FDA To Review Abortion Pill Safety After Junk Science Report | EUROtoday

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Republican Sen. Josh Hawley’s quest to legitimize a junk science report undermining the protection of a extensively used abortion tablet was totally realized this week.

Food and Drug Administration Commissioner Martin Makary confirmed in a Monday letter to the Missouri senator that the company will conduct a security overview of the abortion tablet mifepristone. Makary’s letter is in response to an April request from Hawley for the division to overview mifepristone following a new report revealed by the Ethics and Public Policy Center, an anti-abortion conservative assume tank and advisory board member of Project 2025.

“As with all drugs, FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of early pregnancy,” Makary wrote in his letter. “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.”

The FDA and the Department of Health and Human Services didn’t instantly reply to HuffPost’s request for remark.

Although Makary doesn’t point out the EPPC report, Hawley’s total argument for reviewing mifepristone depends on the junk science paper. The EPPC report claims it’s the “largest-known study of the abortion pill” and that almost 11% of girls “experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion.” But information scientists voiced critical considerations in regards to the validity of the report, declaring that it’s not peer-reviewed and the report’s suggestions don’t line up with the info they analyzed.

“It is highly concerning that the FDA is committed to a new review of mifepristone, given the massive amount of evidence on its safety and efficacy,” mentioned Dr. Angel Foster, co-founder of the Massachusetts Medication Abortion Access Project, a defend legislation apply that gives telehealth abortion care to folks in all 50 states.

“This is purely politically motivated and not rooted in science,” Foster mentioned. “Rolling back access to mifepristone would be a disaster, especially for the patients that The MAP serves every day – patients living in states where abortion is banned, who can’t afford to pay for a procedure, and for whom neither traveling to another state nor remaining pregnant are options.”

Republicans have been laying the groundwork to undermine the protection of mifepristone for months. It is smart that anti-abortion teams have set their sights on the tablet: telehealth abortion care now accounts for 20% of all abortion care for the reason that Supreme Court repealed Roe v. Wade.

Democrats have repeatedly grilled Makary and HHS Secretary Robert F. Kennedy Jr. about their plans for mifepristone. The FDA commissioner’s promise to overview the abortion tablet stands in stark distinction to his previous statements that he has “no plans” to limit mifepristone. But Makary has repeatedly left the door open, hinting that if there was purpose to imagine mifepristone was unsafe his company would overview it.

Makary has not as soon as acknowledged mifepristone’s confirmed security document for the reason that FDA authorised it in 2000. The remedy has been used safely by over 6 million folks within the U.S., in line with the company. Major medical teams have repeatedly mentioned mifepristone is secure, pointing to greater than 100 research which have corroborated its security and effectiveness.

During a current Senate appropriations listening to, Sen. Patty Murray (D-Wash.) requested Makary in regards to the EPPC report and whether or not he would use it in his strategy to mifepristone. Makary mentioned he would need to see the underlying information of the research, however took problem with Murray’s characterization of the EPPC paper as a “sham study.”

“I have not seen that study, senator, and you have not seen that study,” Makary responded. “So how can you call it a sham, bogus study? Neither of us have seen the study, the underlying data, or the methodology.”

The FDA didn’t reply to HuffPost when requested if Makary’s determination to overview mifepristone stemmed from the EPPC report or if he’s seen its underlying information.

“Even apart from all the red flags with the data and supposed analysis, the fact where they land in the recommendations — that has nothing to do with the research itself — indicates this was driven more by ideology than by scientific rigor,” Rachel Jones, a principal analysis scientist on the Guttmacher Institute, mentioned of the EPPC report in April.

Jones informed HuffPost that she wouldn’t name the paper a “study” because it’s unimaginable for different researchers to totally assess the methodology and integrity of its outcomes with out entry to the underlying information.

“We’ve known this moment was coming, and we’ve been sounding the alarm on Martin Makary since his nomination,” Reproductive Freedom for All President and CEO Mini Timmaraju mentioned in a Tuesday assertion.

“After months of signals and dog whistles, it’s now in black and white on official FDA letterhead,” she continued. “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.”

https://www.huffpost.com/entry/fda-to-review-safety-of-abortion-pill-after-junk-science-report-paved-the-way_n_683f59ace4b06694fa0714b6