FDA Commissioner accused of intentionally delaying abortion pill safety review
UPDATE, 12/9/25, 11:00p EST: In an interview with The Daily Signal's Elizabeth Troutman Mitchell, FDA Commissioner Marty Makary stated:
"There are studies that are done using adverse events, self-reported data. But that data's not very good. When you do a study based on self-reported data, you're not capturing a lot of the data that you wanna know in a study. Part of a robust study is data acquisition, and so we are in the data acquisition phase to get the right data to do this study."
EXCLUSIVE‼️: @DrMakaryFDA responded to a report saying he is delaying the review of the abortion pill.
The FDA is currently in the “data acquisition phase” of the review," he told @DailySignal.
“We do an ongoing review, but we’re also engaging in a robust study that can serve
12/9/25: The Food and Drug Administration (FDA) is accused of delaying a review of the abortion pill mifepristone, and as a result, some pro-life leaders have called for President Trump to fire FDA Commissioner Marty Makary.
Key Takeaways:
FDA Commissioner Marty Makary is accused of "slow walking" a study into the safety of the abortion pill, mifepristone.
Pro-life groups have called for him to be fired, but the Trump administration is pushing back, claiming there has been no intentional delay.
Bloomberg.com claimed in its article that the abortion pill has been found safe, but these claims are inaccurate.
The Details:
According to Bloomberg.com, "people familiar with the matter" said the the review of the abortion pill mifepristone has been delayed at the request of Makary, who wanted to put it off until after midterm elections. The Bloomberg report claimed (emphasis added):
Makary and Health and Human Services Secretary Robert F. Kennedy Jr. have told lawmakers and state attorneys general for months that they are actively conducting a review of mifepristone. But behind the scenes, Makary has told agency officials to delay the safety review, people familiar with the discussions said...
... Pushing the closely watched abortion pill study beyond next year’s midterms has the potential to help minimize the role of abortion in the upcoming elections, in which some Republicans are facing tough battles to hold onto their seats. Abortion restrictions popular with the right-wing base don’t necessarily poll well with all voters. A 2024 Pew survey found majorities of moderate or liberal Republicans say abortion should be legal in all or most cases.
RFK Jr. says he has asked FDA to do a thorough review of mifepristone in light of a study indicating serious side effects could be 22x more common than the FDA says
Kennedy and Makary have been publicly saying the study is moving forward. In a Sept. 19 letter to Republican attorneys general, they said “HHS — through the FDA — is conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug.”
A month later, after the agency approved another generic version of the abortion pill, 17 GOP senators pressed Makary for details about the status of that safety review in a letter dated Oct. 16, expressing concern that the agency wasn’t working quickly enough.
The Backstory:
The FDA's promise of a review followed a large insurance claims analysis published by the Ethics and Public Policy Center (EPPC), which suggested a correlation between the removal of in-person requirements to obtain the abortion pill and an increase in subsequent emergency department visits, possibly due to significantly decreased practitioner/patient oversight in the "no-test" and mail-order abortion pill processes.
As Live Action News previously reported, the EPPC data suggested that nearly 11% of women (10.93%) experience sepsis, infection, hemorrhaging, or other serious or life-threatening adverse events following a mifepristone abortion. This means one in 10 women likely experience at least one serious complication from taking mifepristone within 45 days. The authors claimed this was a rate 22 times higher than the “less than 0.5 percent” serious adverse events rate reported by the FDA on the mifepristone label.
Despite concerns, in September of 2025, the FDA greenlit approval of a second generic abortion pill from Evita Solutions LLC. A letter sent by GOP leaders at that time called for those involved in the decision to be ousted.
A letter sent to a group of GOP state attorneys general in September confirmed that the FDA was reviewing evidence about the safety of mifepristone to investigate how it can be safely dispensed.
“This Administration will ensure that women’s health is properly protected by thoroughly investigating the circumstances under which mifepristone can be safely dispensed,” Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary wrote in the letter, sent Sept. 19.
What's Happening Now:
Lila Rose, president and founder of Live Action, responded to the Bloomberg report on X, writing, "If Dr Makary will not act as head of the FDA to protect children and mothers he should be fired..."
If Dr Makary will not act as head of the FDA to protect children and mothers he should be fired. Under his watch abortion pills kill preborn children and endanger women and the study he promised is nowhere to be found. End mail order abortion. Ban the abortion pill now!
Sen. Josh Hawley (R-Mo.) previously wrote on X, according to The Hill, "The FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they’ve just greenlighted new versions of it for distribution. I have lost confidence in the leadership at FDA."
Today, Hawley alleged the "... FDA lied to me and other members of Congress..."
"FDA needs to stop dithering & reinstate the mifepristone safety guardrails. Nothing less is acceptable," he added.
NEW report saying FDA lied to me and other members of Congress & is not actively reviewing the chemical abortion drug at all. FDA needs to stop dithering & reinstate the mifepristone safety guardrails. Nothing less is acceptable news.bloomberglaw.com/health-law-and…
Likewise, Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, stated, "The FDA needs a new commissioner who will immediately reinstate in-person dispensing as it existed under President Trump’s first term and immediately conduct a comprehensive study,” she wrote in a statement. “Commissioner Makary is severely undermining President Trump and Vice President Vance’s pro-life credentials and their position that states should have the right to enact and enforce pro-life protections. Makary must go.”
