A Texas federal judge’s ruling invalidating the Food and Drug Administration’s approval of the abortion pill mifepristone 23 years ago has the potential to be the most sweeping abortion decision since the Supreme Court overturned Roe v. Wade last June.
But there are many uncertainties — especially since a federal judge in Washington state issued a contradictory ruling less than an hour later, saying the FDA should do nothing to limit the availability of the pill in most states that allow abortion.
So the situation is complicated. Here’s what we know and what it could mean.
What did the two statements say?
Both rulings are preliminary injunctions, issued before the full cases have been heard. But the dueling orders sparked a legal confrontation that will likely reach the Supreme Court.
The ruling of Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas, a Trump appointee who has written critically of Roe v. Wade, voids the 2000 FDA approval of mifepristone. It also suspends subsequent FDA decisions that expanded the use of mifepristone in the termination of early pregnancies.
Legal experts said Judge Kacsmaryk’s ruling appeared to be the first time a court had acted to order that an approved drug be withdrawn from the market over FDA objection. to regulate other types of drugs.
The ruling by U.S. District Court Judge Thomas O. Rice of the Eastern District of Washington, an Obama appointee, orders the FDA to maintain the status quo and prohibits it from limiting the availability of mifepristone in the states that have the lawsuit for it filed court. That lawsuit, brought by Democratic attorneys general, challenged the restrictions the FDA still places on prescribing and dispensing mifepristone.
What does this mean for the availability of abortion pills?
For now, mifepristone, the first pill in the two-drug abortion regimen used in more than half of United States terminations of pregnancy, is still available. Judge Kacsmaryk immediately suspended his ruling for seven days to give the Justice Department, which represents the FDA, a chance to appeal to the U.S. Court of Appeals for the Fifth Circuit, and the Justice Department has already filed an appeal.
If the appeals court upholds the judge’s order or refuses to put it on hold until the full case has been heard, the Justice Department will most likely appeal that decision to the Supreme Court, which can quickly decide whether or not to uphold the order. is not suspended. The Supreme Court would also consider the federal judge’s contradictory ruling in the Washington state court’s case, legal experts said.
Even if the Texas ruling is upheld, several scenarios would see mifepristone remaining available in the United States, at least for now. And if the drug eventually becomes unavailable in the United States, patients will likely still be able to get it from abroad. Read on for more information.
How can a judge revoke an approval of a drug that has been legal for 23 years?
The lawsuit in Texas court, brought by a consortium of anti-abortion groups and physicians, argues that the FDA did not adequately review the scientific evidence or follow proper protocols when it approved mifepristone in 2000 and has since addressed the safety risks. of abortion has ignored. the medication.
The FDA and the Justice Department have strongly disputed those claims, saying the agency has conducted rigorous reviews of mifepristone over the years, which have repeatedly confirmed its decision to approve mifepristone, which blocks a hormone that may make pregnancy possible. makes. They point to numerous studies showing that serious complications are rare, with patients requiring 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 medical abortion “chemical abortion,” calling abortion providers “abortionists,” and referring to a fetus as an “unborn human being.” . or ‘unborn child’.
He seemed to agree with virtually all the claims made by the anti-abortion groups, writing: “Here, the FDA acquiesced in its legitimate safety concerns – contrary to its legal duty – on the basis of frankly flawed reasoning and studies that support its conclusions. not supported. There is also evidence that the FDA faced significant political pressure to abandon proposed safety measures in order to better process the process politics goal of greater ‘access’ to chemical abortion.”
The FDA has regulated mifepristone more strictly than many other drugs and has 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 lift that special framework of additional restrictions on mifepristone. Judge Rice denied that request in Friday’s ruling, but ordered the FDA to do nothing to restrict current access to mifepristone.
What are the options for maintaining access if the Texas ruling is upheld?
If the Texas judge’s order remains in effect while the full case moves through the courts, the FDA will most likely argue that it must follow its official drug approval process. That process is lengthy. It requires reviews of extensive research and data and may include advisory committee hearings and a public comment period. The process can take months or years, and while it’s going on, the drug under review remains available.
Legal experts say the FDA also has the authority to decide not to enforce a regulation or ban on a drug if the agency deems the drug to be safe and effective, as with mifepristone. The agency could issue a decision saying it decided not to enforce the ruling, or it could claim it didn’t have the resources to try to prevent the drug from reaching patients across the country.
Because the judge’s ruling only applies to the FDA and not abortion providers, several drug-abortion services have said they will continue to prescribe and dispense mifepristone unless there is an official FDA decision to withdraw the drug that the agency intends 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 sue the FDA to block enforcement of the Texas judge’s order, legal experts say.
What if attempts to keep mifepristone available fail?
Abortion providers and abortion rights advocates are actively preparing for this possibility. Many of them have developed plans to prescribe only the second drug in the two-drug abortion regimen: misoprostol. This drug, which has been available for decades and is approved for medical conditions such as ulcers, causes contractions that result in a process similar to miscarriage.
The World Health Organization has approved a misoprostol-only abortion regimen, and it is used in many countries, especially where there is limited availability of mifepristone. Studies suggest that using misoprostol alone may be slightly less effective than the two-drug combination and cause more side effects such as nausea, but it is safe and in most cases terminates a pregnancy without the need for follow-up surgery. procedure or other intervention.
In the Texas lawsuit, the anti-abortion organizations are also trying to ban the use of misoprostol for abortion, but their request for a preliminary injunction focused on mifepristone.
Can patients still order pills from abroad?
Many patients would likely continue to order both mifepristone and misoprostol from telemedicine abortion services in other countries, most notably Aid Access, a Europe-based organization that has for years provided the two-drug combination to patients in the United States after they complete a 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 in 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 FDA unsuccessfully tried to get Aid Access to stop overseas shipping. Dr. Gomperts said she would remain committed to supplying patients in the United States.
Would withdrawing the approval of mifepristone have consequences beyond abortion?
Mifepristone is also commonly used to help miscarriage patients. It is prescribed along with misoprostol to help expel the tissue from a pregnancy that has not developed. 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 for it to pass on its own, in a process that can be medically risky for some. patients.
Withdrawing mifepristone’s federal approval could also undermine the FDA’s longstanding and previously unchallenged authority – granted by Congress – to regulate virtually any drug. Legal experts say it could lead to challenges over the approval or use of drugs involved in other controversial issues, such as vaccines or emergency contraception. In addition, if drug companies cannot rely on the FDA’s regulatory authority, it could affect their decisions about which drugs to develop.
