FDA admits in abortion pill lawsuit that HHS can suspend any drug if 'imminent threat to public health'

The Health and Human Services (HHS) Secretary has the authority to suspend an application for a drug's approval — including the abortion pill — if they determine that the drug would be an 'imminent hazard to public health.'

This information was included in a response from the Food and Drug Administration (FDA) in an abortion pill lawsuit filed by the State of Louisiana. The lawsuit seeks an injunction over changes to the abortion pill's safety protocols known as REMS, made in 2023, which enabled the mailing of abortion inducing drugs — an act already prohibited by federal law known as the Comstock Act.

Key Takeaways:

• In the case, State of Louisiana v. Food and Drug Administration (FDA), the FDA admitted that "if the Secretary of Health and Human Services finds that a drug presents “an imminent hazard to the public health,” he may suspend the approval of the application (including a supplemental application) 'immediately.' 21 U.S.C. § 355(e)."

• This week, an additional analysis from EPPC suggested that "the rate of serious adverse events following a chemical abortion (mifepristone) was significantly higher after the FDA’s in-person dispensing requirement was removed." This was a result of the 2023 REMS, which Louisiana asked the court to block.

The Backstory:

The case, State of Louisiana v. Food and Drug Administration (FDA), et al. was heard last month in federal court before U.S. District Judge David Joseph.

The lawsuit challenges the 2023 REMS, a safety program which the FDA put in place for the drug. The changes that year enabled the drug to be shipped by mail and dispensed in pharmacies for the first time in history.

In a formal statement, the FDA claimed it is conducting a "safety study of mifepristone" — the abortion pill — expected to be final in a year or "sooner than that timeframe."

In the court record, Trump's FDA claimed Louisiana's lawsuit would "short circuit the [FDA]’s orderly review and study of the safety risks of mifepristone." It asked the courts to "stay judicial review" until the FDA completes its own review of the drug.

In a hearing in the case last month, the District Court asked:

If “during [FDA’s] review process,” the agency “sees a public health issue with the 2023 REMS — particularly the . . . in-person dispensing requirement — is there a way for the FDA to take immediate action to change it, to restore it, or to alter the 2023 REMS to meet the public health concern?”

The court ordered the FDA to address the agency's authority to issue "interim orders addressing the prescribing or distribution" of the abortion pill "if confronted with concerning information during its review."

The Details:

'Imminent Hazard to Public Health' Qualifies HHS to Suspend or Withdraw Drug Application

On March 6, 2026, the FDA filed its Supplemental Brief to respond to the U.S. District Court's question.

There, the FDA claimed the Secretary of HHS, currently Robert F. Kennedy, Jr, can suspend or withdraw a drug's application, which in this case is mifepristone (200mg)/Mifeprex.

An application, the FDA states online, is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S."

The FDA wrote, in part:

The provision of the Federal Food, Drug, and Cosmetic Act that specifies the circumstances in which a drug application can be withdrawn, 21 U.S.C. § 355(e), includes authority to suspend an application prior to its withdrawal.

In particular, if the Secretary of Health and Human Services finds that a drug presents “an imminent hazard to the public health,” he may suspend the approval of the application (including a supplemental application) “immediately.” 21 U.S.C. § 355(e).

The FDA's response promoted concerns from one abortion supporter who feared HHS could "restrict" the abortion pill during the FDA's review:

The FDA cited US statute 21 U.S.C. § 355(e) which outlines that if the Secretary finds that a drug is

• unsafe for use

• is not shown to be safe for use under the conditions of use upon the basis of which the application was approved

• there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling thereof

• the application contains any untrue statement of a material fact

• there is an imminent hazard to the public health."

... then the HHS Secretary "may suspend the approval of such application immediately."

Failing to Maintain Records

The formerly cited statute also states that:

"The Secretary may also, after due notice and opportunity for hearing to the applicant, withdraw the approval of an application submitted under subsection (b) or (j) with respect to any drug under this section if the Secretary finds (1) that the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain such records or to make required reports, in accordance with a regulation or order under subsection..." the law also states.

