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Abortion pill could be pulled off market by Texas lawsuit

Several boxes of the drug mifepristone sitting on a shelf
The nationwide availability of the abortion pill mifepristone is threatened by opponents seeking to reverse the FDA’s approval of the drug.
(Allen G. Breed / Associated Press)
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A Texas lawsuit with a key deadline this month threatens the nationwide availability of medication abortion, which now accounts for the majority of abortions in the U.S.

The case, filed by abortion opponents who helped successfully challenge Roe vs. Wade, seeks to reverse a pill’s decades-old approval by the Food and Drug Administration.

If a federal judge appointed by former President Trump sides with them, it could halt the supply of the drug mifepristone in all states, even those where it remains legal.

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“It could have an immediate impact on the country,” said Mini Timmaraju, president of NARAL Pro-Choice America. “In some ways this is a backdoor ban on abortion.”

On Friday, a group of 22 Democratic-led states weighed in on the lawsuit, saying that reversing the FDA’s approval of the drug could be catastrophic.

A similar-sized group of Republican states filed briefs supporting the reversal, saying the ability to order pills by mail undermines their laws banning abortion.

U.S. District Judge Matthew Kacsmaryk has not indicated when or how he will rule, but NARAL and other abortion rights groups are preparing for a possible decision shortly after a Feb. 24 filing deadline.

There is scant precedent for a lone judge overruling the FDA’s scientific decisions. A swift appeal of any ruling is likely.

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The lawsuit was filed by the group Alliance Defending Freedom, which was also involved in the Mississippi case that led to the Supreme Court’s overturning last year of Roe vs. Wade’s guaranteed right to abortion nationwide.

“Our representatives in Congress created the FDA and gave the FDA the responsibility to make sure that drugs are safe before they’re allowed on the market … the FDA failed that responsibility,” said Julie Blake, senior counsel for the Alliance Defending Freedom.

The organization argues that the FDA overstepped its authority when it approved mifepristone using an accelerated review process reserved for drugs to treat “serious or life-threatening illnesses.”

In its legal response, the agency said it didn’t accelerate the drug’s approval, which came four years after the manufacturer submitted its application to market the pill.

The FDA approved mifepristone — in combination with a second drug — in 2000 as a safe and effective method for ending pregnancy. Common side effects include cramping and light bleeding. Cases of more severe bleeding requiring emergency care are very rare.

Halting access to the drug more than 20 years after its approval would be “extraordinary and unprecedented,” federal lawyers said in a legal filing.

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Kacsmaryk, who previously ruled against a program that provided free birth control to minors in Texas, could also issue a ruling that rolls back regulators’ decisions to ease restrictions on the abortion pill’s availability — decisions based on scientific studies showing women can safely use the drug at home.

In late 2021, the FDA removed a requirement that women pick up the drug in person. Last month the agency dropped another requirement that prevented most pharmacies from dispensing the pill.

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Medication abortion accounted for over half of pregnancy terminations before Roe vs. Wade was overturned, according to research by the Guttmacher Institute, and has grown more necessary since then, said Elizabeth Nash, state policy analyst for the science-based research group that supports reproductive rights.

“The clinics that are open in the receiving states are stretched thin; they don’t have a lot of give in their capacity,” making medication abortion “very, very important,” she said.

Abortion medication is approved for use up to the 10th week of pregnancy. Mifepristone is taken first, swallowed by mouth. The drug dilates the cervix and blocks the effects of the hormone progesterone, which is needed to sustain a pregnancy.

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Misoprostol, a drug also used to treat stomach ulcers, is taken 24 to 48 hours later. It causes the uterus to cramp and contract, resulting in bleeding and the expelling of pregnancy tissue. The combination has been shown to be more than 95% effective in ending pregnancies up to 10 weeks.

If mifepristone’s FDA approval is reversed, providers could prescribe misoprostol alone, which is done in many parts of the world — but that would represent a big shift in U.S. practice, and has not been found to be quite as effective as the combination of drugs.

Such a ruling could also increase the demand for surgical abortions and further increase clinic wait times, which Nash said are already weeks long in some cases since Roe was overturned.

Associated Press writer Matthew Perrone contributed to this report.

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