An anti-abortion organization claims in a Texas lawsuit that the drug's safety was never adequately investigated. This is a representational image. Juan Encalada/Unsplash.

A Texas judge has heard arguments regarding whether a frequently used abortion pill should be sold in the U.S., in a decision that could limit access to the medication across the country.

Mifepristone, a pill that can be administered at home, is used to end pregnancies in more than half of cases in the U.S.

An anti-abortion organization claims in a Texas lawsuit that the drug's safety was never adequately investigated.

For more than 20 years, the use of mifepristone has been permitted.

More than half of all abortions in the US are now performed using abortion pills, making them the most popular way of doing so.

They have also emerged as the new frontier in the conflict over abortion availability in the U.S.

Mifepristone, one of the two pills that make up the most secure and efficient method of pharmaceutical abortion, is the subject of much of the debate.

The drug may soon be taken off store shelves across the country due to a lawsuit in Texas.

The case, which will be determined by former president Donald Trump appointee Judge Matthew Kacsmaryk, comes after the U.S. Supreme Court's landmark decision to reject the constitutional right to abortion last year.

After the four-hour hearing on Wednesday, he promised to make his decision as quickly as possible.

The Alliance for Hippocratic Medicine, an anti-abortion group, submitted the Texas lawsuit, which offers three justifications for why the drug ought to be taken off the market.

One claim in the case is that the U.S. Food and Drug Administration (FDA) committed a mistake by approving the drug under a provision meant to expedite the development of medications for seriously ill patients.

Second, it contends that the FDA authorized mifepristone before sufficient research was done.

Three, it claims that the Comstock Act, an 1873 law that forbade the posting of abortion drugs, makes shipping the substance illegal.

The U.S. Department of Justice's Office of Legal Counsel, however, published a statement in December stating that the Comstock Act does not bar the mailing of abortion drugs meant for medical use.

According to the Washington Post, Judge Kacsmaryk characterized the FDA's approval process as accelerated during testimony.

Before the drug was authorized in 2000, the FDA reviewed it for four years.

Mifepristone, the first tablet in a two-pill regimen advised by the Food and Drug Administration (FDA) to terminate a pregnancy, inhibits the progesterone hormone, which aids in the body's maintenance of the uterus.

For a pregnancy to proceed, progesterone is required.

While the second medication, misoprostol, empties the uterus, mifepristone successfully terminates the fetus.

In September 2000, mifepristone received US approval for the first time to be used to end a pregnancy medically up to seven weeks gestation.

Its authorized usage was increased in 2016 to include the final ten weeks of pregnancy.

Mifepristone is also used to address Cushing syndrome, a hormonal disorder, and miscarriages in female patients.

The FDA, the American College of Obstetricians and Gynecologists (ACOG), and other well-known medical organizations have insisted that mifepristone and misoprostol are both safe to use for more than 20 years.

According to U.S. studies, the two-step medication regimen is roughly 95% successful in ending the pregnancy and only 1% of the time necessitates additional medical follow-up.

Increasingly, anti-abortion campaigners have said that abortion medication, which they call "chemical abortion", is risky and ineffective, but their claims of widespread harm are not supported by leading medical organizations, such as the World Health Organization and the American Medical Association, BBC reports.

Since its approval, mifepristone has been linked to a total of 26 fatalities, or 0.65 deaths per every 100,000 medical abortions, according to the FDA.

For comparison, there are roughly 15.3 fatalities per 100,000 aspirin users who use the drug regularly.

Currently, there is a large supply of mifepristone and misoprostol in places where abortion is permitted.

When the FDA announced in April 2021 that it would waive the in-person dispensing rule for mifepristone during the Covid-19 pandemic, the drugs' accessibility was increased.

The FDA permanently removed that rule in December of last year, allowing the medication to be mailed.

If Judge Kacsmaryk rules that the FDA erred in its approval, sales of the drug - one of only two pills used to induce an abortion - could be halted.

According to Glenn Cohen, a law professor at Harvard University, such an unprecedented ruling would essentially upend the entire foundation of America's independent drug regulatory system.

This might make it harder for millions of women to get access to the medication and might discourage pharmaceutical firms from developing new medications, according to Prof. Cohen.

He stated that it was conceivable for the matter to reach the Supreme Court.

Women could still get an abortion with misoprostol, the other medication that has been authorized, even if the drug were taken off the market.

Judge Kacsmaryk had requested that lawyers not make the date of Wednesday's hearing public due to threats of death and obscene phone calls.

A letter was sent to the court by some media sources criticizing the unusual request and raising concerns about transparency.

A small group of opponents of the lawsuit congregated outside the Amarillo federal courthouse, BBC reports.

Julie Marie Blake, senior counsel for the Alliance Defending Freedom, a conservative group that backs the lawsuit, told the BBC's U.S. partner CBS that the organization is "confident that when any court looks at the law and looks at the science, it will realize that the FDA has completely failed its responsibility to protect women and girls."

According to that court action, the FDA's present drug regulations are "burdensome, harmful, and unnecessary".

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