Contradictory court rulings on mifepristone delay action on abortion drug

Key takeaways:

• A federal judge suspended FDA approval of mifepristone; another ruled to maintain access in states allowing abortion.
• The Biden administration will file an emergency appeal of this ruling within 7 days.

On April 7, a U.S. District Court judge in Texas suspended FDA approval of the abortifacient mifepristone giving the government 7 days to appeal, and a second judge in Washington ruled not to restrict the drug in states allowing abortion.

“The Court does not second-guess FDA’s decision-making lightly," Matthew Kacsmaryk, the judge in the Texas case, wrote in the first ruling. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”

The Biden administration will file an emergency appeal and seek a stay during the appeal process, according to a statement from U.S. Attorney General Merrick B. Garland.

The Texas case, Alliance for Hippocratic Medicine vs. U.S. Food and Drug Administration, brought in the U.S. District Court for the Northern District of Texas, Amarillo Division, challenged the FDA’s approval of mifepristone. The ruling by Judge Kacsmaryk declared the FDA’s approval of mifepristone (Danco) in 2000 invalid and suspended the subsequent decisions expanding the use of this drug in terminating early pregnancies.

In the case brought in U.S. District Court in Eastern District of Washington, the attorneys general of 12 democratic-controlled states sued the FDA to eliminate special restrictions on mifepristone. This lawsuit, State of Washington, State of Oregon, State of Arizona, State of Colorado, State of Connecticut, State of Delaware, State of Illinois, Attorney General of Michigan, State of Nevada, State of New Mexico, State of Rhode Island, State of Vermont, District of Columbia, State of Hawaii, State of Maine, State of Maryland, State of Minnesota and Commonwealth of Pennsylvania vs. U.S. Food and Drug Administration, Robert M. Califf and Xavier Becerra, asked the judge to declare that the mifepristone FDA approval is “lawful and valid.” The ruling by Judge Thomas O. Rice blocks the FDA from restricting the availability of mifepristone in states that filed the lawsuit and currently allow abortions. The Washington State case challenged FDA restrictions that impose on the prescription and dispensing of mifepristone.

Mifepristone is an abortifacient that was first approved by the FDA in September 2000 for medical termination of pregnancy through 7 weeks’ gestation, which was extended to 10 weeks’ gestation in 2016. The drug works by blocking the hormone progesterone, which then breaks down the lining of the uterus to prevent a pregnancy from continuing. When taken up to 48 hours prior to misoprostol, mifepristone-misoprostol empties the uterus similarly to an early miscarriage.

Use of this two-pill medication abortion method increased significantly from 39% in 2017 to 53% in 2020 among those seeking an abortion outside of a hospital since this method is effective in ending an early pregnancy with a 95% to 99% success rate, according to the Guttmacher Institute.

“This [Texas] decision decidedly misrepresents medication abortion care. It is inflammatory, brazenly substitutes the court’s judgment for that of trained professionals and distorts the reality of the ACOG members who compassionately provide abortion care, of the millions of patients whose health and lives have been impacted by medication abortion, and of the decades of decisive scientific data that prove its safety and efficacy,” Iffath Abbasi Hoskins, MD, FACOG, president of American College of Obstetricians and Gynecologists (ACOG), and Maureen G. Phipps, MD, MPH, FACOG, chief executive officer of ACOG, said in a statement from the organization responding to the Texas case ruling. “Mifepristone has been used safely and effectively for medication abortion for more than two decades. That 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. Regardless of the opinion of one judge on this matter, mifepristone is a safe, effective part of comprehensive health care.”

In June 2023, the U.S. Supreme Court decision, Dobbs vs. Jackson Women’s Health Organization, overturned the federal constitutional right to abortion. Since then, 12 states have constituted near-total or early gestational age bans for both procedural and medication abortion. In addition, 15 states currently restrict medication abortion access.

In early 2023, the FDA finalized regulations allowing pharmacies to dispense mifepristone to patients by a certified prescriber or by a certified pharmacy filling a prescription from a prescriber. This change does not allow for individuals to obtain mifepristone in pharmacies in states with abortion bans, according to the Guttmacher Institute.

References:

• 12 States Sue FDA, Seeking Removal of Special Restrictions on Abortion Pill. www.nytimes.com/2023/02/24/health/abortion-pills-fda-lawsuit.html. Published Feb. 24, 2023. Accessed Feb. 27, 2023.
• ACOG Condemns the Court Decision Overturning FDA Approval of Mifepristone. www.acog.org/news/news-releases/2023/04/acog-condemns-court-decision-overturning-fda-approval-mifepristone. Published April 7, 2023. Accessed April 10, 2023.
• Medication Abortion. www.guttmacher.org/state-policy/explore/medication-abortion. Published Feb. 6, 2023. Accessed Feb. 24, 2023.
• Medication Abortion Now Accounts for More Than Half of All US Abortions. www.guttmacher.org/article/2022/02/medication-abortion-now-accounts-more-half-all-us-abortions. Published Feb. 2023. Accessed Feb. 24, 2023.
• Statement from Attorney General Merrick B. Garland. https://www.justice.gov/opa/pr/statement-attorney-general-merrick-b-garland-2. Published April 7, 2023. Accessed April 10, 2023.
• Two Federal Judges Issues Opposing Rulings on Abortion Pills. Here’s What’s Going On. www.nytimes.com/2023/04/08/health/mifepristone-abortion-pills-ruling-judges.html?searchResultPosition=3. Published April 10, 2023. Accessed April 10, 2023.