April 7, 2023 - Texas judge suspends approval of medication abortion pill

A federal judge said he will suspend the FDA’s two-decade-old approval of a medication abortion pill, but he is pausing his ruling for seven days so the federal government can appeal.

CNN is reviewing the judge's 67-page ruling now.

Medication abortion now makes up a majority of abortions obtained in the US. It has become a key focus in the fallout from the overturning Roe v. Wade.

The lawsuit against the FDA, filed by anti-abortion doctors and medical associations, was seeking a preliminary injunction that would require the agency to withdraw or suspend its approval of the drug mifepristone, the first drug in the medication abortion process.

Mifepristone is a drug approved by the US Food and Drug Administration that has been shown to be safe and effective for more than two decades.

The lawsuit from anti-abortion advocates claims that the drug is not safe and that the FDA didn’t study it enough to approve it.

Along with misoprostol, mifepristone is one of the drugs used for an abortion via medication, as opposed to surgery.

Mifepristone is marketed under the brand names Mifeprex and Korlym, and it’s sometimes known as RU 486.

Here are some key things to know:

How mifepristone works: Mifepristone blocks a hormone called progesterone, which helps the body maintain the inside of the uterus so a pregnancy can continue. A healthy uterine lining is what supports a fertilized egg, embryo and fetus.

Without progesterone, the uterus will expel its contents.

Someone having a medication abortion takes mifepristone and then, after 24 to 48 hours, takes misoprostol. That drug helps empty the uterus through heavy bleeding and muscle contractions.

The medications can be taken as soon as someone learns that they are pregnant and up to 70 days or less since the first day of their last period.

This method is effective 99.6% of the time when used to end a pregnancy, studies show.

How safe is mifepristone? Data from hundreds of studies and 23 years of approved use has shown that mifepristone is highly safe and effective, according to 12 of the country’s most respected medical associations, including the American College of Obstetricians and Gynecologists and the American Medical Association, which signed an amicus brief in the Texas case.

This medicine combination for abortion is also available in more than 60 other countries.

Since its approval in the US in 2000, there have been 5 deaths associated with mifepristone for every 1 million people who used it, according to the US Food and Drug Administration. That means the death rate is 0.0005%.

Mifepristone’s safety is on par with those of common over-the-counter pain relievers like ibuprofen and acetaminophen, studies show.

Data analyzed by CNN shows that mifepristone is even safer than some of the most common prescription medications. The risk of death from penicillin, an antibiotic used to treat bacterial infections like pneumonia, for example, is four times greater than it is for mifepristone. The risk of death after taking Viagra – used to treat erectile dysfunction – is nearly 10 times higher.

Side effects of mifepristone: Mifepristone usually doesn’t have many side effects, doctors say, but as with any drug, there can be short-lived ones.

Side effects of mifepristone may include dizziness, weakness, vomiting, headache, diarrhea, nausea, and fever or chills, according to the FDA.

Major adverse events like blood loss, hospitalization or a significant infection are “exceedingly rare,” happening in less than 0.3% of patients, according to the medical associations’ amicus brief.

How often is mifepristone used? The mifepristone-misoprostol combination is the most common abortion method in the US.

Preliminary data published February 2022 from the Guttmacher Institute, a research and policy organization focused on sexual and reproductive health that supports abortion rights, showed that medication abortion accounted for 53% of all abortions in the US.

Read more about the drug here.

The federal judge overseeing the high-profile challenge to the FDA’s two-decade-old approval of certain drugs used to terminate a pregnancy is a deeply conservative jurist with a proclivity for siding with plaintiffs looking to roll back reproductive and LGBTQ rights or block key Biden administration policies.

US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, was confirmed by a 52-46 Senate vote in 2019.

The FDA case, the biggest abortion-related case since the Supreme Court overturned Roe v. Wade last year, has drawn considerable criticism from abortion rights advocates. But Kacsmaryk himself has also drawn scrutiny for the way he’s handled the matter, with critics taking issue with some highly unusual steps he took to delay making the public aware that a hearing was scheduled in the case for March 15.

Since Kacsmaryk took the bench in 2019, he’s helped make Texas a legal graveyard for policies of President Joe Biden’s administration, largely due to the fact that Texas’ rules for how federal cases are assigned in the state have allowed conservatives to file there strategically, almost guaranteeing their complaints will be before sympathetic judges. Kacsmaryk is assigned every case filed in his division.

In recent comments to The Washington Post, Kacsmaryk’s sister, Jennifer Griffith, detailed her brother’s long history of being anti-abortion and how she believes fate brought the abortion case before him.

“I feel like he was made for this,” Griffith said. “He is exactly where he needs to be.”

The group that brought the medication abortion lawsuit, the Alliance for Hippocratic Medicine, incorporated in Amarillo a few months before they filed the suit, according to documents from the Texas secretary of state’s office.

