A Texas judge’s decision last week to freeze access to one of two abortion pills has thrust millions of women into a world of uncertainty.

US District Judge Matthew Kacsmaryk, a Trump appointee, ruled Friday to undo the 2000 Food and Drug Administration (FDA) approval of mifepristone, siding with those who argued that the FDA did not adequately review its safety risks. 

This contradicts what health authorities at the FDA and the Centers for Disease Control and Prevention say about the drug. They instead say there have been no safety concerns since its rollout over 20 years ago.

Judge Kacsmaryk’s 67-page order gave the government seven days to appeal, meaning until Friday, mifepristone is legal. 

The FDA can use enforcement discretion when it deems, based on a mountain of clinical evidence, that the risk of the drug to the public is low. 

So, what are the current laws when it comes to medical abortion, and what happens now? Dailymail.com looks at the most pressing questions in the wake of the landmark decision: 

The Texas ruling against the Food and Drug Administration’s approval of mifepristone will likely have major implications for abortion access throughout the US, even in states where abortion remains legal

What is medication abortion?

A medication abortion typically refers to a two-drug regimen that terminates a pregnancy in the privacy of a woman’s home.

Mifepristone is taken first and works by dilating the cervix and blocking the effects of the hormone progesterone, which is needed to sustain a pregnancy. 

About 24 hours later, the patient takes misoprostol, a drug developed to treat stomach ulcers that causes the uterus to cramp and contract.

This causes bleeding and leads to the expulsion of the pregnancy tissue.

Medical abortion has become the most commonly used method for terminating a pregnancy, making up 53 percent of the procedures in the US. 

This figure increased greatly from 2019 to 2020, as loosened FDA regulations and fear of Covid kept many out of doctor’s offices and instead received medicine at home. 

Previously, mifepristone was only able to be dispensed by a physician in person at a subset of specialty offices and clinics because of safety concerns. 

Mifepristone has been in use since the 1980s, first emerging in Europe. 

More than 5.6 million women have successfully used medication abortion since the drug’s approval 23 years ago, according to the FDA. 

A 2012 meta-analysis of 87 clinical trials published in the journal Contraception affirmed that medication abortion is generally safe. 

In the study, serious complications such as severe vaginal bleeding, pelvic pain, or infection requiring hospitalization occurred in less than 0.3 percent of patients.

Studies show mifepristone is safer and sends fewer people to the emergency department than popular drugs such as Tylenol and Viagra.

The complication rate for carrying a child to term, meanwhile, is considerably higher at 1.4 percent.  

What happened on Friday?

Judge Kacsmaryk ruled Friday in favor of the conservative Alliance for Hippocratic Medicine to repeal the FDA’s approval of the drug.

The group includes doctors who claimed they have had to treat women with complications from medication abortions.

The plaintiff’s claim that the FDA skirted safety guidelines in approving mifepristone, even though the agency imposed several prescribing restrictions to mitigate some of the risk of complications when taking the medication, such as heavy bleeding. 

Judge Kacsmaryk, appointed by President Trump in 2017 and is known to be a staunch Christian conservative, sided with the group.

He said in his decision: ‘The Court does not second-guess FDA’s decision-making lightly. 

‘But here, FDA 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.’

Meanwhile, government lawyers representing the FDA argued that regulators have reviewed extensive data and found no such safety concerns. 

Can I still buy abortion pills? 

The order is not a final ruling on the merits of the case but rather a preliminary injunction, meaning that it bans the drug while the case proceeds. 

It is still legal to prescribe and dispense at least until Friday, when the week-long stay that Judge Kacsmaryk imposed to give the government time to appeal expires.

Pharmacies that have been certified to dispense the pills can still do so until then. 

The FDA, Department of Justice, and Danco Laboratories, the manufacturer of the pill, have filed appeals to the 5th Circuit Court.

If the appeals court does not grant at least one of them emergency relief then the drug will be pulled from shelves on Friday. 

