A federal judge in Texas handed down a ruling Friday that could potentially eliminate access to the most widely used medication for abortion care and miscarriage management in the United States.
The U.S. Food and Drug Administration (FDA) approved mifepristone, one of two drugs used in medication abortion, in 2000. It’s been safely used by millions of pregnant people for over two decades — yet it could be pulled from distribution in just a few days.
This case is totally unprecedented: Never has a court overruled the FDA’s approval of a drug, much less a drug that has been on the market for over 20 years.
“I don’t know of a precedent where the judiciary has intervened or taken this kind of action to overturn an agency’s decision-making,” Dr. Jane Henney, a former FDA commissioner, said on a call with reporters on Monday. Henney oversaw the approval process of mifepristone when she served as FDA commissioner from 1999 to 2001.
The decision and its outcome have national implications that could drastically change access to what little abortion care is left in the country. Below is a quick overview of the ruling, the stakes and what comes next.
What is mifepristone?
Mifepristone is one of two medications used in abortion pills. Most abortion clinics offer a combination of mifepristone and another drug called misoprostol to induce abortion. The medicine also treats uterine fibroids and Cushing’s disease, a syndrome where the body creates too much cortisol.
Mifeprex, the brand name of mifepristone, is manufactured and distributed by Danco Laboratories; it was the first pill to be available in 2000. In 2019, the FDA approved a generic form of mifepristone, Mifepristone Tablets, manufactured by GenBioPro.
Years of research show that mifepristone is extremely safe and effective when used in a two-drug regimen with another drug called misoprostol. When used together, mifepristone and misoprostol are more than 95% effective and safer than Tylenol. The combination is used around the U.S. for miscarriage and abortion care through the first 10 weeks of pregnancy. Although the FDA approved its use up until 10 weeks of pregnancy, the World Health Organization says mifepristone can be safely used until 12 weeks.
Major medical groups have repeatedly said that mifepristone is safe and should be accessible to patients nationwide. The drug is a “safe, effective and important component of treatment and management for early pregnancy loss ... and induced abortion,” the American Medical Association and the American College of Obstetricians and Gynecologists wrote in a letter to the FDA in June.
What happened on Friday?
U.S. District Court Judge Matthew Kacsmaryk ruled that the FDA unlawfully approved mifepristone when it first went to market over two decades ago. However, the judge stayed the ruling for seven days, putting his ruling on hold until Friday at midnight to give time for the Biden administration to appeal. Alliance Defending Freedom, a conservative Christian legal group, filed the lawsuit in November in Amarillo, Texas, because Kacsmaryk is the only judge presiding over cases in that federal court.
Kacsmaryk, a far-right Donald Trump appointee well-known for his anti-choice views, claimed in his ruling that the FDA rushed the approval process for mifepristone.
The judge argued in his ruling that the FDA “manipulated and misconstrued” certain parts of the drug approval process to “greenlight elective chemical abortions on a wide scale.” Throughout the 67-page document, Kacsmarykroutinely referred to medication abortion as “chemical abortion” and fetuses as “unborn children”— rhetoric used by the religious right that’s not based in medical science.
In the same hour on Friday, a federal judge in Washington state issued a competing ruling that blocked the FDA from removing mifepristone from the market in 17 states and the District of Columbia, where abortion is currently legal.
Because both decisions were made in federal courts, they have national implications that fall well beyond the borders of Washington and Texas.
Is this how other medications are normally taken off the market?
The short answer is no. Under normal circumstances, there is a process to eliminate approval for a drug that’s currently on the market. That process can take years and includes several critical steps to ensure the decision is sound and evidence-based.
“It’s a rogue case that operates completely outside of the normal structure in which a court would review such a claim,” Nancy Northup, president and CEO of the Center for Reproductive Rights, told reporters on a Monday call.
A judicial review like Kacsmaryk’s is often limited when taking drug approval away, said Jessica Ellsworth, counsel for Danco Laboratories, the manufacturer of mifepristone who is named alongside the FDA in the lawsuit.
“There are rules of the road that courts are supposed to follow related to who gets to challenge agency action,” Ellsworth said, naming three separate avenues normally taken before judicial review. “Here, the district court ran roughshod over all three of those to get to the merits, and then once it reached the merits question, it did not defer to the agency’s actual articulated analysis and explanation,n which is what courts are supposed to do when they review agency action. That is the way it is supposed to work.”
Why is this happening?
Many pro-choice experts told HuffPost that this ruling is part of a long endgame for the anti-abortion rights movement.
“The anti-choice movement has been going after medication abortion well before Dobbs [overturned Roe v. Wade]... but they weren’t able to get in front of the right judge,” said Mini Timmaraju, president of NARAL Pro-Choice America. “We’ve always known this was a backdoor abortion ban tactic.”
And if mifepristone approval is pulled, it won’t just impact states where abortion is banned.
“What we do know for sure is this, the Texas case was brought as the next step to ban abortion nationwide,” said Dalven from the ACLU. “If Judge Kacsmaryk gets away with his attempt to undo the approval of mifepristone for the entire nation, the effect will be felt in all 50 states, even where abortion is legal and protected.”
What was the Biden administration’s response?
The Department of Justice immediately appealed the ruling to the U.S. Court of Appeals for the 5th Circuit on Friday night. U.S. Attorney General Merrick Garland said in a statement that the DOJ “strongly disagrees with the decision” and the department “will continue to defend the FDA’s decision” to approve mifepristone.
