FDA says it plans for abortion pill safety review to be completed in a year 'or sooner'

The U.S. Food and Drug Administration (FDA) published a formal statement on its website regarding a "safety study of mifepristone" — the abortion pill — claiming that a safety review of the drug is expected to be final in a year or "sooner than that timeframe."

Key Takeaways:

• In February of this year, the FDA updated its website, claiming that it is "conducting a safety study of mifepristone" and that the "current agency plan is to have this study done sooner than" the typical year-or-more timeframe.

• It has been made clear in litigation and court rulings that the FDA's reasoning has been circular: the decision to halt the reporting of non-fatal adverse events (complications) of the abortion pill in 2016 led to the faulty 2021 conclusion that the drug is safe because there was an absence of non-fatal adverse-event reports.

• In addition, the abortion industry itself has for years executed an end-run around adverse event reporting (even before the 2016 reporting changes) by urging women to go to the ER (not back to the medical provider or prescriber) when experiencing abortion pill complications, knowing full well that only the prescribers — not hospital ER staff — was contractually obligated to report complications.

• The Fifth Circuit Court of Appeals stated, "It’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the absence of data to support its decision."

The Details:

The FDA's statement

In February 2026, the FDA updated its website page, "Questions and Answers on Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation." The last time this website was updated was in February of 2025, one year prior.

The FDA wrote this month (emphases added):

FDA is conducting a safety study of mifepristone.

As of February 2026, the FDA continues to work on the collection of the robust and timely data that is necessary for a well-controlled study with adequate statistical power. The next steps of the mifepristone safety study will be data exploration, evaluation of data integrity, and implementation of the analyses, validation, and peer-review.

Once the FDA finishes its analysis of the data, the agency will decide whether to make substantive changes to the REMS.

If the FDA determines that changes to the REMS are warranted, then the agency will take appropriate action.

The agency is taking care to do this study properly and in the right way.

We are planning to complete the study as soon as possible while ensuring we are not cutting any corners from a scientific research standpoint.

In academia, studies like these, including the appropriate steps described above, often take approximately a year or more to conduct. The current agency plan is to have this study done sooner than that timeframe. Drug safety is a paramount issue with all drugs that the agency approves. We will continue to keep you posted on this project.

The Backstory:

The abortion pill mifepristone (200 mg) was approved by the FDA in 2000. In 2011, following the deaths of women from a serious infection the drug was placed under a safety program known as the Risk Evaluation and Mitigation Strategy (REMS), which the FDA can "require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks."

REMS are rare, and are different from the warnings typically listed on other drugs.

The REMS initially required:

• in-person dispensing of the abortion pill

• all adverse events to be reported to the FDA

• prescribers of the drug had the ability to handle complications and rule out potentially deadly ectopic pregnancies

• gestational age must be limited to no more than 10 weeks

These requirements have been eroded multiple times.

In 2023, the Biden-era FDA eroded the REMS to remove the in-person requirement enabling the drug to be dispensed by mail and in pharmacies.

What prompted the review?

When running for the President, Donald Trump incorrectly claimed that the Supreme Court had made a decision on the legality of the abortion pill.

“First of all, the Supreme Court just approved the abortion pill and I agree with their decision to have done that, and I will not block it,” Trump stated in a 2024 debate.

That claim was based on a ruling by SCOTUS in the Alliance for Hippocratic Medicine (AHM) lawsuit, in which the court ruled that the Plaintiff doctors did not have standing to sue.

However, the Court did not rule on the merits of the case nor approve the deadly drug. Since then, multiple states which do have standing have filed lawsuits demanding injunctive relief from the FDA's 2023 erosion of the abortion pill's REMS, claiming the drug is not safe and harms women, among other claims.

Timeline

• May 2025: the Ethics and Public Policy Center (EPPC) published an analysis, “The Abortion Pill Harms Women,” which looked at insurance data and allegedly revealed that serious adverse events from mifepristone are happening about 22 times more often than the FDA reports. That same month the FDA Secretary asked FDA for a complete review.

• September 2025: FDA Secretary told Republican states this week that the FDA would conduct a new review of abortion pills.

• November 2025: 175 members of Congress sent a letter to FDA Secretary Robert F. Kennedy Jr and Commissioner Martin Makary, MD asking for an investigation and review of the safety of mifepristone.

• December 2025: The FDA Commissioner was accused of delaying the review.

Elizabeth Troutman Mitchell

@TheElizMitchell

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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

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10:56 PM · Dec 9, 2025

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Since then, demands for the review have only grown louder.

FDA claims it is 'monitor[ing]' safety data - but is it?