NEW — SBA Pro-Life America: Fire Makary
Today, SBA Pro-Life America called for FDA Commissioner Marty Makary to be fired amid reports that he has slow-walked a promised safety study of women’s real-world experiences taking abortion drugs.
More 🔽
sbaprolife.org/newsroom/press…
The @FDA promised American women an urgent review of dangerous abortion pills. Instead, not only have they slow walked their review, but at the same time, they approved a second generic version of these deadly drugs that are proven to harm women and kill preborn children.
No
“It’s politics over women,” Brad Kehr, government affairs director for Americans United for Life, wrote on X. “Votes over safety.”
However, HHS spokesperson Andrew Nixon told Bloomberg.com, “Assertions that the FDA is slow walking this review for political purposes are baseless. FDA’s comprehensive scientific reviews take the time necessary to get the science right.”
According to the Washington Examiner, HHS press secretary Emily Hilliard also claimed the FDA's reviews take time in order to get quality results. "The FDA's comprehensive scientific reviews take the time necessary to get the science right, and that's what Dr. Makary is ensuring," she said.
A senior White House official made the same claim, telling RealClearPolitics (RCP), “The study is not being ‘slow walked.' Comprehensive and exhaustive reviews take time."
RCP added:
“FDA Commissioner Marty Makary is working diligently to ensure that Americans have the best possible, Gold Standard Science study of mifepristone. The White House maintains the utmost confidence in Commissioner Makary,” Trump spokesman Kush Desai told RCP in a statement, pointing to “one landmark victory for the American people after another” from his crackdown on artificial food ingredients to the first safety review of baby formula in decades.
“Uninformed attacks against Commissioner Makary from individuals outside the administration will not change these facts,” said Desai.
Debunking Bloomberg's claims:
Bloomberg claimed that the abortion pill mifepristone is safe, but evidence shows otherwise.
BLOOMBERG CLAIM: A "large body of evidence shows that the pill is safe enough for women to take at home."
THE TRUTH: The "evidence" linked to by the media outlet is actually a Bloomberg article suggesting that the abortion pill is "safer than Tylenol" — a claim previously debunked by Live Action News multiple times.
“No caring physician would call Mifepristone ‘as safe as Tylenol,’” Missouri Attorney General Hanaway recently said. “That claim was always false. Women are ending up in emergency rooms, and manufacturers know it.”
BLOOMBERG CLAIM: "Studies the FDA cites in its prescribing information puts the rate of serious side effects at less than 0.5%."
THE TRUTH: The previously mentioned EPPC analysis suggested that rate is likely much higher for women taking it outside a carefully controlled trial — which is why the review was requested to begin with.
BLOOMBERG CLAIM: "A 2013 paper reviewing abortion data for 45,000 women showed just 0.3% of patients who took the pill ended up hospitalized. The study’s authors concluded that abortion by pill is 'highly effective and safe.'”
THE TRUTH: That review was authored by pro-abortion activists Elizabeth G. Raymond and Beverly Winikoff, both associated with Gynuity Health Projects. Gynuity conducted mail-order abortion clinical trials, and its own 2021 telabortion study resulted in approximately 6% of women facing complications from the abortion pill which resulted in ER or urgent care visits.
In 2016, the Obama FDA removed all requirements that any of mifepristone's adverse events (other than fatalities) be reported. Live Action News has documented that for decades, the abortion industry has participated in a scheme to hide abortion pill complications by advising women to present to emergency rooms and falsely claim that they are experiencing natural miscarriages. This deception virtually guarantees that complications have been misreported for many years, and quite possibly will never be accurately reported.
Key Timeline:
April 28, 2025: Ethics and Public Policy Center published an analysis suggesting that "The real-world rate of serious adverse events following mifepristone abortions is at least 22 times as high as the summary figure of 'less than 0.5 percent' in clinical trials reported on the drug label."
May 14, 2025: Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. asks FDA for ‘complete review’ of abortion pill risks.
September 5, 2025: Pro-abortion Center for Reproductive Rights (CFRR) filed a lawsuit over what it claims is Trump Administration's "failure to respond to multiple Freedom of Information Act [FOIA] requests seeking transparency around its re-evaluation of abortion pill safety."
September 19, 2025: HHS Secretary Kennedy, Jr. and FDA Commissioner Martin Makary sent letters to certain state attorneys general (AGs), informing them the FDA would be conducting a full review of the safety of the abortion pill.
November 13, 2025: Pro-abortion ACLU files a lawsuit to compel compliance with the Freedom of Information Act" seeking "records" to promote "transparency and ensure the integrity of FDA’s review of its regulation of mifepristone."
December 9, 2025: Bloomberg.com reports FDA has delayed review of Mifepristone (200).
The Bottom Line:
Despite two pro-abortion lawsuits filed for "transparency" over the abortion pill review, it is important to note that the full record on the abortion pill's original approval process has yet to be unveiled by the FDA, despite demands for those records.
Today, while abortions overall are on the rise, Planned Parenthood's former"special affiliate," the Guttmacher Institute, recently attributed those higher numbers tomail-order abortion pills.
And, as delays in the FDA's abortion pill review continue, the casualties mount.
The FDA's latest report estimates that, since its approval in 2000, the number of women using mifepristone to abort their children through December 2024 has now climbed to "approximately 7.5 million.”
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Abortion Pill·By Carole Novielli
