The abortion drug mifepristone should be more tightly regulated than it is now, with limits on the drug at seven weeks of gestation and requirements that patients obtain the pill in person instead of through the mail, a federal appeals court ruled Wednesday.
The decision by the 5th U.S. Circuit Court of Appeals won't have an immediate impact on access to the drug, at least for now. But the ruling paves the way for the case to land before the U.S. Supreme Court in coming months as expected, putting the hotly contested question of abortion rights before the high court ahead of the 2024 election.
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In a statement, drugmaker GenBioPro noted that the medication remains accessible and legal.
"We remain concerned about extremists and special interests using the courts in an attempt to undermine science and access to evidence-based medication, as well as attempts to undermine the US Food and Drug Administration's regulatory authority," the company wrote. "We will continue to use our company's legal and regulatory tools to ensure access to mifepristone, which is essential to the health of many in the United States."
White House press secretary Karine Jean-Pierre said Wednesday evening, the White House "strongly disagrees" with the ruling from the Fifth Circuit Court of Appeals on mifepristone.
"Due to the Supreme Court's stay, mifepristone remains broadly available for now. But if the Fifth Circuit's ruling stands, it will significantly roll back the ability for women in every state to get the health care they need, and undermine FDA's scientific, evidence-based process for approving safe and effective medications that patients rely on," Jean-Pierre said in the statement.
Vice President Harris has also issued a statement on the 5th Circuit Court ruling, reiterating the White House's phrasing that she "strongly disagrees" with the ruling.
"As I have continually said, this lawsuit is a threat to a woman's freedom to make decisions about her own body and another step towards the ultimate goal of a nationwide abortion ban. It endangers our entire system of drug approval and regulation by undermining the independent, expert judgment of the FDA. Americans across the country should be able look in their medicine cabinets and know that FDA-approved medication prescribed by a doctor will remain available. This decision stands between doctors and their patients," Harris wrote.
The VP continued, "The Biden-Harris Administration will continue our efforts to protect access to abortion and defend the FDA in the courts. The President and I remain committed to protecting a woman's right to make decisions about her own health care."
At issue is the U.S. Food and Drug Administration's oversight of abortion medication, which has grown in popularity in recent years and is now used in more than half of all abortions. Under FDA rules, the brand name drug Mifeprex by Danco Laboratories and its generic counterpart by GenBioPro can be used up to 10 weeks of gestation and provided via mail after a telehealth appointment so long as the clinician follows certain rules.
After the Supreme Court overruled Roe v. Wade, the drug became illegal in states that banned abortion. Still, anti-abortion rights groups say access has been difficult to regulate because the medication remains so widely available in other parts of the country and around the world.
Mifepristone (Mifeprex) and Misoprostol, the two drugs used in a medication abortion, are seen at the Women’s Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, N.M., June 17, 2022.Robyn Beck/AFP via Getty Images, FILE
MORE: Abortion pill will stay on the market for now, but it will be harder to get
In a bid to curb access, at least within the U.S., a conservative-backed group known as Alliance for Hippocratic Medicine filed a lawsuit arguing that FDA approval of the drug should be suspended entirely, and that if that doesn't happen, access to the drug should at least be severely restricted. A Trump-appointed judge in Amarillo, Texas, sided with the plaintiffs, although his ruling was ultimately put on hold by the Supreme Court which wanted to give the case a chance to be heard in full by the 5th U.S. Circuit Court of Appeals.
On Wednesday, the appeals court said it didn't think the FDA's 2000 approval could be eliminated entirely because too much time had passed. The judges also upheld the FDA's approval of the generic version of the drug in 2019.
But the appeals court three-judge panel said it did believe the FDA should impose the same restrictions on the drug as when it first hit the market in 2000, including a seven-week gestation limit and a prohibition on mailing the drug.
"The scientists at the FDA deserve our respect and our gratitude, but not our blind deference," the judges wrote.
The FDA cites more than two decades of safety data in defending its decision in recent years to ease access to the drug.
Kirsten Moore, director of an advocacy group focused on expanding abortion medication access called the EMAA Project, said politically appointed judges shouldn't get to replace FDA judgment on drug safety.
"While the court has acknowledged that mifepristone – both brand and generic versions – can stay on the market, they are insisting we should roll back the clock to 2000 and put the medication under lock and key," Moore said in a statement. "The extremist judges ignored the FDA, our basic rights, and more than 20 years of scientific evidence showing mifepristone is safe and effective, rolling back decades of advancement in the standard of care."
The Justice Department said it would appeal to the Supreme Court.
"As the Attorney General has said before, the Justice Department is committed to defending the FDA's scientific judgment and protecting Americans' access to safe and effective reproductive care. The Department strongly disagrees with the Fifth Circuit's decision in Alliance for Hippocratic Medicine v. FDA and will be seeking Supreme Court review of that decision," a spokesperson said.
Sourse: abcnews.go.com
