HHS and FDA announce plans to review abortion pill safety protocols

Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. and FDA Commissioner Martin Makary have sent letters to certain state attorneys general (AGs), informing them that the Food and Drug Administration (FDA) will be conducting a full review of the safety of the abortion pill.

Key Takeaways:

• Robert F. Kennedy, Jr. (RFK) was chosen by President Trump to lead HHS, and promised to reinstate pro-life policies in the department.

• Over the summer, six pro-life groups asked HHS and the FDA to reinstate abortion pill safeguards, which had been severely loosened under the Biden administration. Over 20 state AGs did the same.

• Kennedy and Makary have since sent a letter, apparently in response to these AGs, informing them that a full review will be conducted into the safety of the abortion pill.

The Details:

Gateway Pundit obtained a copy of the letter, which was written in response to the July 31 letter from 22 AGs asking the FDA to put abortion pill safety standards back into place.

Kennedy and Makary wrote:

HHS is committed to studying the adverse consequences reported in relation to mifepristone to ensure the REMS are sufficient to protect women from unstated risks. Therefore, through the FDA, HHS will conduct a study of the safety of the current REMS, in order to determine whether modifications are necessary.

HHS's decision to do so is informed by the lack of adequate consideration underlying the prior REMS approvals and by recent studies raising concerns about the safety of mifepristone as currently administered.

To that end, 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...

The concerns you have raised in your letter merit close examination. This Administration will ensure that women's health is properly protected by investigating the circumstances under which mifepristone can be safely dispensed.

HHS and FDA remain committed to protecting the health and safety of pregnant women. This review will help ensure that the FDA's decisions are grounded in Gold Standard Science and rigorous, transparent, and objective evidence.

The pair cited recent studies, including an analysis completed by the Ethics and Public Policy Center (EPPC) which examined a large insurance database and found that women who took the abortion pill experienced serious adverse complications at a rate 22 times higher than the rate reported on the FDA label for the drug (mifepristone 200 mg).

1st Trimester Abortion | The Abortion Pill | What Is Abortion?

The Backstory:

The abortion pill (mifepristone 200mg) was originally approved by the FDA in 2000, with safety protocols placed on the drug (REMS) to ensure it was administered safely. The Obama administration began to weaken the safety protocols, allowing the abortion pill to be taken through 10 weeks instead of seven, and removing the in-person requirement for an abortion client to take the pills in front of a physician. The administration also removed the reporting requirement for non-fatal adverse events, meaning only deaths associated with the abortion pill would be reported to the manufacturer.

The Biden-Harris administration continued to weaken the safeguards, allowing abortion pills to be sent through the mail, which has resulted in several reported cases of forced or coerced abortion. The administration also permanently eliminated the requirement for the drug to be dispensed in person, and allowed retail pharmacies to dispense abortion pills.

Why It Matters:

The abortion industry frequently claims the abortion pill regimen is “safer than Tylenol,” though there are numerous known complications. Side effects can include severe cramping, contractions, and heavy bleeding, as well as nausea, vomiting, diarrhea, abdominal pain, and headaches.

One study found that women are frequently unprepared for the pain after taking the abortion pill; other studies found that abortion pills are four times more dangerous than a first-trimester surgical abortion. In another study, 6% of women had complications which required a visit to the emergency room or urgent care. Yet another study, this time in Ireland, found that 12% of women 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.

Even with all of these studies, the real number could be much higher, as the abortion industry has been caught telling women to lie to emergency room providers and say they are experiencing natural miscarriages, instead of post-abortion complications. This leaves providers, abortion pill manufacturers, the FDA, and the public in the dark.

The abortion industry also has promoted the “no-test” abortion pill protocol, even though it is even more dangerous for women. Without an ultrasound or blood test, neither the preborn child’s gestational age nor the absence of an extra-uterine pregnancy can be verified — both of which are contraindications for the abortion pill.

The Bottom Line:

It is long past time for a review of the abortion pill to be conducted to verify how risky chemical abortions truly are for women.