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Supreme Court Retains FDA Approval of Abortion Drugs, Maintains Access for Now

Washington – The Supreme Court on Friday left the Food and Drug Administration’s approval of the widely used abortion drug in place to preserve access to the drug and reinstated a number of procedures by agencies to make abortion drugs more affordable. We have granted a request from the Department of Justice to Legal proceedings continue.

of decision from the courtConservatives hold the majority, 6 to 3. Overthrowing the Roe v. Wade Case In less than a year, more than a dozen states have decreed to ban abortion almost completely, throwing the legal environment into turmoil. The Supreme Court not only granted the Department of Justice’s request for emergency relief, but also a similar request from Danko His Laboratories, maker of the abortion drug mifepristone.

Judge Clarence Thomas said he would have denied the expedited petition, and Judge Samuel Alito opposed the decision, leaving both the Department of Justice and Danko likely to suffer irreparable harm while the appeals process continues. Alito created a majority opinion overturning Roe.

Biden Administration and Danko Take to Supreme Court in Legal Battle Over Mifepristone After Texas Federal Judge FDA suspends 23-year-old approval This would have hindered access to drugs nationwide, including in states where abortion is legal.

“A district court has overturned scientific judgments that the FDA has maintained over five administrations, nullified the approval of a drug that has been used safely by millions of Americans for more than two decades, and reduced drug availability. It has overturned faith in a health care system that relies on mifepristone as an alternative to surgical abortion for women who choose to legally terminate an early pregnancy,” the Department of Justice said. I have written to court.

The Biden administration has asked the Supreme Court to suspend aspects of a district court order and a federal appeals court decision that limited how late in pregnancy mifepristone can be taken, who can prescribe it, and how it can be dispensed. asked the court.US Court of Appeals for the Fifth Circuit Hold The most important part of the district court’s decision — suspending FDA approval of mifepristone — blocked action by the FDA to relax regulations on the drug after 2016.

The Court of Appeals also hastened the Biden administration’s appeal of the district court’s decision, giving arguments on May 17.

“If allowed to take effect, the lower court’s order could overturn the regulatory regime for mifepristone, significantly impacting the pharmaceutical industry, women who need access to the drug, and the FDA’s ability to exercise its statutory powers. Attorney General Elizabeth Preroger told the court of the U.S. District Judge Matthew Kacsmaryk and the Fifth Circuit Court’s decision.

Hours after the Department of Justice asked the Supreme Court to intervene, Alito issued an administrative action, making mifepristone available while the court considered the matter. It was set to expire at midnight.

In a statement, President Biden criticized the lower court’s decision, saying it would “undermine the FDA’s medical judgment and endanger women’s health.” He reiterated that he would continue to fight the “attack”, but urged the American people to elect Congressmen to support the inclusion of abortion protections in federal law.

“I continue to support FDA’s evidence-based approval of mifepristone, and my administration will continue to defend FDA’s independent expert authority to review, approve, and regulate a wide range of prescription drugs,” the president said in a statement. I will,” he said. “For women across America, the stakes just don’t get any higher.”

A controversy over abortion drugs brought by conservative legal groups has pushed the Supreme Court back into the center of the national debate over sexual and reproductive rights. Uncertainty about the availability of mifepristone after a series of conflicting orders from a Texas court and a federal judge in Washington further complicated the abortion access landscape. Days later, a Fifth Circuit ruling imposing restrictions on abortion drugs only added to the confusion.

Since the Supreme Court rescinded the constitutional right to abortion last June, more than a dozen states have banned abortion or imposed severe restrictions on it. Fifteen states have restrictions that make it difficult for patients to obtain medical abortions, such as mandating that medication be provided by a doctor.

Medical abortions are becoming increasingly common, accounting for more than half of all abortions in the United States by 2020, according to the Centers for Disease Control. Mifepristone is used in combination with a second drug, misoprostol, to terminate pregnancies up to 10 weeks’ gestation.

Since the FDA approved mifepristone in 2000, there have been several changes to abortion drug regulations. In 2016, the FDA increased the gestational age limit from her 7 weeks to 10 weeks, reducing the number of in-person clinic visits required and broadening the range of health care providers who prescribe the drug. In 2019, the FDA approved a generic version of mifepristone and in 2021 lifted the requirement to dispense tablets in person.Earlier this year, the Biden administration expanded the availability Selling abortion pills to more retail stores and online pharmacies.

