Update Friday, Apr. 21, 2023, at 4:15 p.m. PT: In a shadow docket ruling late on Friday, April 21, the Supreme Court has decided to block a previous ruling from the U.S. Court of Appeals for the Fifth Circuit from taking effect, allowing the abortion pill mifepristone to remain on the market under current rules.
“While SCOTUS offered temporary relief, the fate of a medication approved by the FDA more than 20 years ago should have never been before the Supreme Court to begin with,” said Kirsten Moore of Expanding Medication Abortion Access Project (EMAA Project). “The FDA has the authority and scientific expertise to evaluate and approve medications—not politicians, not activists, and not judges. We must now move forward to ensure access to safe and effective medication abortion care nationwide without any further interference—our freedom to make our own health care decisions is on the line.”
Dueling federal rulings on the abortion pill mifepristone have set up a Supreme Court fight. Before the Court weighed in on Friday, April 21, the dueling rulings on mifepristone were as follows:
- Friday, April 7: In a much-awaited decision, Trump-appointed federal judge Matthew Kacsmaryk of the Northern District of Texas ruled that the FDA improperly approved mifepristone—setting off a chain of responses from various other courts.
- Friday, April 7: Less than an hour later, Judge Thomas O. Rice of the U.S. District Court for the Eastern District of Washington issued an injunction blocking the FDA from “altering the status quo and rights as it relates to the availability of mifepristone.”
- Wednesday, April 12: The Fifth Circuit Court of Appeals issued a ruling on mifepristone limiting its use up to just seven weeks of pregnancy, which reproductive advocates warn would significantly impair access to abortion. (The appeals court concluded that the plaintiffs had waited too long to challenge the original approval of mifepristone in 2000, but were timely in their challenges to modifications of the approval in 2016, 2019, 2021 and 2023. Those modifications included allowing use of the medication through 10 weeks of pregnancy, lowering the recommended dosage to decrease side effects, allowing nurses and midwives to administer mifepristone, decreasing the number of appointments required to prescribe the medication from three to one, allowing the medication to be prescribed by telemedicine and mail, approving a generic version of mifepristone produced by GenBioPro and allowing certified pharmacies to dispense mifepristone.)
- Thursday, April 13: Rice ruled that the FDA must follow his order, “irrespective” of the Fifth Circuit appeals court—a reference to a separate ruling issued on Wednesday on mifepristone that limits its use up to just seven weeks of pregnancy, which reproductive advocates warn would significantly impair access to abortion. “No judge in Texas or the Fifth Circuit gets to override what a federal judge in Washington state has decided,” said Washington state’s Attorney General Bob Ferguson. Rice’s order applies to Arizona, Colorado, Connecticut, Delaware, District of Columbia, Illinois, Michigan, Nevada, New Mexico, Oregon, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania and Washington. Rice declined to apply his ruling nationwide.
The Circuit Court for the Eastern District of Washington also ruled the FDA was enjoined from “altering the status quo and rights, as it relates to the availability of mifepristone” as of January 2023—a direct conflict with the Fifth Circuit order staying modifications of the 2000 approval in 2016, 2019, 2021 and 2023. Those modifications include allowing use of the medication through 10 weeks of pregnancy, instead of seven in the original approval; lowering the recommended dosage to decrease side effects; allowing nurses and midwives to administer mifepristone; decreasing the number of appointments required to prescribe the medication from three to one; allowing the medication to be prescribed by telemedicine and mail; and approving a generic version of mifepristone produced by GenBioPro.
The continued contradictory orders of various courts have escalated the issue to the Supreme Court, which weighed in twice so far:
- Friday, April 14: The Supreme Court placed a five-day stay on the Fifth Circuit ruling in the mifepristone case, giving the Court until April 19 to rule in the case. (The request went to Samuel Alito, who is assigned to handle emergency matters from the New Orleans-based Fifth U.S. Circuit Court of Appeals. If SCOTUS hadn’t issued its temporary order before midnight on Friday, strict restrictions on mifepristone would have taken effect across the country.)
- Friday, April 21: The Supreme Court blocked a previous ruling from the U.S. Court of Appeals for the Fifth Circuit from taking effect, allowing the abortion pill mifepristone to remain on the market under current rules.
The case will now be heard in the U.S. Fifth Circuit Court of Appeals; oral arguments are scheduled for May 17 at 1 p.m. CT.
If the Fifth Circuit ruling had gone into effect, access to mifepristone would have decreased significantly across the country. Such a ruling would end telemedicine abortion, which has expanded significantly since the FDA approved it in 2021.
If the Fifth Circuit order had stood, women would have to travel long distances to find certified doctors, who are already far and few between. They would have to make multiple visits over several days to obtain abortion pills. And doctors could only prescribe the medication in the first seven weeks of pregnancy (49 days)—which means just five weeks after conception, since pregnancy is dated from the first day of the last menstrual period.
