Yahoo Finance The fight over mailbox access to abortion pill could be headed to Supreme Court
Mail access to the abortion medication mifepristone will remain in place for the time being.
A US appellate court in New Orleans said the FDA wasn't authorized to allow expanded access to abortion medication mifepristone but upheld the agency's original approval of the drug, propelling a fight over access to the medication to the Supreme Court.
The ruling, which is contingent on the Supreme Court's review, says the FDA went too far when it allowed providers to prescribe mifepristone through telemedicine consultations and for prescriptions to be shipped to patients by mail.
For now, telemedicine and mail access to the chemical abortion pills will stay in place due to a Supreme Court order from earlier this year that says the status quo must remain until it receives an appeal from the ruling. The US Justice Department said the Biden administration would appeal the decision, Reuters reported.
The ruling comes roughly a year after the high court in Dobbs v. Jackson Women’s Health Organization overturned its landmark 1973 decision in Roe v. Wade, and its 1992 case Planned Parenthood v. Casey, that together secured the constitutional right to obtain an abortion up until a fetus's "viability."
The three-judge panel for the Fifth Circuit Court of Appeals said in its split decision that the FDA overstepped its regulatory authority when it loosened rules around mifepristone access in 2016 and 2021, following the agency's original approval in 2000.
The panel's majority agreed with a Texas district court that those FDA moves to relax the rules for mifepristone's use should be reversed.
"In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it," US appeals court judge Jennifer Walker Elrod wrote in the majority opinion.
The court's decision favors a group of doctors and religious organizations opposed to abortion that filed a lawsuit against the Biden administration in a Texas district court. Mifepristone manufacturer Danco Laboratories later intervened in the case to argue in favor of the FDA’s decisions.
Danco said during oral arguments that a rollback of the FDA's expanded access posed an "existential threat" to the company's business. The company's representative told Yahoo Finance that the ruling "could potentially be disadvantageous to Danco’s financial position."
In the US, two companies have obtained FDA approval to produce mifepristone: Mifeprex brand manufacturer Danco and generic manufacturer GenBioPro. Both could see shrinking and shifting markets if the Fifth Circuit's decision is upheld. Another company, Corcept Therapeutics, produces mifepristone tablets sold under the name Korlym, used to treat Cushing’s syndrome.
A secondary drug, misoprostol, is also needed to complete an abortion. The pill is taken 24 to 48 hours after mifepristone. Misoprostol is also used to treat stomach ailments, including ulcers.
Neither Danco nor GenBioPro publicly discloses mifepristone sales data, though abortion rights advocacy organization Guttmacher Institute estimates that more than 50% of the 880,000 abortions obtained in the US each year are through the use of mifepristone.
According to the FDA, 3.7 million people underwent a medication abortion from 2000 to 2018. The average cost for a medication abortion, Danco told Yahoo Finance, is $400 to $500, a portion of which goes to purchase mifepristone.
All three companies also contend with higher-than-usual distribution costs because of a patchwork of state laws that vary on methods for dispensing the pills. Some states permit distribution by mail and through retail pharmacies, while others effectively outlaw the practice by prohibiting prescription through telehealth appointments.
In December, the Biden administration permanently lifted a restriction that prevented mifepristone from being mailed to consumers. Before that, patients were required to pick up abortion pills, in person, from a medical office, clinic, or hospital.
Still, at least 19 states made that change irrelevant by outlawing practitioners from prescribing medications through telehealth appointments.
The anti-abortion doctors and medical organizations fighting the FDA's approvals claimed that the relaxed regulations were unsafe and in turn led to emotional and financial injuries for doctors asked to provide emergency care related to mifepristone users.
The medical and religious organizations claimed they were forced against their will to expend resources on abortion care, and that their member doctors paid more for malpractice coverage as a result of the regulations.
In April, the US Supreme Court froze a ruling from the Fifth Circuit that temporarily reverted FDA approvals back to 2016 restrictions, as well as a Texas district court’s ruling that temporarily invalidated the FDA’s approval altogether.
In another federal case in Washington state brought by 17 states with Democratic attorneys general, US District Judge Thomas Rice temporarily barred the FDA from taking mifepristone off the US market.
Alexis Keenan is a legal reporter for Yahoo Finance. Follow Alexis on Twitter @alexiskweed.
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