Kacsmaryk is the only federal district judge seated in the Amarillo division of the US District of Northern Texas.

Read more about Kacsmaryk here.

For about four hours of arguments on March 15, the federal judge in Texas asked questions that suggested he is seriously considering undoing the US Food and Drug Administration’s approval of a medication abortion drug and the agency’s moves to relax the rules around its use.

But the judge, US District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, also indicated he was thinking through scenarios in which he could keep the drug’s 2000 approval intact while blocking other FDA rules.

Anti-abortion doctors and medical associations are seeking a preliminary injunction that would require the FDA to withdraw or suspend its approval of the drug, mifepristone, and that would block the agency’s more recent regulatory changes making the pills more accessible.

Here are some of the big takeaways:

Judge focused on FDA's process for approving abortion pills: Kacsmaryk showed a particular interest in the arguments by the abortion opponents that the FDA approved mifepristone in an unlawful way.

He zeroed in on a claim by the abortion foes that the studies that the FDA looked at when deciding whether to approve the drug did not match the conditions under which the agency allows it to be administered.

Erik Baptist, attorney for the challengers, alleged that those studies all featured patients who received ultrasounds before being treated with the drug, which is not among the FDA’s requirements for prescribing abortion pills. Baptist accused the FDA of “examining oranges and declaring apples to be safe.”

Justice Department attorney Daniel Schwei defended the FDA’s approach, arguing that the relevant law gives the FDA discretion to determine what studies are adequate for approving a drug’s safety. He also said the challengers’ claims were factually flawed because the FDA also was looking at studies where the patients did not receive an ultrasound.

Impact of the reversal of Roe v. Wade: The medication abortion lawsuit targets actions the FDA took around medication abortion pills before last summer’s Supreme Court reversal of Roe v. Wade’s abortion rights protections.

While that decision, known as Dobbs v. Jackson Women’s Health Organization, didn’t play a major role in Wednesday’s arguments, the judge referenced it and suggested it could have an impact on his thinking about the case.

He asked Erin Hawley, an attorney for the challengers, whether Dobbs was an “intervening event” that has “changed the landscape” around the relationship between state and federal government concerning abortion policy. Hawley agreed, calling it a “sea change.”

Read more takeaways.

Medication abortion has become the most common method for abortion, accounting for more than half of all US abortions in 2020, according to the Guttmacher Institute.

The growing popularity of medication abortion is largely because of its accessibility, said Abigail Aiken, associate professor at the University of Texas at Austin who leads a research group on medication abortion.

“It reduces the cost, it reduces barriers where people may not want to go to a clinic,” she said.

It is also a safer option than both procedural abortion or childbirth. The rate of major complications — like hemorrhages or infections — for medication abortions is about one-third of a percent, according to a 2015 study conducted by Upadhyay. That means out of more than 11,000 cases, 35 experienced any major complications.

The likelihood of serious complications via procedural abortion — performed second-trimester or later — is slightly higher than medication abortion at 0.41%, according to the same study. And childbirth by far comes with the highest risk, at 1.3%.

If access to mifepristone is cut off, abortion clinics and telehealth organizations could pivot to misoprostol-only abortions, Aiken told CNN. Although misoprostol-only abortions are used around the world, they are less effective, associated with a higher risk of serious complications and often more painful than the mifepristone and misoprostol combination, she said.

In the latest study of self-managed misoprostol-only medication abortions in the US, Johnson found misoprostol-only abortions to be a safe alternative, though less safe than using both pills. The study, published in February, analyzed data from online telehealth medication abortion provider Aid Access from 2020. Nearly 90% of 568 users reported completed abortions and 2% experienced serious complications using only misoprostol.

Mifepristone and misoprostol together is still considered the gold standard, Aiken told CNN. People who used the two-pill combination were less likely to experience serious complications than those who went with the misoprostol-only regimen.

“It’s clear people can use these medications, mifepristone and misoprostol, at home even without the help of a medical professional very safely,” said Aiken.

Because misoprostol is used to treat multiple ailments including stomach ulcers, it’s readily stocked in pharmacies and unlikely to be taken off the market anytime soon, Johnson told CNN.

However, a lesser-effective method means more people will likely have unsuccessful abortions.

“It’s possible that it might not work for some people, and it will prolong their abortions,” said Upadhyay. “Then by the time they get back to the clinic, they’re seeking abortion later in pregnancy.”

Before the ruling, 19 states already restricted telehealth abortion care, limiting access to medication abortion. Nearly half of US adults were unsure whether medication abortion was currently legal in their state as of late-January, according to a survey conducted by the Kaiser Family Foundation. Experts say that confusion will only be exacerbated.

“People are not going to be sure mifepristone or misoprostol in fact, is available. I think it’s going to be confusing,” said Aiken. “As people look around for options or feel unsure about their options, they may end up delaying [care].”