Six pro-life medical groups ask HHS & FDA to reinstate abortion pill safeguards

Six pro-life medical groups with over 30,000 members have asked the heads of the U.S. Department of Health and Human Services (HHS) and U.S. Food & Drug Administration (FDA) to reconsider the status of the abortion pill and to reinstate prior safety protocols.

Key Takeaways:

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

• The Biden-Harris administration followed suit, making abortion pills even more readily available by mail-order and pharmacy distribution.

• Recent studies have stated that the complication rate for chemical abortions is significantly higher than previously reported.

• Six pro-life groups are asking HHS head Robert F. Kennedy, Jr (RFK) and FDA head Dr. Martin Makary to consider reinstating the FDA’s previous abortion pill safeguards.

The Details:

Six pro-life groups sent a letter to both RFK and Makary, urging HHS and FDA to analyze the dangers posed by the abortion pill. The groups that signed the letter represent over 30,000 medical professionals — the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), the American College of Pediatricians (ACPedS), the American College of Family Medicine (ACFM), the Christian Medical & Dental Associations (CMDA), the Coptic Medication Association of North America (CMANA), and the Alliance for Hippocratic Medicine (AHM).

“Americans must be able to trust that no matter what, the FDA will rely on the most robust safety standards before and after approving any drug and that they can have truly informed consent by knowing what the risks to taking FDA-approved drugs are,” the groups stated. “Unfortunately, the latest data strongly suggests that hundreds of thousands of women have been harmed by mifepristone while believing that it is ‘safer than Tylenol’.”

The letter noted that the more recent studies should be examined, with the HHS and FDA conducting their own evaluations on the dangers of the abortion pill. Additionally, the groups urged the FDA to reinstate the pre-2016 REMS standards, which would limit the use of the drug to seven weeks’ gestation, require patients to obtain the pills in-person with follow-up appointments, and require reporting of even non-fatal adverse events.

Abortion Doctors Share How The Most Common Abortion Procedures Take Place

Why It Matters:

As Live Action News previously noted:

Decades ago, the abortion industry began encouraging women to lie about their abortion pill complications when visiting the ER.

This protected the drug instead of the women themselves, and led to the rollback of safeguards surrounding the drug.

This deception, in turn, has misled other women — and the rest of the public — about the drug’s actual risks.

Abortion pill prescribers offload their patients to ERs, encouraging women to lie if injured [which means that] neither prescribers nor ER personnel learn the truth about the [abortion pill’s] adverse events.

[Then] no one reports those adverse events to the manufacturer [so that] the manufacturer never learns of the adverse events to report to [the] FDA [and] the FDA stays in the dark about true complications, impacting safeguards.

What this indicates is that a massive coverup began decades ago to hide the true impact of the drug’s complications from the public, the manufacturer, and the FDA. This puts women at risk.

The Backstory:

After the abortion pill (mifepristone 200mg) was originally approved by the FDA in 2000, safety protocols were placed on the drug (REMS) meant to ensure it was administered in as safe a manner as possible. But in 2016, the Obama administration began to make changes, weakening the safety protocols so that the abortion pill could be taken through 10 weeks instead of seven and were no longer required to be taken in-person with a clinician. In addition, the administration removed the requirement for non-fatal adverse events (complications) to be reported. Only deaths associated with the drug would now be reported to its manufacturer.

That trend continued in the Biden-Harris administration, which allowed abortion pills to be sent through the mail and permanently eliminated the requirements for the drug to be dispensed in person. Additionally, permission was given for retail pharmacies to dispense abortion pills.

According to the abortion industry, the abortion pill regimen is “safer than Tylenol,” despite its numerous known complications. Side effects can include severe cramping, contractions, and heavy bleeding, as well as nausea, vomiting, diarrhea, abdominal pain, and headaches.

One recent 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 at least one study, 6% of women experienced complications severe enough to require a visit to the emergency room or urgent care; however, the real number of visits could be even higher, as women are encouraged to lie to emergency room providers and say they are experiencing natural miscarriages as opposed to post-abortion complications.

The “no-test” abortion pill protocol is even more 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 pregnancy or any other contraindications that may put the mother at risk.

The Context:

Recent research released this year reinforced the idea that the abortion is much more risky than what is officially reported.

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, while 16% suffered incomplete abortions.

Another analysis, published in April of 2025 by the Ethics and Public Policy Center (EPPC), 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 was determined 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 — this time 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 FDA’s previous deregulation of mifepristone opened the door to mail-order abortion, which subjects pregnant women to an unacceptably low standard of care, leaving them vulnerable to life-threatening complications, and empowers abusers and traffickers who wish to force unwanted abortions on their victims,” Dr. Christina Francis, AAPLOG CEO and board-certified OB-GYN, said in the medical groups’ press release.

“Our doctors have seen the devastating impact this recklessness has had on patients, which makes clear the dire need for the FDA to reprioritize women and girls by reexamining the drug’s safety and reinstating basic safeguards that should never have been lifted.”

Follow Live Action News on Facebook and Instagram for more pro-life news.