The ruling by a federal judge in Texas invalidating the Food and Drug Administration’s approval 23 years ago of the abortion pill mifepristone has the potential to be the most consequential abortion decision since the Supreme Court overturned Roe v. Wade last June.
But there are a lot of uncertainties — especially because a federal judge in Washington State issued a contradictory ruling less than an hour later saying the F.D.A. should do nothing to restrict the pill’s availability in most states that allow abortion.
So the situation is complicated. Here is what we know and what it could mean.
What did the two rulings say?
Both rulings are preliminary injunctions, issued before the full cases have been heard. But the dueling injunctions set up a legal showdown that is likely to reach the Supreme Court.
The ruling by Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas, a Trump appointee who has written critically about Roe v. Wade, declares the F.D.A.’s approval of mifepristone in 2000 to be invalid. It also suspends the F.D.A.’s subsequent decisions that expanded the use of mifepristone in terminating early pregnancies.
Legal experts said Judge Kacsmaryk’s ruling appeared to be the first time that a court had acted to order that an approved drug be removed from the market over the objection of the F.D.A. If it stands, they said, it could have repercussions for the federal government’s authority to regulate other types of drugs.
The ruling by Judge Thomas O. Rice of the U.S. District Court for the Eastern District of Washington, an Obama appointee, orders the F.D.A. to maintain the status quo and blocks it from restricting the availability of mifepristone in the states that filed the lawsuit before that court. That lawsuit, filed by Democratic attorneys general, challenged restrictions the F.D.A. still imposes on the prescribing and dispensing of mifepristone.
What is mifepristone and can patients still get it?
Mifepristone is the first pill in the two-drug medication abortion regimen that is used in over half of pregnancy terminations in the United States. It blocks a hormone that allows a pregnancy to develop. For now, it is still available.
Judge Kacsmaryk immediately stayed his ruling for seven days to give the Department of Justice, which represents the F.D.A., a chance to appeal it to the U.S. Court of Appeals for the Fifth Circuit, and the Justice Department has already filed notice of its appeal.
If the appeals court upholds the judge’s order or declines to put it on pause until the full case is heard, the Justice Department will most likely appeal that decision to the Supreme Court, which could quickly decide whether or not to suspend the injunction. The Supreme Court would also take into account the contradictory ruling by the federal judge in the Washington district court case, legal experts said.
Even if the Texas ruling is upheld, several scenarios would allow mifepristone to remain available in the United States, at least for the time being. And if the drug does eventually become unavailable in the United States, patients would probably still be able to get it from overseas. Read on for details.
How can a judge withdraw an approval of a drug that has been legal for 23 years?
The lawsuit in the Texas district court, filed by a consortium of groups and doctors opposed to abortion, argues that the F.D.A. did not adequately review the scientific evidence or follow proper protocols when it approved mifepristone in 2000 and that it has since ignored safety risks of the medication.
The F.D.A. and the Department of Justice have strongly disputed those claims and said that the agency undertook rigorous reviews of mifepristone over the years that repeatedly reaffirmed its decision to approve mifepristone.They point to numerous studies showing that serious complications are rare, with patients needing hospitalization in less than 1 percent of cases.
In his ruling, Judge Kacsmaryk, who previously worked for a conservative Christian legal organization, repeatedly used the language of abortion opponents, calling medication abortion “chemical abortion,” calling abortion providers “abortionists” and referring to a fetus as an “unborn human” or “unborn child.”
He appeared to agree with virtually all of the anti-abortion groups’ claims, writing: “Here, F.D.A. acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions. There is also evidence indicating F.D.A. faced significant political pressure to forgo its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion.”
The F.D.A. has regulated mifepristone more stringently than many other drugs and applied a special framework of restrictions that is currently used for only 60 drugs in the country. In the case filed in federal court in Washington State, Democratic attorneys general from 17 states and the District of Columbia are seeking to eliminate that special framework of extra restrictions on mifepristone. Judge Rice did not grant that request in his ruling Friday but did order the F.D.A. not to do anything to limit current access to mifepristone.
What are the options for preserving access if the Texas ruling is upheld?
If the Texas judge’s injunction stays in place as the full case makes its way through the courts, the F.D.A. will most likely assert that it needs to follow its official process for withdrawing the approval of a drug. That process is lengthy. It requires reviews of extensive studies and data and could involve advisory committee hearings and a public comment period. The process can take months or years, and while it is underway, the drug being reviewed remains available.
Legal experts say the F.D.A. also has the authority to decide not to enforce a regulation or prohibition of a drug, if the agency considers the drug to be safe and effective, as it does with mifepristone. The agency could issue a determination saying it had decided not to enforce the ruling, or it could argue that it did not have the resources to try to stop the drug from reaching patients all over the country.
Because the judge’s ruling applies only to the F.D.A. and not to abortion providers, several medication abortion services have said they will continue prescribing and dispensing mifepristone unless there is an official F.D.A. decision to withdraw the drug that the agency plans to enforce.
It’s also possible that one or both of the companies that make mifepristone in the United States, Danco Laboratories and GenBioPro, could file suit against the F.D.A. to block its enforcement of the Texas judge’s order, legal experts say.
What if efforts to keep mifepristone available fail?
Abortion providers and supporters of abortion rights are actively preparing for this possibility. Many of them have developed plans to prescribe only the second medication in the two-drug abortion regimen: misoprostol. This drug, which has been available for decades and is authorized for medical conditions like ulcers, causes contractions that result in a process resembling a miscarriage.
The World Health Organization has endorsed a misoprostol-only regimen for abortion, and it is used in many countries, especially where there is limited availability of mifepristone. Studies suggest that using misoprostol on its own may be slightly less effective than the two-drug combination and can cause more side effects like nausea, but it is safe and, in a majority of cases, terminates a pregnancy without requiring a follow-up surgical procedure or other intervention.
In the Texas lawsuit, the anti-abortion organizations also seek to ban the use of misoprostol for abortion, but their request for a preliminary injunction focused on mifepristone.
Could patients still order pills from abroad?
Many patients would probably continue to order both mifepristone and misoprostol from telemedicine abortion services based in other countries, especially Aid Access, an organization based in Europe that for years has provided the two-drug combination to patients in the United States after they complete medical consultation forms.
Currently, for patients in states with abortion bans or restrictions, Aid Access has the pills shipped from a pharmacy in India, while patients in states where abortion is legal receive their pills from providers within the United States.
If the Texas ruling stands, Aid Access would most likely ship the pills from India to patients in every state, the organization’s founder, Dr. Rebecca Gomperts, a Dutch physician, said in an interview. In 2019, the F.D.A. tried unsuccessfully to get Aid Access to halt overseas shipping. Dr. Gomperts said she would remain committed to supplying patients in the United States.
Would revoking the approval of mifepristone have effects beyond abortion?
Mifepristone is also frequently used to assist patients who are experiencing miscarriages. It is prescribed along with misoprostol to help expel the tissue from a pregnancy that has failed to develop. So, if access to mifepristone is blocked, miscarriage patients will lose access to that treatment and will either have to undergo surgical removal of the tissue or wait days or weeks until it passes on its own, in a process that can be medically risky for some patients.
Revoking the federal approval of mifepristone could also undermine the F.D.A.’s longstanding and previously unquestioned authority — granted by Congress — to regulate virtually any drug. Legal experts say it could lead to challenges over the approval or use of medications involved in other controversial issues, such as vaccines or emergency contraception. In addition, if pharmaceutical companies cannot rely on the F.D.A.’s regulatory authority, that could affect their decisions about which drugs to develop.