Federal Judge in Texas Withdraws FDA Approval of Mifepristone, Threatening Access to Medication Abortion Nationwide
A federal judge in Texas has issued a ruling that could dramatically alter the landscape of abortion access in the United States by withdrawing the Food and Drug Administration's (FDA) approval of mifepristone, the first drug used in medication abortion, 23 years after it was first approved. Mifepristone is one of the drugs currently used for nearly all medication abortions in the US. The decision places a hold on the FDA approval, but won’t go into effect for seven days, to give the government time to appeal. Afterward, the Department of Justice submitted a notification of appeal to the Fifth Circuit Court of Appeals. If the Supreme Court overturns Roe v. Wade, the case will serve as a challenge to the Court's commitment to treating abortion as a regular issue and allowing “the people and their representatives” rather than judges who are not elected to decide on the matter.
The ruling has potentially explosive implications for the availability of abortion nationwide. The case is just the latest battleground in reproductive rights after the Supreme Court overturned Roe v. Wade last summer, voiding the constitutional right to an abortion. Judge Matthew Kacsmaryk of Texas prohibited the FDA's endorsement of mifepristone for medical abortions, stating that the organization “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.” Afterwards, he issued a pause on his previous decision, pushing back the date when it would take effect by a week, to allow the government the opportunity to challenge it. The Justice Department took swift action and appealed the ruling.
The decision, which applies nationwide, marks the first time in history that a court has claimed the authority to single-handedly pull a drug from the market, a power that courts do not, in fact, have. From beginning to end, Kacsmaryk's decision is unjustifiable and will be remembered as one of the most outrageous and illegal instances in the history of the judicial system. The situation surpasses initial expectations, leading to the potential implementation of “fetal personhood,” a belief that requires all states to prohibit abortion as it is considered the killing of a human being. The release of the decision sparked a constitutional crisis within an hour. A federal judge in Washington quickly issued an opposing injunction that required the FDA to permit the use of mifepristone in 17 states and the District of Columbia. The District of Columbia had filed a separate lawsuit in Washington.
It should be clarified that the distinction between an abortion solely with misoprostol and one that incorporates mifepristone is not significant. The utilization of misoprostol as a standalone method is highly secure, well-tolerated, and has a high probability of effectively ending a pregnancy. At its core, it is unethical to deny patients access to a gold-standard medical treatment in order to fulfill a personal religious or political agenda. When mifepristone is not available, misoprostol is commonly used as a standalone option in countries with limited access. When mifepristone is unavailable, the World Health Organization suggests it as a substitute for the two-drug treatment. And misoprostol’s widespread accessibility—it is sold over the counter in Mexico and is much less stringently regulated by the FDA than mifepristone—has also made it a popular choice for people managing their own abortions in the US.
Even if mifepristone is removed from the market, individuals in need of abortions can still receive surgical procedures at physical clinics. However, these methods often come with a higher price tag and demand additional time and resources from already overburdened abortion clinics. The Justice Department cautioned that if mifepristone is removed from the market as proposed in the Texas case, clinics would face more delays and overcrowding. These clinics are already dealing with an influx of out-of-state patients since Roe v. Wade was overturned.
The lawsuit against mifepristone is an attack on the main tactic used by supporters of abortion rights to ensure access to abortion in states where it is still permitted. In recent years, there has been an increasing number of women who choose to end their pregnancies through medication. According to the Guttmacher Institute, over 50% of abortions in 2020 were conducted using pills, which is a significant increase from 37% in 2017. At the onset of the COVID-19 outbreak, the FDA eased its limitations on medication abortion on a temporary basis, allowing healthcare providers to prescribe abortion pills via telehealth. Later in 2021, the FDA made the relaxed regulations a permanent fixture. In recent years, numerous companies focused solely on telehealth for abortions have entered the market, resulting in a growing trend of women acquiring abortion pills without having to visit a doctor in person.
The consequences are significant. Should the FDA follow the Texas judge's ruling, mifepristone will not be available to abortion clinics until the injunction is lifted or the case is resolved. This will create substantial disruption, particularly for the sizeable portion of abortion providers who exclusively offer medication abortion. The cases from Texas and Washington will ultimately make their way to the Supreme Court. By overturning both decisions, they provide the majority with a chance to demonstrate fairness, a move that abortion supporters should accept as it would maintain the current status quo. Justices such as Kavanaugh and Barrett are now facing a moment of truth, as they claimed their dissent towards Roe was based on constitutional principles rather than religious faith.
0. “Rival rulings on medication abortion hypercharge the post-Roe legal war” KTVZ, 8 Apr. 2023, https://ktvz.com/politics/cnn-us-politics/2023/04/07/rival-rulings-on-medication-abortion-hypercharge-the-post-roe-legal-war/
1. “A Texas Judge’s Decision Could Reduce Abortion Access … Again” FiveThirtyEight, 8 Apr. 2023, https://fivethirtyeight.com/features/mifepristone-ruling-abortion-access
2. “Matthew Kacsmaryk's ruling against mifepristone will force the Supreme Court to act fast.” Slate, 8 Apr. 2023, https://slate.com/news-and-politics/2023/04/matthew-kacsmaryk-mifepristone-medication-abortion-supreme-court.html
3. “Federal Judges Issue Dueling Orders on Abortion-Pill Access” New York Magazine, 8 Apr. 2023, https://nymag.com/intelligencer/2023/04/federal-judges-issue-dueling-orders-on-abortion-pill-access.html
4. “Q & A: Implications of Two Conflicting Federal Court Rulings on the Availability of Medication Abortion and the FDA's …” KFF, 8 Apr. 2023, https://www.kff.org/policy-watch/q-a-implications-of-two-conflicting-federal-court-rulings-on-the-availability-of-medication-abortion-and-the-fdas-authority-to-regulate-drugs/
5. “Mifepristone ban: You will still be able to get a medication abortion—even if this inhumane ruling out of Texas stands.” Slate, 8 Apr. 2023, https://slate.com/news-and-politics/2023/04/mifepristone-ban-medication-abortion-still-available.html
6. “Texas and Washington abortion rulings, explained” Vox.com, 8 Apr. 2023, https://www.vox.com/2023/4/8/23675237/abortion-pill-mifepristone-kacsmaryk-contradictory-rulings