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FDA chief says no current plans to restrict mifepristone access

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April 25, 2025
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FDA chief says no current plans to restrict mifepristone access

Food and Drug Administration (FDA) Commissioner Marty Makary said he has no plans to change current policy to restrict access to the abortion pill mifepristone, despite a steady pressure campaign from abortion opponents. 

Speaking at the Semafor World Economy Summit on Thursday, Makary said he would reconsider if there is new data that would suggest a safety issue.  

The Food and Drug Administration approved mifepristone in 2000 to terminate pregnancies up to seven weeks. The drug is taken in conjunction with misoprostol in a two-medication regimen that constitutes the majority of abortions in the country.   

Scientists and top medical groups contend it has been studied extensively and is proven to be safe. It’s been used by millions of women with minimal side effects.  

A group of anti-abortion physicians and medical associations previously sued to impose additional restrictions on mifepristone and ban telehealth prescribing, but the Supreme Court punted on the case last year and ruled the doctors had no legal standing to sue, keeping current access rules in place. 

Makary went further in his answer Thursday than he did during his confirmation hearing.  

During the hearing, Makary didn’t commit to any specific action. He said he had no preconceived plans to limit mifepristone access and would “review the data” once he took office. 

Health and Human Services Secretary Robert F. Kennedy Jr. promised Republican senators he would faithfully implement any Trump administration anti-abortion policies, and during his confirmation hearing he indicated the administration was likely to closely scrutinize mifepristone because of “safety’ concerns.   

“President Trump has asked me to study the safety of mifepristone,” Kennedy said at the hearing. “He has not yet taken a stand on how to regulate it. Whatever he does, I will implement those policies.”  

Following Makary’s comments on Thursday, Sen. Josh Hawley (R-Mo.) — an avowed abortion opponent whose wife argued the Supreme Court case against the pill — said on social media the remarks were “exceptionally disappointing to say the least. Not a good beginning at the FDA.” 

Also during the summit, Makary said he would support an effort from Kennedy to withdraw the government’s recommendation that children should receive a COVID-19 vaccine.

“Most Americans do not believe in the COVID booster shot for young, healthy children at this point,” Makary said. “So if [Kennedy] does something with the COVID vaccine in children, I think it’ll be warmly welcomed by a lot of Americans.”

Makary was a prominent critic of the Biden administration’s response to the COVID-19 pandemic, particularly vaccine mandates. He also has long argued healthy people, especially children, were at low risk of severe complications from the virus and should not have received booster doses.

Makary said he has not received any COVID vaccine boosters.

Kennedy is reportedly considering removing the shot from the Centers for Disease Control and Prevention’s childhood vaccine schedule. He has previously raised doubts about the shot’s safety and questioned its effectiveness.

In an interview with Fox News’s Jesse Watters earlier this week, Kennedy called the initial recommendation that children get the COVID vaccine “dubious”  because the “vaccine itself does have profound risk.”

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