What is Mifepristone abortion pill and why a Texas judge banned it?

Two judges in two different states of the United States delivered contradicting rulings on mifepristone, which is one of the most commonly used drugs in the country to terminate a pregnancy.  

A Texas judge on Friday suspended the Food and Drug Administration’s approval of the medicine. Within an hour a judge in Washington State issued an order asking the FDA to refrain from making any changes to the availability of mifepristone. The rulings have put a question mark on the future of the drug, which has been in news for over 20 years.  

According to news reports, the abortion pill mifepristone is one of the most commonly used drugs and is often prescribed along with misoprostol to terminate a pregnancy within the first 10 weeks. Medical abortions are one of the popular ways of terminating pregnancies in the US.

Not only in the US, but the medicine is also widely used in more than 70 countries. France was the first country to approve mifepristone to terminate pregnancies in 1988.  

What is mifepristone?

Mifepristone, which is clinically known as RU-486, is  one widely available medicine. As mentioned above, it is prescribed with misoprostol to bring terminate a pregnancy and manage early miscarriage. According to WebMD, Mifepristone, which is taken orally, blocks a natural substance (progesterone) that is needed for your pregnancy to continue.

The medicine helps in breaking the uterus lining, while Misoprostol, which is taken after a few days, softens the cervix and cleans up the uterus. The medicine combo is considered a safe and effective method of abortion, with a success rate of over 95 per cent.

What’s the issue with the ban?

Anti-abortion activists and lawmakers have been lobbying against the medicine claiming it is unsafe and should be heavily regulated or banned altogether.  

The activists have said that the drug can lead to major health risks for individuals who take it and can cause excessive bleeding and infection. Under such circumstances, the patients would need a licensed healthcare provider, and self-medication could be risky and life-threatening.

Texas vs Washington State

In November 2022, a lawsuit was filed by Alliance Defending Freedom (ADF), a conservative Christian legal advocacy group, arguing that the FDA exceeded its regulatory authority when it approved mifepristone. The FDA has denied the charges and said that the drug is highly regulated.

US District Judge Matthew J. Kacsmaryk, who was a Trump administration appointee, has been trying to push a law that will ban the usage of the pill.  

The law, if it is passed, would make the whole process more difficult and expensive as many individuals use the medicine without continuing with the medical care for long.

The law would put them at risk of legal action if they are caught using it without following the strict guidelines.

On Friday, Judge Kacsmaryk in his 67-page ruling halted the FDA's approval of mifepristone. The ruling will not go into effect for seven days to allow the government time to appeal.

On the other hand, the Washington State judge issued a competing 31-page injunction on a separate case, ordering the FDA to keep the drug on the market in the Democratic-run states that brought the lawsuit.

What’s in store?

The FDA and Department of Health and Human Services can appeal against Kascmaryk’s ruling, escalate the case to the fifth circuit, and then, if needed, to the Supreme Court.

Experts have said the court orders make it likely that the issue will be escalated to the US Supreme Court. The Biden administration have defended the use of the medicine and has claimed that the drug's approval was well supported by science.

Following the rulings, President Joe Biden on Friday said that his administration will fight against the federal judge's order and called the ruling the next step towards an abortion ban.  

In a tweet, he said: “The medication in question is used for medication abortion. It doesn't just affect women in Texas. If it stands, it'd prevent women across the country from accessing the medication. It's the next step toward an abortion ban that Republican elected officials vowed to make law."

Legal experts have further warned that the contradicting rulings could upend decades of precedent, setting the stage for political groups to overturn other FDA approvals of controversial drugs and vaccines.

(with agency inputs)