In court papers, the Justice Department argued that the risk of serious adverse events when mifepristone was taken as directed was extremely low, and the lower court’s order “was determined by the FDA to be safe and effective. It could disrupt the regulatory regime that governs pharmaceuticals,” he warned. Approved terms. More than 5 million women have used Mifepristone to terminate pregnancies.

but, filing Anti-abortion rights physicians and medical associations who sued the FDA over the approval of mifepristone told the Supreme Court that the Fifth Circuit’s order provided “a marginal safety” for pregnant women using the drug. He said he would recover and would not cut off access to drugs. Mifepristone. Instead, Pill will be subject to the same restrictions for 16 years from her 2000 approval.

“Both the Fifth Circuit and District Court orders paint a disturbing picture of this lawlessness, at the expense of all the women and girls the FDA is supposed to protect,” they said. Told.

The legal battle targeting medical abortion began in November with a lawsuit filed by the League for Freedom on behalf of doctors and medical groups. Opponent argued that the FDA did not adequately consider the health and safety risks of mifepristone when he approved it in 2000. The lawsuit was filed in federal court in Amarillo. There, only Kaksmalik, appointed by former President Donald Trump, oversees the case.

Kacsmaryk’s decision prevented not only FDA’s approval of mifepristone, but also the FDA’s subsequent actions to expand access to the drug.

The Fifth Circuit Court of Appeals stated, “Plaintiffs’ challenge to the Food and Drug Administration’s approval of mifepristone in 2000 appears to be barred by the statute of limitations.” But the Court of Appeals said the agency “relied on zero studies that evaluated the safety and efficacy outcomes of the 2016 changes.”

23 blue states and the District of Columbia, and 235 Democrats who backed the Biden administration to keep FDA approval for mifepristone, warn lower court orders would be far more effective filed separate buddy briefs with the Supreme Court.・If you leave it as it is, it will affect you.

“Decades after the FDA’s first approval, and somehow taking a stance of urgency, a district court has intruded into the FDA’s drug approval process, casting a shadow of uncertainty over its decisions. We dropped it,” said a group of Democrats in the House and Senate. Said court. “The danger of this unjust judicial intervention in science-based decisions cannot be overstated.”

On the other side of the aisle, 21 at-risk states and 147 Republican lawmakers asked the Supreme Court to keep the Fifth Circuit’s decision intact.

“By approving and then deregulating chemical abortion drugs, the FDA did not follow Congress’ statutory drug approval process and undermined Congress’ important public policy interest of preserving patient welfare,” Republicans said. Representatives and Senators said. I have written.

Read the Supreme Court Order here:

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Washington – The Supreme Court on Friday left the Food and Drug Administration’s approval of the widely used abortion drug in place to preserve access to the drug and reinstated a number of procedures by agencies to make abortion drugs more affordable. We have granted a request from the Department of Justice to Legal proceedings continue.of decision from the courtConservatives hold the majority, 6 to 3. Overthrowing the Roe v. Wade Case In less than a year, more than a dozen states have decreed to ban abortion almost completely, throwing the legal environment into turmoil. The Supreme Court not only granted the Department of Justice’s request for emergency relief, but also a similar request from Danko His Laboratories, maker of the abortion drug mifepristone.Judge Clarence Thomas said he would have denied the expedited petition, and Judge Samuel Alito opposed the decision, leaving both the Department of Justice and Danko likely to suffer irreparable harm while the appeals process continues. Alito created a majority opinion overturning Roe.

Biden Administration and Danko Take to Supreme Court in Legal Battle Over Mifepristone After Texas Federal Judge FDA suspends 23-year-old approval This would have hindered access to drugs nationwide, including in states where abortion is legal. “A district court has overturned scientific judgments that the FDA has maintained over five administrations, nullified the approval of a drug that has been used safely by millions of Americans for more than two decades, and reduced drug availability. It has overturned faith in a health care system that relies on mifepristone as an alternative to surgical abortion for women who choose to legally terminate an early pregnancy,” the Department of Justice said. I have written to court.

The Biden administration has asked the Supreme Court to suspend aspects of a district court order and a federal appeals court decision that limited how late in pregnancy mifepristone can be taken, who can prescribe it, and how it can be dispensed. asked the court.US Court of Appeals for the Fifth Circuit Hold The most important part of the district court’s decision — suspending FDA approval of mifepristone — blocked action by the FDA to relax regulations on the drug after 2016.The Court of Appeals also hastened the Biden administration’s appeal of the district court’s decision, giving arguments on May 17.”If allowed to take effect, the lower court’s order could overturn the regulatory regime for mifepristone, significantly impacting the pharmaceutical industry, women who need access to the drug, and the FDA’s ability to exercise its statutory powers. Attorney General Elizabeth Preroger told the court of the U.S. District Judge Matthew Kacsmaryk and the Fifth Circuit Court’s decision.Hours after the Department of Justice asked the Supreme Court to intervene, Alito issued an administrative action, making mifepristone available while the court considered the matter. It was set to expire at midnight.

