For now, a federal appeals court has upheld access to an abortion medicine, but with stricter restrictions that would only permit the treatment to be supplied for a maximum of seven weeks, not ten, and not by mail.
Mifepristone, a medication used with misoprostol to stop an early pregnancy, has been approved for use by the Food and Drug Administration for over 20 years. Just before midnight on Wednesday, the 5th U.S. Circuit Court of Appeals in New Orleans issued its decision.
By a 2-1 margin, a panel of three justices limited for the time being a ruling made on Friday by a lower court judge in Texas that had entirely disallowed the FDA’s approval of the medication in response to a complaint brought by mifepristone’s opponents.
The lower court’s decision had been put on hold for a week to allow for an appeal. On Monday, the Biden administration requested that the 5th Circuit stay the district court’s ruling because it was “extraordinary and unprecedented.”
As stated in the appeals court’s ruling, “it appears that the statute of limitations bars plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000.”
However, the FDA would put on hold modifications enacted since 2016 that loosened the restrictions on prescribing and dispensing mifepristone. These include making it possible to use the medication throughout pregnancy and allowing it to be sent to patients via mail without a doctor’s appointment.
Kurt Engelhardt and Andrew Oldham, the two judges who voted in favor of tighter regulations, were both chosen by the late President Donald Trump. George W. Bush, a former president, appointed Catharina Haynes as the third judge.
She claimed that in order to allow for oral arguments in the case, she would have wholly suspended the lower court’s decision. The Justice Department announced on Thursday that it intends to ask the Supreme Court for immediate relief.
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Karine Jean-Pierre, the press secretary for the White House, announced Thursday that the government would continue to fight for the reinstatement of full approval for mifepristone while President Biden was in Dublin, Ireland. “We believe that the law is on our side, and we will prevail,” she said.
Since the Supreme Court reversed Roe v. Wade last year, Democratic leaders in areas where abortion is still legal claim they are preparing in case mifepristone are banned.
States governed by Democrats have made steps to increase their stockpiles of misoprostol, the second medical abortion pill that can be used alone to end an early pregnancy.
However, compared to the two-drug regimen of mifepristone and misoprostol, which is between 95% and 99% successful, a misoprostol-alone medication abortion is only slightly less effective (between 80% and 99%).
Gov. Maura Healy of Massachusetts ordered healthcare providers to bank additional doses of mifepristone. The University of Massachusetts Amherst purchased roughly 15,000 doses, enough to last the state for more than a year.
The doses are scheduled to arrive this week. On Monday, Gov. Gavin Newsom of California announced that the state secured an emergency stockpile of up to 2 million misoprostol pills. Kathy Hochul, the governor of New York, announced on Tuesday that her condition would have 150,000 doses of misoprostol on hand.
A separate ruling by a federal district judge in Washington, also rendered on Friday, further complicated the legal situation by prohibiting the FDA from changing the case involving the availability of mifepristone in 16 states and the District of Columbia.
In an effort to protect access to the medicine, those states and Washington, D.C., filed a lawsuit against the Biden administration in February over a set of limits placed on it.
On Monday, the Justice Department requested clarity from the Washington court regarding its responsibilities in light of the two orders from the district court that appear to conflict.
This week, pharmaceutical executives also signed a letter denouncing the Texas verdict and cautioning that the FDA’s clearance of other medications could be in jeopardy if U.S. District Judge Matthew Kacsmaryk’s order is upheld. Almost any precedent exists for a single judge to overturn the FDA’s medical advice.
The Biden administration requested that the 5th Circuit postpone Kacsmaryk’s order, and 23 states, the District of Columbia, and Danco Laboratories, the company that manufactures mifepristone, supported this motion.
“The decision below is an extreme outlier: No court has ever ‘stayed’ or ‘suspended’ the longstanding approval of a drug consistently found safe and effective by FDA,”
Danco wrote in its own request to the appeals court. “The court’s mandatory injunction is an unprecedented judicial assault on a careful regulatory process that has served the public for decades.”
While this was going on, the states issued a warning, stating that restricting access to medication abortion would lead to more abortions taking place later in pregnancy, raising costs and health hazards.
Additionally, they cautioned that Kacsmaryk’s “unprecedented” ruling might have significant repercussions for the FDA.
“The district court’s ruling was legally erroneous, undermines the regulatory scheme for drug approvals, and presents devastating risks to millions of people across the country,” they said in a filing with the 5th Circuit.
The 5th Circuit was also informed by 240 congressional Democrats, including the party’s leaders in the House and Senate, that Kacsmaryk’s order stopping the FDA’s approval of mifepristone in 2000 and the subsequent actions “has no basis in law” and “threatens the congressionally mandated drug approval process.”
Congress, they said, designated the FDA “as the expert federal agency with authority to review and approve drug applications, including subsequent changes to those applications.
While Congress permitted some judicial review of FDA’s approval decisions, it did not invite federal courts to substitute their judgment for the expert conclusions of FDA’s scientists.”
The Alliance Defending Freedom, which was also involved in the Mississippi case that resulted in Roe v. Wade being reversed, filed the lawsuit contesting the approval of mifepristone. The lawsuit’s central claim is that the FDA’s first approval of mifepristone was defective because it lacked sufficient consideration of safety hazards.
Millions of women have taken mifepristone over the past 23 years, and medical associations recently emphasized that difficulties from mifepristone use are less common than those with colonoscopies, wisdom teeth extraction, and other common operations.
Since the FDA first approved the abortion pill, several changes have been made, including the approval of a generic version of mifepristone in 2019 and the removal of the requirement that the pills be given out in person in 2021, allowing the medication to be prescribed by a doctor during telemedicine appointments and sent by mail.
The Biden administration informed the 5th Circuit that major adverse events are uncommon when mifepristone is taken as prescribed by the FDA, and that medication abortions accounted for more than half of all abortions in the U.S. in 2020, according to the Centers for Disease Control and Prevention.
Only 28 fatalities associated with the use of mifepristone were documented through June 2022, even though more than 5 million women have taken it. Some of these deaths were linked to “obvious alternative causes” unrelated to the use of the abortion pill, according to the FDA.
“The court upended the status quo with its abrupt and sweeping nationwide order,” the Biden administration said, seeking a stay of Kacsmaryk’s ruling. “If allowed to take effect, that order will irreparably harm patients, healthcare systems, and businesses.
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