The three companies approved by the U.S. Food and Drug Administration to sell the most popular chemical abortion drug on the market are under investigation by Senate Republicans for their allegedly shady business practices and potential failure to comply with safety regulations.
U.S. Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bill Cassidy, joined by Sens. Steve Daines, Lindsey Graham, Cindy Hyde-Smith, and James Lankford, kicked off the investigation on Wednesday with several letters demanding answers about mifepristone manufacturers’ role in the ongoing scheme to circumvent pro-life states’ laws with mail-order abortion pills known to cause babies and women death and harm.
The FDA-approved Mifeprex label warns that a mother whose pregnancy is further along than the recommended 10 weeks should not take mifepristone because her risk of complications is so high. In their March 25 letter to Mifeprex maker Danco Laboratories, the senators expressed concerns that “Danco is not ensuring the REMS requirements are met, especially as it pertains to the online prescribing of Mifeprex.”
“It seems unlikely that Danco is effectively enforcing compliance with the Mifepristone REMS Program when it appears to actively facilitate access to its drug outside of the window for which it is approved by FDA,” the letter continues.
Similarly, in their letter to GenBioPro Inc., the senators questioned how the company could adequately follow the FDA REMs when it directs customers to order pills online who advertise unapproved use of abortion drugs.
“Furthermore, because many online clinics allow individuals, including men, to order these drugs anonymously, it is unclear how prescribers can ensure that the Patient Agreement Form is reviewed with the patient, signed by the patient, and placed in the patient’s medical record,” the letter states. “It is also unclear how an online prescriber could adequately explain the risks of the mifepristone treatment regimen to the patient in accordance with the existing REMS.”
The last company probed by the committee is Evita Solutions, which the FDA granted permission to sell a generic version of mifepristone in October 2025.
The letter to the newest approved abortion pill manufacturer demanded answers about how Evita Solutions plans to “ensure compliance” with the FDA’s Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program. The Republicans also raised questions about the company’s “business practices and transparency” and where in the world its abortion pills would be made.
“Notably, key aspects of Evita’s corporate structure and leadership are obscure despite being the sponsor of an FDA-approved drug that will be marketed and sold to Americans. The company has a very minimal online presence and thus far, no principals or spokespeople for the company have been publicly named,” the senators wrote.
The Republicans also sent a letter demanding FDA Commissioner Marty Makary “take immediate action to prevent misbranded and unapproved versions of the chemical abortion drugs, mifepristone and misoprostol, from being marketed in the U.S. by online retailers in violation of federal law.”
“We also urge FDA to quickly reinstate the REMS requirements removed by Democrat administrations, especially the in-person dispensing requirement and the requirement for manufacturers to report non-fatal adverse events to FDA,” the GOP senators wrote.
News of the investigation broke the same day as polling showing seven in 10 Americans say the FDA should reinstate in-person doctor visits as a requirement to obtain abortion pills.
They noted that both national and international online abortion pill sellers often market the drug beyond what the FDA’s current REMs permits, such as claiming mifepristone can be used beyond 10 weeks gestation. In some cases, the letter notes, abortion pills are “illegally imported from foreign countries, including Mexico and India, and then repackaged before distribution to
customers.” Others are “unapproved and misbranded chemical abortion drugs” dispensed by a “plethora of websites acting as online pharmacies.”
The Republicans emphasize that FDA has the power to punish such violations, including issuing abuse complaints, interdiction, and prosecutions, but has so far failed to act.
“You stated in a recent announcement: ‘It’s a new era. We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action,’” the letter states. “Yet, to date, FDA has not sent any warning letters to illegal chemical abortion drug sellers during your tenure, despite the harms these unapproved and misbranded drugs continue to cause.”
The investigation comes two weeks after Sen. Josh Hawley introduced legislation to ban the most popular abortion drug on the market and give survivors a legal remedy against foreign abortion pill makers. At his press conference to announce the bill, Hawley warned that “greedy foreign corporations” are making “billions of dollars in profits by endangering women’s health and shipping to them a drug that they know is dangerous.”
More than one in 10 women who take mifepristone suffer a serious adverse event such as hemorrhage or infection. The risk of contracting a life-threatening side effect linked to pill-induced abortion is at least 22 times higher than what the FDA and Danco claim. As researchers Ryan T. Anderson and Jamie Bryan Hall recently revealed in The Federalist, “new research shows that the chemical abortion drug mifepristone became significantly more dangerous to women after the Biden administration watered down safety rules in an effort to appease pro-abortion advocates.”
Jordan Boyd is an award-winning staff writer at The Federalist and producer of “The Federalist Radio Hour.” Her work has also been featured in The Daily Wire, Fox News, and RealClearPolitics. Jordan graduated from Baylor University where she majored in political science and minored in journalism. Follow her on X @jordanboydtx.
