A Texas judge’s decision last week to freeze access to one of two abortion pills has plunged millions of women into a world of uncertainty.
U.S. District Judge Matthew Kacsmaryk, a Trump appointee, ruled Friday to overturn the 2000 Food and Drug Administration’s approval of mifepristone, siding with those who argued the FDA had not adequately assessed the safety risks.
This contradicts what the FDA and Centers for Disease Control and Prevention health authorities say about the drug. Officials from those health agencies say there have been no safety issues since its rollout more than 20 years ago.
Judge Kacsmaryk’s 67-page order gave the government seven days to appeal, meaning mifepristone is legal until Friday.
The FDA will now have to decide whether to uphold the ruling in Texas.
So, what are the current laws when it comes to medical abortion, and what’s happening now? Dailymail.com looks at the most pressing questions after the historic decision:
The Texas ruling against the Food and Drug Administration’s approval of mifepristone is likely to have major implications for access to abortion in the US, even in states where abortion remains legal
What is Medication Abortion?
A medical abortion usually 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 maintain a pregnancy.
About 24 hours later, the patient takes misoprostol, a drug used to treat stomach ulcers that causes the uterus to contract and contract, causing bleeding and expelling the pregnancy tissue.
Medical abortion has become the most common method of terminating a pregnancy.
Mifepristone – in particular – has been used since the 1980s, first in Europe.
Since the drug’s approval 23 years ago, more than 5.6 million women have successfully used medication abortion, according to the FDA.
A 2012 meta-analysis of 87 clinical trials published in the journal Birth control confirmed that drug-induced abortion is generally safe. Serious complications occurred in the study, such as severe vaginal bleeding, pelvic pain, or an infection requiring hospitalization less than 0.3 percent of patients.
Studies show that mifepristone is safer and sends fewer people to the emergency department than Tylenol and Viagra.
The complication rate for carrying a child to term, meanwhile, is considerably higher, at 1.4 percent.
In 2020, the two-drug cocktail was responsible for 54 percent of all abortions in the U.S., compared to about 44 percent in 2019.
This is due in part to the rise of telemedicine and a general preference to stay away from doctors’ offices during the pandemic.
Previously, due to safety concerns, mifepristone could only be dispensed in person by a physician in a subset of specialty offices and clinics.
The Food and Drug Administration increased the leeway for prescribers during the height of the pandemic, allowing patients to get the drug through telehealth appointments and send it in the mail.
What happened Friday?
Texas District Judge Matthew J. Kacsmaryk, an appointee of former President Donald Trump and a staunch supporter of Christian ideology, ruled Friday in favor of the conservative Alliance for Hippocratic Medicine, which filed suit against anti-abortion doctors alleging that they had to treat women with complications from medication-induced abortions.
The plaintiff’s claim that the FDA circumvented safety guidelines in approving mifepristone, even though the agency imposed several prescribing restrictions to reduce some of the risk of complications from taking the medication, such as heavy bleeding.
He said in his decision, “The Court does not lightly question the FDA’s decision. But here the FDA conceded its legitimate safety concerns—in violation of its legal duty—based on plainly flawed reasoning and studies that did not support its conclusions.”
Government lawyers representing the FDA, meanwhile, argued that the government 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 it prohibits the drug while the case continues.
It is still legal to prescribe and hand out at least until Friday, when the week-long stay Kacsmaryk imposed to give the government time to appeal ends. Pharmacies certified to dispense the pills can still do so until then.
Now that the FDA, the Department of Justice and Danco Laboratories, the pill’s manufacturer, have appealed, the 5th Circuit Court will have to grant emergency relief to at least one of them to prevent the ruling from going into effect at the end of term . week.
Without it, access to the pill could be cut off in most states.
What happens now?
Less than an hour after Judge Kacsmaryk delivered his ruling, a liberal judge in Washington state issued a very different verdict.
Judge Thomas O. Rice of the U.S. District Court for the Eastern District of Washington, an Obama appointee, muddied the waters further when he ordered the FDA not to make any changes to access to mifepristone, contrary to what Judge Kacsmaryk said.
The lawsuit in Washington was brought by a coalition of Democratic attorneys general in 17 states and the District of Columbia tried to prevent the FDA from removing the drug from the market.
Washington State Attorney General Bob Ferguson believes the ruling could allow patients in those blue states and D.C. to continue accessing mifepristone for abortion in the short term, even after the Texas decision goes into effect. has become.
Ferguson told NPR: “If you live in Washington State or in one of the 17 states that joined Washington in our lawsuit…then the judge’s ruling in our case maintains the status quo to ensure access to mifepristone remains available.
For the rest of the states, the Texas judge’s ruling “has serious potential to eliminate that access for mifepristone here in the next few days.”
In the Washington lawsuit, abortion rights activists argue that the FDA was actually too restrictive when it approved mifepristone in 2000, as it placed restrictions and certification requirements on pharmacies and physicians to dispense and prescribe the drug.
This legal clash has caused alarm and confusion, especially among the approximately 58 million women of childbearing age who do not live in a state where abortion is banned.
More than a dozen states have restricted access to abortions after the overthrow of Roe V Wade
What is the most likely outcome?
The dispute over drug abortion, the most common method of terminating a pregnancy, is likely to reach the Supreme Court.
In short, that is not entirely clear. The pill’s legality is assured until Friday, but what comes next is murkier.
Because the Texas ruling did not expressly direct the FDA to remove mifepristone from the market, legal scholars such as Temple University’s Rachel Rebouche said the agency could exercise enforcement power and keep the drug in circulation. In that same vein, it could decide to halt all production and distribution of the drug.
In deciding whether to use its enforcement powers not to restrict access to the medication, the FDA would also cooperate with Judge Rice, who ordered the agency to maintain the status quo, at least in the states at stake.
Oregon Democratic Senator Ron Wyden, who has long said banning access to mifepristone would not be legitimate, said Friday: “Whatever happens in seven days, I believe the Food and Drug Administration has the authority to ignore statement. I again call on President Biden and the FDA to do just that.”
Women in blue states who are suddenly faced with the possibility that they are not entitled to the medication-abortion regimen may have recourse depending on where they live. In Washington, for example, the Department of Corrections has bought up tens of thousands of doses of mifepristone that are soon to be dispensed.
And Whole Women’s Health, an independent abortion provider, said Friday: “[W]We follow FDA guidelines and not Texas anti-abortion judges who have no formal medical training. Whole Woman’s Health will continue to provide 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 Texas’ ruling, the DOJ would most likely appeal that decision to the Supreme Court, which could quickly decide whether or not the order should be suspended.
Does this mean the end of drug abortion as we know it?
It could be that medication abortion could move from a two-drug regimen to just one drug, the ulcer drug misoprostol.
A misoprostol-only regimen is standard practice in many parts of the world and is even fully endorsed by the World Health Organization. In the absence of mifepristone, it is a reliable means of terminating a pregnancy, although it may have some additional side effects, such as nausea and a slight decrease in efficacy.
Abortion providers have prepared for the possibility of misoprostol being the only tool in the drug abortion tool belt. Planned Parenthood, Abortion on Demand, Aid Access, Carafem, Choix, Forward Midwifery, Hey Jane and Just the Pill have said they are willing to prescribe misoprostol-only abortions as a temporary solution.