Abortion pill makers shirk oversight responsibility while making millions, Senate GOP finds

Abortion pill manufacturers are not fulfilling their obligation to oversee prescribers despite making tens of millions each year in profit, according to the findings of a months-long investigation from Senate Republicans. A new investigation from Senate Committee on Health, Education, Labor and Pensions chairman Bill Cassidy (R-LA) into the makers of the abortion drug mifepristone found the pharmaceutical companies may not be complying with safety oversight regulations. The report documents that three drug company sponsors that make mifepristone – Danco Laboratories, GenBioPro, and Evita Solutions – were not able to provide details on how they remain in compliance with Food and Drug Administration requirements that sponsors oversee prescribing procedures for the abortifacient. The Senate investigation into the companies was led by Cassidy, along with Sens. Steve Daines (R-MT), James Lankford (R-OK), Cindy Hyde-Smith (R-MS), and the late Lindsey Graham (R-SC).“Abortion drug companies are putting mothers at risk through their failure to properly oversee the prescription and distribution of their products,” Cassidy said in a press release with the report. “We are seeing that the explosion in online sales of chemical abortion drugs has opened the door to coercion and abuse of women.”Mifepristone, the first drug in a two-part chemical abortion regimen, has become a flashpoint in the abortion debate since the Supreme Court overturned Roe v. Wade in 2022. Abortion pills are used in roughly two thirds of the more than 1 million abortions each year in the United States. Although the FDA lifted restrictions in 2023 to allow the abortion drug to be prescribed online without an in-person doctor’s visit, the agency still requires the drug makers to ensure prescribers are compliant with the safety protocols, known as the Risk Evaluation and Mitigation Strategies, or REMS, for mifepristone.Under the current REMS safety requirements, the drug makers have a responsibility to ensure that prescribers are certified by the FDA and are able to assess the duration of a patient’s pregnancy, diagnose life-threatening ectopic pregnancies, and provide surgical intervention or blood transfusion in the event of complications.But, according to the Senate report, Danco and GenBioPro told the committee that they are not responsible for that healthcare providers prescribing mifepristone and pharmacies carrying the drug remain in compliance with FDA safety requirements, including establishing a direct relationship with the patient to whom they are prescribing the abortion pills.Evita Solutions, which only received FDA approval for its generic mifepristone product in October 2025, also said it will be the healthcare providers and pharmacy’s responsibility to ensure the REMS are being complied with for patient safety, according to the report.The Washington Examiner contacted all three companies with requests for comment on their respective REMS compliance.“The fact that none of the three mifepristone sponsors were able to articulate any steps they are taking or will take to address the plethora of online prescribers clearly prescribing their drugs in violation of REMS requirements is startling,” reads the report. Under FDA rules as of 2023, the companies are also required to conduct audits of prescribers and pharmacies to ensure they are in compliance with safety protocols. Danco and GenBioPro told the committee they respectively have never decertified any individual prescribers. Danco decertified two pharmacies between October 2024 and September 2025, but GenBioPro has never decertified a pharmacy for noncompliance with the REMS.The new Senate investigation also found that both Danco and GenBioPro make profits almost solely from mifepristone, to the tune of millions annually.Danco told Senate Republican staff the company’s annual revenue is an average of $16 million, a figure that has ranged from $1 million to $26 million in the 26 years the name brand drug Mifeprex has been on the market. GenBioPro, which makes generic mifepristone, did not provide dollar figures to the committee investigators, but the company did confirm that roughly 95% of its revenue comes from the sale of chemical abortion drugs. In the company’s amicus brief for the Supreme Court case in 2023 on the FDA’s approval of mifepristone, GenBioPro said that it supplies roughly two-thirds of the domestic market for mifepristone abortions. The senators also allege in the report that online clinics create an anonymous environment in which it is impossible to ensure that prescribing healthcare providers ensure the patient has received informed consent or follow up with complications.Anti-abortion Republicans argue online abortion pill sales have prevented the 13 states that have entirely prohibited elective abortion, including Cassidy’s home state of Louisiana, from effectuating their anti-abortion statutes passed after the demise of Roe.According to the pro-abortion think tank the Guttmacher Institute, roughly 91,000 women from states with total abortion bans received abortion pills via telehealth in 2025, up from 72,000 the year prior.Cassidy and the other senators involved in the investigation have pressured the Trump administration for months to reinstate the in-person screening requirements as part of the REMS protocol for mifepristone.TRUMP CABINET’S ADDICTION EXPERIENCE SHAPES FEDERAL RECOVERY POLICYCassidy said the findings of the investigation ought to influence the FDA to increase oversight on abortion pill manufacturers.“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,” Cassidy said.