What happens now?

Less than an hour after Judge Kacsmaryk issued his ruling, a liberal judge in Washington State issued a contrary decision. 

Judge Thomas O. Rice of the U.S. District Court for the Eastern District of Washington, an Barack Obama appointee, ordered the FDA not to make changes to mifepristone access.

The Washington suit was filed by a coalition of Democratic attorneys general in 17 states and the District of Columbia sought to block the FDA from pulling the drug from the market.

The decision has further muddied the waters, making it even more unclear what the drug’s fate will be. 

Washington Attorney General Bob Ferguson believes the ruling could make it possible for patients in the 18 blue states and DC to continue getting access to mifepristone.

In his hope, the drug will remain available even after the decision goes into effect on Friday. 

Ferguson told NPR: ‘If you live in Washington State or one of the 17 states that joined Washington in our lawsuit…then the judge’s ruling in our case preserves the status quo on ensuring that access to mifepristone remains available.

For the rest of the states, though, the Texas judge’s ruling ‘seriously has the potential to eliminate that access for mifepristone here in the coming days,’ he continued.

In the Washington suit, abortion rights activists argue the FDA was actually too restrictive when it approved mifepristone in 2000.

At the time, regulators attached limitations and certification requirements for pharmacies and doctors to dispense and prescribe the drug.

This legal clash has sowed alarm and confusion, especially among the roughly 58 million women of reproductive age who do not live in a state where abortion is banned.

More than a dozen states have restricted access to abortions following the overturning of Roe V Wade

What is the most likely outcome?

The conflict over medication abortion, which is the most common method for terminating a pregnancy, will likely reach the Supreme Court.

In short, that’s not entirely clear. The pill’s legality is ensured until Friday but what comes next is murkier.

Because the Texas ruling did not expressly order the FDA to remove mifepristone from the market, legal scholars such as Rachel Rebouche from Temple University said the agency could exercise enforcement discretion and keep the drug in circulation. In that same vein, it could decide to halt all manufacturing and dispensation of the drug.

In deciding to use its enforcement discretion to not restrict access to the medication, the FDA would also be in cooperation with Judge Rice who ordered the agency to maintain the status quo at least in the states at issue in the litigation.

Oregon Democratic Sen Ron Wyden, who has long said banning access to mifepristone would not be legitimate, said on Friday: ‘No matter what happens in seven days, I believe the Food and Drug Administration has the authority to ignore this ruling, which is why I’m again calling on President Biden and the FDA to do just that.’

Women in blue states suddenly confronted with the possibility of not having a right to the medication abortion regimen may have some recourse, depending on where they live. In Washington, for instance, the Department of Corrections has bought up tens of thousands of doses of mifepristone that it will soon become authorized to dispense.

And Whole Women’s Health, an independent abortion provider, said on Friday: ‘[W]e follow directives from the FDA, and not anti-abortion judges in Texas who lack any formal medical training. Whole Woman’s Health will continue to dispense Mife in our clinics and our Pills by Mail program for the next week as we monitor both decisions.’

If the 5th Circuit were to uphold the Texas ruling, the DOJ would most likely appeal that decision to the Supreme Court, which could quickly decide whether or not to suspend the injunction

Is this the end of medication abortion as we know it?

It could be in that medication abortion could go from a two-drug regimen to just a single medication, the stomach ulcer drug misoprostol.

A misoprostol-only regimen is standard in many parts of the world and even has the full endorsement of the World Health Organization. In the absence of mifepristone, it is a trustworthy means of terminating a pregnancy, though it may come with some additional side effects such as nausea and a slight dip in efficacy.

Abortion providers have been preparing for the eventuality in which misoprostol is the only tool in the medication abortion toolbelt. Planned Parenthood, Abortion on Demand, Aid Access, Carafem, Choix, Forward Midwifery, Hey Jane, and Just the Pill have said they are prepared to prescribe misoprostol-only abortions as a workaround.