Weekend Brief: The FDA v. one Texas judge

A Texas court's decision to rescind the approval of mifepristone, an abortion medication, could have dire consequences for healthcare.
Weekend Brief: The FDA v. one Texas judge

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Should judges be deciding which drugs are safe and which aren’t? Aren’t there specialized government agencies to do just that?

Just over a week ago, Matthew Kacsmaryk, a federal judge in Texas, invalidated the approval of mifepristone, a drug used to induce abortions until the 10th week of pregnancy. The US Food and Drug Administration (FDA) had approved mifepristone 23 years ago, but that wasn’t good enough for Kacsmaryk, a judge who has been described as a “one-time Christian activist.”

Kacsmaryk’s decision ostensibly addressed drug safety concerns. But mifepristone has a lower incidence of complications than many over-the-counter medications. Besides, the real spirit of the ruling shows through the judge’s choice of terminology, reflecting his anti-abortion beliefs. He frequently described a fetus as an “unborn human” or “unborn child,” the kind of lexicon common to anti-abortion activists.

The Biden administration filed an emergency appeal to the ruling, which resulted in a stay, but a partial one: Mifepristone is still available, but it can be prescribed only up to the seventh week of pregnancy, and not by mail. This greatly limits the use of the drug. For women (and transgender men), seven weeks may not be enough time to realize they are pregnant and then get an abortion. Eliminating mail delivery reduces access for communities, particularly in rural areas, who don’t live in proximity of abortion care providers.

The Justice Department will seek emergency relief from the Supreme Court to reinstate the FDA’s approval of mifepristone. But this is, one must remember, the court that overturned Roe v. Wade, setting off the chain of events that diminished women’s reproductive rights and resulted in decisions like Kacsmaryk’s.


If his ruling is upheld, the FDA will be forced to remove mifepristone from the market across the US. Medicated abortion—the most common, and less invasive, method—would still be an option in states that allow it, although exclusively through misoprostol, the drug currently used in combination with mifepristone to end pregnancies. Misoprostol, which is not FDA-approved for abortion, does work by itself, but it has lower success rates and can cause more painful abortions with more bleeding. Just as banning abortions doesn’t actually stop them and only renders them more dangerous, curbing access to mifepristone will leave American women with fewer, more difficult options.

Not surprisingly, the burden will fall disproportionately on women of lower financial means, particularly if they have to resort to surgical abortions. The cost of these procedures is roughly the same as medicated abortions. But the time and travel they require add up to a much higher bill, including transportation, loss of wages, and child care (most women who seek abortions already have children).

But the implications don’t stop there. By setting a precedent of overstepping the FDA as the ultimate authority in drug assessment, Kacsmaryk’s decision opens the door to all sorts of other political interference in scientific processes. Anything from vaccines to treatments for addiction to Alzheimer’s could become a political pawn. (Hormone therapy for transgender people may well be the next candidate to be endangered.) Stripping the science out will also heighten risks when it comes to the accessibility and safety of medications that might not be subject to FDA evaluation, but are placed or withdrawn from the market as a result of political debates.


95: The number of countries that have approved mifepristone since 1987

37: US states where medical abortion is legal

97%: The rate of effectiveness of medical abortion

11 per 1,000 live births: The rate of abortion in the US.

200 mg: The dose of mifepristone typically used in combination with misoprostol

800 mcg: The dose of misoprostol used in combination with mifepristone, or alone

53%: Americans who think medical abortion should be legal in their state

22%: Americans who think medical abortion should be illegal in their state

53%: The proportion of US abortions that happen through medication

0.00035%: The death rate for users of mifepristone

$800: The maximum cost of mifepristone in the US


1880: All US states have laws restricting abortion.

1910: Abortion is banned nationwide.

1920: The female suffrage amendment is ratified.

1967-1973: Seventeen states remove or amend their abortion bans.

1970: New York is the first state to legalize abortion.

1973: With Roe v. Wade, the US Supreme Court protects the right to abortion.

1976: The Hyde Amendment bans the use of federal money (including through Medicare and Medicaid) to pay for abortions.

1984: With his Mexico City Policy, US president Ronald Reagan bans foreign nonprofits receiving US money from performing abortions or advocating for it.

1992: With Planned Parenthood v. Casey, the Supreme Court protects the right to abortion but allows laws that don’t pose “undue burden” on obtaining abortion to stand, which limits access.

2000: Mifepristone is approved in the US.

2016: With Whole Woman’s Health v. Hellerstedt, the Supreme Court decides that two complex requirements to obtain abortions in Texas are unconstitutional.

2021: Texas imposes a six-week-ban on abortion.

2022: With Dobbs v. Jackson Women’s Health Organization, the Supreme Court rescinds the constitutional right to abortion and overturns Roe v Wade.

2023: The FDA makes mifepristone available outside clinics; a federal judge in Texas rescinds the FDA approval of mifepristone.


What will the FDA do if the Supreme Court upholds Kacsmaryk’s decision?

The situation is so unprecedented that it’s difficult to say; no court has ever suspended an FDA approval before. The agency’s chief strategy, at least during the Biden administration, would likely be to do nothing—to refrain from curbing sales and distribution of this freshly unapproved drug. This kind of discretionary restraint won’t be extraordinary; a Science investigation in 2020 found that the FDA’s enforcement capabilities have been declining for years. But it puts a scientific agency in the delicate position of making an important political decision, and it’s extremely probable that, under a Republican president, the FDA will crack down on mifepristone in the market. At which point, politics would have comprehensively trumped science, to the detriment of women all across the US.



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Thanks for reading! And don’t hesitate to reach out with comments, questions, or topics you want to know more about.

Have a weekend full of control over your own body.

— Annalisa Merelli, senior reporter

Additional contributions by Julia Malleck and Samanth Subramanian