Dear FDA: Who is overseeing the abortion pill's prescribers?

Though the U.S. Food and Drug Administration (FDA) developed a safety system to monitor adverse events from the abortion pill, it appears no one is overseeing prescribers to ensure they are following the rules.

Prescribers of the abortion pill mifepristone are supposed to...

• prescribe it only according to the safety protocols (known as REMS) and the drug's label.

• prioritize the safety of women.

• confirm compliance with complication/death reports.

Key Takeaways:

• The abortion pill, mifepristone, was placed under the FDA's REMS safety guidelines to protect women.

• The safety requirements have been relaxed in recent years, which has led to confusion about the safety of the abortion pill.

The Details:

The History

The drug mifepristone (200mg)/Mifeprex, approved in 2000, was placed under a safety system known as REMS in 2011 after reports of serious complications and deaths emerged.

Pro-abortion presidential administrations eroded those safety requirements in subsequent years, most recently in 2023, to remove the in-person dispensing requirement and to allow for mail-order and pharmacy dispensing of the drug.

"REMS" stands for Risk Evaluation and Mitigation Strategy, defined by the U.S. Food and Drug Administration (FDA) as "a drug safety program" that the FDA can "require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks."

The manufacturer is usually responsible for making abortion pill training available to providers and is also in charge of certifying and decertifying prescribers. The drug's original manufacturer is Danco Laboratories, but two more generic manufacturers have since been approved:

• 2019: Trump FDA approved GenBioPro (GBP) as the first generic abortion pill manufacturer.

• 2025: Trump FDA approved Evita Solutions as the second.

Certifying prescribers

Those wanting to become certified prescribers of mifepristone must complete the Prescriber Agreement Form and agree that they fulfill the following qualifications:

• Ability to assess the duration of pregnancy accurately

• Ability to diagnose ectopic pregnancies

• Ability to provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made plans to provide such care through others, and ability to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary

The form is clear that prescribers must oversee "compliance with the Mifepristone REMS Program":

By signing this form, you agree that you meet the qualifications below and will follow the guidelines for use. You are responsible for overseeing implementation and compliance with the Mifepristone REMS Program. You also understand that if the guidelines below are not followed, the distributor may stop shipping mifepristone to the locations that you identify and certified pharmacies may stop accepting your mifepristone prescriptions.

The Problem:

Manufacturers aren't overseeing prescribers

The REMS documents state that mifepristone manufacturers must (emphasis added) "[e]nsure that healthcare providers who prescribe their mifepristone are specially certified in accordance with the requirements described above and de-certify healthcare providers who do not maintain compliance with certification requirements."

Live Action News previously asked the FDA if any prescribers had been de-certified, and it responded by email, stating:

Consistent with our obligations under applicable laws, including the Trade Secrets Act, and FDA regulations, including 21 CFR 20.61, the FDA does not disclose this type of information when submitted by an applicant.

However, there is plenty of evidence that the 'sponsors' (manufacturers) are not policing their prescribers or de-certifying those who violate the REMS.

Prescribers are failing to ensure that the abortion drugs are taken in accordance with safety rules and have even schemed to bury the truth about the rate of complications associated with mifepristone.

Prescribers disregard approved gestational limits and dispense pills to non-pregnant women

According to REMS documents, the abortion pill (mifepristone 200mg/Mifeprex) has only been approved by the FDA for use "in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation." The FDA's website confirms this. And yet:

• Abortion providers advertise its use into the second trimester.

• Abortion providers also advocate for its use even into the third trimester, despite its increased rate of failure as pregnancy advances.

Prescribers of the abortion pill are mandated under REMS to accurately determine the gestational age of the pregnancy; however, the industry has been

• prescribing the abortion pill in "advance" of confirmed pregnancy

• selling the pill for "future use"

• selling it as "missed period" pills

READ: Planned Parenthood sells abortion pill past FDA-approved limit… and it’s failing twice as often

In a lawsuit, one abortion pill client alleged she was told "not to call law enforcement" after presenting clinic staff with the body of her 30 to 36-week-old son, who died from the abortion drugs the clinic had prescribed.

Even long-time late-term abortionist Warren Hern criticized this trend of late abortion pill use, questioning the lack of follow-up exams to ensure the uterus is empty, and asking who will care for women with complications.

