WASHINGTON, D.C. — The report is the result of a monthslong investigation by the committee into Danco Laboratories, GenBioPro, and Evita Solutions. Cassidy accuses abortion pill makers of allowing third-party retailers to sell drugs without oversight and failing to report non-fatal adverse events. He stated that the Department of Justice should explore legal avenues to address willful noncompliance with safety requirements.

Cassidy also stated that the FDA should take immediate action to reestablish an in-person dispensing requirement for mifepristone. "We are seeing that the explosion in online sales of chemical abortion drugs has opened the door to coercion and abuse of women," he said. In the report, Cassidy accused the FDA of "dragging its feet" on the review of the safety of the abortion drug. The report calls on legal and regulatory authorities to take action regarding the companies' reported failures to comply with federal safety reporting obligations.

The report cites the website Aid Access as an example of a platform allowing individuals to order mifepristone online without an in-person patient-provider relationship. The Aid Access website advertises prescribing mifepristone through 14 weeks of pregnancy, exceeding the FDA's 10-week limit. Both Danco and GenBioPro have links on their websites to Aid Access.

Danco and GenBioPro told the committee that they have no role in ensuring healthcare providers maintain compliance with FDA requirements. The Senate report is based on a five-month investigation into FDA-approved sponsors of mifepristone.

From 2000 to 2016, Danco reported approximately 4,000 non-fatal adverse events related to mifepristone. In the last 10 years, Danco reported 150 non-fatal adverse events related to mifepristone.

Mifepristone has been available in the U.S. for 25 years. The Biden administration lifted the in-person dispensing requirement for mifepristone in 2021. By 2023, medication abortion accounted for 63 percent of all abortions in the U.S. according to the Guttmacher Institute.

Louisiana is suing the FDA in a case that could determine the availability of mail and telehealth abortion pills nationwide. The Supreme Court granted an emergency request from abortion drug makers earlier this year to preserve telemedicine access to medication abortion while the case continues. The Fifth Circuit Court of Appeals is scheduled to hear oral arguments on the Louisiana v. FDA case on September 9.

More than 250 House and Senate Democrats wrote in an amicus brief to the Supreme Court that preserving evidence-based access to mifepristone is necessary to mitigate imminent harm. Cassidy is leaving Congress in January.

Why It Matters

The debate centers on regulatory enforcement and patient safety protocols for mifepristone, which has been used in the United States for 25 years. Medication abortion now accounts for the majority of abortions in the country, following policy changes in 2021 that removed in-person dispensing requirements. The committee's findings reflect tensions between manufacturers, regulators, and lawmakers regarding oversight of online distribution channels.

Timeline

Sen. Bill Cassidy released a report on Thursday accusing abortion pill manufacturers of failing to meet legal responsibilities for FDA safety compliance.

FDA case on September 9. Sen. Bill Cassidy is leaving Congress in January.

What's New

Additional reporting indicates that Dr. Christina Francis of the American Association of Pro-Life OBGYNs published a video in which she ordered mifepristone through Aid Access while posing as a 13-year-old with an IUD, anemia, blood-thinning medication, three prior C-sections, and an ectopic pregnancy. Abortion pill manufacturers are making tens of millions each year in profit.