Chairman Cassidy Exposes Lack of Action by Chemical Abortion Drug Companies Endangering Mothers in New Report

WASHINGTON - U.S. Senator Bill Cassidy, M.D. (R-LA), Chairman of the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee, released a new report detailing the business practices of chemical abortion drug companies and the lack of visibility into prescribing patterns, especially by online-only prescribers, that are likely putting mothers' lives at risk. This comes after a months-long investigation into abortion pill companies, including Danco Laboratories, GenBioPro, and Evita Solutions.

"Abortion drug companies are putting mothers at risk through their failure to properly oversee the prescription and distribution of their products. We are seeing that the explosion in online sales of chemical abortion drugs has opened the door to coercion and abuse of women," said Dr. Cassidy. "FDA and the sponsors of these drugs have a responsibility to the American people to crack down on these prescribers that violate the prescribing requirements and reinstate the safeguards that keep mothers and babies safe."

Previous Democrat administrations recklessly removed the Food and Drug Administration's (FDA) Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program requirements for reporting non-fatal adverse events and in-person dispensing of chemical abortion drugs, among other important safeguards. Ending these requirements has led to horrific instances of coerced abortions and the proliferation of chemical abortion drugs outside FDA-approved channels in ways that mislead pregnant women and seriously endanger their health and safety.

Despite these dangers, Danco, GenBioPro, and Evita do not take sufficient steps to ensure that their drugs are only available through REMS-compliant channels and that certified prescribers and pharmacies comply with the few remaining FDA requirements, especially when pills are sold online and without the in-person oversight of a medical professional. An example of this is the website Aid Access, which allows individuals to order mifepristone without any medical oversight or direct patient-prescriber relationship. Furthermore, since the 2016 removal of the requirement for prescribers to report non-fatal adverse events to the mifepristone sponsor, the total number of adverse events reported to the FDA has dropped dramatically, raising questions about whether adverse events are being undercounted. From 2000 through 2016, over 4,000 adverse events were reported to FDA, while only 150 were reported in the decade that followed the removal of the reporting requirement in 2016.

In the course of the investigation, Danco and GenBioPro told the Committee that they have no role in ensuring that doctors and other health care providers who prescribe chemical abortion drugs maintain compliance with the FDA requirements, implying that the onus is on the prescribers to police themselves. Given the lack of oversight, there are concerns that these sponsors are disregarding the safety risks of chemical abortions and either overtly or tacitly allowing their products to be sold to bad actors who seek to exploit women for profit.

Background

As Chairman of the HELP Committee, Cassidy led a hearing in January with Louisiana Attorney General Liz Murrill on the dangers of chemical abortion drugs and filed multiple amicus briefs to restore mifepristone's in-person dispensing requirement. He also led conservative Republicans in calling on the U.S. Secretary of Health and Human Services Robert F. Kennedy, Jr., and the FDA to complete a safety review of abortion drugs.

Read the full report here.

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