Missouri AG files lawsuit against FDA to restore abortion pill restrictions

Missouri Attorney General Catherine Hanaway announced Thursday that her office has filed a lawsuit against the U.S. Food and Drug Administration (FDA) seeking to stop the distribution of dangerous abortion pills through the mail, and to block the latest approval of a generic mifepristone drug.

Key Takeaways:

• The lawsuit filed by Missouri, Kansas, and Idaho seeks to restore pre-2016 safety standards for the abortion pill, stop mail-order abortion drugs, and negate the most recent FDA approval of generic mifepristone.

• Since first approving it in 2000, the FDA has loosened the safety restrictions (REMS) surrounding the abortion pill several times, including allowing it to be distributed via mail.

• Despite the loosened restrictions, women continue to suffer injuries after taking the abortion pill.

The Details:

Joining with Kansas and Idaho, Missouri's lawsuit seeks several actions to curtail the widespread distribution of the abortion pill (mifepristone), including:

• Blocking the new generic mifepristone approval

• Restoring pre-2016 safety standards

• Enjoining the mail-order distribution of abortion drugs

• Stopping drug manufacturers and distributors from enabling violations of state law

A press release from Hanaway's office explains:

Federal law has long prohibited sending abortion drugs through the mail. But instead of following that law, abortion-pill distributors and national telehealth networks have built a nationwide mail-order abortion economy, shipping these drugs to women in all 50 states without ensuring they receive in-person screening, follow-up care, or emergency medical support.

For Missouri and other states with strong protections for unborn life and maternal health, the widespread mail-order distribution of mifepristone directly undermines state law and burdens state hospitals, emergency rooms, and taxpayers.

In October, just days after HHS Secretary Robert F. Kennedy Jr said that the FDA would be reviewing the safety of mifepristone, the FDA issued approval for a generic version of the Mifeprex (mifepristone 200mg) abortion pill from Evita Solutions. The Missouri lawsuit also takes issue with this approval.

This new lawsuit focuses specifically on the 2025 approval of a new generic mifepristone product manufactured by Evita Solutions, even though the drug is chemically identical to earlier versions already linked to severe complications. The product was approved without requiring any new safety studies and relies on unsafe changes made in previous years.

“Mifepristone is sending women to the hospital with life-threatening complications, and yet drug companies continue pushing new versions of it into the market without basic medical safeguards,” said Attorney General Hanaway. “Mail-order abortion drugs are dangerous when taken without in-person care, and Missouri will not stand by while manufacturers gamble with women’s lives.”

The lawsuit also states:

On September 30, 2025, the FDA continued its pattern of ignoring the dangerous effects of mifepristone on pregnant women and girls and, relying on the 2016 Major Changes, approved a second generic version of the drug. This approval marks the FDA’s most recent violation in a long string of unlawful decisions.

This generic drug, produced by Evita Solutions LLC (Evita) is subject to the same REMS and labelling as the brand drug, Mifeprex which is produced by Danco Laboratories, LLC (Danco). The generic drug is chemically identical to Danco’s Mifeprex and GenBioPro, Inc.’s generic mifepristone....

Accordingly, Evita’s generic mifepristone brings with it the same side effects, risks, and harms to pregnant women and girls as Mifeprex and GenBioPro. Just as the FDA’s unlawful 2019 ANDA Approval led to an increase in the number of women obtaining chemical abortions, the FDA’s 2025 ANDA Approval will increase accessibility to chemical abortions.

The lawsuit contends, "The supply of mifepristone will increase, the cost will decrease, and the number of chemical abortions will rise in Plaintiff States and across the nation."

Zoom Out:

When it was first approved by the Food and Drug Administration (FDA) in 2000, the abortion pill had a number of safety protocols (REMS) in place, including that it could only be taken in front of a physician or clinician, and only through seven weeks of pregnancy. Those restrictions were eventually loosened; the approved time frame was extended to 10 weeks, the requirement to report injuries resulting from the drug other than fatalities was removed, and later, the requirement that a woman take the pill in front of a clinician was also removed.

In 2021, the REMS were loosened even further so that the pill could be sent through the mail, even though the federal Comstock Act prohibits the mailing of “any article, instrument, substance, drug, medicine, or thing [that] may, or can be used or applied for producing abortion.”

As the safety restrictions were eliminated, injuries to women continued to climb.

Mifepristone’s known complications include severe cramping, contractions, heavy bleeding, nausea, vomiting, diarrhea, abdominal pain, and headaches. One study found the abortion pill to be four times more dangerous than a first-trimester surgical abortion. Another study recently found that serious adverse events from mifepristone occur at a rate approximately 22 times higher than the rate reported on the Food and Drug Administration’s (FDA) label for the drug.

Despite all of these complications, the abortion industry continues to insist that the abortion pill is "safer than Tylenol."

“No caring physician would call Mifepristone ‘as safe as Tylenol,’” Attorney General Hanaway said in a press release. “That claim was always false. Women are ending up in emergency rooms, and manufacturers know it. If the FDA is reevaluating the brand-name drug’s safety, then it needs to stop rubber-stamping new mail-order generic versions before more women are hurt.”

The Bottom Line:

The abortion pill continues to be dangerous to women, and lethal to their preborn children.

“Every woman deserves real medical care, not a dangerous pill in a mailbox,” said Attorney General Hanaway. “Our lawsuit demands accountability from manufacturers and distributors and places women’s health above political pressure.”

Go Deeper:

Read more about the abortion industry's abortion pill safety claims and other related information at the links below.

• ‘Baseless’: New research debunks claim that ‘abortion pill is safer than Tylenol’

• ‘Safer than Tylenol’? Report casts doubt on Planned Parenthood’s abortion pill safety claim

• FACT CHECK: Is the abortion pill actually ‘safer than Tylenol and Viagra’?

• The abortion pill is not like Tylenol, and parents should know if minors obtain it

• Florida sues Planned Parenthood over abortion pill safety claims

• Bloomberg writer parrots claim that abortion pill is safer than Tylenol – but here’s the truth

• Six pro-life medical groups ask HHS & FDA to reinstate abortion pill safeguards

• 51 senators ask the FDA to stop allowing mail-order abortions