AMARILLO, Texas — Federal judges in Texas have ruled time and time again in favor of opponents of abortion.
They backed a state law that allows $10,000 rewards to be placed on any that helps a woman to abort; ruled that someone opposed abortion based on religious beliefs can block a federal program from providing birth control to teens; and determined that ER doctors should weigh equally the life of a pregnant woman and her embryo or fetus.
Now abortion rights advocates, galvanized by the reversal of roe v. calf — are preparing for another decision by a Texas court that could force the FDA to recall a widely used abortion pill from pharmacies and doctors’ offices across the country.
he wide-ranging demandbrought forward by a conservative Christian legal group, argues that the FDA’s approval process flawed more than two decades ago when it authorized the use of mifepristone, which stops the development of a pregnancy and is part of a two-drug regimen used in medical abortions. .
“The FDA has one job, which is just to protect Americans from dangerous drugs,” said Denise Harle, a senior counsel with Alliance Defending Freedom, part of a conservative coalition that filed the lawsuit in federal district court in Amarillo, Texas. . “And we are asking the court to eliminate that chemical drug regimen until and unless the FDA actually does the proper testing that it is required to do.”
A decision in the case was expected as soon as Friday. If successful, the lawsuit would force federal officials to rescind mifepristone’s approval and the makers would be barred from shipping the drug anywhere in the United States, including states like California, Massachusetts, Illinois and New York where abortion continues. being legal.
Abortion rights advocates and medical groups have rejected the lawsuit’s claims. Twelve leading medical organizationsincluding the American Medical Association and the American College of Obstetricians and Gynecologists, say that medical abortion is effective and safe.
In fact, decades of research show that the risk of serious complications from taking abortion pills is less than 0.4%, safer than commonly used medications like Tylenol or viagra.
“We have 23 years of national data showing how safe medical abortion is, and it’s been used internationally for decades,” said Amy Hagstrom Miller, executive director of Whole Woman’s Health, a medical organization with clinics in several states. “It’s much safer than forcing someone to have a pregnancy against her will.”
About 5 million women in the United States, federal data shows, and millions more around the world, have used abortion pills safely. They can be taken up to 10 weeks into a pregnancy and are also used by OB/GYNs to manage early miscarriages. In all, more than half of all abortions in the US are the result of medication rather than a medical procedure, according to research from the Guttmacher Institute.
Medical abortion consists of taking two pills: mifepristone, which blocks the pregnancy hormone progesterone; and misoprostol, which induces a miscarriage. Both drugs have long and safe histories: misoprostol was approved in 1988 to treat gastric ulcers, and mifepristone gained approval in 2000 to terminate early pregnancy.
By filing its lawsuit in Amarillo, Alliance Defending Freedom was almost guaranteed to appeal to the US District. Judge Matthew Kacsmaryka President Donald Trump appointee who served as deputy general counsel at the First Liberty Institute, a conservative nonprofit organization that advocates for religious liberty, before being confirmed to the federal judiciary in 2019.
Kacsmaryk’s nomination for the Northern District of Texas was universally opposed by civil rights groups. US Sen. Susan Collins, a Maine Republican, said during the confirmation process that Kacsmaryk displayed “alarming bias against LGBTQ Americans and a disregard for Supreme Court precedent.”
“He made statements against reproductive rights, linking reproduction to the feminist movement and making anti-feminist statements,” said Elizabeth Sepper, a law professor at the University of Texas-Austin, adding that the Supreme Court decision last summer in Dobbs v. Jackson Women’s Health Organization, that overturned roe, allowed the lawsuit against the FDA to proceed. “Before Dobbs, abortion rights would have gotten in the way of this lawsuit. But now the conservative legal movement feels empowered.”
The lawsuit is the latest effort by opponents of abortion rights to block the use of abortion pills, which many people prefer for abortion because it allows them to control their own medical care and provides privacy for a process that involves cramping and bleeding, similar to a spontaneous abortion.
“When you have a medical abortion, part of the process happens at home. And a lot of people like that,” said Hagstrom Miller of Whole Woman’s Health. “People can be home with their loved ones and can schedule the pace of the pregnancy around their work schedule or childcare schedule.”
Harle, however, said the FDA used a provision to approve the drug that it should be used only for drugs that treat diseases, and that pregnancy is not a disease, but rather a condition.
“They did not meet the standards of federal law,” he said.
The approval of mifepristone was investigated in 2008, during the Republican administration of George W. Bush, by the Government Accountability Office, a congressional watchdog, which found the process to be consistent with FDA regulations.
“It’s hard to think of a drug that has come under more scrutiny than mifepristone,” said I. Glenn Cohen, a professor at Harvard Law School and one of 19 FDA scholars who filed an amicus brief opposing the the demand. “We don’t think there is a problem here legally or medically. It would be very dangerous to allow a single judge sitting in Amarillo to basically order a drug used by many women in America to be taken off the market.”
But Harle said no amount of scientific data would be enough to convince her that mifepristone should be on the market.
“I think that chemical abortion does great harm to women and their unborn children,” she said. “And that’s what this lawsuit is really about.”
Abortion providers like Hagstrom Miller are bracing for the ruling. “I think people know that what happens in Texas doesn’t stay in Texas,” she said. “Some of the most progressive states in the country will face restrictions if this lawsuit is successful.”
If that’s the case, their clinics and OB/GYNs across the country will be forced to use only misoprostol for miscarriage and early abortion, which will reduce the effectiveness of the method: while taking the two pills together is effective than 99.6% for terminating early pregnancy, misoprostol alone, while still extremely safe, is about 80% effective.
Hagstrom Miller also notes that the side effects of misoprostol can be more severe, including nausea, diarrhea, and severe cramping and bleeding.
“And that matters, right?” she said. “People should have access to the highest level of medical care.”
KHN (Kaiser Health News) is a national newsroom that produces detailed journalism on health issues. Along with Policy Analysis and Polling, KHN is one of the top three operating programs in KFF (Kaiser Family Foundation). KFF is an endowed non-profit organization that provides information on health issues to the nation.
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