The "applicant" or sponsor of the abortion pill (meaning name-brand manufacturer Danco Laboratories and generic manufacturers GenBioPro and Evita Solutions) is also tasked with overseeing prescribers of the drug.

The REMS requires prescribers to "[e]nsure that any deaths of patients who received mifepristone are reported" to the manufacturers.

These reports would then be published to FDA's Adverse Event Reporting System (FAERS) system. This system has been relied upon by FDA when eroding REMS requirements for the abortion pill.

But the drug's applicants/sponsors (manufacturers) have not properly policed their prescribers, and as such, it is estimated that adverse events reports are skewed.

As previously detailed at Live Action News:

• Prior to 2016 REMS changes, prescribers were required to report all adverse events, including "any hospitalization, transfusion or other serious event to Danco Laboratories," which was the sole manufacturer at that time.

• With the 2016 changes, no adverse events other than death were required to be reported.

• Even prior to 2016, Big Abortion concocted a fraudulent scheme: bypass this 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) and claim to be experiencing complications of natural miscarriage instead of the abortion pill.

In other words, abortion pill makers (sponsors) having policing power over prescribers of the drug, the abortion industry has for years executed an end-run around adverse event reporting (even before the 2016 reporting changes) by urging women to go to the ER (not back to the medical provider or prescriber) when experiencing abortion pill complications.

Yet it was only the prescribers — not hospital ER staff — that were contractually obligated to report complications.

New Evidence Emerges

Insurance claims data analyzed by the Ethics & Public Policy Center (EPPC) suggests that in the real world, the failure rate of mifepristone is nearly double what is currently listed on the FDA-approved drug label.

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

That happened as a result of the 2023 REMS, which Louisiana asked the court to block.

Ryan T. Anderson

@RyanTAnd

·Follow

NEW REPORT. Our 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. The Trump FDA can fix: thefederalist.com/2026/03/10/tru…

12:18 PM · Mar 10, 2026

48

Reply

Copy link

Read 15 replies

EPPC's latest analysis also alleged that the rate of serious adverse events was "especially true of the incidence of mifepristone being inappropriately prescribed for women with an ectopic pregnancy...."

Key Concerns:

• 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.

Timeline:

The abortion pill, mifepristone (200mg)/Mifeprex, was approved by the FDA in 2000 for the termination of pregnancy in a regimen with a second drug, misoprostol. The abortion pill's mechanism of action blocks progesterone, which deprives the preborn baby of nutrients needed to survive.

• 2011: Following reports of serious adverse events, the drug was placed under a safety system known as REMS.

• 2016: Obama's FDA weakened the REMS by enabling the drug to be used up to 10 weeks gestation and removing the requirement that all adverse events other than death be reported. Those changes were pushed and financed by a pro-abortion coalition.

• 2023: Despite a prohibition under the federal Comstock Act, Biden's FDA eroded the REMS further to remove the in-person dispensing requirement and allow for mail order and pharmacy dispensing of the drug.

What Could Happen Next:

In the brief, the FDA explained the process should the application be withdrawn:

The Secretary then must “give the applicant prompt notice of his action and afford the applicant the opportunity for an expedited hearing” on whether to withdraw approval.

Approval may be withdrawn if, among other things, “new evidence of clinical experience . . . evaluated together with the evidence available to [FDA] when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved.”

Apart from the Secretary’s suspension authority, there are no “interim orders” FDA could issue. However, FDA possesses authority to require a sponsor to propose changes to a drug’s conditions of use, including by adding or modifying a REMS requirement related to prescribing or dispensing. The timing of implementation is influenced by factors outside FDA’s control, most notably the degree of cooperation of the drug’s sponsor.

The Bottom Line:

Instead of joining states like Louisiana and Missouri requesting an injunction of the 2023 REMS, the FDA is demanding courts stay or dismiss lawsuits until their review of the drug is finalized.

Yet evidence suggests the abortion pill poses a threat to public health, aside from the direct threat to the preborn child in the womb.