Garland said in his Friday night statement that the DOJ is also reviewing the Washington state judge’s decision.
“My Administration will fight this ruling,” President Joe Biden said in a statement referring to the Texas ruling. “The Department of Justice has already filed an appeal and will seek an immediate stay of the decision. But let’s be clear — the only way to stop those who are committed to taking away women’s rights and freedoms in every state is to elect a Congress who will pass a law restoring Roe v. Wade. Vice President Harris and I will continue to lead the fight to protect a woman’s right to an abortion and to make her own decisions about her own health. That is our commitment.”
Is mifepristone still legal?
As of Tuesday, mifepristone is still legal and available for Americans in states where abortion is accessible. That will likely stay the case until at least Friday, April 14, at midnight, when Kacsmaryk’s ruling goes into effect.
So, what happens now?
If the 5th U.S. Circuit Court of Appeals, which is notoriously conservative, doesn’t block Kacsmaryk’s decision, then the case will likely move up to the U.S. Supreme Court. However, the Supreme Court is usually in session from October to June, and it’s unclear if the case would be heard during the current session. Though the court could take the case on the shadow docket, which the high court has been doing more frequently with urgent cases. It’s also unclear if the ruling will be stayed until the Supreme Court reviews the case.
“The dueling decisions leave the FDA and health care providers in a very difficult situation that only the Supreme Court can fully resolve,” Wendy Parmet, professor of law at Northeastern University, said in a statement.
“There have been many other situations in which courts from different circuits have issued conflicting decisions. But I cannot think of any closely comparable to this, and certainly, none in which one court has ordered the FDA to withdraw its approval of a widely used drug and the other court has ordered the FDA to continue assuring access to that same drug.”
What about the Washington decision?
On Monday, the Department of Justice filed a motion to clarify the Washington preliminary injunction because there is “significant tension” between the Texas and Washington ruling – meaning they’re contrasting orders.
“The court did not address the interaction between these two orders, and it is significant... about what the administration can do next, how certain arguments can be crafted to determine what this preliminary injunction specifically means,” Jenny Ma, senior counsel for the Center for Reproductive Right, said on a Monday press call.
“The DOJ has now filed a five-page motion to clarify the preliminary injunction in Washington, and we assume that the court will weigh in very soon.”
What happens if the judge’s ruling goes into effect on Friday at midnight?
If there is no injunction before Friday at midnight, Kacsmaryk’s ruling will go into effect — putting access to mifepristone in serious limbo. Mifepristone cannot be manufactured or distributed in the U.S., but physicians or clinics who have mifepristone stocked will likely be able to continue prescribing it until their stockpile runs out. Given how unprecedented this ruling is some experts believe there could be a total recall of mifepristone which would force prescribers to send back whatever mifepristone they have stocked in their clinics.
Some experts have also pointed out that GenBioPro, the generic manufacturer of mifepristone, was not named in the lawsuit, meaning the pharmaceutical company could continue manufacturing the medication. However, it’s unclear if this would be the case since GenBioPro used the Danco research to bring the generic to market — and that research is now being questioned under Kacsmaryk’s ruling.
Other providers note that the ruling does not include mifepristone prescribed for Cushing’s disease — allowing physicians to prescribe mifepristone off-label for abortion care or miscarriage management.
Every expert stressed that a lot could happen this week. However, most say it’s just too early to tell.
“What we do know is that there will be significant confusion, a significant delay in people being able to access care in many places,” said Jennifer Dalven, director of the ACLU Reproductive Freedom Project. “There will be real difficulties as providers struggle… to provide the best possible care in the timeliest manner that they can for their patients, while now having to contend with these impossible legal rulings.”
What happens if mifepristone’s FDA approval is withdrawn?
There are a lot of things that need to happen before mifepristone loses FDA approval, thanks to this ruling. With that said, if the worst does happen, the FDA will likely seek to re-approve the medication.
The re-approval for mifepristone depends on many variables, but it could take years, explained Kirsten Moore, the director of Expanding Medication Abortion Access Project. If the FDA no longer approves mifepristone, the country could face a reality where people can only access the drug in clinical trial settings for two to three years.
Misoprostol alone can also induce an abortion, although it is not used in the in-clinic setting because it’s not approved by the FDA for abortion care. Instead, this method is often used abroad or when people are forced to self-manage their abortions at home. However, the misoprostol-only method is less effective than the mifepristone and misoprostol combination. Twelve misoprostol tablets — four tablets dissolved under the tongue every three hours over nine hours — will induce an abortion and lead to cramping and bleeding that will end a pregnancy.
Does the Biden administration have any other tools to fight this?
Technically, yes. The FDA has sole authority to approve or pull approval of a current drug on the market. That’s why this ruling is so unprecedented and could have drastic long-term impacts on other medicines on the market (think: HIV/AIDs medication or Plan B ― drugs that some political and religious groups have taken issue with).
The Biden administration could choose not to enforce Kacsmaryk’s ruling since the Texas order doesn’t require the FDA to do anything, explained David Cohen, a law professor at Drexel University who has written extensively about abortion rights.
“Just like a police officer is not ignoring the fact that the speed limit is 55 when they don’t pull you over for doing 57 ― they’re just saying, ‘We are using our discretion to go after things that matter a lot more than us to someone driving 57 in a 55,’” Cohen said.
A handful of lawmakers have called on the Biden administration to take this route, but a Health and Human Services official on Monday said the administration would not ignore the ruling.