U.S. Senator Josh Hawley (R-Mo.) sent letters to chemical abortion drug manufacturers Danco Laboratories and GenBioPro notifying them that he is opening an investigation into their business practices related to mifepristone as a growing body of evidence shows women are suffering alarming rates of adverse-effects from the drug.
“I write to inform you that I am opening an investigation into Danco Laboratories and its manufacture, distribution, and marketing practices relating to mifepristone,” Hawley said in his March 19 letter.
“Mounting evidence suggests that mifepristone poses grave risks to women,” Hawley said. “Yet your company has continued to profit from the widespread distribution of this drug even as serious questions have emerged about hemorrhage, infection, sepsis, and other dangerous complications associated with its use.”
[Click here to subscribe to Pregnancy Help News!]
Hawley said the concerns are particularly serious given that while mifepristone was becoming more widely dispensed, the abortion drug companies were able to learn significantly more about the drug’s actual outcomes than the public.
The senator told the drug companies that as the market for their product grew, the greater the access they had to adverse-event information, complication data, provider feedback, pharmacy complaints, and post-market safety signals.
“Yet serious questions remain about whether your company fully investigated those dangers and accurately conveyed them to regulators and the public,” he wrote. “The success of your company’s mifepristone business depends on broad distribution and public confidence in the drug’s safety, so your company has a powerful financial incentive to avoid facts that could threaten sales, invite scrutiny, or justify stronger safeguards.”
Tweet This: Serious questions remain on whether drug makers fully investigated chemical abortion pill dangers - Sen. Josh Hawley
Chemical abortion drug mifepristone is the subject of ongoing criticism related to safety issues associated with the drug and because of insufficient regulation.
Mifepristone has a REMS classification, one of about 73 drugs in the class, a small segment of the thousands of prescription medications approved by the U.S. Food and Drug Administration (FDA).
The FDA’s REMS, or Risk Evaluation and Mitigation Strategies, is a drug safety program that the agency can mandate for "certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks,” according to the FDA.
Mifepristone also has an FDA Black Box Warning, the highest degree of safety warning.
The REMS for mifepristone have been loosened over the last 10 years under the Obama and Biden administrations, including an initial in-person doctor visit to screen for ectopic pregnancy and other serious conditions, and a follow-up visit to check for life-threatening complications such as internal bleeding and infection. The requirement that abortion providers report non-fatal adverse events to the FDA Adverse Event Reporting System was also eliminated.
Following this mifepristone was allowed to be mailed and dispensed by pharmacies, and then the Biden FDA permanently removed the in-person dispensing requirement in 2023.
This opened the door for abusers to obtain chemical abortion drugs on-line and force or otherwise coerce pregnant women to take them and for abortion activists to sell the drugs across state lines in states where they may be prohibited by law. Accounts of coerced abortion have continued to emerge since.
Pro-life and pregnancy help advocates continually call for the FDA to review the safety standards for mifepristone, the review promised by the Trump administration in what has actualized into a protracted process.
A report release in April 2025 by conservative think tank Ethics and Public Policy Center (EPPC) found that nearly 11% of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days of taking the drug. The analysis of 865,000 insurance claims of women who were prescribed mifepristone abortions between 2017 and 2023 showed that mifepristone is 22 times more dangerous than previously recognized in FDA data.
A more recent analysis from the EPPC said that removing the REMS for the abortion pill has increased risks for women, in particular when the drug is prescribed without an in-person medical visit.
Hawley introduced legislation last week to ban chemical abortion drug mifepristone and allow women harmed by the drug to sue its manufacturers.
The Safeguarding Women from Chemical Abortion Act would withdraw the FDA’s approval of mifepristone for abortion, make distributing and labeling mifepristone for pregnancy termination violations of the Federal Food, Drug, and Cosmetic Act, and create a private right of action for women harmed by chemical abortion to sue manufacturers for damages.
At the March 11 press conference announcing the proposed bill Hawley hosted women who had been harmed by mifepristone.
With the March 19 announcement of his investigation of Danco Laboratories and GenBioPro Hawley announced he is also opening a hotline for women who have been harmed by chemical abortion to share their stories with his office. Their information will remain confidential.
Hawley requested that the two drug companies produce safety, adverse-event, and complication data; REMS compliance and postmarketing surveillance; communications with FDA and other regulators; clinical, medical, and scientific analyses; marketing, promotional, and public messaging; manufacturing, quality, and supply chain information; corporate structure, ownership, and financial incentives; litigation, complaints, and insurance specifics; and custodians and data preservation.
“Congress must determine what your company knew about the harms associated with mifepristone, when it knew it, what it told regulators, and what it may have failed to disclose to women and the public,” Hawley told the abortion drug manufacturers. “Accordingly, please produce the documents and information described in the attached Schedule by no later than April 24, 2026. The women exposed to the risks of this drug deserve a full accounting.”
Women wishing to make a report to the chemical abortion drug hotline can do so by contacting Hawley's office via phone at (202) 224-6154 or emailing
Hawley’s full letter to the abortion drug companies is available HERE.
