U.S. federal judge invalidates FDA’s abortion pill approval

A federal judge in Texas issued a highly-controversial rule Friday to invalidate the FDA’s (U.S. Food and Drug Administration) two-decade-old approval of an abortion pill called mifepristone,

The ruling by U.S. District Judge Matthew Kacsmaryk is the most significant abortion-related ruling since Roe v. Wade was overturned by the Supreme Court last year.

Kacsmaryk’s 67-page preliminary ruling gave the federal government seven days to appeal to the United States Court of Appeals for the Fifth Circuit.

“FDA ‘entirely failed to consider an important aspect of the problem’ by omitting any evaluation of the psychological effects of the drug or an evaluation of the long-term medical consequences of the drug,” Kacsmaryk wrote.

“Considering the intense psychological trauma and post-traumatic stress women often experience from chemical abortion, this failure should not be overlooked or understated,” he said.

“Simply put, FDA stonewalled judicial review — until now.”

Kacsmaryk did not fully comply with what the plaintiffs requested which was a full revocation of the FDA’s approval of the abortion drug, but he put a “stay” on the approval. If the judge’s preliminary rule is upheld in court, the drug could be removed from shelves in all states, including those where abortion is legal.

The judge first heard arguments on March 15 in a lawsuit against the FDA which sought a preliminary injunction that required the FDA to withdraw or revoke its two-decade-old approval of mifepristone, the abortion drug.

The lawsuit was filed in August in Amarillo, Texas, by the Alliance for Hippocratic Medicine — a conservative legal advocacy organization. The group claimed that the FDA failed to follow proper protocols and review evidence when it approved mifepristone 23 years ago, and that it ignored the drug’s safety risks ever since.

Serious complications caused by the pill are very rare. The FDA said more than 3.7 million U.S. women have used mifepristone since its approval in 2000. The agency has received 26 reports of deaths in women using the medication, including two involving ectopic pregnancies, which grow outside the womb.

The medications are not recommended for certain patients, including those with suspected ectopic pregnancies or implanted IUD birth control devices.

Medication abortions, terminating a pregnancy through taking a pill (or pills) account for more than half of all abortions in the U.S., according to a 2022 report by the Guttmacher Institute, a research group that supports worldwide abortion rights. The method became more common after Roe v. Wade was reversed, according to the institute.

The FDA-approved abortion method in the U.S. includes the use of mifepristone for pregnancy up to 10 weeks. Taken along with another pill called misoprostol, the two-drug regimen is referred to as the “abortion pill.” The two pills taken together are the gold standard for medication abortion amongst the medical community.

The abortion pill can be used to end a pregnancy up to 12 weeks gestation, according to the World Health Organization. Mifepristone is used to terminate pregnancies in 60 countries.

Misoprostol can be taken on its own too, but it is less effective and associated with a higher risk of serious complications than the combination of mifepristone and misoprostol versus misoprostol-only abortions.

The U.S. FDA announced this year that patients with prescriptions can now obtain abortion pills from their local and certified pharmacies, without having to see a doctor. Walgreens and CVS, two of the country’s largest pharmacy chains, announced they will start distributing the drugs.

That new policy allows patients to get prescriptions via consultations over the phone, and order pills through the mail, depending on the state. Meaning, people living in states with strict abortion bans, can still receive prescriptions and order pills from other states, regardless of their state’s restrictions.

This is the biggest abortion-related case since the reversal of Roe v. Wade. A legal battle has been raging in the U.S. by groups on both sides of the debate over abortion rights ever since the reversal, and the access to abortion pills is just the latest front.

14 states have already banned or restricted surgical abortions ever since the reversal of the 1973 decision. The state legislatures which had adjourned following the historic reversal are now back in session.

Other federal judges can issue rulings that conflict Kacsmaryk’s orders which can lead to a legal battle that could end up moving to the Supreme Court.

Kacsmaryk was appointed in 2019 by then-U. S. President Donald Trump. He had previously worked as an attorney for a Christian legal group and written an opinion piece criticizing Roe v. Wade, gay marriages, and premarital affairs in 2015.

Kacsmaryk is the only federal district judge seated in the Amarillo division of the U.S. District of Northern Texas. Abortion rights activists claim conservatives use his courtroom to get favourable rulings.

In 13 states including Texas, Arkansas and Oklahoma, most abortions are banned including medication abortions with no exceptions for rape or incest. Some states, including New York, Washington and California, allow abortions unless new bans are enacted. In others, abortions are legal but still may be limited like in Kansas, where a bill introduced earlier this year would ban the mailing of pills.

Experts told the Star before that any of the U.S. rulings do not really affect Canada in terms of access to abortion pills but it is too early to predict if there would be a spillover from the U.S. in the long term.

“The ruling has no immediate effect on Canadian accessibility,” said Kelly Bowden, director of policy and advocacy for Action Canada, a sexual rights advocacy group.

“It will however result in a rise of misinformation about medication abortion which could increase barriers to access for those seeking services in Canada. People in Canada should know that mifepristone remains available in Canada.”

“We know this medication is both safe and effective. It is recommended for use by the World Health Organization.”

The abortion pill brand in Canada is called Mifegymiso, which is a combination of two drugs called mifepristone and misoprostol. The use of the drug was approved by Health Canada in July 2015. The medication became available in Canada in January 2017.

“I can’t speculate on the impact of any legal ruling in Texas or its consequences for Canada,” said Dana Tenenbaum, the general manager of Canadian operations for Linepharma last month.

“We have not seen an impact in Canada following the 2022 overturn of Roe v. Wade.”

Item Koca is an Ottawa-based general assignment reporter for the Star. Reach her via email: [email protected]


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