Prescribers choose profit over safety

The abortion pill's label notes potential serious complications, and while the REMS requires providers to review the patient agreement, some question whether prescribers allocate sufficient time to review the abortion pill's risks with patients.

Prescribers are required under the REMS to have the “[a]bility to assess the duration of pregnancy accurately” and the “[a]bility to diagnose ectopic pregnancies.” 

Yet, prescribers knowingly place women at risk by choosing not to assess either the duration of pregnancy or the existence of an ectopic pregnancy via the no-test protocol.

Nothing is done about this violation, and there are no penalties.

This has been exacerbated by mail-order dispensing and the industry's 'no-test' protocol levied during the COVID-19 pandemic. These methods remove in-person examination, blood work, and lab tests.

Important to Note:

• The failure to conduct appropriate testing can lead to a failure to diagnose a potentially fatal ectopic pregnancy.

• Knowing this, pro-abortion physicians have alerted emergency room staff regarding a potential increase in undiagnosed ectopic cases due to the no-test protocol used by most abortion pill prescribers.

• In 2020, when the abortion industry implemented the “no-test” protocol, it did so despite openly admitting that no-test “criteria are not going to rule out every ectopic pregnancy” and prescribers would then "detect ectopics after treatment….”

After treatment?

With an ectopic pregnancy, time is of the essence.

Given that a baby who has implanted inside the mother’s fallopian tube can cause a rupture and become fatal if not caught in time, a woman must receive prompt care.

The abortion industry, of its own admission, does not rule out an ectopic pregnancy for every abortion pill client. Taking the abortion pill while experiencing an ectopic pregnancy will have no effect on the pregnancy, and the baby will continue to develop in the fallopian tube, putting the mother's life in danger.

While she is expecting to suffer complications from the abortion pill, those expected effects may mask the effects of an ectopic pregnancy.

Attorneys at AbortionInjuries.com point out:

Failure to diagnose an ectopic pregnancy can lead to catastrophic consequences, including rupture, internal bleeding, and loss of fertility. In some cases, women nearly lose their lives because abortion providers overlooked or ignored obvious warning signs.

These tragedies are preventable with basic medical diligence. Legal claims not only provide compensation but also spotlight the reckless practices that put women at risk.

Additional law firms have expressed similar concerns.

Prescribers scheme to hide adverse events

The REMS requires prescribers of the abortion pill to "[e]nsure that any deaths of patients who received mifepristone are reported" to the manufacturers (GBP, Danco, and Evita).

While this sounds simple, it isn't.

• Prior to 2016 REMS changes, prescribers were required to report all adverse events, including "any hospitalization, transfusion or other serious event to Danco Laboratories," which was the sole manufacturer at that time.

• With the 2016 changes, no adverse events other than death were required to be reported.

• Even prior to 2016, Big Abortion concocted a fraudulent scheme: bypass this reporting structure by instructing women at the point of sale to seek emergency care (outside of the clinic setting, at a hospital ER or urgent care) and claim to be experiencing complications of natural miscarriage instead of the abortion pill.

• While abortionists encourage women to do this allegedly for their own protection (despite the fact that currently, women are not penalized under laws restricting abortion), the real goal is to protect the abortion pill.

• One clinical trial sponsor even suggested that emergency room personnel should falsify information to cover up adverse events.

This practice intentionally circumvents the proper reporting chain of adverse events, in which a woman should notify the prescriber, who in turn notifies the manufacturer, who then reports the adverse event to the FDA, which can then track the true dangers of the abortion pill.

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

"As with all drugs, the FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of pregnancy," the FDA claimed. However, the latest published report of adverse events is dated December 2024, over a year ago.

The real problem is not whether the FDA is monitoring reports, but whether those reports are being created at all.

Go Deeper:

Read Live Action News' "Bad Actors" series for further information:

• BAD ACTORS: Abortion industry openly ignores FDA’s abortion pill use limits

• BAD ACTORS: Abortion industry dispenses abortion pills to clients who aren’t pregnant

• BAD ACTORS: As abortion industry veers from FDA abortion pill rules, are they risking client safety?

• BAD ACTORS: Abortion industry set to promote failure-prone abortion drug if abortion pill goes away

• BAD ACTORS: Abortion pill clients left to deal with ectopic pregnancies on their own

• BAD ACTORS: Abortion industry encourages women and doctors to conceal abortion pill complications