Sen. Josh Hawley opens investigation into abortion pill manufacturers

Senator Josh Hawley has opened an investigation into the abortion pill marketing practices of manufacturers Danco Laboratories and GenBioPro, according to the official letters sent to the companies.

According to Fox News, "The letters demand that the companies share documents relating to the investigation by April 24. Those documents include all adverse event reports relating to mifepristone, relevant internal databases and a litany of other documents."

The Backstory:

Multiple state lawsuits are seeking to enjoin the FDA's 2023 REMS change to safety regulations for the abortion pill, removing in-person dispensing requirements for the drug (mifepristone 200 mg) and enabling mail-order and pharmacy dispensing. These changes were made despite a prohibition to mail abortion-inducing drugs exists under the federal Comstock Act.

Last year, insurance claims data analyzed by the Ethics & Public Policy Center (EPPC) suggested that the failure rate of mifepristone was nearly double what is currently listed on the FDA-approved drug label.

In March 2026, additional analysis from EPPC suggested "the rate of serious adverse events following a chemical abortion (mifepristone) was significantly higher after the FDA’s in-person dispensing requirement was removed."

Earlier this month, Senator Josh Hawley introduced legislation to revoke the U.S. Food and Drug Administration's (FDA) approval for mifepristone (the abortion pill), and to empower women to sue the drug's manufacturers if they are harmed by the drug.

The Details:

Hawley's Demands

Hawley wrote to the abortion pill manufacturers, stating his plan to open an investigation into each, "and its manufacture, distribution, and marketing practices relating to mifepristone," saying:

Mounting evidence suggests that mifepristone poses grave risks to women. 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.

Hawley added:

These concerns are especially serious because as mifepristone became more widely distributed, your company was in a position to learn far more about the drug’s real-world consequences than the public. The larger the market for your product has become, the greater your access 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.

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.

1. Safety, adverse-event, and complication data

Hawley is seeking from the manufacturers all documents...

• "... reflecting actual or estimated rates of complications, emergency-room visits, hospitalization, surgery, transfusion, ambulance transport, or physician follow-up after use of your company’s mifepristone product."

• "... sufficient to show what information the company receives, requests, or tracks from prescribers, pharmacies, distributors, telehealth providers, call centers, patient-support services, or third parties regarding complications or outcomes."

In 2016, Obama's FDA eroded the drug's REMS by removing the requirement to report any complications other than death. This move was led and funded by a coalition of abortion advocates.

Even prior to 2016, Big Abortion concocted a fraudulent scheme:

• bypass the adverse events reporting structure by instructing women at the point of sale to seek emergency care (outside of the clinic setting, at a hospital ER or urgent care).

• claim to be experiencing complications of natural miscarriage instead of the abortion pill.

While abortionists encourage women to do this allegedly for their own protection (despite the fact that currently, women are not penalized under laws restricting abortion), the real goal is to protect the abortion pill.

2. REMS compliance and post-marketing surveillance

Live Action News has documented how abortion pill manufacturers are failing to police prescribers by not decertifying prescribers who fail to abide by the REMS.

Shockingly, the manufacturers are even linking to websites that advertise selling the drug past FDA-approved gestational limits and which are illegally shipping them into pro-life states.

Hawley's letters demand:

• "All documents concerning compliance with the Mifepristone REMS Program, including prescriber certification, pharmacy certification, Patient Agreement Forms, audit procedures, internal compliance reviews, deviations, violations, corrective actions, and communications with any REMS administrator."

• "All REMS assessments, periodic submissions, internal draft assessments, supporting datasets, and communications concerning the effectiveness of REMS elements."

• "All documents concerning whether the company believed additional REMS elements, stronger screening requirements, or renewed in-person requirements were warranted."

3. Communications with FDA and other regulators

In addition to communications over labeling changes, adverse events, and other topics, the letter is demanding:

All communications with any state attorney general, state medical board, state pharmacy board, foreign regulator, or other governmental entity concerning the safety, distribution, labeling, or legality of mifepristone.

4. Clinical, medical, and scientific analyses

Prescribers are required under the REMS to have the “[a]bility to assess the duration of pregnancy accurately” and the “[a]bility to diagnose ectopic pregnancies.” 

Yet, prescribers knowingly place women at risk by choosing not to assess either the duration of pregnancy or the existence of an ectopic pregnancy via the no-test protocol.

• In 2020, Big Abortion implemented a “no-test” protocol, openly admitting that no-test “criteria are not going to rule out every ectopic pregnancy” and prescribers would then "detect ectopics after treatment….”

• Since then, pro-abortion physicians have alerted emergency room staff regarding a potential increase in undiagnosed ectopic cases due to the no-test protocol used by most abortion pill prescribers.

Hawley's demand letters ask for clinical studies, reviews and manuscripts concerning the alleged safety of the drug. In addition, the letter demands:

• "All documents concerning cases of ongoing pregnancy, failed abortion, use beyond labeled gestational age, use where ectopic pregnancy was later identified, and any congenital-anomaly or fetal-harm reports following failed abortion..."

• "All documents evaluating whether passive adverse-event collection undercounts complications."

According to the legal website abortioninjury.com:

Failure to diagnose an ectopic pregnancy can lead to catastrophic consequences, including rupture, internal bleeding, and loss of fertility. In some cases, women nearly lose their lives because abortion providers overlooked or ignored obvious warning signs. These tragedies are preventable with basic medical diligence. Legal claims not only provide compensation but also spotlight the reckless practices that put women at risk.

5. Marketing, promotional, and public messaging

Hawley is demanding all "patient-facing materials, prescriber-facing materials, pharmacy-facing" marketing materials and all "substantiation documents for claims that the product is 'safe,' 'effective,' 'wellstudied,' 'comparable' to other products, or appropriate for mail-order or telehealth dispensing."

6. Manufacturing, quality, and supply chain

Live Action News has documented much secrecy surrounding the abortion pill, including the full record of experts who approved the pill, the manufacturing locations, and who is behind the manufacturing companies.

The letter demands:

• "All documents sufficient to identify each manufacturer, contract manufacturer, packager, relabeler, distributor, fulfillment partner, pharmacy channel, and shipping vendor involved in the manufacture or distribution of your company’s mifepristone product."

• "All inspection reports, warning letters, audit findings, deviation reports, corrective action/preventive-action materials, stability reports, batch-failure reports, and quality complaints relating to mifepristone."

• "All documents concerning changes in manufacturing location, supplier, active pharmaceutical ingredient source, packaging, labeling, or distribution channel."

7-9. In addition, the demand letter requests:

• Corporate structure, ownership, and financial incentives

• Litigation, complaints, and insurance

• Custodians and data preservation

A full accounting of 'grave risks to women'

"The chemical abortion drug poses grave risks to women; yet these foreign companies are making billions from it," Sen. Hawley wrote on X.

"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," Sen. Hawley wrote. "The women exposed to the risks of this drug deserve a full accounting," he added.

The letters state that the abortion pill makers must produce the documents no later than April 24, 2026.

The Bottom Line:

The abortion pill has ended the lives of over 7.5 million precious preborn babies between September 2000 and December 2024. It is now the most common form of abortion, and the erosion of the 2023 REMS has been credited with the increase in abortions nationally.

Go Deeper:

• GET THE FACTS: The abortion pill's history of eugenics and secrecy

• GET THE FACTS: Is the abortion pill truly 'safe'?

• Live Action's report: The State of Chemical Abortion a Mechanism of Death