60 lawmakers file brief supporting Louisiana's FDA abortion pill challenge

Citing the federal Comstock Act which prohibits the mailing of abortion inducing drugs, 60 lawmakers have filed an amicus brief in support of the State of Louisiana's challenge to the FDA's eroding safety regulations for the abortion pill.

The move follows a separate filing of amici by 21 separate states.

Key Takeaways:

• Sixty lawmakers (20 senators and 40 representatives) have filed an amicus brief in Louisiana's lawsuit against the FDA regarding abortion pill regulations.

• The lawmakers are calling out the FDA for violating the Comstock Act when it (under the Biden administration) eroded safeguards on mifepristone, allowing it to be sent by mail or obtained by telehealth. The Comstock Act bans the mailing of anything intended for use in an abortion.

• The lawmakers claimed the Biden administration's "expressly stated goal" was "subverting state abortion prohibitions" when it allowed for "the requirement of in-person dispensing of mifepristone" to be eliminated from the FDA's REMS.

• They claim the Biden FDA "did not have a sufficient evidentiary basis to conclude that eliminating the in-person dispensing requirement was safe" and "relied on insufficient data to establish the safety of foregoing the in-person requirement."

• They also claim in the brief that a "federal agency action that rewrites, contradicts, or ignores a federal statute violates the separation of powers."

The Details:

Twenty U.S. Senators — including Bill Cassidy (La.), Marsha Blackburn (Tenn.), Ted Cruz (Texas), Steve Daines (Mont.), Josh Hawley (Mo.), James Lankford (Okla.), Cindy Hyde-Smith (Ala.), and Rand Paul (Ky.) — signed onto the amicus brief against the FDA's 2023 REMS changes which removed the requirement for in-person dispensing of the drug (mifepristone 200mg/Mifeprex) by allowing the abortion pill to be mailed or dispensed in a pharmacy. In addition, 40 members of the U.S. House of Representatives, including Chris Smith (N.J.), Andy Biggs (Ariz.), Kat Cammack (Fla.), Michelle Fischbach (Minn.), Mary E. Miller (Ill.), Chip Roy (Texas) and others signed on.

The Comstock Act

The lawmakers called out the FDA for violating the federal Comstock Act by eroding the drug's Risk Evaluation and Mitigation Strategy (REMS), which the [FDA] can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication."

The brief pointed out the stipulations of the Comstock Act:

• "Imposes felony criminal liability on the mailing of '[e]very article or thing designed, adapted, or intended for producing abortion' and '[e]very article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion.' 18 U.S.C. § 1461."

• "Applies similar criminal penalties for importing and using a 'common carrier' (like FedEx) or 'interactive computer service' 'for carriage in interstate or foreign commerce . . . any drug, medicine, article, or thing designed, adapted, or intended for producing abortion.' 18 U.S.C. § 1462."

According to the Comstock Act, violators...

• “shall be fined . . . or imprisoned not more than five years, or both, for the first such offense” and

• “fined . . . or imprisoned not more than ten years, or both, for each such offense thereafter.”

The brief made several points — one of which is that while the FDA has been given the power by Congress to "approve drugs and regulate their safety and efficacy within the parameters set by federal law," the Comstock Act, passed by Congress, already made it illegal to mail "'[e]very article or thing designed, adapted, or intended for producing abortion.' 18 U.S.C. § 1461."

The brief accuses the Biden administration's FDA of violating this "longstanding federal law," adding:

Unelected, unaccountable bureaucrats in Biden’s FDA therefore overrode the will of the American people as expressed through their elected representatives in Congress and in state legislatures and subverted Congress’s critical public policy interests in upholding patient welfare.

The brief called these actions "lawless," adding that they "have also caused real harm and continue to endanger women and girls undergoing chemical abortions, warranting preliminary relief."

Subverting state abortion restrictions

The lawmakers went further, saying that the Biden administration's "expressly stated goal" was "subverting state abortion prohibitions authorized by Dobbs..." and that this was what the administration had in mind when it allowed for "the requirement of in-person dispensing of mifepristone" to be eliminated from the FDA's REMS.

The lawmakers continued in their brief:

The change was made precisely so that abortionists in pro-abortion states could prescribe and mail abortion drugs to women or girls in pro-life states with tighter regulations on these drugs.

Former President Biden admitted as much when he issued an Executive Order directly challenging “the continued advancement of restrictive abortion laws in States across the country.”

This action contravenes federal laws passed by the elected representatives of the American people. It also contravenes state laws prohibiting abortion, such as Louisiana’s, even though “the authority to regulate abortion” belongs to “the people and their elected representatives,” not unelected bureaucrats.

Putting women in danger

"When looking at the full administrative record, it becomes clear that rather than letting science and evidence drive its decision making, the Biden FDA reached a predetermined and politically motivated conclusion to expand access to abortion drugs despite lacking enough evidence to show the change would be safe," the brief states.

Lawmakers contended that the Biden FDA

• "did not have a sufficient evidentiary basis to conclude that eliminating the in-person dispensing requirement was safe."

• "relied on insufficient data to establish the safety of foregoing the in-person requirement"

They allege that the "FAERS data on the safety of chemical abortion drugs significantly understates the risk," because the requirement to report complications was removed in 2016.

But, as Live Action News previously demonstrated, long before those changes occurred, Big Abortion had schemed to hide complications by advising women at the point of sale to bypass those requirements to report by claiming to experience natural miscarriage complications when presenting to an ER.

In addition, the lawmakers pointed out:

"The 2023 REMS also opens the door for those who seek to coerce a woman into having an abortion because it removes the ability of a doctor to ensure a woman receiving chemical abortion drugs actually wishes to take them."

FDA violated separation of powers

"Federal agency action that rewrites, contradicts, or ignores a federal statute violates the separation of powers," the brief states. "Violating the separation of powers is nothing less than antithetical to our system of government, as 'the separation of powers is the defining feature and virtue of our Constitution.'"

The brief added:

The FDA cannot purport to authorize conduct criminalized under federal law — that would exceed its constitutional authority. A federal agency “lacks the authority to ‘rewrite clear statutory terms to suit its own sense of how the statute should operate,’ particularly in a way that undercuts a statute’s purpose.”

"Exceeding its mandate is illegal and also harmful, both to the separation of powers and to women taking mifepristone. The Court should grant the preliminary relief requested by Plaintiffs," lawmakers added.

The Timeline:

• September 2025: The State of Louisiana along with Rosalie Markezich filed a motion to intervene in an ongoing abortion pill lawsuit. Markezich alleged in her complaint that her boyfriend ordered abortion pills from a California provider and coerced her into taking the pills. Her baby died.

• August 2025: Judge Judge Matthew Kacsmaryk denied the motions by Texas, Florida, and Louisiana and moved the venue to Missouri.

• October 2025: Alliance Defending Freedom (ADF) refiled the lawsuit in State of Louisiana v. FDA (along with Rosalie Markezich) in the Western District of Louisiana, Lafayette Division.

• December 9, 2025: A new lawsuit, State of Florida and the State of Texas v. FDA, was