“This middle-of-the-night ruling, while keeping mifepristone on the market, rolls back years of medical progress,” said Kirsten Moore, director of the Expanding Medication Abortion Access Project.
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.
Update April 14, 7:05 a.m. PST: Danco has filed an emergency appeal 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 argue 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.
Update April 14, 3:45 a.m. PST: Judge Thomas O. Rice of the U.S. District Court for the Eastern District of Washington issued an order requiring the FDA to maintain full access to mifepristone in 17 states and the District of Columbia in a lawsuit filed by attorneys general of those jurisdictions. The order said that the FDA must follow his order “irrespective” of any Fifth Circuit appeals court ruling.
Update April 13, 10:54 a.m. PST: The Department of Justice says it will file an emergency appeal of the Fifth Circuit decision to the Supreme Court. Danco Laboratories, which makes the brand-name version of mifepristone called Mifeprex, also said it will petition the Supreme Court for emergency relief.
GenBioPro, maker of the generic mifepristone, released a statement by their CEO Evan Masingill expressing their intention to continue selling mifepristone, saying “In the United States, once a drug has been through the rigorous FDA review process and received approval, federal law protects the right to market the drug. GenBioPro will use all regulatory and legal tools to protect access to mifepristone for patients and providers.”
In a divided opinion issued late Wednesday, the U.S. Court of Appeals for the Fifth Circuit ruled that the abortion medication mifepristone will remain approved for use throughout the United States, but only up to seven weeks of pregnancy when a doctor dispenses the medication in person. This ruling, if allowed to stand and followed, would significantly impair access to abortion throughout the United States.
On Thursday, the Biden administration’s Justice Department said it would ask the Supreme Court to intervene as soon as possible. Attorney General Merrick Garland said the DOJ “strongly disagrees with the Fifth Circuit’s decision. We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.”
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 and 2021. 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, and approving a generic version of mifepristone produced by GenBioPro.
“The Fifth Circuit’s decision to roll back recent measures that have ensured greater access to medication abortion care undermines the FDA’s authority and science, all while real people pay the price,” said Morgan Hopkins, president of All* Above All. “It proves just how entrenched anti-abortion extremism is in our judicial system and shows just how far they will go to take away our rights and freedom. We know this is not the end—we will keep fighting for a world with abortion justice, where abortion care is available, affordable, and supported for anyone who needs it.”
Clinicians can still prescribe the medication off-label later in pregnancy, as many are already doing through 11 weeks gestation, but limitations on who can prescribe the medication and telemedicine abortion could block access for many. The removal of the generic medication from the market could also significantly decrease access to the medication and increase the cost.
The Fifth Circuit decision was written by two Trump-appointed judges—Kurt Engelhardt and Andrew Oldham—and released just after midnight last night. A third judge—Catharina Haynes, appointed by George W. Bush—would have fully reversed the Texas court’s decision.
“The Fifth Circuit’s latest ruling shows exactly why courts have no place interfering in healthcare,” said Kirsten Moore, director of the Expanding Medication Abortion Access Project. “This middle-of-the-night ruling, while keeping mifepristone on the market, rolls back years of medical progress by reinstating restrictions that were lifted in 2016 and forcing people to go back to picking up their medications in person, essentially eliminating teleheath access and forcing people to travel, in some cases hundreds of miles, just to receive care.”
Over 400 pharmaceutical executives, including the CEO of Pfizer, have signed a letter objecting to the Texas ruling, which could destabilize the drug market in the United States. “In the face of laws and rulings that aim to undermine the evidence-based and legislatively sanctioned authority of federally mandated institutions such as FDA to protect public interests, and by putting an entire industry focused on medical innovation at risk, we cannot stay quiet,” the letter read. Several major pharmaceuticals companies have not signed the letter, including Moderna, Johnson & Johnson and Eli Lilly.
On Friday, April 7, federal judges in both Texas and Washington state issued contradictory rulings on the abortion pill mifepristone. Federal judge Matthew Kacsmaryk of the Northern District of Texas ruled that the FDA improperly approved mifepristone and said he would void the approval on April 14. One hour later, fellow federal judge Thomas O. Rice in 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.”
