Heartbeat International continues to back Louisiana's legal effort to safeguard women from risky chemical abortion drugs and coerced abortion.
Heartbeat filed an amicus brief June 22 in State of Louisiana v. FDA, asking the Fifth Circuit Court of Appeals to re-instate its injunction on the 2023 Risk Evaluation and Mitigation Strategy (REMS) for chemical abortion drug mifepristone.
A decision from the Fifth Circuit in Louisiana's favor could again halt remote prescribing and dispensing of mifepristone and bring the case back to District Court to be further litigated on the merits.
Louisiana v. FDA concerns what pro-life advocates regard as dangerous deregulation and removal of critical safety standards of chemical abortion drugs, putting women at unnecessary risk.
The state and a Louisiana woman, Rosalie Markezich, who had been coerced to take abortion drugs, are suing the FDA over the 2023 REMS which allow out-of-state abortion activists and doctors to traffic the drugs into the state.
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The U.S. Food and Drug Administration’s (FDA) REMS, or Risk Evaluation and Mitigation Strategies, is a drug safety program that the FDA can require for "certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks,” according to the FDA.
Mifepristone has a REMS classification, one of 73 drugs with such classification, a small fraction of the thousands of prescription medications approved by the FDA. Mifepristone also carries an FDA Black Box Warning, the highest level of safety warning.
The REMS for mifepristone have been loosened in steps over time under the Obama and Biden administrations, including an initial in-person doctor visit to screen for ectopic pregnancy and other serious conditions, and a follow-up visit to check for life-threatening complications such as internal bleeding and infection. The requirement that abortion providers report non-fatal adverse events to the FDA Adverse Event Reporting System was also eliminated.
Allowing mifepristone to be mailed and dispensed by pharmacies came next, and the Biden FDA permanently removed the in-person dispensing requirement in 2023.
This paved the way for abusers to procure chemical abortion drugs on-line and force or otherwise coerce pregnant women into taking them and for abortion activists to sell the drugs across state lines where they may be prohibited by law.
Heartbeat, the largest network of pregnancy help organizations in the U.S. and the world, manages the Abortion Pill Rescue Network (APRN), which serves women who have started, but not yet completed, the chemical abortion process and wish to continue their pregnancies.
The APRN answers more than 200 calls per month from women amid a chemical abortion who regret their decision to abort and are seeking to save their pregnancies. The Network also regularly takes calls from women who report that they were coerced or forced into taking abortion pills.
The brief states:
Given its regular interactions with women who have obtained abortion drugs they later regret ingesting as well as women who were coerced, such as Plaintiff Markezich, or even physically forced into taking abortion drugs obtained by others, Heartbeat is uniquely positioned to provide relevant factual background on the impact of removing certain health safeguards for mifepristone and misoprostol.
Heartbeat notes in its brief that the FDA’s actions to make mifepristone more easily available are based upon the flawed premise that pregnancy is an illness to be cured and violate the Comstock Act, which prohibits interstate mailing and shipping of abortion-inducing drugs. The FDA’s relaxed rules also undermine state abortion regulations, Heartbeat argues, which were recognized even under Roe v. Wade and Planned Parenthood v. Casey, and obstructs the intended return of the abortion issue to the states in the Supreme Court Dobbs v. Jackson Women’s Health Organization ruling.
Heartbeat argues as well that the FDA’s loosening of its safety standards for mifepristone puts women at psychological, emotional, and medical risk and in danger of coerced or forced abortion.
“The FDA's decision to remove in-person prescription and allow for nationwide mailing of mifepristone completely flies in the face of state authority to protect life and regulate abortion within its own borders, as well as directly puts women at serious risk,” said Danielle White, general counsel for Heartbeat International.
Heartbeat’s president echoed her thoughts.
"Increasing risk is the exact opposite of what our government should be accomplishing with policy,” Jor-El Godsey said. “When a local government is seeking more common-sense protections for women from risky drugs and dangerous predators, the courts should support that effort, not stand in the way.
“Women should be valued and protected in pregnancy,” said Godsey, “not endangered by an abortion industry bent on profits and political power."
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Heartbeat’s brief is in response to the Supreme Court's undoing of the Appellate Court's injunction that temporarily paused the remote prescription and dispensing of mifepristone.
The State of Louisiana filed a lawsuit in October 2025 seeking to end the FDA’s 2023 REMS on mifepristone.
The Trump FDA petitioned the court in January to pause the state’s lawsuit while the FDA continues its promised review of the drug, which has dragged on, though the FDA said it could be done in less than a year.
While the stay was granted, the judge ruled that the state and Markezich “are likely to succeed on the merits” due to the FDA’s “own shortcomings” in loosening mifepristone’s safety restrictions.
Louisiana and Markezich filed an appeal after the Western District Court of Louisiana granted the Trump Administration’s requested stay.
Louisiana Attorney General Liz Murrill filed a motion for preliminary relief in December, asking the court to stay the effective date of the 2023 REMS, or alternatively grant a preliminary injunction ordering the FDA to suspend or withdraw the 2023 REMS while the case proceeds.
On May 1, a three-judge panel of the Fifth Circuit Court of Appeals granted Louisiana’s request to reverse the FDA rules that enabled remote prescribing, mailing, and retail pharmacy dispensing while the appeal proceeded, requiring in-person dispensing of mifepristone nationally.
Abortion pill manufacturers Danco Laboratories and GenBioPro, intervenors for the FDA, immediately filed a stay application with the Supreme Court, which issued a one-week administrative stay that paused the Fifth Circuit ruling until May 11.
The Supreme Court extended the stay until May 14, when the Court then undid the Fifth Circuit’s decision, upholding remote dispensing of mifepristone while the case went back in the Fifth Circuit, where the appeal process continues.
Heartbeat had also filed an amicus brief in the case in the US District Court Western District of Louisiana in February arguing that the FDA’s 2023 REMS “lowered the standard of care for treating a pregnant mother, placing her health at greater risk.”
Editor's note: Heartbeat International manages the Abortion Pill Rescue® Network (APRN) and Pregnancy Help News. Heartbeat is currently the subject of two lawsuits concerning sharing information about Abortion Pill Reversal.
