Abortion pill could be withdrawn from sale due to lawsuit in Texas

WASHINGTON – A lawsuit in Texas that expires this month threatens the nationwide availability of medical abortion, which currently accounts for the majority of abortions in the US.

The case, brought by anti-abortion advocates who helped oppose Roe v. Wade, seeks to reverse years of approval from the Food and Drug Administration.

If a federal judge appointed by former President Donald Trump sides with them, it could halt the supply of the drug mifepristone to every state, both where abortion is illegal and where it remains legal.

“This could have an immediate impact on the country,” said Mini Timmaraju, president of NARAL Pro-Choice America. “In a way, it’s a behind-the-scenes ban on abortion.”

On Friday, a group of 22 Democratic-led states spoke out, saying the consequences of reversing the approval could be “nothing short of catastrophic.” by mail undermines their anti-abortion laws.

U.S. District Judge Matthew Kachsmarik did not specify exactly when or how he would make the decision, but groups like Timmaraju were preparing for a possible decision shortly after the Feb. 24 filing deadline. There are few precedents for a lone judge overruling FDA scientific decisions. A quick appeal of any decision is likely.

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The lawsuit was filed by Alliance Defending Freedom, which was also involved in the Mississippi case that led to the dismissal of Roe v. Wade.

“Our congressional representatives have created the FDA and made the FDA responsible for ensuring the safety of drugs before they are released to the market… The FDA has not lived up to that responsibility,” said Julie Blake, the group’s senior adviser.

They allege that the FDA overstepped its authority by approving mifepristone using an expedited review process meant for drugs to treat “serious or life-threatening conditions.”

But in its legal response, the agency said it did not expedite the drug’s approval, which came four years after the manufacturer first applied to sell the pill.

In 2000, the Food and Drug Administration (FDA) approved mifepristone in combination with a second drug as a safe and effective method of terminating a pregnancy. Common side effects include seizures and light bleeding. Cases of more severe bleeding requiring emergency care are very rare.

Terminating access to the drug more than 20 years after approval would be “extraordinary and unprecedented,” federal prosecutors said in a legal document.

Kachmarik, who has previously opposed a program that provides free contraception to minors in Texas, could also issue a ruling overturning regulators’ decisions to ease restrictions on pill availability. They were based on scientific studies showing that women can safely use the drug at home.

At the end of 2021, the FDA lifted the requirement that women receive the drug in person. Last month, the agency lifted another requirement that prevented most pharmacies from selling pills.

Before Roe v. Wade was dropped, medical abortion accounted for more than half of all abortions, according to a study by the Guttmacher Institute. It’s become more important since then, says Elizabeth Nash, a public policy analyst for a research group that supports abortion rights.

“The clinics that are open in the host states are overwhelmed, they have little capacity, and the availability of medical abortion is very, very important,” she said.

Abortion drugs are approved for use up to the 10th week of pregnancy. First, mifepristone is taken, swallowed orally. The drug dilates the cervix and blocks the action of the hormone progesterone, which is necessary to maintain pregnancy.

Misoprostol, a drug also used to treat stomach ulcers, is taken 24 to 48 hours later. This causes the uterus to contract and contract, causing bleeding and expulsion of the pregnant tissue. The combination has been shown to be over 95% effective in terminating pregnancies up to 10 weeks.

If mifepristone is discontinued, providers may instead prescribe misoprostol alone, an approach that is used in many parts of the world but would be a big shift in US practice and has not been found to be as effective.

The decision could also increase the need for surgical abortion and further lengthen waiting times at clinics, which in some cases are already weeks after the U.S. Supreme Court’s decision to overturn Row, Nash said.