In a Few Short Days, a Federal Judge in Texas Could Threaten the Availability of Abortion Pills Across the U.S.—Here’s What To Know

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In January, the U.S. Food and Drug Administration (FDA) took significant steps to expand access to abortion pills in the U.S., with a rule change that allowed retail pharmacies to begin distributing mifepristone, a drug used in a medication abortion.  However, that access is now under attack with a new Texas ruling on abortion pills—a federal judge could block the use of abortion medication across the United States.

The lawsuit, filed last November by Alliance Defending Freedom (ADF)—a Christian conservative legal advocacy group dedicated to the elimination of abortion—seeks to revoke the FDA’s approval of mifepristone, with the goal of removing the drug from circulation.

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If the judge rules in favor of the plaintiffs, a nationwide injunction on mifepristone will ensue, even impacting states where the procedure is legally permitted.

“This case filed before a federal court in Texas could effectively ban medication abortion nationwide,” says Jenny Ma, senior counsel at the Center for Reproductive Rights. “That means people in every state—including California, Illinois, and New York—will not be able to get abortion pills.”

Filed in Amarillo, Texas, a state that already restricts access to abortion, this case has drawn significant attention. It was assigned to U.S. District Court Judge Matthew Kacsmaryk, a conservative appointee nominated by former President Donald Trump. Kacsmaryk is well-known for his conservative stance on reproductive health, immigration, and same-sex marriage.

Despite the ADF’s claims, medication abortion is a highly safe and effective method, supported by extensive scientific research and numerous studies that attest to its safety and efficacy. As of now, medication abortion accounts for more than half of all abortions in the U.S., according to The Guttmacher Institute.

How do abortion pills work?

When taken in combination with the drug misoprostol, mifepristone can be used to eliminate a pregnancy up to 10 weeks. The effectiveness of the drug lies in its ability to inhibit the action of progesterone, a hormone that is vital for the progression of pregnancy.

According to Mayo Clinic, in order for the drug to work, individuals undergoing a pregnancy termination must follow a regimen that involves the administration of mifepristone followed by misoprostol 24 to 48 hours later. Patients are then recommended to consult with their healthcare provider seven to 14 days post the intake of mifepristone.

Prior to the FDA’s ruling, access to mifepristone was restricted to select medical practitioners, clinics, and mail-order pharmacies. However, misoprostol, the accompanying drug in the regimen, could already be obtained from various retail pharmacies with a valid prescription.

The FDA declared it would permanently lift its in-person dispensing restriction on abortion pills in December 2021.

What is the basis of the lawsuit?

The lawsuit has two pieces to it, says Kirsten Moore, director of the EMAA Project, which stands for Expanding Medication Abortion Access. The first part is the ADF alleging that the FDA did not approve mifepristone in 2000 according to the usual process, and therefore fast-tracked the drug. As a result, the ADF is suing the FDA, urging that the new drug application approval for mifepristone, which the FDA granted back in 2000, should be revoked. That would result in Danco Laboratories, the pharmaceutical company which distributes mifepristone, no longer having the authority to manufacture the drug.

Moore says the second piece revolves around the Comstock Act of 1873, a federal law in the U.S. that made it illegal to distribute “obscene, lewd, or lascivious” material through the mail – including birth control and information about contraception.

Therefore, mifepristone couldn’t be dispensed using telehealth and mailed to people’s homes.

Moore says anti-abortion advocacy groups have begun relying on these “flat-out, bonkers” laws to restrict the distribution of abortion medication throughout the U.S.

“This is very clearly the anti-abortion movement’s successful attempt to do a backdoor abortion ban if this case lands where we think it might,” Moore said. “Basically the plaintiffs are just doing an end run around the FDA by going to a Trump-appointed judge who has a track record of extreme points of view regarding anti-contraception, anti-same-sex marriage, anti-abortion, and thinks this judge will be favorable to their argument.”

In addition, the 113-page lawsuit alleges that the FDA approved the drug despite evidence of intense side effects, due to the pressure to do so from the administration of then-President Bill Clinton.

What could happen with this ruling on abortion pills?

The outcome of this ruling represents a significant danger to the ability of individuals to access abortion across the U.S. if the judge sides with the anti-choice group. For one, access to telehealth services, where patients can obtain abortion pills remotely, would no longer be an option. This would force all patients to undergo in-clinic procedures, exacerbating the already overwhelming burden on clinics, particularly those serving patients in states where abortion is restricted or banned.

This potential strain on clinics could have far-reaching consequences for women seeking safe and accessible abortion services.

“This is the most common form of abortion in the United States today and then all of the sudden it would not be available,” Moore says. “Again, no matter where you live, even if you’re in California, you would not have access to mifepristone with misoprostol, the FDA-approved regime. So what that means is that patients would be forced to choose an in-clinic procedure. Given the current state of access in red states, you’re going to have to transport yourself to a state that has an abortion clinic you can go to. Those clinics are going to be under tremendous pressure. They already are. They’re already seeing an uptick in patients who can’t get access in their own state.”

However, Moore believes that if Kacsmaryk rules in favor of the plaintiffs, mifepristone will only be taken off shelves temporarily, rather than indefinitely.

“Given the FDA’s robust track record of review of mifepristone and the fact that there isn’t any safety concern here, the FDA would invite Danco to resubmit a drug application and try to get that turn around as quickly as possible. But that’s a very disruptive business model. You are making pills, then all of a sudden you have to stop making pills, then go back through the FDA’s process which is not anything. They really do take this seriously. So it’s not like it’s going to be back on the market within the next month or two.”

Moore says she expects the process to take at least 10 to 18 months. If Kacsmaryk backs the anti-abortion advocates, Moore says she expects the Department of Justice to quickly file an appeal. However, it could be months before the appeal is even considered.

For decades, anti-abortion advocates have been actively working to abolish abortion using various tactics, such as protests, lobbying, and political activism, to further their cause. When the Supreme Court decided to overturn Roe v. Wade last summer, significant implications were placed on women's reproductive rights and their access to abortion services.

Sadly, this newfound Texas ruling on abortion pills will have far-reaching and devastating consequences for a multitude of individuals, making it nearly impossible for them to seek the care they need. The judge is expected to make the ruling on February 24—so for now, we’ll have to wait and see what happens.

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