Mail order and telemed access to chemical abortion pill mifepristone continues for now as the U.S. Supreme Court granted the requests of abortion drug manufacturers for a stay of the Fifth Circuit Court of Appeals decision requiring a return to in-person dispensing of the drug while the Louisiana v. FDA case moves forward.
Louisiana v. FDA focuses on what pro-life and pregnancy help advocates consider the dangerous deregulation of chemical abortion drugs and the removal of critical safeguards for women.
The SCOTUS decision released in the evening May 14 means the Biden Administration’s Food and Drug Administration (FDA) policy removing the in-person dispensing requirement for mifepristone remains in place and the case returns to the Fifth Circuit for consideration on the merits.
The FDA’s REMS, or Risk Evaluation and Mitigation Strategies, is a drug safety program that the FDA can mandate for "certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.”
Mifepristone has a REMS classification, one of approximately 73 drugs with such status, a small fraction of the thousands of prescription medications approved by the FDA. Mifepristone also has 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, aside from the initial in-person doctor visit to screen for ectopic pregnancy and other serious conditions, 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.
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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 has opened the door for abusers to obtain 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.
Louisiana v. FDA also includes Rosalie Markezich, a Louisiana woman coerced by her boyfriend to abort her unborn child with chemical abortion drugs.
The head of the largest network of pregnancy help organizations in the U.S. noted how the May 14 Supreme Court decision leaves women at unnecessary risk.
“Women deserve better than dangerous abortion drugs sent through the mail without physician oversight or in-person support,” said Jor-El Godsey, president of Heartbeat International.
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Heartbeat had filed an amicus brief in the case arguing that the FDA’s 2023 REMS “lowered the standard of care for treating a pregnant mother, placing her health at greater risk.”
This increased risk includes medical complications and harm to physical health, Heartbeat argued, along with abortion regret, emotional or psychological complications, and increased risk of coerced or forced abortions.
The State of Louisiana filed a lawsuit in October of last year seeking to end the FDA’s 2023 REMS on mifepristone.
The Trump FDA petitioned the court in January to pause the state’s lawsuit in 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” owing 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 the U.S. Court of Appeals for the Fifth Circuit granted Louisiana’s request to pause the FDA’s 2023 decision permitting mifepristone to be dispensed by mail. The unanimous ruling temporarily halted both telemed prescribing and mail distribution of mifepristone nationwide while the appeal continued.
Abortion pill manufacturers Danco Laboratories and GenBioPro 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.
Then Justice Samuel Alito extended the stay until May 14 at 5 p.m. to allow the Court more time to consider the case.
Alito issued a dissenting opinion to the May 14 decision, stating, “What is at stake is the perpetration of a scheme to undermine our decision in Dobbs v. Jackson Women’s Health Organization… which restored the right of each State to decide how to regulate abortions within its borders… Louisiana’s efforts have been thwarted by certain medical providers, private organizations, and States that abhor laws like Louisiana’s and seek to undermine their enforcement.”
Justice Clarence Thomas issued a dissenting opinion as well, saying that “it is a criminal offense to ship mifepristone for use in abortions” and the manufacturers and distributors of abortion “are not entitled to a stay of an adverse court order based on lost profits from their criminal enterprise.”
The FDA responded to the May 14 decision in a tweet stating that it will also “press forward” with its review of mifepristone and “in an effort to provide greater transparency, will provide updates as key milestones are reached.”
Godsey remarked as well on the states’ rights to protect women and their unborn children from chemical abortion drugs trafficked across state lines.
“A state, like Louisiana, that values life in its laws should be able to protect its smallest residents as well as their moms,” he said. “A judicial system that fails to do so will mean we can only be the United States of Abortion. A state, or even a nation, that cannot protect its next generation is doomed to decline.”
Editor's note: Heartbeat International manages Pregnancy Help News.