The FDA has always tightly restricted mifepristone, despite overwhelming medical evidence that the medication is extremely safe and effective. Mifepristone, originally called RU 486, was developed in 1980 by the French pharmaceutical company Roussel Uclaf and approved for use in France in 1988. But in the United States, the Bush administration blocked approval of the medication.
When President Bill Clinton won office in 1992, anti-abortion pressure kept the drug from being approved for another eight years.
Finally, in 2000, the FDA approved mifepristone, but with significant restrictions, including:
- Pharmacies were barred from dispensing mifepristone.
- Only doctors registered with the drug manufacturer could prescribe the medication.
- Certified doctors had give the medications directly to patients in a medical facility, which meant doctors had to order, stock and dispense the medication themselves.
- Patients had to make three separate visits to a certified physician over several days to obtain the medication.
- Patients had to sign a patient agreement with a “black box” warning about the medication.
- Certified doctors could only distribute the medication in the first 49 days of pregnancy.
- Certified doctors had to report any adverse effects of the medication to the FDA.
In addition to these restrictions, the FDA approved a 600-microgram dose of mifepristone, then a 400-microgram oral dose of misoprostol 48 hours later.
Subsequent research revealed that a lower dosage of mifepristone was effective for early abortion and had fewer side effects. So in 2016 the FDA lowered the recommended dosage to 200 micrograms of mifepristone. The same year, the FDA made several other modifications to its approval of mifepristone, including:
- allowing certified providers to prescribe the medication through ten weeks of pregnancy;
- replacing the term “physician” with “healthcare provider,” opening the door for nurses, nurse midwives and physician’s assistants to dispense the medication;
- eliminating the requirement that the dose of misoprostol be administered in a medical facility and allowed a remote follow-up visit, reducing the required number of visits from three to one; and
- removing the requirement that provider had to report adverse reactions to mifepristone.
The FDA made these changes based on extensive evidence on the safety of mifepristone. The FDA’s 2016 modification of its mifepristone approval significantly expanded access to the medication.
Subsequent FDA modifications to the drugs approval further expanded access, including:
- In 2019, the FDA approved a generic version of mifepristone produced by GenBioPro.
- In 2021, the FDA allowed certified providers to prescribe the medication at a telehealth appointment and mail the medications to their patients.
- In 2023, the FDA allowed certified pharmacies to dispense mifepristone.
The Texas judge claims the FDA rushed the original approval of mifepristone. In fact, anti-abortion political interference with bringing the drug to market in the United States delayed the approval of the medication. Advocates had to fight for 12 years to get mifepristone on the market. The FDA’s review of the drugmaker’s application took over three times longer than for other drugs at the time: 54 months to approve mifepristone, compared to an average wait time of 15 months for approval of other medications at the time.
The Texas judge and the Fifth Circuit judges raise concerns about the safety of mifepristone, citing research on anonymous blog posts but also the FDA’s black box warning, ironically. Over 100 scientific studies have proven mifepristone to be a safe method for ending a pregnancy. Mifepristone is safer than penicillin and Viagra, which are not subject to similar restrictions. Mifepristone is even safer than over the counter medications such as Tylenol. Over 5 million women have safely used mifepristone in the United States since it was approved in 2000. In March 2018, the Government Accountability Office issued a report on the FDA’s Mifeprex labeling changes and ongoing monitoring efforts and found that the FDA followed its standard review process, based its approval on peer reviewed published research and that the FDA determined the rates of adverse events were acceptably low.
Leading medical associations, including ACOG and the AMA, contend that the FDA has in fact overregulated mifepristone, by placing it in a drug safety program called the Risk and Evaluation Mitigation System (REMS). The plaintiff attorneys general in the Washington case are asking the federal court to remove the REMS restrictions on mifepristone, including the requirement that clinicians and pharmacies must be certified to prescribe mifepristone. They argue that these restrictions are not based on medical science and that they unnecessarily burden access to mifepristone.
Danco and DOJ Ask Supreme Court to Weigh in
Thursday, April 14, Danco filed an emergency appeal of the Fifth Circuit decision to the Supreme Court, arguing that the plaintiffs lack standing, lack any viable merits claims, and that the 2023 FDA changes were not before the Fifth Circuit. They also argued that the equities overwhelmingly favor a stay because Danco faces substantial, certain, unrecoverable harm, whereas the plaintiffs face no irreparable harm from a stay, and the public interest favors a stay.
The Department of Justice then also filed an emergency appeal to the Supreme Court.
In Dobbs v. Jackson Women’s Health Organization, the Supreme Court said that “the authority to regulate abortion must be returned to the people and their elected representatives.” The states before the Washington court have voted to keep abortion legal and accessible. It remains to be seen if the Supreme Court really meant what they said.
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