Sen. Bill Cassidy, R-La., released a new report Wednesday claiming federal regulators and abortion pill manufacturers are putting mothers at risk. The months-long investigation found that there is a lack of oversight and significant gaps in patient safety protections and calls on the Food and Drug Administration to act.

The report, obtained by the Daily Signal, was led by Dr. Cassidy, chairman of the U.S. Senate Health, Education, Labor, and Pensions Committee. It details the business practices of three major abortion pill companies, their lack of medical oversight, improper telemedicine prescriptions, lack of transparency, and underreported complications of the drug.

"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," Cassidy said.

"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," he continued.

The Companies Investigated

Cassidy and the HELP Committee investigated three major abortion pill companies: Danco Laboratories, which makes Mifeprex; GenBioPro, which produces generic mifepristone; and Evita Solutions, maker of the newest generic version.

The report found that these companies provide limited information about their operations and have no role in ensuring healthcare providers comply with FDA requirements.

According to the report, these companies conduct no meaningful prescriber or manufacturer oversight. It cites concerns about overseas manufacturing and the drugs being sent to multiple undisclosed locations for finishing.

Danco's pharmaceutical ingredient for Mifeprex is manufactured in Spain but is finished at an undisclosed facility "elsewhere in Europe." The company refused to provide Cassidy with additional information, citing security concerns and commercial sensitivity. GenBioPro's and Evita's products are manufactured at facilities throughout India.

Guardrails Removed

In the report, Cassidy highlights the FDA's Risk Evaluation and Mitigation Strategy and how the previous Democrat administration removed the requirements for reporting nonfatal adverse events and for requiring in-person prescription.

Cassidy claims the removal of these guardrails led to coerced abortions and the distribution of chemical abortion drugs outside FDA approval, endangering women's health and safety.

This is also how providers can prescribe the pill over the phone, through telehealth visits, or even online without seeing a doctor. The report cites examples in which investigators obtained mifepristone online using fake patient information.

Providers are not required to certify patients' identities, gestational ages, or compliance with state restrictions.

The report found that once healthcare providers are approved to prescribe the drug, there is little to no oversight to ensure they continue to follow the safety requirements.

Cassidy claims the FDA has relaxed its restrictions on the drug. Manufacturers do not have to audit providers who prescribe it, and no provider has ever lost FDA certification.

Strengthening the Safety Programs

The report calls the findings of the investigation "startling" and calls the new standard of mail-order abortions nationwide the "Wild West."

"It is clear that more stringent oversight mechanisms are needed, beginning with the reinstatement of the in-person dispensing requirement," reads the conclusion.

It calls on the FDA to "step in" and put stricter safety requirements in place.

Cassidy also calls on the Department of Justice to work with the FDA to identify and pursue legal action against healthcare providers who knowingly violate the safety requirements.

Without action, the findings claim public trust in healthcare will continue to erode and pregnant women will continue to be put in harm's way.

The Abortion Pill Study

Last month, the Daily Signal found that a few members of Congress were told to expect the FDA's safety review of the abortion pill to be completed by September.

If the FDA finds the abortion pill is unsafe, it could then update the REMS to restore the in-person dispensing requirement for the drug, eliminating mail-order abortion pills.

The Daily Signal has reached out to Danco Laboratories, GenBioPro, Evita Solutions, and the FDA for comment on this breaking story, and will update this article as warranted.