In a statement, President Biden criticized the lower court’s decision, saying it would “undermine the FDA’s medical judgment and endanger women’s health.” He reiterated that he would continue to fight the “attack”, but urged the American people to elect Congressmen to support the inclusion of abortion protections in federal law.”I continue to support FDA’s evidence-based approval of mifepristone, and my administration will continue to defend FDA’s independent expert authority to review, approve, and regulate a wide range of prescription drugs,” the president said in a statement. I will,” he said. “For women across America, the stakes just don’t get any higher.”A controversy over abortion drugs brought by conservative legal groups has pushed the Supreme Court back into the center of the national debate over sexual and reproductive rights. Uncertainty about the availability of mifepristone after a series of conflicting orders from a Texas court and a federal judge in Washington further complicated the abortion access landscape. Days later, a Fifth Circuit ruling imposing restrictions on abortion drugs only added to the confusion.Since the Supreme Court rescinded the constitutional right to abortion last June, more than a dozen states have banned abortion or imposed severe restrictions on it. Fifteen states have restrictions that make it difficult for patients to obtain medical abortions, such as mandating that medication be provided by a doctor.Medical abortions are becoming increasingly common, accounting for more than half of all abortions in the United States by 2020, according to the Centers for Disease Control. Mifepristone is used in combination with a second drug, misoprostol, to terminate pregnancies up to 10 weeks’ gestation.Since the FDA approved mifepristone in 2000, there have been several changes to abortion drug regulations. In 2016, the FDA increased the gestational age limit from her 7 weeks to 10 weeks, reducing the number of in-person clinic visits required and broadening the range of health care providers who prescribe the drug. In 2019, the FDA approved a generic version of mifepristone and in 2021 lifted the requirement to dispense tablets in person.Earlier this year, the Biden administration expanded the availability Selling abortion pills to more retail stores and online pharmacies.In court papers, the Justice Department argued that the risk of serious adverse events when mifepristone was taken as directed was extremely low, and the lower court’s order “was determined by the FDA to be safe and effective. It could disrupt the regulatory regime that governs pharmaceuticals,” he warned. Approved terms. More than 5 million women have used Mifepristone to terminate pregnancies.

but, filing Anti-abortion rights physicians and medical associations who sued the FDA over the approval of mifepristone told the Supreme Court that the Fifth Circuit’s order provided “a marginal safety” for pregnant women using the drug. He said he would recover and would not cut off access to drugs. Mifepristone. Instead, Pill will be subject to the same restrictions for 16 years from her 2000 approval.“Both the Fifth Circuit and District Court orders paint a disturbing picture of this lawlessness, at the expense of all the women and girls the FDA is supposed to protect,” they said. Told.The legal battle targeting medical abortion began in November with a lawsuit filed by the League for Freedom on behalf of doctors and medical groups. Opponent argued that the FDA did not adequately consider the health and safety risks of mifepristone when he approved it in 2000. The lawsuit was filed in federal court in Amarillo. There, only Kaksmalik, appointed by former President Donald Trump, oversees the case. Kacsmaryk’s decision prevented not only FDA’s approval of mifepristone, but also the FDA’s subsequent actions to expand access to the drug. The Fifth Circuit Court of Appeals stated, “Plaintiffs’ challenge to the Food and Drug Administration’s approval of mifepristone in 2000 appears to be barred by the statute of limitations.” But the Court of Appeals said the agency “relied on zero studies that evaluated the safety and efficacy outcomes of the 2016 changes.”23 blue states and the District of Columbia, and 235 Democrats who backed the Biden administration to keep FDA approval for mifepristone, warn lower court orders would be far more effective filed separate buddy briefs with the Supreme Court.・If you leave it as it is, it will affect you.”Decades after the FDA’s first approval, and somehow taking a stance of urgency, a district court has intruded into the FDA’s drug approval process, casting a shadow of uncertainty over its decisions. We dropped it,” said a group of Democrats in the House and Senate. Said court. “The danger of this unjust judicial intervention in science-based decisions cannot be overstated.”

On the other side of the aisle, 21 at-risk states and 147 Republican lawmakers asked the Supreme Court to keep the Fifth Circuit’s decision intact.”By approving and then deregulating chemical abortion drugs, the FDA did not follow Congress’ statutory drug approval process and undermined Congress’ important public policy interest of preserving patient welfare,” Republicans said. Representatives and Senators said. I have written.Read the Supreme Court Order here:

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https://www.cbsnews.com/news/supreme-court-abortion-pill-access-mifepristone/ Supreme Court Retains FDA Approval of Abortion Drugs, Maintains Access for Now

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