Mifepristone Oversight Senate Report: Summary and Reaction
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The abortion pill now accounts for the majority of abortions in the United States. Studies show that it can cause serious complications including hemorrhaging, incomplete abortion, sepsis, and death. To protect women, the Food and Drug Administration (FDA) has rules and protocols in place to help prevent those complications. However, the companies responsible for implementing those safeguards cannot say, with any confidence, that the people prescribing the abortion pill are actually following them.
A new Senate Health, Education, Labor, and Pensions Committee investigative report released in August examined the three companies that sponsor FDA-approved mifepristone. The report confirmed what pro-life advocates have argued for years: the abortion industry answers to no one.
Under the FDA’s Risk Evaluation and Mitigation Strategy, or REMS, mifepristone prescribers must attest that they can accurately determine gestational age, diagnose ectopic pregnancy, arrange emergency care, and comply with specific patient-counseling and record-keeping requirements.
The companies Danco and GenBioPro (GBP) have each certified thousands of such prescribers. Neither has ever decertified a certified prescriber. Under questioning, Danco admitted it does not audit individual prescribers or independently verify the attestations they sign. GBP took the same position. When investigators asked how GBP makes sure online prescribers actually follow the rules, the company pointed to the Prescriber Agreement Form instead, saying responsibility belongs to the prescriber, not the company. That directly contradicts the FDA's own position, which holds the manufacturer responsible for implementing the REMS.
The report discusses an example of what can happen when no one is ensuring prescribers follow the law. Dr. Christina Francis of the American Association of Pro-Life Obstetricians and Gynecologists conducted an undercover investigation by ordering mifepristone through the abortion pill website Aid Access. She never spoke directly with a prescribing physician.
Dr. Francis posed as a 13-year-old girl and reported that she had an IUD, anemia, blood-thinning medication, blood-pressure medication, three previous C-sections, and a prior ectopic pregnancy. In a doctor’s office, any one of those conditions, much less their extraordinary combination, should have led to an assessment, follow-up questions, or a possible end to the transaction. According to the report, she had a prescription in two minutes, no questions asked, and pills in her mailbox within the week.
This careless approach to prescribing the abortion pill not only places women and girls at risk of complications from the pills they order but also creates endless opportunities for abuse. A medication that can be obtained anonymously, prescribed without a face-to-face encounter, and mailed to any address in the country will inevitably be received by people with no intention to take it themselves.
In fact, there have been documented cases in which male partners obtained mifepristone online and used it to force pregnant women into taking it without their knowledge or consent. There seems to be no one following up to ensure prescribers are actually following the guidelines that could prevent these abuses.
Worse yet, some prescribers who don't follow the safety protocols may be deliberately difficult to identify. The REMS depends on knowing who prescribed the drug, who received it, and what happened afterward. Despite this, several states have enacted so-called "Shield Laws,” enabling anonymity for providers dispensing abortion pills. California, Maine, New York, Vermont, and Washington let prescribers remove their names from a mifepristone prescription label. By Danco’s count, nearly half of its certified prescribers practice in states where they can anonymously prescribe the drug.
This lack of accountability is by design. A medical consultant for Danco admitted the company fought for years to eliminate the safety rules entirely. GBP bragged, in its own marketing, about lobbying to loosen prescriber requirements before the drug was even approved. The industry wrote the rules it now refuses to enforce.
Pro-life Americans have said for years that regulators rushed this drug to market and shielded it from real accountability. President Trump's FDA now has the evidence, the authority, and the responsibility to fix this situation. It’s time to immediately reinstate the in-person visit requirement, restore adverse-event reporting, hold these companies accountable, and start enforcing the rules already on the books.
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Herb Geraghty is the Director of Communications at Secular Pro-Life, a nonprofit organization run by atheists that exists to advance secular arguments against abortion and bring more nontraditional voices into the pro-life movement.
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