would take a "solid, hard look" at the data on chemical abortion pill mifepristone Thursday.
Dr. Marty Makary made his remarks on the abortion drug before the Senate Health, Education, Labor and Pensions committee during his hearing for FDA Commissioner, according to multiple news outlets.
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Mifepristone is the first for two drugs in a chemical abortion and was approved in 2000 in a process that some pro-life advocates argue was hurried, not in accord with science or law, and steeped in politics. The FDA then loosened its own safety standards on the drug in 2016 and 2021.
The safeguards for mifepristone removed by the FDA over the last nine years include an initial in-person doctor visit to screen for ectopic pregnancy and other serious conditions, and a follow-up visit to check for life-threatening complications such as internal bleeding and infection. The FDA then lessened its Risk Evaluation and Mitigation Strategy (REMS) requirements for chemical abortion drugs, permitting them to be dispensed and mailed by pharmacies. The Biden administration made access to the drug without in-person dispensing permanent in 2023, according to NBC News.
“I do think it makes sense to review the totality of data and ongoing data,” Makary said in the March 6 Senate hearing, referring to mifepristone access.
“I know personally of OB doctors who prefer, to insist, even though they have the option to prescribe otherwise, but they choose to insist that mifepristone be taken when necessary in their office as they observe the person taking,” Makary said. “I think their concern is that if this drug is used in the wrong hands, it could be used for coercion.”
Tweet This: FDA Commissioner nominee Dr. Marty Makary said he knew of OBs concerned that abortion drug mifepristone could be used for coercion.
In U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, a group of pro-life doctors and organizations challenged the FDA's decision to remove those remove key health and safety measures from the prescribing requirements for chemical abortions. The U.S. Supreme Court ruled in June that the doctors did not have standing - but upheld their conscience rights and also refrained from ruling on the merits of the case, leaving the door open for other parties to take up the case. Three states that were allowed to join the case could continue with the case.
Pro-life concerns about mifepristone include the physical risk to women but also the possibility for the drug would be used in human trafficking and other scenarios involving abuse or coercion.
Among the minor side effects possible with mifepristone are cramping, nausea, and vomiting. Severe complications that require immediate medical attention include extremely heavy bleeding, severe infection, and retained tissue.
Aside from the risks, many chemical abortions result in the mother left to encounter delivering her deceased child at home or in other circumstances without medical oversight, and very often women have not been prepared for this.
Abortion proponents have claimed throughout that mifepristone is safe and effective, even at times saying the drug is safer than Tylenol.
Part of the FDA’s reducing of its safety standards for mifepristone has included eliminating the requirement that abortion providers report non-fatal adverse events to the FDA Adverse Event Reporting System.
Trump's Secretary of Health and Human Services Robert F. Kennedy Jr. said upon confirmation to his post that this was "inexcusable."
“During the Biden administration the NIH did something that was inexcusable,” Kennedy said, “which is to tell doctors and patients not to report injuries and that’s not a good policy.”
RFK Jr. said that Trump has not yet “made a decision about the issue” of chemical abortion drug mifepristone but asked him to study its safety.
“And I think that that’s worth doing,” Kennedy said.
Estimates vary but they all indicate that chemical abortions account for a clear majority of all abortions conducted in the U.S.
