gayatri malhotra 0XFPG5ntedo unsplash 769ff

A Trump-Appointed Judge Just Reversed FDA Approval of Mifepristone. What Happens Next?

by Emily Lauletta

FDA approval of the popular abortion pill mifepristone is now at risk. A Trump-Appointed judge is responsible for the reversal of the approval of the drug, which was first greenlit by the FDA over 20 years ago in 2000. 

Used in combination with misoprostol to terminate a pregnancy, mifepristone is reported to be the most common method of abortion, with 51% of all pregnancy terminations occurring via pill. Republican US District Judge Matthew Kacsmaryk decided to suspend approval of mifepristone and has given the US Government 7 days to appeal his decision. Conservatives are taking advantage of the legislative blurred lines brought about by the overturning of Roe V. Wade, which could severely impact access to reproductive care nationwide.  

The FDA approved mifepristone 23 years ago, and its reversal could be the most detrimental blow to abortion rights in the US yet. Kacsmaryk’s ban of mifepristone is on the basis of it being an unsafe drug, which isn’t true, given how several studies have shown mifepristone to be safer than drugs such as penicillin. This is also the first time we’ve seen a court order that an approved drug be removed from the market completely (over the objection of the FDA). This court case could also be consequential to the government’s ability to regulate other drugs. 

This isn’t the first time mifepristone has been in the news recently. Ever since the overturning of Roe V Wade in 2022, access to mifepristone has been a hot-button issue for anti-abortion lobbyists and pro-choice activists everywhere. 

On March 2, Walgreens announced it would halt distribution of mifepristone as a result of mounting pressure from Republican state officials and other right-leaning political figureheads. Activist groups have been threatening to take legal action against pharmacies like Walgreens that continue to distribute the drug by mail. Whether it’s by a strongly worded letter, or by picketing & protesting, the fight for abortion rights is getting hit from all sides.

So What Happens Now?

Unfortunately, it seems as though the future legality of mifepristone is up in the air right now. Though we should clarify, at this current moment as of the publication of this article, mifepristone is still legal in the United States outside of the 13 states where medication abortion has been banned

The FDA Could Appeal or Ignore The Ruling

Hours after Judge Kacsmaryk’s horrendous ruling, the FDA filed a notice of appeal to the US Court of Appeals for the 5th Circuit. If the 5th Circuit (of the thirteen federal appellate courts) decides to not grant the appeal, the FDA could then immediately file another appeal to the SCOTUS. This would, in turn, block the ruling for as long as the appeal process takes IF the courts provide a stay.

The FDA could also, in theory, just ignore the ruling. Many Democrats and even one Republican, South Carolina Representative Nancy Mace, say that the FDA should do so. The potential problem with this is that Republicans could retaliate by defunding certain other FDA programs.

A Federal Stay Could Block the Ruling

Around the same time the FDA appealed this ruling, Attorney General Merrick Garland stated the government would request a stay to block the mifepristone ruling while the appeal is being debated in court. Unfortunately, both the appeal and the stay need to go into effect in order for the availability of mifepristone to remain as it is. If the courts agree to the appeal but don’t grant the stay, then mifepristone could be banned across the US as we await the final decision of the case.

Biden Could Use His Executive Powers To Override the Ruling

The Biden administration has already rushed to appeal the ruling that would ban Mifepristone, but lots of people, including us, think he should do more. Especially since he can. Many left-wing politicians and abortion supporters are calling on Biden to use his executive powers to protect the drugs’ availability before the case is heard by the 5th U.S. Circuit Court of Appeals. This would be a great idea, given that the court that will be hearing the case is conservative-leaning. However, the Biden administration has expressed concern at a move like this, as they fear it could hurt its position while the case moves through the appeals process. Basically, Biden has a lot of faith that a higher-up court will overturn this ruling, so he’s just trusting that. Great! *sarcasm*

A Washington State Judge’s Ruling Could Challenge The Decision

On the same day as Kacsmaryk’s ruling, Judge Thomas O. Rice from the United States District Court in the Eastern District of Washington was joined by 16 other attorneys general to challenge the FDA’s decision to restrict the prescription and dispensing of mifepristone through the Risk Evaluation and Mitigation System (REMS). Rice and co claim that the restrictions on the dispensing of the drug imposed by the FDA are unnecessary and only work to limit its availability. (And they’re right). The outcome of this case was a ruling that ordered the FDA to continue to allow Mifepristone to be available in the 17 states that were represented in this case.

The Case Could (And Probably Will) Go To The Supreme Court To Decide

Essentially, the FDA is facing two rulings that are basically asking them to do opposite things. This means it’s likely both rulings will be debated and settled in the Supreme Court. Given that SCOTUS ruled in favor of overturning Roe v. Wade in 2022, the likelihood that they’ll rule in support of the availability of mifepristone is not high. That being said, there’s always the possibility that certain SCOTUS judges take a day off from being supervillains

Can Misoprostol Work On Its Own?

For now, Kacsmaryk’s ruling does not affect the availability of misoprostol, or the availability of surgical abortions. 

As stated above, misoprostol is most often used in combination with mifepristone in order to terminate a pregnancy. Without mifepristone, someone seeking an abortion would just take a slightly higher dosage of misoprostol. Though, it should be stated that only taking one drug has proven to be slightly less effective in ending a pregnancy according to clinical trials. Misoprostol is not FDA-approved to terminate pregnancies on its own. In order for it to be used for an abortion, a doctor would have to prescribe it off-label.

You Can Get Pills Elsewhere

Aid Access is one organization that can provide patients with the abortion pills. Founded by a Dutch physician, the organization is Europe based but can send pills so any US state. The typical cost for the pills is 95 US dollars, but can be free if the patient is in need of financial help. This is a great resource to know about if mifepristone becomes totally banned in the US, as this organization will still have access to the medication (the pills for Aid Access aren’t manufactured in the US). That being said, patients would still be taking a risk by using the drug, as even though they could obtain it, many abortion bans prohibit the prescription and administration of the abortion pills.

So what does this mean for reproductive rights and access to pregnancy termination across the US? It means that Republicans, lobbyists, and anti-abortion groups will fight as hard as they can to take away our rights. We’re just going to have to fight even harder to keep them.

Top photo: Gayatri Malhotra on Unsplash

You may also like

Get the print magazine.

The best of BUST in your inbox!

Subscribe to Our Weekly Newsletter

About Us

Founded in 1993, BUST is the inclusive feminist lifestyle trailblazer offering a unique mix of humor, female-focused entertainment, uncensored personal stories, and candid reporting that tells the truth about women’s lives.

©2023 Street Media LLC.  All Right Reserved.