Mifepristone Has its Day in Court

On an otherwise normal Friday in June 2022, the Supreme Court ruled in Dobbs v. Jackson Women’s Health Organization (Dobbs) that the Constitution of the United States did not guarantee a right to an abortion, overturning Roe v. Wade (Roe) and Casey v. Planned Parenthood in the process.¹

The 6-3 majority decision sent shockwaves across the country and ended access to a medical procedure that had become status quo after almost half a century from the Roe decision in 1973.

Justice Samuel Alito wrote the reasoning behind the Dobbs decision, which reinvigorated the question of the legality of abortion in the United States. Since the decision, the country has been transformed into a patchwork of laws and court battles that have left the fate of the procedure up in the air for millions of Americans.

As of May 2023, abortion is banned in 14 states, while 2 others have limited the procedure to between 6 and 12 weeks. Abortion remains legal in 25 states and Washington DC (DC) beyond the 22 week mark for gestation, while 9 states have limits between 15 and 22 weeks but still allow the procedure.²

Court cases have further defined the period post-Roe in the country, with judges in numerous states blocking both various laws that have been passed since the Dobbs decision and “zombie” trigger laws that automatically were put in place after the overturning of Roe.³

As of November 2022, the legal challenges to abortion have expanded to target mifepristone (Mifeprex; Danco Laboratories), commonly called a “medication abortion.” Depending on the outcome of pending court cases, including a potential decision from the Supreme Court, litigation around the use of mifepristone could have wide-ranging implications across the country.

The 6-3 majority decision of the Supreme Court sent shockwaves across the country. Image Credit: Adobe Stock - Jim Glab

Mifepristone and its FDA Approval

According to the FDA, mifepristone is used to block progesterone, a hormone that is necessary for a pregnancy to continue. When used in conjunction with misoprostol (Cytotec; Pfizer), another drug that causes contractions to lead to a medically induced miscarriage, it serves as a safe and effective way to terminate a pregnancy.⁴

Mifepristone was first approved by the FDA in September 2000, originally designated for use through the first 7 weeks of pregnancy. In 2016, the FDA increased this threshold to 10 weeks gestation. Although data have since revealed the possibility of some adverse effects (AEs) and cautions for use in certain populations, the FDA has concluded the data continue to affirm the safety of the drug, upholding the 2016 approval.

“The FDA approved [mifepristone] more than 20 years ago based on a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use,” the FDA wrote on their website, maintaining that they will “continue to closely monitor the postmarketing safety data on mifepristone for the medical termination of pregnancy.”

Notably, it remains possible and safe to have a medication abortion through only taking misoprostol, and it has been widely used for this purpose for decades. But it often requires more doses and could lead to more painful AEs like nausea, fever, or cramping. In 2020, 98% of medical abortions in the United States used the 2-drug protocol.⁵

As of 2020, medication abortions make up most of all abortions in the United States, according to a census from the Guttmacher Institute.⁶

A Pill Has its Day in Court

In November 2022, a case was filed in a district court in Texas by the Alliance for Hippocratic Medicine (AHM), an anti-abortion advocacy group, against the FDA alleging the administration had unlawfully approved mifepristone for medication abortions without acknowledging supposed dangers regarding safety and efficacy.

The AHM argue in the case that because of the FDA’s unlawful approval of this drug, the group has suffered “organizational harms” due to the time and resources they have spent researching the dangers of medication abortion and advocating against it.⁷

Judge Matthew Kacsmaryk, who is presiding over the case and was appointed by former President Trump, issued a preliminary injunction in April 2023 ordering a ban on the sale of mifepristone nationwide while the case continued.^8,9

Twenty minutes after Kacsmaryk’s ruling, a district court in Spokane, Washington led by Judge Thomas Rice directed the FDA to not ban mifepristone and make no changes to its availability. This was the result of a separate suit filed by 17 states and DC against the government to maintain the prior status quo around mifepristone. Rice’s decision only applied to those 17 states and DC.¹⁰

Only a few days after Kacsmaryk’s injunction, a federal court of appeals in New Orleans struck down the Texas ruling against keeping mifepristone on the market. However, the court let stand other restrictions that would essentially roll back years of FDA work to expand availability of the pill, including restricting it beyond 7 weeks of pregnancy and banning distribution by mail.¹¹

Following the conflicting court orders and the appeals court ruling, the Biden administration asked the Supreme Court to issue an emergency stay of mifepristone and any FDA-approved regulations around it, which was enacted on April 21. This move allows mifepristone to continue to be available to Americans, as well as allows the pill to be shipped throughout the country by mail.¹²

Now, the case is back in the hands of the appeals court in New Orleans, which began hearing oral arguments on May 17. The 3-judge panel—all appointed by Republicans—were scathing in their arguments against the Biden administration, a sign they will side with Texas’s lower court ruling against mifepristone.¹³

However, it could take weeks for a final decision to be announced, and any ruling will most likely be appealed.

Ron Lanton III, Esq, partner at Lanton Law PLLC, spoke with Pharmacy Times about the complicated legal situation surrounding mifepristone.

“Either they take up the case and determine the outcome or the Court declines to take the case and leaves the 5th Circuit's ruling in place, which would significantly change the outcome of this conversation, depending on what happens,” Lanton said.

