A Texas judge’s decision last week to freeze access to one of two abortion pills plunged millions of women into a world of uncertainty.
US District Judge Matthew Kacsmaryk, a judge appointed by Trump, ruled Friday to overturn the Food and Drug Administration’s (FDA) approval of mifepristone in 2000, siding with those who argued that the FDA assessed safety risks have not been adequately addressed.
This is contrary to what the FDA and Centers for Disease Control and Prevention say about the drug. Instead, they say there have been no security issues since it was introduced 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 can take enforcement action if it believes, based on a body of clinical evidence, that the drug poses little risk to the public.
So what are the current laws when it comes to medical abortion and what is happening now? Dailymail.com explores the most pressing questions following the historic decision:
The Texas ruling against the Food and Drug Administration’s approval of mifepristone is likely to have a significant impact on access to abortion in the United States, even in states where abortion remains legal
What is a medical abortion?
Medical abortion usually refers to a two-drug treatment that ends a pregnancy in the privacy of a woman’s home.
Mifepristone is taken first and works by dilating the cervix and blocking the action of the hormone progesterone, which is needed to maintain a pregnancy.
About 24 hours later, the patient takes misoprostol, a drug used to treat ulcers that cause spasms and contractions in the uterus.
This causes bleeding and causes the pregnancy tissue to be expelled.
Medical abortion has become the most common method of terminating a pregnancy, accounting for 53 percent of all procedures in the United States.
That number skyrocketed between 2019 and 2020, when relaxed FDA regulations and Covid fears kept many away from doctor’s offices and instead getting medication at home.
Until now, for safety reasons, mifepristone could only be dispensed in person by a doctor in a subset of specialist practices and clinics.
Mifepristone has been used since the 1980s and first appeared in Europe.
According to the FDA, more than 5.6 million women have successfully obtained an abortion since the drug was approved 23 years ago.
A 2012 meta-analysis of 87 clinical trials published in the journal Contraception confirmed that drug-induced abortions are generally safe.
In the study, less than 0.3 percent of patients experienced serious complications, such as B. heavy vaginal bleeding, pelvic pain, or an infection that required hospitalization.
Studies show that mifepristone is safer and sends fewer people to the emergency room than popular drugs like Tylenol and Viagra.
The complication rate when a child is carried to term is significantly higher at 1.4 percent.
what happened on friday
On Friday, Judge Kacsmaryk ruled in favor of the conservative Alliance for Hippocratic Medicine withdrawing the FDA’s approval of the drug.
The group includes doctors who claimed to treat women with complications from medical abortions.
Plaintiff’s claim that the FDA bypassed safety guidelines with the approval of mifepristone, even though the agency imposed several prescription restrictions to reduce some of the risk of complications from the use of the drug, such as B. heavy bleeding to reduce.
Judge Kacsmaryk, appointed by President Trump in 2017 and known as a staunch Christian conservative, sided with the group.
He said in his ruling, “The court does not lightly challenge the FDA’s decision.
“But here, the FDA admitted its legitimate safety concerns — contrary to its legal duty — based on clearly flawed arguments and studies that did not support its conclusions.”
Meanwhile, government lawyers representing the FDA argued that regulators reviewed extensive data and found no such safety concerns.
Can I still buy abortion pills?
The order is not a final decision on the matter, but an injunction, meaning it bans the drug while the case is pending.
It is still legal to prescribe and serve him at least until Friday, when the week-long suspension that Judge Kacsmaryk imposed to give the government time to appeal expires.
Pharmacies certified to dispense the pills can still do so until then.
The FDA, the Department of Justice and Danco Laboratories, the pill’s manufacturer, appealed to the 5th Circuit Court.
If the appeals court does not grant emergency relief to at least one of them, the drug will be taken off the shelves on Friday.
What happens now?
Less than an hour after Judge Kacsmaryk delivered his ruling, a liberal judge in Washington state ruled against the case.
