FDA to review abortion pill safety after sustained GOP ire

FDA to review abortion pill safety after sustained GOP ire 

The Food and Drug Administration (FDA) on Friday said it will be following through with plans to conduct a safety review of the abortion pill mifepristone, responding to months of pressure from anti-abortion lawmakers. 

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The retrospective analysis of data is likely to take six months to complete, according to an administration official, but initial results could be released earlier. The official said the study has been underway for months, pushing back on claims by anti-abortion lawmakers who felt the administration was slow-walking the promised review. 

The White House has been under pressure from anti-abortion lawmakers and activists to crack down on the availability of mifepristone, which can be sent through the mail even to states that limit or outright ban abortion. 

“The FDA has been actively working on a science-based safety review of the mifepristone REMS for months, as the agency has stated publicly and in court filings,” the agency said in a statement.  

“Any reporting suggesting otherwise, including that a study is just being started, is either false or based on a fundamental misunderstanding of how complex scientific safety studies work.” 

The review was kicked into high gear partly because of a change in the health agency’s leadership, the official said. Marty Makary was ousted as FDA chief last month and replaced by acting Commissioner Kyle Diamantis, who has been in regular communication with anti-abortion movement leaders. 

Diamantis faced scrutiny from Republicans after he was chosen to temporarily replace Makary, due to having previously co-led as a private attorney representing Florida’s Planned Parenthood chapter. 

Trump allies quickly sought to assuage concerns about Diamantis,........

© The Hill