Where Do Stakeholders Go From Here?

Until the AHM suit against the FDA makes its way back to the Supreme Court, mifepristone will continue to be available by rule of the Supreme Court’s emergency order. In the meantime, states, pharmacies, and the government are preparing for a potential new reality for patient access to mifepristone.

Many state governors have announced plans to stock up on misoprostol in preparation of a potential mifepristone ban. California Gov. Gavin Newsom has made plans to acquire up to 2 million misoprostol pills, and others have acquired large stockpiles of mifepristone.¹⁴

However, in the face of new developments in abortion care, pharmacists may be caught off guard by whatever the eventual legal resolution may be.

“As always, I think that pharmacists will continue to be a trusted resource for patients to go to so that patients can get their questions answered about mifepristone,” Lanton said, noting that he foresees mifepristone’s general availability being upheld in the 5th Circuit case while also upholding restrictions that make it difficult to obtain. “Although, nothing at this point would surprise me,” he noted.

Lanton also explained that, if legislation around mifepristone use were to become a reality, disruptions could occur for those seeking to purchase mifepristone since manufacturers would have to alter labeling and guidance for the drug, potentially causing production delays.

In terms of what individual pharmacists can do to continue treating their patients, Lanton said “I would advise the pharmacists under this scenario to seek their own legal counsel and discuss their options with them.”

He also suggested pharmacists consult with their respective state boards of pharmacy and medicine “to see how they are reviewing this issue with prescribers.”

Whatever the future of mifepristone holds, it is sure to be just as messy as the nationwide landscape of abortion is today.

References

1. Abortion in the United States dashboard. KFF. Accessed June 21, 2023. https://www.kff.org/womens-health-policy/dashboard/abortion-in-the-u-s-dashboard/
2. de Vogue A, Sneed T. Supreme Court protects access to abortion pill. CNN. April 21, 2023. Accessed June 21, 2023. https://www.cnn.com/2023/04/21/politics/supreme-court-abortion-pill-mifepristone/index.html
3. Expert discusses long-term implications of Roe v. Wade decision for pharmacists, contraception access. Pharmacy Times. June 30, 2022. Accessed June 26, 2023. https://www.pharmacytimes.com/view/expert-discusses-long-term-implications-of-roe-v-wade-decision-for-pharmacists-contraception-access
4. Jones K R, Nash E, Cross L, Philbin J, Kirstein M. Medication abortion now accounts for more than half of all US abortions. Guttmacher Institute. February 24, 2022. Accessed June 21, 2023. https://www.guttmacher.org/article/2022/02/medication-abortion-now-accounts-more-half-all-us-abortions
5. Kimball S. Key court ruling does not restrict abortion pill access in 17 states, federal judge says. CNBC. April 13, 2023. Accessed June 21, 2023. https://www.cnbc.com/2023/04/13/abortion-pill-mifepristone-court-ruling-doesnt-affect-17-states-ag-says.html
6. Latest mifepristone legal debates raise more questions, confusion for health care professionals. Pharmacy Times. May 8, 2023. Accessed June 21, 2023. https://www.pharmacytimes.com/view/latest-mifepristone-legal-debates-raise-more-questions-confusion-for-health-care-professionals
7. McCammon S. Why an ulcer drug could be the last option for many abortion patients. NPR. February 24, 2023. Accessed June 21, 2023. https://www.npr.org/2023/02/24/1159075709/abortion-drug-mifepristone-misoprotol-texas-case
8. McCammon S. With abortion pill access uncertain, states strike deals to stock up. NPR. April 11, 2023. Accessed June 21, 2023. https://www.npr.org/2023/04/10/1162182382/california-strikes-deal-to-stock-up-on-abortion-pills
9. Pierson B. Explainer: Kacsmaryk suspends approval of abortion pill. What’s next? Reuters. April 10, 2023. Accessed June 21, 2023. https://www.reuters.com/world/us/texas-judge-suspends-approval-abortion-pill-what-happens-next-2023-04-08/
10. Questions and answers on mifepristone for medical termination of pregnancy through ten weeks gestation. U.S. Food and Drug Administration. January 4, 2023. Accessed June 21, 2023. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation
11. Sobel L, Salganicoff A, Felix M. Legal challenges to the FDA approval of medication abortion pills. Women’s Health Policy, KFF. March 13, 2023. Accessed June 21, 2023. https://www.kff.org/womens-health-policy/issue-brief/legal-challenges-to-the-fda-approval-of-medication-abortion-pills/
12. Sneed T. Conservative appeals judges tear into Biden administration defense of anti-abortion drug approval. CNN. May 17, 2023. Accessed June 21, 2023. https://www.cnn.com/2023/05/17/politics/mifepristone-abortion-appeal-5th-circuit/index.html
13. Totenberg N, McCammon S. Supreme Court overturns Roe v. Wade, ending right to abortion upheld for decades. NPR. June 24, 2022. Accessed June 21, 2023. https://www.npr.org/2022/06/24/1102305878/supreme-court-abortion-roe-v-wade-decision-overturn
14. VanSickle A, Belluck P. The abortion pill ruling: what’s happened, what’s at stake, what’s next. The New York Times. May 17, 2023. Accessed June 21, 2023. https://www.nytimes.com/article/supreme-court-abortion-pill-ruling.html