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US Judge Withdraws FDA Approval of First Medication Abortion Drug After 23 Years: What This Means for Abortion Access in the US

A U.S. judge has issued an unprecedented ruling 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. The ruling places a hold on the FDA approval of mifepristone, which will render sales of the widely used drug illegal. It is 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.[0] Kacsmaryk's ruling is indefensible from top to bottom and will go down in history as one of the judiciary's most shocking and lawless moments.[0] It goes even further than expected, raising the possibility that he will impose “fetal personhood,” which holds that every state must ban abortion because it murders a human. [0]

The highly anticipated and unprecedented ruling from Texas puts on hold the Food and Drug Administration's approval of mifepristone, which was cleared for use in the United States in 2000. It was the first time a judge suspended longtime FDA approval of a medication despite opposition from the agency and the drug's manufacturer.[1] The ruling will not go into effect for seven days to give the government time to appeal. [1]

In November, the Northern District of Texas received a case from the Alliance for Hippocratic Medicine, a group opposing abortion. Their argument was that the U.S. Food and Drug Administration had not sufficiently evaluated the risks of mifepristone during its approval in 2000. The conservative group behind the lawsuit argues that the agency didn't follow the appropriate protocol when it first authorized the use of mifepristone in 2000 and failed to study the safety of the drugs as required, putting “politics over science.” 

The arguments in the case are seen by legal experts as a stretch.[2] But in a strategic move, Alliance Defending Freedom filed the complaint in Amarillo, Texas—virtually guaranteeing that it would be heard by Judge Kacsmaryk.[2] A former staff attorney for a religious-right legal firm, the controversial judge was already known for making anti-abortion and anti-LGBTQ statements at the time he was nominated by Trump and confirmed by a Republican Senate. [2]

The ruling will throw into chaos abortion access nationwide amid a legal landscape that has been upended since the Supreme Court reversed Roe v. Wade last June.[3] At least a dozen states have enacted near-total bans on the procedure or imposed tighter restrictions in the wake of the decision to unwind the right to an abortion under the U.S. Constitution. [3]

If a higher court doesn't step in and the FDA complies with the judge's order, clinics will have a choice.[1] It's possible to safely terminate a pregnancy by taking several doses of misoprostol, the drug that's used with mifepristone under normal practice now.[4] Misoprostol-only abortions are common globally, particularly in countries where abortion access is restricted, but the mifepristone-misoprostol combination was widely adopted in the U.S. because it's more effective — and less painful. 

In the absence of a block by the 5th Circuit, women who wish to terminate their pregnancies will have two choices: either undergo a surgical abortion or consume misoprostol, a single pill that is less effective if not taken along with mifepristone.[5] The latest data shows that 98% of medication abortions that occur in the US use the two-pill method, according to the Guttmacher Institute. [6]

One alternative could be to opt for a medication-induced abortion using solely misoprostol. Although not approved by the FDA, this approach is supported by the World Health Organization and commonly used to terminate pregnancies globally.[5] In the United States, the initial analysis of misoprostol-only abortions was conducted and in the previous month, the study was published. The research team discovered that the drug had an efficacy rate of 88%, and there were limited instances of severe adverse effects or indications of a potential pregnancy termination complication. In comparison, research in the US on using mifepristone and misoprostol together have shown success rates of 95 percent. [4]

The decision has already spurred the start of a constitutional crisis: A federal judge in Washington swiftly issued a dueling injunction compelling the FDA to continue allowing mifepristone in 17 states and District of Columbia, which brought a separate suit in Washington. A federal judge in Washington issued a potentially conflicting ruling that blocks the FDA from “altering the status quo …

0. “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

1. “Texas judge suspends FDA approval of abortion pill; second judge protects access” The Washington Post, 8 Apr. 2023, https://www.washingtonpost.com/politics/2023/04/07/texas-abortion-pill-ruling-mifepristone

2. “Federal Judge Orders the FDA to Suspend Approval for the Most Common Form of Abortion Nationwide” Mother Jones, 7 Apr. 2023, https://www.motherjones.com/politics/2023/04/texas-judge-abortion-mifepristone-medication/

3. “Abortion pill ruling: Texas Judge Matthew Kacsmaryk halts FDA approval of mifepristone; Biden administration will appeal” CBS News, 8 Apr. 2023, https://www.cbsnews.com/news/federal-judge-halts-fda-approval-of-abortion-pill-mifepristone/

4. “A Texas Judge’s Decision Could Reduce Abortion Access … Again” FiveThirtyEight, 8 Apr. 2023, https://fivethirtyeight.com/features/mifepristone-ruling-abortion-access

5. “Texas abortion pill ruling: The status of medication abortion in America after the Texas decision” Vox.com, 7 Apr. 2023, https://www.vox.com/policy/2023/4/7/23593396/medication-abortion-pills-mifepristone-misoprostol-pregnancy-texas

6. “Abortion Pill to Be Blocked Nationwide Under Judge's Order (3)” Bloomberg Law, 8 Apr. 2023, https://news.bloomberglaw.com/us-law-week/abortion-pill-blocked-nationwide-under-order-from-us-judge

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