A Texas judge’s ruling that could block access to a widely used abortion pill alarmed health care providers and legal experts in Massachusetts and across the country.
US District Judge Matthew Kacsmaryk on Friday ruled that the Food and Drug Administration should not have authorized mifepristone, more than 22 years after the agency first approved the drug and it hit the market. He stayed his ruling until Friday to give the Biden administration an opportunity to appeal.
An hour later, a ruling out of Washington state came down drawing the opposite conclusion: Judge Thomas O. Rice directed the FDA to keep mifepristone available in the 17 states and Washington, D.C., which had filed their own lawsuit to expand access to the drug.
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For now, the pill remains available. The conflicting rulings likely put the issue on an accelerated path to the US Supreme Court. Amid the confusion, here’s what to know and how Massachusetts could be affected.
What is mifepristone?
Mifepristone is the first of two drugs used for medical abortions, and it works by blocking progesterone, a hormone that’s necessary for a pregnancy to continue. Decades of research has shown the pill to be safe and effective. The drug is also used to treat Cushing syndrome, a condition in which the body produces too much of the hormone cortisol.
Doctors generally prescribe mifepristone with misoprostol, a drug used to treat stomach ulcers, that can also induce contractions. When taken together, the two pills have an over 95 percent efficacy rate in safely ending pregnancies with no further intervention.
Misoprostol, which remains unaffected by the Texas ruling, may be used to induce an abortion on its own, but it’s less effective, with a 15 percent failure rate, and it also causes more bleeding and cramps.
Why did a Texas judge rule against the abortion pill?
Kacsmaryk, a Trump appointee, signed an injunction directing the FDA to stay mifepristone’s approval while a lawsuit challenging the safety and approval of the drug continues.
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The lawsuit in the Texas case was filed by the Alliance Defending Freedom, which was also involved in the Mississippi case that led to Roe v. Wade being overturned. The lawsuit alleges that the FDA’s initial approval of mifepristone was flawed because it did not adequately review its safety risks.
Legal experts have charged that the Christian group’s filing was full of questionable arguments and factual inaccuracies, but Kacsmaryk essentially agreed with the plaintiffs on all of their major points. Kacsmaryk’s ruling also used the term “unborn human,” which antiabortion groups use for the fetus.
There is practically no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration.
Will the ruling affect access in Massachusetts?
Governor Maura Healey has said her administration will do all it can to ensure abortion medications remain available in Massachusetts. She is expected to announce a plan on Monday to preserve the supply of mifepristone in the state, as well as measures to protect providers who administer it.
Some clinics in Massachusetts have been stockpiling mifepristone in case it becomes unavailable.
If the Texas ruling is upheld, it remains unclear if it would still be legal to provide the drug from such stockpiles.
Although abortions are clearly legal under Massachusetts law, some legal experts cautioned that federal decisions can supersede those protections.
Could the ruling have ramifications beyond abortion drugs?
President Biden, who vowed to fight the Texas ruling, said on Friday, “If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.”
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Experts told the Globe that Kacsmaryk’s ruling could not only undercut women’s reproductive care, it could also have far-reaching implications for other health services, including vaccines, contraceptives, and treatments for HIV, or sexually transmitted diseases. If allowed to stand, it would undermine the FDA’s expertise and authority, legal experts said.
The ruling could also create a chilling effect for pharmaceutical companies, which may have to weigh whether their efforts are worth the risk if judges can overturn regulatory processes from the bench.
Material from Bloomberg, The Associated Press, and New York Times wire services was used in this report.
Sahar Fatima can be reached at sahar.fatima@globe.com Follow her @sahar_fatima.