In a new move, US District Judge Matthew Kacsmaryk on Friday suspended the Food and Drug Administration’s long-term approval of the key abortion pill mifeprison, but gave the government a week to appeal its decision that could throw access to the abortion drug into question nationwide.
For more than 20 years, the FDA has approved mifepristone to be used in combination with a second drug, misoprostol, to terminate pregnancies up to 10 weeks. More than half of US abortions are caused by abortion drugs, according to the Guttmacher Institute, a research group that supports abortion rights. The rulings became increasingly significant in the battles over abortion access that followed Roe v. Wade was overthrown.
A coalition of anti-abortion groups, collectively called the Hippocratic Medicine Alliance, won a challenge in November over the process by which the FDA evaluated and approved mifepristone. They argue that the government did not adequately assess the safety of drugs and did not access them through telehealth during the pandemic.
The injection plaintiffs sought to block the national use of mifepristone while the case plays out.
A judge on Friday upheld the initial approval of mifepristone, but also ordered that the ruling be remanded in custody for seven days pending an appeal.
“The court does not second guess the FDA’s decision lightly,” Kacsmaryk wrote. “But here, the FDA has acquiesced to its legitimate safety concerns — contrary to its legitimate duty — based on completely insane reasoning and studies that do not support its conclusions.”
Without an appeal, the ruling could mean the FDA-approved prescription for medical abortion is no longer available anywhere in the US. That would leave the surgical procedure or off-site use of misoprostol as the only options in states where abortion is legal.
After the president was released Friday evening, Vice President Kamala Harris said the Biden administration “stand with the women of America and do everything we can to ensure that women have the ability to make decisions about health care, about the care of their reproductive health. But they need substance and decision, not government.
The Supreme Court will likely have the final say on whether the Texas rule goes into effect, with the Justice Department likely to immediately seek to block it from taking effect.
Even if an interim 5th U.S. Circuit Court of Appeals in New Orleans blocks the ruling, then opponents could ask the Supreme Court to overturn that decision within days.
The case would prove the Supreme Court’s ruling last summer when it overturned Roe v. They went on a 5-4 vote that left the issue of abortion up to the states and other branches of government to decide the issue.
In a concurring opinion, Justice Brett Kavanaugh emphasized that the rule “does not prevent so many states that allow abortion easily from allowing abortion.”
The votes of Kavanaugh and Chief Justice John Roberts, who ruled against overturning Roe, could be pivotal.
Merle Hoffman, founder and CEO of Choices Women’s Medical Center in Queens, called the return of access to drug abortions “an outstanding intervention and battle in medical care.”
It has also been warned that the state’s protections are sufficient to guarantee access to abortion, she added.
“As far as I’m concerned, there is no longer a safe place for women and girls in this country,” Hoffman said. “Maybe this will wake people up.”
Eric Baptista, senior counsel for the Alliance to Defend Freedom, said Friday that the FDA would never authorize the drug. “We represent this significant victory to doctors and medical associations, and more importantly, the health and safety of women and girls,” he said.
Kristen Wagoner, CEO and president of the conservative Christian advocacy legal group, tweeted that “If the FDA appeals, we’ll see them in court again.”
In the lawsuit, the Hippocratic Medical Alliance alleges that the abortion medication has “potentially serious and life-threatening side effects,” yet studies suggest that when mifepristone and misoprostol are used together in consultation with physicians, the regimen can successfully terminate a pregnancy. 99.6% of the time and has * 0.4% risk of major complications.
In a court filing, the FDA said it “extensively reviewed the scientific evidence and determined that the benefits outweigh the risks” and that “the public would be dramatically harmed” if the drug were removed from the market.
The case is also called extraordinary and unheard of.
There is little legal precedent for a court ruling to overturn FDA approval of a drug.
Minutes after the Texas ruling, in a separate case, a federal judge in Washington state issued an injunction, preventing the FDA from “changing the status quo and rights regarding the availability of mifepristone.”
A coalition of Democratic attorneys general challenged the FDA’s proposed new rules on mifepristone in February, and asked the court to remove “unnecessary” restrictions that would limit access to it.
A pilot from a judge in the state of Washington applies only from the states that obtained: Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota; Taranto and Washington, DC
Earlier in Kacsmaryk’s career, a Trump appointee, he represented a conservative legal group called the First Christian Freedom Institute. The group sued the federal government challenging part of the Affordable Care Act, which required employers to provide free insurance coverage for birth control.
Misoprostol, which is not affected by the ban, can be used by itself to terminate the uterus. But it’s not FDA approved for such use without mifepristone — doctors had to prescribe a label. Some abortion providers intend to do so because if access to mifepristone is cut off, access to the drug has also been shown to be one. clinical trials as slightly less effective than the two-pill system.