To support his decision, Kacsmaryk cited bogus anti-abortion “studies” claiming abortion pills are dangerous. In fact, mifepristone is safer than many over-the-counter medications, such as Tylenol. The American Medical Association says mifepristone has a “stellar safety record.” The president and CEO of the American College of Obstetricians and Gynecologists Drs. Iffath Abbasi Hoskins and Maureen G. Phipps said mifepristone’s “safety and efficacy is backed up by robust, evidence-based, clinical data and its observed use by millions of people with support from clinicians, including obstetrician–gynecologists.”
On Wednesday, Physicians for Reproductive Health, All* Above All and over 900 other healthcare providers, educators, and researchers sent a letter to President Biden urging the administration to take bold and immediate action to protect safe, effective medication abortion care.
Legal experts are also urging the FDA to exercise its enforcement discretion to keep mifepristone widely available. As David S. Cohen, Greer Donley and Rachel Rebouché wrote in the Guardian:
“Enforcement discretion allows the agency to provide safe harbor for technical violations of law … the agency could announce that it would not pursue action against the entities that market or dispense the drug to maintain the status quo as required by the Washington case… enforcement discretion is a normal part of the FDA’s operation and only relevant if the drug becomes unapproved as ordered. The FDA could exercise this discretion without being ordered to by the Washington court, but the Washington case provides enormous political cover for the agency to use this discretion.”
In 2020, medication abortion accounted for 54 percent of all pregnancy terminations in the U.S. Over five million women have safely used mifepristone over the last 23 years. After a federal court lifted the FDA requirement that clinicians distribute the medication in person in July of 2020, telemedicine abortion services surged across the United States, becoming available in over 20 states, expanding further after the FDA permanently lifted the in-person distribution requirement in December of 2021.
After the Supreme Court reversed Roe v. Wade last June, abortion pills and telemedicine abortion became a critical way women were able to end pregnancies in states restricting abortion access.
The Fifth Circuit sustained Kacsmaryk’s ruling that mailing abortion pills is a crime in violation of the antiquated 1873 Comstock Act, which banned sending obscene literature, contraceptives, abortifacients or any sexual information through U.S. mails. The DOJ last month issued its own opinion that mailing abortion pills does not violate Comstock.
Legal experts say the Texas ruling on Comstock has limited applicability. “Judge Kacsmaryk’s ruling that Comstock bans the mailing of abortion pills binds no one other than the FDA. NO ONE ELSE in the country is required to follow that ruling,” tweeted David Cohen.
“Women’s historians have been warning for decades that we never took the Comstock Act off the books. And now here we are,” tweeted historian Lara Freidenfelds.
Concerned about the ramifications of the Texas case, governors in pro-abortion states have begun to stockpile abortion pills. Massachusetts Governor Maura Healey announced the state has bought 15,000 doses of mifepristone—a two-year supply—to “ride out” the legal challenge. Last week, Washington Governor Jay Inslee bought 30,000 doses of mifepristone, a three-year supply for that state.
This week, California secured an emergency stockpile of 2 million pills of misoprostol, another abortion medication that can be taken with mifepristone or on its own to induce a safe and effective abortion. New York Governor Kathy Hochul announced Wednesday that New York state would also purchase 150,000 misoprostol pills. (A standard misoprosol-only abortion typically uses 12 pills in total.)
Laws Are Not Stopping People From Accessing Abortion Pills
Despite abortion restrictions and bans, people are obtaining abortion pills online. The organization Plan C has a comprehensive guide to finding abortion pills on their website, which is continually updated and has all the latest information on where to find abortion pills from anywhere in the U.S.
The Austria-based telemedicine abortion provider Aid Access serves people in all 50 states. Patients of all ages can obtain abortion pills, including advance provision, for a sliding scale fee of $110.
Meanwhile, reproductive health advocates will continue to fight back to maintain medication abortion access through the medical system in the United States.
“The FDA followed decades of science and evidence when it expanded access to mifepristone—a court with no medical experts that has a long history of extremist rulings on abortion has no place taking that away,” said Moore. “The Biden administration needs to make every effort to keep mifepristone, an FDA-approved drug, on the market so we all have the freedom to make personal decisions about our healthcare without politicians or the courts standing in the way.”
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