By Elise Hammond, Matt Meyer, Tori B. Powell and Amir Vera, CNN
From CNN's Tierney Sneed
In a dramatic turn of events, a federal judge in Washington state said Friday night in a new ruling that the FDA must keep medication abortion drugs available in 17 liberal states and Washington, DC, that sued the FDA to make the abortion pills.
This lawsuit is separate from the ruling that came down in Texas minutes earlier that will halt the approval of the drug. That ruling was paused for seven days, giving the Justice Department time to appeal.
A federal judge's decision could have long-term impacts on the trust in the FDA's approval process and chill pharmaceutical companies from developing new drugs, according to Elizabeth Cohen, CNN senior medical correspondent.
Mifepristone has about 5 deaths per million users, while other commonly used drugs like Penicillin have about 20 deaths per million users, she said.
“So if this judge is so concerned about side effects, why isn't he saying let's take penicillin off the market?” Cohen said.
“This is why decisions are not made by judges. Medical and drug decisions are made by doctors and scientists, by teams of them at the FDA," she added.
Further, Cohen said a ruling that allows a judge to take a drug off the market could make pharmaceutical companies nervous. She said confidence in scientists at the FDA is critical for the development and creation of new drugs people need.
"If they think that just one judge can take that drug off the market, they may not be willing to invest that kind of money," Cohen said.
The move to suspend the FDA's two-decade-old approval of mifepristone was a stunning move, CNN's senior medical correspondent Elizabeth Cohen said Friday.
"Not having this for doctors to prescribe for patients is really quite stunning," Cohen said. "It will be quite devastating to many patients."
She said it will "be a real problem for reproductive healthcare" if women aren't allowed to take mifepristone.
She added that FDA scientists are "the ones who look through all the data."
"To have a single judge say essentially that he's smarter than the FDA is really quite stunning," she said.
More than half of abortions in the United States are medication abortions, said Elizabeth Cohen, CNN senior medical correspondent, which means a new ruling from a federal judge in Texas to suspend FDA approval of one of the medical abortion drugs is going to impact people across the country.
He is pausing his ruling for seven days so the federal government can appeal, but if at any point that suspension goes into effect, it will take away the option of medical abortion.
The drug, mifepristone, is the first drug in the medication abortion process.
"The implications really are quite scary," Cohen said. "This would, if it goes through, would get rid of that because of the opinion of one judge. So women really rely on this."
Cohen said women rely on mifepristone and medical abortions for other circumstances as well, including when they have miscarriages or need to have an abortion because the fetus is non-viable.
"They rely on this for all sorts of reasons, and they wouldn't be able to do that," Cohen said.
From CNN's Devan Cole
CNN Supreme Court analyst Steve Vladeck said Judge Kacsmaryk’s ruling “may never go into effect,” but that the administration will now have to appeal it to higher courts that are stacked with conservative jurists.
“This isn't going to be the last word. Even Judge Kascmaryk recognizes that he can’t let this ruling go into immediate effect. And it may never go into effect,” said Vladeck, who is a professor at the University of Texas School of Law.
“But this puts the onus on the Biden administration to get either the most conservative appeals court in the country, or the most conservative Supreme Court in our lifetime, to freeze this ruling before it can go into effect,” Vladeck added.
From CNN's Annette Choi and Will Mullery
Data analyzed by CNN shows mifepristone, the drug at the center of the Texas medication abortion lawsuit, is even safer than some common, low-risk prescription drugs, including penicillin and Viagra.
There were five deaths associated with mifepristone use for every 1 million people in the US who have used the drug since its approval in 2000, according to the US Food and Drug Administration as of last summer. That’s a death rate of 0.0005%.
Comparatively, the risk of death by penicillin — a common antibiotic used to treat bacterial infections like pneumonia — is four times greater than it is for mifepristone, according to a study on life-threatening allergic reactions. Risk of death by taking Viagra — used to treat erectile dysfunction — is nearly 10 times greater, according to a study cited in the amicus brief filed by the FDA.
“(Mifepristone) has been used for over 20 years by over 5 million people with the capacity to become pregnant,” said Ushma Upadhyay, an associate professor in the department of obstetrics, gynecology and reproductive science at the University of California, San Francisco. “Its safety is very well established.”
The lawsuit, filed by a coalition of anti-abortion national medical associations against the FDA, under the umbrella of the “Alliance for Hippocratic Medicine” and several doctors, sought a number of actions by the court, chief among them an injunction ordering the FDA “to withdraw mifepristone and misoprostol as FDA-approved chemical abortion drugs and to withdraw defendants’ actions to deregulate these chemical abortion drugs.”
“Plaintiffs now ask this court to do what the FDA was and is legally required to do: protect women and girls by holding unlawful, setting aside, and vacating the FDA’s actions to approve chemical abortion drugs and eviscerate crucial safeguards for those who undergo this dangerous drug regimen,” they wrote in their initial complaint.
A federal judge said Friday he will suspend the FDA’s two-decade-old approval of mifepristone, but he is pausing his ruling for seven days so the federal government can appeal.
A federal judge in Texas ruled to suspend the FDA’s approval of a medication abortion pill. He is pausing his ruling for seven days so the federal government can appeal.
Read the decision here:
From CNN's Ariane de Vogue
US District Judge Matthew Kacsmaryk said that the Food and Drug Administration had “entirely failed to consider an important aspect of the problem by omitting any evaluation of the psychological effects of the drug or an evaluation of the long term-term medical consequences of the drug," referring to mifepristone, the first drug in the medication abortion process.
“Considering the intense psychological trauma and post-traumatic stress women often experience from chemical abortion, this failure should not be overlooked or understated,” he said.
Kacsmaryk also was critical that the drug was not tested for under-18 girls undergoing reproductive development.
“But that is not all,” he continued, criticizing how the FDA handled ultrasounds to identify ectopic pregnancy.
From CNN's Tierney Sneed
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.
