GUEST OPINION: Abortion pill makers fail to do job of enforcing drug's safeguards

Disclaimer: Opinions expressed in this guest post are solely those of the author.

People often ask whether a class-action lawsuit against the manufacturers of mifepristone (Danco Laboratories’ Mifeprex and GenBioPro’s generic) is feasible under traditional product-liability theories. I explain that those claims face steep hurdles: the drug carries FDA-approved labeling with prominent warnings, courts generally defer to the agency’s safety determinations, and proving specific causation for rare adverse events in individual patients is expensive and difficult. 

There is, however, a potentially more straightforward avenue: suing the manufacturers for failing to enforce the Risk Evaluation and Mitigation Strategy (REMS) program — a safety protocol — they are legally required to maintain.

Key Takeaways:

• Prescribers of the abortion pill, mifepristone/Mifeprex, are required to hold to certain standards.

• The manufacturers are responsible for certifying these prescribers, monitoring compliance, and de-certifying those who are non-compliant. Evidence suggests this is widely left unenforced.

• REMS enforcement records, distribution data, and adverse-event reports should be examined to find out whether the manufacturers are properly policing prescribers.

The Details:

The FDA-mandated mifepristone REMS exists precisely to mitigate serious risks—sepsis, excessive bleeding, and undiagnosed ectopic pregnancy—by restricting distribution to certified prescribers and pharmacies who agree to specific safeguards. 

Under the REMS, prescribers must certify that they can:

•  Accurately assess gestational age (the drug is approved only through 70 days).

•  Diagnose ectopic pregnancies.

•  Provide or arrange surgical intervention for incomplete abortion or severe bleeding and assure access to facilities equipped for blood transfusions and resuscitation.

They must also review the FDA-approved Patient Agreement Form with each patient, fully explain the risks (including serious infection and heavy bleeding), obtain the patient’s signature, provide her a copy along with the Medication Guide, and keep the signed form in the medical record. Pharmacies that dispense the drug must similarly certify.

Accountability issues

The manufacturers (sponsors) are responsible for certifying these providers and pharmacies, monitoring compliance, and de-certifying those who fail to maintain it. They control distribution and are supposed to ensure the drug reaches only compliant parties. 

The drug label has a black box warning, which states: “Serious and sometimes fatal infections and bleeding occur very rarely following … medical abortions, including following MIFEPREX use.”

It highlights atypical presentations of sepsis (sometimes without fever) and warns that prolonged heavy bleeding may signal incomplete abortion or other complications requiring immediate intervention.

Ectopic pregnancy is a contraindication because mifepristone does not terminate it.

The labeling also requires the same Rh-isoimmunization prevention measures used in surgical abortion. 

Yet evidence suggests widespread non-enforcement.

Online and telehealth providers often rely on patient self-reporting of last menstrual period (LMP) for gestational dating. ACOG notes that roughly half of women do not accurately recall their LMP date. 

Studies of abortion-seeking patients show that while many can self-assess early gestation reasonably well, the error rate is non-trivial, and the REMS places the accuracy obligation on the certified prescriber.

Duties and obligations

Some clinics and telehealth services advertise the abortion pill as “safer than Tylenol,” a claim that directly contradicts the black-box warnings and has drawn state attorney-general scrutiny (e.g., Florida’s recent action against Planned Parenthood). 

If manufacturers are certifying (or continuing to supply) providers and pharmacies that ignore these obligations—failing to verify gestational age properly, allowing misleading safety claims, or skipping required counseling and documentation—then they are not fulfilling their REMS duties. The sponsors’ own agreements state they will de-certify non-compliant parties and stop distribution to them.

What good is a REMS if the companies charged with enforcing it treat certification as a mere formality?

The FDA is the primary regulator, but private plaintiffs harmed by alleged violations have standing to seek remedies when manufacturers breach duties that directly protect patients. A class action focused on systemic failure to enforce the prescriber and pharmacy agreements could be far more targeted than diffuse product-liability suits.

It would force the companies to either police their network rigorously or face financial consequences for the gaps that leave women exposed to the very risks the REMS was designed to prevent.

The Bottom Line:

Plaintiffs’ attorneys who care about patient safety—regardless of their views on abortion—should examine the REMS enforcement records, distribution data, and adverse-event reports. The manufacturers have the contractual and regulatory tools; the question is whether they are using them. If not, the courts are an appropriate venue to hold them accountable.

Michael Seibel is a pro-life abortion malpractice attorney based in Albuquerque. Mr. Seibel has prosecuted abortion malpractice cases on behalf of women injured by the abortion industry. He may be contacted at (505) 275-1700 or mikeseibel@qwestoffice.net. His website is: https://abortioninjury.com/