Over 20 attorneys general call on FDA to reinstate abortion pill safeguards

Safety regulations on abortion pills have been increasingly relaxed in recent years, and now, a group of 22 attorneys general have sent a letter to the FDA asking for the previous protocols to be reinstated.

Key Takeaways:

• The Obama administration began weakening the Risk Evaluation and Mitigation System (REMS) safety requirements for mifepristone (the abortion pill) in 2016.

• This trend continued with the Biden-Harris administration, with abortion pills even more readily available through mail-order and retail pharmacy distribution.

• Recent analysis found the complication rate for chemical abortions is significantly higher than previously reported.

• Now, 22 attorneys general have sent a letter to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and Food and Drug Administration (FDA) head Martin Makary demanding the pre-2016 REMS requirements be reinstated.

The Details:

According to Fox News, a coalition of 22 Republican attorneys general, led by Kansas Attorney General Kris Kobach, sent a letter to Kennedy and Makary requesting that the previous REMS requirements be reinstated, citing a recent analysis from the Ethics and Public Policy Center (EPPC), which found that women experience serious adverse complications at a rate 22 times higher than the rate reported on the FDA label for abortion pills.

“Recent comprehensive studies of the real-world effects of the chemical abortion drug mifepristone report that serious adverse events occur 22 times more often than stated on the drug’s label, while the drug is less than half as effective as claimed. These facts directly contradict the drug’s primary marketing message of ‘safe’ and ‘effective,'” the letter said. “Based on that review, the FDA should consider reinstating safety protocols that it identified as necessary as recently as 2011 in its issuance of a Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, but which were removed by the Obama and Biden administrations.”

If the safeguards cannot be put back into place, the letter asked that the abortion pill be made unavailable completely, until a review of its safety can be completed. Furthermore, the AGs suggested that the weakening of the REMS safeguards was initiated based on political beliefs, not based on evidence that it would increase the wellbeing of women.

“The FDA’s removal of these crucial safety protocols in 2016 (and in 2023) that only five years before the FDA considered necessary begs the question of whether the removal was motivated by considerations other than the safety of patients … The current FDA’s dedication to the health and wellbeing of all Americans is encouraging, as is the much-needed review of mifepristone that Secretary Kennedy has promised,” the group concluded.

Zoom In:

The abortion pill (mifepristone 200mg) was originally approved by the FDA in 2000, with safety protocols were placed on the drug (REMS) to ensure it was administered safely. But in 2016, the Obama administration began weakening the safety protocols, allowing the abortion pill to be taken through 10 weeks instead of seven. Additionally, requirements to report non-fatal adverse events (complications) and to take the pills in-person with a clinician were removed. Only deaths associated with the drug would thereafter be reported to its manufacturer.

When Joe Biden took office, the standards continued to be weakened, with pills allowed to be sent through the mail, and distributed through retail pharmacies. The requirements for the drug to be dispensed in person were permanently eliminated.

Why It Matters:

Another overlooked issue is the fact that women reporting to ERs as a result of abortion pill complications (like hemorrhaging, for instance) have for decades been encouraged to lie to doctors and staff about the fact that they took the drugs; instead, the abortion industry has told them to say they are experiencing a natural miscarriage (despite the women having no risk of prosecution for an abortion).

Because prescribers 1) offload complications to ERs and 2) encourage women to lie, in addition to the fact that 3) the Obama FDA said reporting even serious non-fatal complications wasn’t necessary, this has made the abortion pill appear far safer than it actually is. A vast amount of abortion pill complications are never reported to the drug’s manufacturers, and are therefore also never reported to the FDA.

There are already numerous known complications of the abortion pill regimen, with side effects including severe cramping, contractions, and heavy bleeding, as well as nausea, vomiting, diarrhea, abdominal pain, and headaches. The “no-test” abortion pill protocol, which has been championed by the Biden administration, is extremely risky for women. Without an ultrasound or any blood tests beforehand, there is no way to truly confirm a preborn child’s gestational age, and no way to rule out an extra-uterine (ectopic) pregnancy or any other contraindications that may put the mother at risk.

One study found that women were almost always unprepared for how painful the chemical abortion process would be, while other studies found that chemical abortions are four times more dangerous than a first-trimester surgical abortion.

In Ireland, 12% of women who underwent chemical abortions between January 2019 and December 2022 experienced complications severe enough to require a visit to the emergency room, with 16% suffering incomplete abortions.

The analysis cited by the AGs found that nearly 11% of women (10.93%) experienced sepsis, infection, hemorrhaging, or other serious or life-threatening adverse events within 45 days of taking the abortion pill, which the EPPC was able to determine by examining an insurance claims database. This is 22 times higher than the “less than 0.5 percent” serious adverse events rate reported by the FDA on the mifepristone label. This means more than one in ten women experienced at least one serious complication from taking mifepristone within 45 days, according to information gleaned from a large insurance database.

Still more research — a peer-reviewed study from the Charlotte Lozier Institute released in May of 2025 — further debunked the claim that the abortion pill regimen is ‘safer than Tylenol.’

The Bottom Line:

The abortion industry has scammed the American people with sleight of hand surrounding the abortion pill for decades. The abortion pill is not safe for women, and it’s long past time for action to be taken.

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