Sen. Josh Hawley is demanding answers from the two companies that manufacture the nation’s most widely used abortion drug, and he wants their internal records on the table by late April.
The Missouri Republican sent letters to Danco Laboratories and GenBioPro notifying both firms that he is launching formal investigations through the Senate Judiciary Subcommittee on Crime and Counterterrorism, which he chairs. The letters demand a trove of documents, including all adverse event reports tied to mifepristone, internal databases, and other records, by an April 24 deadline, as Fox News Digital reported.
The core question: what did these companies know about the risks of their product, and did they hide it?
Hawley’s letters pull no punches. In the correspondence obtained by Fox News Digital, the senator wrote:
“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.”
That is not a vague policy complaint. It is an accusation that these manufacturers kept selling a product while alarm bells rang louder.
Hawley pressed further in the letters:
“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.”
Neither Danco Laboratories nor GenBioPro responded to Fox News Digital’s request for comment.
Mifepristone is not a niche product. Data from the Guttmacher Institute, formerly affiliated with Planned Parenthood, shows the drug was used in 63% of all abortions in the United States in 2023. The same group estimated 1,038,100 clinician-provided abortions occurred in 2024.
That scale makes the safety question urgent.
Research by the Washington, D.C.-based Ethics and Public Policy Center found that the rate of side effects from mifepristone is 22 times higher than what the FDA-approved drug label indicates. The study revealed more than one in 10 women reported experiencing “infection, hemorrhaging, or another serious or life-threatening adverse event.”
National Review reported that the EPPC study analyzed 865,727 mifepristone abortions from 2017 to 2023 and found nearly 11 percent of women experienced a serious adverse event within 45 days, far higher than the rate reflected on the current drug label.
If those findings hold, the gap between the label and reality is staggering.
Hawley’s investigation does not exist in a vacuum. The senator has pushed the FDA hard on this issue for months. Newsmax noted that FDA Commissioner Marty Makary told Hawley he is committed to conducting a review of mifepristone safety data, writing that he would work “with the professional career scientists at the Agency who review this data.”
But pro-life leaders say that promised review has stalled. RealClearPolitics reported that major groups, including Susan B. Anthony Pro-Life America and Live Action, urged President Trump to fire Makary over allegations the safety review was deliberately delayed until after the midterms. Marjorie Dannenfelser of SBA Pro-Life America said bluntly: “Enough is enough: FDA Commissioner Makary should be fired immediately.”
The White House denied any slowdown and expressed “utmost confidence” in Makary. Hawley, however, said “the FDA lied” to Congress about the review.
Hawley is not relying on oversight alone. The investigation comes roughly a week after he introduced a new bill to strip FDA approval from mifepristone entirely. On Tuesday, the Safeguarding Women from Chemical Abortion Act was introduced in the Senate. If passed, the legislation would:
The senator framed the stakes in stark terms:
“The science is clear: The chemical abortion drug is inherently dangerous to women and prone to abuse. Yet major companies like Danco Laboratories are making billions off it.”
He added: “That’s why I am introducing new legislation to ban the use of mifepristone for abortion and empower women to sue its manufacturers. Congress must act now to protect the health and safety of women.”
This is not Hawley’s first swing at the issue. He introduced proposed legislation last year that would ban mifepristone and give women the right to sue manufacturers. Last May, he introduced a separate bill directing the FDA to create safeguards on the drug and allowing women who suffered complications to sue telehealth providers and pharmacies for damages.
Each bill sharpens the same blade: accountability for the companies profiting from a drug whose real-world risks may dwarf its official safety profile.
The April 24 document deadline will test whether Danco and GenBioPro cooperate or stonewall. The scope of the demand is broad, adverse event reports, internal databases, and more. A subcommittee chairman with subpoena power is not someone pharmaceutical companies can easily ignore.
Mifepristone access remains tangled in ongoing litigation as well, with states including Idaho, Kansas, and Missouri pressing forward with legal challenges.
When a drug is used in nearly two-thirds of all abortions and the real complication rate may be 22 times higher than the label claims, the question isn’t whether Congress should investigate. It’s why it took this long.
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