Judge Thomas O. Rice of the US District Court for the Eastern District of Washington, an agent for Barack Obama, ordered the FDA to make no changes to access to mifepristone.
The Washington lawsuit was filed by a coalition of Democratic attorneys general in 17 states, and the District of Columbia sought to block the FDA from taking the drug off the market.
The decision further muddies the waters, making it even more unclear what the fate of the drug will be.
Washington Attorney General Bob Ferguson believes the ruling could allow patients in the 18 blue states and DC to continue to have access to mifepristone.
He hopes the drug will remain available after the decision takes effect on Friday.
Ferguson told NPR, “If you live in Washington state or any of the 17 states that joined Washington in our lawsuit … then the judge’s decision in our case preserves the status quo to ensure access pending mifepristone. ” remains available.
For the rest of the states, the Texas court’s ruling has “serious potential to eliminate this access for mifepristone here in the next few days,” he continued.
In the Washington lawsuit, abortion rights activists argue that the FDA was actually too restrictive when it approved mifepristone in 2000.
At the time, regulators set restrictions and certification requirements for pharmacies and doctors to dispense and prescribe the drug.
This legal conflict has caused alarm and confusion, especially among the approximately 58 million women of childbearing age who do not live in states where abortion is prohibited.
More than a dozen states have restricted access to abortion after Roe V Wade’s ouster
What is the most likely outcome?
The dispute over drug abortion, the most common method of abortion, is likely to go to the Supreme Court.
In short, it is not entirely clear. The pill’s legality is assured until Friday, but what comes after that is murkier.
Because the Texas ruling did not specifically order the FDA to take mifepristone off the market, legal scholars such as Temple University’s Rachel Rebouche said the agency could exercise enforcement powers and keep the drug in circulation. Likewise, it can decide to stop all production and distribution of the drug.
In deciding to use its enforcement powers not to restrict access to the drugs, the FDA will also join Judge Rice, who ordered the agency to at least maintain the status quo in affected states.
The Democratic Sen. Ron Wyden of Oregon, who has long said banning access to mifepristone is not legal, said Friday: “Whatever happens in seven days, I believe the Food and Drug Administration has the authority to testify.” to ignore. Again, I call on President Biden and the FDA to do just that. “
Washington State has created a three-year supply of abortion pills
Gov. Jay Inslee, a Democrat, announced that his administration has purchased 30,000 doses of generic mifepristone, one of two drugs used to induce a home abortion, and will keep the drugs available regardless of the Texas decision.
Women in blue states who are suddenly faced with the possibility of not being eligible for the medical abortion regime may have an appeal based on where they live. In Washington, for example, the Department of Corrections has purchased tens of thousands of mifepristone doses to be distributed soon.
And Whole Women’s Health, an independent abortion provider, said Friday: “[W]We follow FDA guidelines and not the Texas anti-abortionists who have no formal medical training. Whole Woman’s Health will continue to make Mife available in our clinics and pill-by-mail program over the next week as we monitor both decisions.”
If the 5th Circuit upholds the Texas ruling, the DOJ will likely appeal that decision to the Supreme Court, which could quickly decide whether or not to stay the order.
Does this mean the end of drug abortion as we know it?
It may be that medical abortion can move from a two-drug regimen to just one drug, the stomach ulcer drug misoprostol.
Pure misoprostol therapy is standard in many parts of the world and is even fully supported by the World Health Organization. In the absence of mifepristone, this is a reliable way to terminate a pregnancy, although it may have some additional side effects, such as nausea and a slight decrease in effectiveness.
Abortion providers braced for the possibility that misoprostol could be 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 stated that they are willing to prescribe misoprostol abortions only as a temporary solution.
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Crystal Leahy is an author and health journalist who writes for The Fashion Vibes. With a background in health and wellness, Crystal has a passion for helping people live their best lives through healthy habits and lifestyles.
