U.S. Food and Drug Administration (FDA) Commissioner Marty Makary committed on Monday to review the safety of mifepristone, the first drug used in a two-drug medication abortion regimen.
Makary committed to a review of the drug in a letter responding to Sen. Josh Hawley’s (R-MO) concerns about mifepristone, following a the release of a new study suggesting real-world complications from the pill are 22 times higher than what is listed on the FDA-approved drug label.
“FDA is committed to safeguarding public health by ensuring the safety, efficacy, and quality of the products it regulates. The Agency carefully evaluates the scientific data, leveraging rigorous science to make informed decisions. As with all drugs, FDA continues to closely monitor the postmarking safety data on mifepristone
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