Senate Report Rips Abortion Pill Makers' Oversight

Sen. Bill Cassidy, R-La., has released a Senate report accusing the three companies that make the abortion drug mifepristone of failing to police the doctors who prescribe it — and is asking the FDA to bring back the in-person dispensing requirement.

The report caps a months-long investigation by the Senate Health, Education, Labor and Pensions Committee, which Cassidy chairs, into Danco Laboratories, GenBioPro and Evita Solutions.

It also asks the Justice Department to explore legal action against prescribers who knowingly violate federal safety rules.

What The Report Says

Cassidy's central charge is that the manufacturers say they have no role in making sure prescribers comply with FDA requirements — even as pills move through online third-party sellers. According to the report, Danco and GenBioPro both told the committee as much, and both link to the website Aid Access from their own sites.

Aid Access lets people order mifepristone online without an in-person patient-provider relationship, which is permitted under Biden-era rules. The report says it is unclear who actually supplies the drug in those orders or whether those parties are certified under the FDA's Risk Evaluation and Mitigation Strategy program, and notes the site advertises prescribing through 14 weeks of pregnancy — past the FDA's 10-week limit.

The report says investigators obtained mifepristone online using fake patient information, and that prescribers are not required to verify a patient's identity, gestational age or compliance with state restrictions. It says no provider has ever lost FDA certification, and manufacturers are not required to audit prescribers.

On adverse events: since the reporting requirement for non-fatal complications was dropped, very few have been logged. Danco reported roughly 4,000 non-fatal adverse events between 2000 and the 2016 change, the report says, but only 150 in the last 10 years.

The report also flags overseas manufacturing. Danco's active ingredient for Mifeprex is made in Spain and finished at an undisclosed facility elsewhere in Europe; the company declined to give the committee more detail, citing security concerns and commercial sensitivity. GenBioPro's and Evita's products are made at facilities in India.