Breaking Down the Recent SCOTUS Declaration About Mifepristone Access and the Legal Battle Ahead
When the Supreme Court of the United States overturned the Roe vs. Wade decision in the summer of 2022, it opened up the floodgates for legal battles to play out across the country. The Roe vs. Wade ruling from 1973 was a landmark decision that guaranteed access to abortion in all 50 states. However, with the overturning of that ruling, the legality of abortion fell to the jurisdiction of each state. Several legal tests have been undertaken since then. One of these recent challenges has to do with the legality of the abortion pill known as mifepristone. Recently, the Supreme Court ordered that mifepristone will remain available despite attempts to suspend its FDA approval that has been in place for more than 20 years.
Whether you are a public health communicator or a member of the general public, being up to date on the challenges to abortion legality is critical to understanding how it impacts health access within your local community. Here’s what you need to know about the recent SCOTUS order as well as what is upcoming in the trial to ban mifepristone.
What Is Mifepristone?
Mifepristone is a pill that is used to terminate pregnancies. It is a safe alternative to surgical termination of pregnancies. Mifepristone is also available under the brand name Mifeprex. It is currently FDA-approved to be used in combination with another medicine known as misoprostol to end pregnancies that are ten weeks in gestation or less. This medication has been approved since 2000. According to policy experts, since its approval, this medication has been safely used by more than 5.6 million people, with an established safety record. Currently, there is a program in place to distribute this medication by mail if it is issued by a certified prescriber.
What Legal Challenge Has Been Levied Against the FDA?
In November 2022, a group known as the Alliance for Hippocratic Medicine filed a lawsuit against the FDA that challenged the legality of the FDA’s original approval of the medication mifepristone in 2000. The Alliance for Hippocratic Medicine is formed by the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, the Christian Medical & Dental Association, and three independent physicians. In this case, the Alliance alleges that the FDA did not act within its authority when initially approving the medication. The FDA’s initial approval of mifepristone is being challenged on the grounds that the process was expedited under a provision that was intended to create pathways for life-threatening illnesses (and pregnancy is not an illness). However, the actual process was not expedited because it took four years.
What Was the Initial Court Ruling Regarding the FDA’s Mifepristone Approval?
The initial case was filed in the district court of North Texas. It represents the first time that a court has been asked to overturn the approval of a drug. The federal judge involved in the case sided with the plaintiffs on April 7, 2023, effectively suspending the FDA’s approval of mifepristone nationwide. Almost immediately, a federal judge in Washington D.C. countered this decision, requesting that the FDA not alter the status quo and keep mifepristone available while the decision was appealed. The Justice Department then appealed the Texas ruling, and President Biden vowed that his administration would also fight the ruling. The case will now head to the U.S. 5th Circuit Court of Appeals, with oral arguments scheduled for May 17, 2023.
What Is the Recent SCOTUS Order Regarding Mifepristone?
As the legal battle plays out, the Supreme Court has announced an order that mifepristone should remain accessible on the market. On April 21, 2023, it granted a request from the Biden administration and mifepristone’s manufacturer, Danco Laboratories, to keep the drug available while the litigation process continues. According to experts, this pronouncement by SCOTUS will likely ensure that access to mifepristone continues into at least 2024.
What Is Next in The Challenge of Mifepristone’s FDA Approval?
After the case is heard by the U.S. 5th Circuit Court of Appeals, it may be further appealed to the Supreme Court. This appeal would take place within three months of the lower court’s ruling, but there is no fixed timeframe for the Supreme Court to decide whether or not to hear the case. Regardless of the outcome, the challenges to mifepristone’s FDA approval leave ultimate reproductive access hanging in the balance for the foreseeable future. To learn more, you can read the full case here.
Research and materials for this article were compiled, written, and distributed on behalf of the National Public Health Information Coalition. The views and opinions expressed in this blog are those of the various authors and do not necessarily reflect the official policy or position of the National Public Health Information Coalition or its members.
Sources
[1] Information about Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation
[2] Legal Challenges to the FDA Approval of Medication Abortion Pills. https://www.kff.org/womens-health-policy/issue-brief/legal-challenges-to-the-fda-approval-of-medication-abortion-pills/
[3] IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS AMARILLO DIVISION. https://adfmedialegalfiles.blob.core.windows.net/files/AllianceForHippocraticMedicineComplaint.pdf
[3] Federal judge suspends FDA abortion pill approval, gives Biden administration time to appeal. https://www.cnbc.com/2023/04/07/federal-judge-stays-fda-abortion-pill-approval-gives-time-to-appeal.html
[4] Supreme Court preserves access to abortion pill for now. https://apnews.com/article/supreme-court-abortion-pill-mifepristone-access-f781488016640bf571faf36096339ea4
[5] Supreme Court says abortion pill mifepristone will remain broadly available during legal battle. https://www.cnbc.com/2023/04/21/supreme-court-says-abortion-pill-mifepristone-will-remain-broadly-available-during-legal-battle.html