Washington – The Supreme Court on Friday granted a Justice Department request to halt the Food and Drug Administration’s approval of a widely used abortion pill, preserving access to the drug and restoring a series of of agency steps that facilitated obtaining while court proceedings continue.
The court decisionwhich has a 6-3 conservative majority, came in the most significant abortion case since overturned Roe v. Wade Less than a year ago, a ruling that threw the legal landscape into chaos and led to the near-total ban on abortion in more than 12 states. In addition to approving the Justice Department’s request for emergency relief, the Supreme Court also approved a similar request from Danco Laboratories, the maker of the abortion drug mifepristone.
Justice Clarence Thomas said he would have denied the emergency requests, and Justice Samuel Alito dissented, writing that neither the Justice Department nor Danco have shown they suffer irreparable harm while the appeal process. Alito authored the majority opinion that overturned Roe.
Biden administration, Danco head to Supreme Court in legal battle over mifepristone after federal judge in Texas suspended 23-year FDA approval of the drug on April 7, which would have cut off access to the medication nationwide, even in states where abortion is legal.
“The district court overturned a scientific judgment that the FDA has upheld over five administrations; overturned approval of a drug that has been used safely by millions of Americans for more than two decades; and “altered the vested interests in a health care system that depends on the availability of mifepristone as an alternative to surgical abortion for women who choose to legally terminate their first pregnancies,” the Justice Department said. he wrote in court
The Biden administration asked the Supreme Court to halt the district court order and aspects of a federal appeals court decision that limited how much mifepristone could be taken in pregnancy, who could prescribe it and how it could be dispensed. The United States Court of Appeals for the 5th Circuit put on hold the most important part of the district court’s decision, stopping the FDA’s approval of mifepristone, but blocked the agency’s actions since 2016 that relaxed the rules surrounding the drug.
The appeals court also fast-tracked the Biden administration’s appeal of the district court’s decision, setting arguments for May 17.
“If allowed to take effect, the lower courts’ orders would alter the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and the FDA’s ability to implement its legal authority ” said Attorney General Elizabeth Prelogar. decisions by U.S. District Judge Matthew Kacsmaryk and the 5th Circuit told the court.
Hours after the Justice Department asked the Supreme Court to intervene, Alito issued an administrative stay, which ensured mifepristone remained available while the court considered the issue. Alito’s order expired at midnight Friday.
President Biden criticized the lower court’s decision in a statement, saying it would have “undermined the FDA’s medical judgment and put women’s health at risk.” He reiterated that his administration would continue to fight “political attacks on women’s health,” but urged the American people to elect lawmakers to Congress who support enshrining abortion protections into law federal
“I am moving forward with the FDA’s evidence-based approval of mifepristone, and my administration will continue to uphold the FDA’s expert and independent authority to review, approve, and regulate a wide range of prescription drugs,” he said. the president in a statement. “The stakes couldn’t be higher for America’s women.”
The abortion pill dispute, brought by a conservative legal organization, put the Supreme Court back at the center of the national debate over reproductive rights. Further complicating the landscape for abortion access was uncertainty over the availability of mifepristone after a Texas court and a Washington federal court judge issued back-to-back contradictory orders. The 5th Circuit’s ruling days later, imposing limits on the abortive drug, only added to the confusion.
Since the Supreme Court struck down the constitutional right to abortion last June, more than a dozen states have banned or imposed strict limits on abortion. In 15 states, there are restrictions that make it difficult for patients to obtain a medication abortion, including the requirement that the medication be provided by a doctor.
Medication abortions have become increasingly common and accounted for more than half of all abortions in the US in 2020, according to the Centers for Disease Control. Mifepristone is taken in combination with a second medicine, misoprostol, to terminate the pregnancy during the 10th week of gestation.
Since the FDA approved mifepristone in 2000, it has made several changes to the rules surrounding the abortion pill. In 2016, the agency increased the gestational age limit from 7 weeks to 10 weeks, reduced the number of in-person clinic visits required, and expanded the pool of health care providers to prescribe the drug. In 2019, the FDA approved a generic version of mifepristone and in 2021 lifted the requirement that the pills be dispensed in person, allowing a provider to prescribe the drug during telemedicine appointments and send it by mail. Earlier this year, the Biden administration extended availability of the abortion drug at more retail and online pharmacies.
The Justice Department has argued in court filings that mifepristone’s risk of serious adverse events is extremely low when taken as directed and warned that lower court orders would “upset the regulatory regime governing a drug that the FDA determine that it was safe and effective under the approved conditions.” More than 5 million women have ended their pregnancies using mifepristone.
But in a filing with the Supreme Court, the doctors and anti-abortion medical associations who sued the FDA over its approval of mifepristone said the 5th Circuit’s order restores “a modicum of safety” for pregnant women who use the drug and would not close access to mifepristone. Instead, the pill would be subject to the same restrictions in place for 16 years after its approval in 2000.
“Both the Fifth Circuit’s and the district court’s orders paint an alarming picture of this illegality, all to the detriment of the women and girls the FDA is supposed to protect,” they said.
The legal battle against medication abortion began in November with the lawsuit filed by the Alliance Defending Freedom on behalf of doctors and medical groups. The challengers argued that the FDA did not adequately consider the health and safety risks of mifepristone when it approved the drug in 2000. The case was filed in federal court in Amarillo, where only Kacsmaryk , appointed by former President Donald Trump, oversees the cases.
Kacsmaryk’s decision blocked not only the FDA’s approval of mifepristone, but also the agency’s subsequent actions to expand access to the drug.
The 5th Circuit said, “The statute of limitations appears to bar plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000.” But the appeals court said the agency “relied on zero studies evaluating the safety and efficacy consequences of” the 2016 changes.
Supporting the Biden administration in its push to preserve FDA approval of mifepristone were 23 blue states and the District of Columbia and 235 Democratic lawmakers, who separately filed friend-of-the-court briefs before the Supreme Court warning that lower court orders would take a long time. – reach ramifications if left alone.
“Decades after the FDA’s initial approval, but somehow in an emergency posture, the district court intruded into the FDA’s drug approval process, casting a shadow of uncertainty over their decisions,” said a group of House and Senate Democrats. he said the court “The dangers of such unwarranted judicial intervention in science-based determinations can hardly be overstated.”
Across the aisle, 21 red states and 147 Republican lawmakers had urged the Supreme Court to uphold the 5th Circuit’s decision.
“By approving and then deregulating chemical abortion drugs, the FDA failed to follow the drug approval process statutorily prescribed by Congress and subverted the critical public policy interests of Congress to defend patient welfare,” they say GOP members of the House and Senate. he wrote.
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