Last week, Senator Bill Cassidy (R-La.), chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a new report: “Mifepristone Without Guardrails: An Investigation Into How Chemical Abortion Drug Makers Are Putting Mothers and Babies At Risk.” The report follows months of investigation by the committee into the business practices of the three companies that manufacture mifepristone, the first drug taken in the chemical abortion regimen, often referred to as “the abortion pill.”

The report confirms what many in the pro-life movement had already suspected — mifepristone manufacturers are contributing to the current abortion drug crisis happening in our country by failing to follow their obligations under FDA regulations. This shouldn’t come as a big surprise, but several findings in the report are notable.

For background, the three manufacturers (or “sponsors,” as the report refers to them) currently approved by the FDA to market mifepristone for abortion are Danco Laboratories, LLC, GenBioPro, Inc. (GBP), and Evita Solutions, LLC. Mifepristone is subject to a drug safety program called Risk Evaluation and Mitigation Strategies (REMS) meant to safeguard against potential serious side effects. The REMS include requirements for the sponsors of a drug as well as the prescribers. Under the program, prescribers must undergo a training and enrollment process to become certified to prescribe mifepristone.

One of the requirements for the sponsors of mifepristone under the REMS is that they ensure that those who prescribe their mifepristone are properly certified and that they decertify any prescriber not following the certification requirements. To become certified, a health care provider must sign a Prescriber Agreement Form stating that they have the ability to (1) accurately assess the unborn child’s gestational age, (2) diagnose ectopic pregnancies, (3) perform surgery if needed in the case of incomplete abortion or severe bleeding, or to have plans to provide this care through others, and (4) ensure patients have access to medical facilities providing blood transfusions and resuscitation if necessary.

It’s no secret that mifepristone is being shipped through the mail at an alarming rate, and women often have no meaningful contact with a doctor at all, let alone one who is fulfilling the above requirements. As the report notes, Dr. Christina Francis, CEO of the American Association of Pro-Life OB/GYNs (AAPLOG), released a video exposing this very reality. In the video, Dr. Francis orders mifepristone from Aid Access, an online abortion drug seller. She states that she is 13 years old, has an intrauterine device, takes blood pressure and blood-thinning medication, had three caesarean sections, and had an ectopic pregnancy.

Such health issues would put a woman at risk of serious (possibly life-threatening) complications from a mifepristone abortion. However, Dr. Francis received an email within two minutes letting her know that she would be prescribed the pills once they got confirmation of payment. According to AAPLOG, Dr. Francis received generic mifepristone from GenBioPro within one week. How can a prescriber be expected to assess the child’s gestational age accurately, diagnose an ectopic pregnancy, or ensure the patient has access to follow-up care in this scenario?

As the report notes, either the prescriber in this situation is properly certified by the FDA to prescribe mifepristone, but they did not follow the requirements laid out in the REMS, or they are not a certified prescriber at all, making the prescribing and dispensing itself in violation of the REMS. Either way, FDA regulations are being violated.

It seems that Aid Access would be a prime candidate for decertification under the REMS, but when Senator Cassidy asked the mifepristone sponsors to provide a list of prescribers that have been decertified, each company reported that they had never decertified a single prescriber of mifepristone. Not one. Cassidy asked the sponsors how they ensure that their certified prescribers are complying with FDA regulations. They did not provide an answer, but GenBioPro indicated that it is the certified prescriber’s responsibility to ensure compliance with the REMS. As the report says, “In other words, the onus is on the certified prescribers to police themselves, not the mifepristone sponsor.”

The report also notes that both Danco and GenBioPro have links on their websites directing consumers to third-party websites to help them find a mifepristone prescriber. Each of their lists includes sellers that market the drugs to women beyond the FDA-approved limit of 10 weeks of pregnancy. When Cassidy and the committee asked the drug sponsors why they point people to sites that advertise use of mifepristone beyond the FDA’s limit, both Danco and GenBioPro “sought to disclaim any responsibility.” As the report notes, “While it may not violate any law or regulation for Danco and GBP to list those third-party websites on their own websites, it raises the question of whether the two sponsors are indifferent as to whether their drugs are actually prescribed as approved by FDA and in compliance with state laws.” According to AAPLOG, up to 8% of women will require surgical completion of their abortion and this percentage is “much higher” beyond 10 weeks.

Women across the country are undoubtedly experiencing serious complications from mifepristone and the lack of medical oversight, but due to a 2016 change under the Obama administration, there is no longer a requirement for certified prescribers to report non-fatal adverse events from mifepristone to the drug sponsor. This 2016 change also eliminated a previous requirement that prescribers dispense mifepristone in-person. Now, certified prescribers are only required to report deaths.

Cassidy asked the drug sponsors for data related to fatal and non-fatal adverse events, and they pointed to the FDA’s Adverse Event Monitoring System (AEMS) database. Given the 2016 change, the results are unsurprising, but nonetheless, striking. The FDA’s AEMS database shows a significant change in reporting in the number of non-fatal adverse events from before the 2016 change compared to after. Up until the 2016 change, Danco reported approximately 4,000 non-fatal adverse events related to mifepristone (a 16-year period from the drug’s approval in 2000). Since the 2016 change, Danco only reported 150 non-fatal adverse events over the last 10 years. GenBioPro’s generic form of mifepristone was approved after the 2016 change, but it has reported only 10 non-fatal adverse events in the last seven years. Predictably, when prescribers are not required to report non-fatal adverse events, they don’t do it, making the number of women rushed to the emergency room (some of whom barely escape death) unknown.

As the report points out, Danco and GenBioPro have claimed in court documents that reporting non-fatal adverse events is unnecessary, but they have also pointed to the lack of data as justification for the FDA’s move to eliminate the in-person dispensing requirement for mifepristone. The United States Court of Appeals for the Fifth Circuit described this reasoning as a “deeply troubling” “ostrich’s-head-in-the-sand approach.”

The report concludes: “It is also an indictment of FDA that the agency would continuously approve a REMS that did not require any sort of oversight into the prescribers, given the well-documented history of mifepristone marketing and access in violation of the REMS. This posture may have been acceptable while the in-person dispensing requirement was still in place, but in the Wild West of mail-order abortion nationwide without a required provider-patient relationship, it is clear that more stringent oversight mechanisms are needed, beginning with the reinstatement of the in-person dispensing requirement.”

Some might conclude from this that the FDA simply needs more stringent regulations when it comes to sponsors and prescribers of mifepristone, but they’re missing the point. While a reinstatement of the in-person dispensing requirement for mifepristone would be a start, it is by no means sufficient. More stringent regulations may reduce the harms to women and babies, but it would not eliminate them. A drug as dangerous as mifepristone that would require such stringent and complex regulations just to keep women from dying or being rushed to the emergency room should not be on the market. A drug that is approved for the sole purpose of ending human life in the womb should have never been approved in the first place.

I’m grateful for Senator Cassidy and the Senate HELP Committee’s hard work in putting together this informative and comprehensive report. Let’s add it to the growing mountain of evidence for why the FDA should withdraw its approval for mifepristone altogether.

Chantel Hoyt serves as legislative assistant at Family Research Council.