“As with all drugs, FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of early pregnancy,” Makary wrote. “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.”
Mifepristone is the first drug in the medication abortion regimen, which comprised nearly two-thirds of all abortions in 2023. The FDA approved the drug in 2000, and over 100 studies have confirmed that medication abortion, which most commonly uses the pills mifepristone and misoprostol, is extremely safe—safer than Tylenol or Viagra. Currently, you can get a telemedicine prescription for the abortion pill up to 10 weeks of pregnancy, which the FDA approved in 2021. Conservatives want the FDA to roll that back to seven weeks.
During his confirmation hearings, Makary said he wouldn’t restrict access to the drug. He reiterated this at the Semafor World Economy Summit on April 24 but added 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.” Enter Hawley, who, on April 28, posted his plea to Makary.
A couple of quick notes about this “study,” the most important being that it wasn’t peer-reviewed. It’s insanely titled, “The Abortion Pill Harms Women: Insurance Data Reveals One in Ten Patients Experiences a Serious Adverse Event,” and was published by the far-right Ethics & Public Policy Center, a Project 2025 partner whose president is against marriage equality and IVF. It uses conservative boogeyman terms like “chemical abortion” and claims that 11 percent of women who use mifepristone for abortion experience a “serious adverse event,” which is much higher than the current 0.5% rate determined by every other study. However, the study casts a pretty wide net for what it considers a “serious adverse event.” Contributing writer Susan Rinkunas reported at the time:
But mifepristone isn’t just used for abortions—it can be prescribed for miscarriage management. As journalist Garnet Henderson pointed out, EPPC’s definition of “mifepristone abortions” could have turned up claims of people who were given mifepristone without misoprostol, the second drug in the medication abortion regimen, or of people who never even took the drug.
The group also considers needing an abortion procedure if the pills fail a “serious adverse event.” But while it’s annoying when a medication doesn’t work, this is neither a serious nor an adverse result. “This is a known potential outcome of the treatment,” OB/GYN Daniel Grossman told writer Jessica Valenti. “And patients are told that medication abortion is about 95%-97% effective before they choose this abortion method.” So EPPC is over-counting complications.
“After months of signals and dog whistles, it’s now in black and white on official FDA letterhead,” Mini Timmaraju, the president and CEO of Reproductive Freedom for All, said in a statement on Tuesday in response to Makary’s letter. “This review is not grounded in new data or real safety concerns – it’s driven by Project 2025-aligned groups and right-wing politicians who want to ban abortion nationwide. We are now one step closer to the Trump administration’s ultimate goal of a national abortion ban.”
Congrats to all these stellar men for using their one wild and precious life to make it more difficult and dangerous for women to decide how to use theirs.
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