"As with all drugs, the FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of pregnancy," FDA claimed, adding (emphases added):

As with all approved drugs, when the FDA receives new information regarding adverse events, the agency reviews the new information and, as appropriate, takes necessary action. This could include, for example, providing updates to health care providers and their patients so that they have information on how to use a drug safely...

The FDA continuously reviews reports of adverse events to, among other things, determine whether they are known risks or whether they are signals of emerging safety concerns.

However, the latest document of reported adverse events published by the FDA is dated December 2024 — over a year ago.

READ: FALLOUT: How dumping patients and pushing a lie misled everyone about the abortion pill

Reality Check:

Scheme to hide abortion pill safety record

In 2016, the Obama FDA changed several things about the REMS, including:

• Removing the requirement to report any abortion pill complications other than deaths

• Allowing expanded use of the drug, increasing it from seven to 10 weeks gestation

Interestingly, the 2016 REMS erosion was not one that Danco, the drug's manufacturer, originally sought. In fact, at that time, Danco claimed it was short the millions of dollars to even attempt it.

The REMS change was instead pushed and financed by a pro-abortion coalition — including groups like Planned Parenthood, NARAL, and others — who helped the manufacturer "raise money."

So, it should come as little surprise that even the adverse events reporting requirements were flouted in a deliberate hoax created by Big Abortion, to hide complications from those required to report, which in turn keeps the FDA in the dark about the real-world risks and complications from the abortion pill.

As Live Action News previously demonstrated, long before 2016 changes occurred, Big Abortion had schemed to hide complications by advising women at the point of sale to lie about their complications, should they ever need to visit the emergency room.

The reporting structure set up by the FDA's REMS would be that the abortion client would report an adverse event to the prescriber who would inform the manufacturer (Danco, GenBioPro), who would then report to the FDA.

Instead, abortion pill prescribers openly (under the nose of the manufacturers in charge of decertifying and policing prescribers) advised abortion pill clients to simply present to an emergency department (ER) and claim to be experiencing a natural miscarriage instead. This way, the prescriber — who was contractually obligated by their Prescriber Agreement to have the ability to handle an abortion pill complication or refer them to a facility who could, and who was required to report complications) — would remain ignorant of the complications (by design), and therefore, would never be expected to report them.

In other words, all complications were offloaded intentionally to overcrowded ERs, and likely on the backs of taxpayers who may be forced to unknowingly foot the bill (especially for those who were advised to lie). And, as Big Abortion knew all too well, emergency departments - unlike the prescriber and abortion pill manufacturer - were not required to report any abortion pill complication to the FDA.

On the Frontlines of the Abortion War: Death Threats and Arsons

Is the absence of data a reasonable metric?

A group of five dozen lawmakers appropriately pointed out in an amicus brief supporting Louisiana's lawsuit against the FDA's 2023 REMS that the prior removal of the reporting of non-fatal adverse events (and misrepresentation of prior reporting as well) has created a "lack of data" as a "logical consequence" of the FDA's changes to the 2016 REMS (emphases added):

The FDA’s conclusion heavily relies on adverse events collected from the drug manufacturers and the FDA’s Adverse Event Reporting System (FAERS) during periods when the in-person dispensing requirement was not being enforced to conclude that eliminating the in-person requirement would not affect safety.

But this is not evidence of safety. The Biden FDA admitted that “[r]ates of occurrence [for an adverse event] cannot be established with [FAERS] reports.”

... Thus, as the Fifth Circuit explained, “FDA’s decision to rely so heavily on data from FAERS ‘runs counter to’ the critical limitations associated with that data.”

... And the lack of data is the logical consequence of the FDA’s action in 2016 to remove the requirement for providers who prescribe abortion drugs to report non-fatal adverse events. Because of this, FAERS data on the safety of chemical abortion drugs significantly understates the risk.

As the Fifth Circuit has already pointed out, “[a]fter eliminating that adverse-event reporting requirement, FDA turned around in 2021 and declared the absence of non-fatal adverse-event reports means mifepristone is ‘safe.’”

"It’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the absence of data to support its decision," the Court document explained.

It is also unreasonable for the FDA to rely on a reporting system by trusting that the abortion pill's manufacturers would properly train and police prescribers. Instead Danco and GenBioPro looked the other way while Big Abortion's scheme to bury adverse events from the abortion pill unfolded.

The Bottom Line:

As part of the FDA's already-delayed review, it is hoped that the government agency will look at adverse event reports that were intentionally kept hidden by deception and lies in order to keep the drug on the market.

Read more about these and other concerns in Live Action's comprehensive report, "The State of Chemical Abortion: A Mechanism of Death."