Yves here. Aiee, I somehow missed that this case contesting the FDA authorization of mifepristone, an abortion drug that works by blocking progesterone, which then leads to the breakdown of the lining of the uterus.
I wonder if the FDA can finesse the apparently unduly thin safety approvals on the original drug with it later approval of the generic, which relied on extensive safety data from usage. In other words, the brand name version gets knocked out but not the generic.
This article skips over the fact that being restricted to using only the second pill in the 1-2 chemical abortion cocktail, misoprostol, which effectively induces a miscarriage, could potentially be blocked down the road by an omnibus spending bill that includes a provision that allows the FDA to block “off label” uses of approved drugs. Misoprostol is not approved for inducing abortions except in combination with mifepristone. It’s not hard to imagine the FDA in a Republican administration barring that application.
Separately, I also wonder why reproductive freedom advocates are not regularly reminding women to use morning after pills, which are available OTC, if they’ve had unprotected sex and are not trying to become pregnant.
By Sarah Varney, Kaiser Health News Senior Correspondent, who regularly produces segments for PBS NewsHour and has had stories publised in The New York Times, The Washington Post, the Los Angeles Times and KHN’s other print partners. Originally published at Kaiser Health News
Federal judges in Texas have delivered time and again for abortion opponents.
They upheld a state law that allows for $10,000 bounties to be placed on anyone who helps a woman get an abortion; ruled that someone opposed to abortion based on religious beliefs can block a federal program from providing birth control to teens; and determined that emergency room doctors must equally weigh the life of a pregnant woman and her embryo or fetus.
Now abortion rights advocates — galvanized by the reversal of Roe v. Wade — are girding for another decision from a Texas courtroom that could force the FDA to remove a widely used abortion pill from pharmacies and physicians’ offices nationwide.
The wide-ranging lawsuit, brought by a conservative Christian legal group, argues that the FDA’s approval process more than two decades ago was flawed when it authorized the use of mifepristone, which stops the development of a pregnancy and is part of a two-drug regimen used in medication abortions.
“The FDA has one job, which is just to protect Americans from dangerous drugs,” said Denise Harle, senior counsel with the Alliance Defending Freedom, part of a conservative coalition that brought the suit in federal district court in Amarillo, Texas. “And we’re asking the court to remove that chemical drug regimen until and unless the FDA actually goes through the proper testing that it’s 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 manufacturers would be unable to ship the drug anywhere in the United States, including to states like California, Massachusetts, Illinois, and New York where abortion remains legal.
Abortion rights supporters and medical groups have pushed back on the lawsuit’s claims. Twelve leading medical organizations, including the American Medical Association and the American College of Obstetricians and Gynecologists, say medication abortion is effective and safe.
Indeed, decades of research show the risk of major complications from taking abortion pills is less than 0.4% — safer than such commonly used drugs as Tylenol or Viagra.
“We’ve got 23 years of data domestically that shows how safe medication abortion is, and it’s been used internationally for decades,” said Amy Hagstrom Miller, chief executive of Whole Woman’s Health, a medical organization with clinics in several states. “It’s much safer than somebody being forced to carry a pregnancy against their will.”
About 5 million women in the United States, federal data shows — and millions more across the world — have safely used abortion pills. They can be taken up to 10 weeks into a pregnancy and are also used by OB-GYNs to manage early miscarriages. All told, more than half of all abortions in the U.S. are a result of medication rather than a medical procedure, according Guttmacher Institute research.
Medication abortion involves taking two pills: mifepristone, which blocks the pregnancy hormone, progesterone; and misoprostol, which induces a miscarriage. Both drugs have long and safe track records: Misoprostol was approved in 1988 to treat gastric ulcers, with mifepristone earning approval in 2000 to end early pregnancy.
By filing its lawsuit in Amarillo, the Alliance Defending Freedom was almost guaranteed to draw U.S. District Judge Matthew Kacsmaryk, a President Donald Trump appointee who worked as deputy general counsel at First Liberty Institute, a conservative nonprofit advocating for religious liberty, before being confirmed to the federal judiciary in 2019.
Civil rights groups universally opposed Kacsmaryk’s nomination to the Northern District of Texas. U.S. Sen. Susan Collins, a Republican from Maine, said during the confirmation process that Kacsmaryk showed “alarming bias against LGBTQ Americans and disregard for Supreme Court precedents.”
“He’s made statements in opposition to reproductive rights, linking up 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’s decision last summer in Dobbs v. Jackson Women’s Health Organization, which overturned Roe, allowed the suit against the FDA to proceed. “Prior to Dobbs, the right to abortion would have stood 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 stymie the use of abortion pills, which many people seeking abortion prefer because it allows them to control their own health care and affords privacy for a process that involves cramping and bleeding, similar to a miscarriage.
“When you have medication 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 at home with their loved ones and can sort of schedule the passing of the pregnancy around their work schedule or their child care schedule.”
Harle, however, said that the FDA used a provision to approve the drug that should be used only for medications that treat illness, and that pregnancy is not an illness, but a condition.
“They didn’t meet the standards of federal law,” she said.
Mifepristone’s approval was investigated in 2008 — during the Republican administration of George W. Bush — by the Government Accountability Office, a congressional watchdog, which found that the process was consistent with FDA regulations.
“It’s hard to think of a drug that’s been under more scrutiny than mifepristone,” said I. Glenn Cohen, a Harvard Law School professor and one of 19 FDA scholars who filed an amicus brief opposing the lawsuit. “We don’t think there’s a problem here statutorily or medically. It’d be very dangerous to allow a single judge sitting in Amarillo to essentially order a drug that’s used by many women in America off the market.”
But Harle said that no amount of scientific data would be enough to convince her that mifepristone should be on the market.
“I think chemical abortion does great harms to women and their unborn children,” she said. “And that’s what this lawsuit is really about.”
Abortion care 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, her clinics and OB-GYNs across the country will be forced to use only misoprostol for miscarriage and early abortion care, something that will reduce the efficacy of the method: While taking the two pills together is 99.6% effective in terminating early pregnancy, misoprostol alone — although still extremely safe — is about 80% effective.
Hagstrom Miller also notes that side effects from misoprostol can be more intense, 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.”
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