The Supreme Court will hear abortion pill case today as justices consider access to widely used drug
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Washington – The Supreme Court is scheduled to convene Tuesday to hear arguments. Cases involving commonly used abortion drugs and recent actions by the Food and Drug Administration to increase drug availability.
At the center of the legal battle is mifepristone, a pill taken along with other drugs to terminate early pregnancies. Approved by the FDA in 2000, more than 5 million patients have taken mifepristone, and studies cited in court filings show mifepristone is safe and effective, according to the FDA. It has been shown that
In recent years, the FDA has taken a series of steps to make mifepristone more accessible, including allowing mifepristone to be taken up to the 10th week of pregnancy and being delivered by mail without an in-person doctor's visit. ing. These actions, taken in 2016 and 2021, came under legal scrutiny after anti-abortion rights doctors and physician association groups argued that the FDA violated the law when it relaxed rules. is subject to.
The Supreme Court is Federal Court of Appeals Judgment The agency's actions were found to be illegal. A ruling overturning these changes could limit access to mifepristone nationwide, even in states with laws protecting abortion access.
Since the High Court issued its order last April, access to mifepristone has remained unchanged while the legal proceedings in the case continue. maintain availability. The relief will remain in place until the Supreme Court issues its ruling, expected by the end of June.
Robin Beck/AFP via Getty Images
Arguments in the case come less than two years after the Supreme Court ruled in June 2022 that: Relaxing the constitutional right to abortion and sends the matter back to the state. And this dispute isn't the only abortion dispute the justices are expected to consider within the next month. second case Federal law includes whether emergency room doctors in states that ban abortions will be required to treat pregnant patients whose lives are at risk.
The court's review also follows new research showing that medical abortions have increased in the United States since the Supreme Court overturned Roe v. Wade.
a research has been published The medical journal JAMA on Monday revealed that the number of self-administered abortions using the pill has increased in the six months since the high court overturned Roe's decision. A study released last week by the Guttmacher Institute, an organization that supports abortion rights, found that medication abortions Accounts for 63% of all abortions in the U.S. healthcare system in 2023, up from 53% in 2020.
Controversy surrounding Mifepristone
The challenge to the FDA's efforts regarding mifepristone was filed in November 2022 by a group of physician organizations opposed to abortion rights, more than 20 years after the drug became available in the United States. The group, led by the Hippocratic Medical Alliance, went to federal district court in Texas to challenge the FDA's initial approval in 2000 and recent changes in 2016 and 2021.
As part of these actions, the FDA will allow mifepristone to be taken until 10 weeks of pregnancy instead of 7, reduce the number of required in-person visits from three to one, and encourage more healthcare providers to administer the drug. and eliminated the requirement for face-to-face prescriptions.
The group, represented by the conservative legal group Alliance Defending Freedom, says the FDA lacks the authority to approve mifepristone for sale and has not adequately reviewed the drug's safety and effectiveness. insisted.
The federal judge overseeing the case, U.S. District Judge Matthew Kaksmarik, agreed that the FDA's 2000 approval and subsequent actions were likely illegal.he Blocked FDA's initial action allow the drug to be sold in the United States
But Mr. Kaczmarik put the verdict on hold for a week, and the Federal Court of Appeals and Supreme Court intervened.In the end, the high court maintained access He was put on mifepristone while the legal process continued.
A few months later, the U.S. Court of Appeals for the Fifth Circuit decided Supported FDA approval in 2000 However, the agency said recent changes violate the law. However, the Court of Appeal's decision is preempted by the Supreme Court's early April 2023 order protecting access.
The Department of Justice and Danko Laboratories (maker of Mifeprex, the brand-name version of Mifepristone) have asked the Supreme Court to reconsider the Fifth Circuit's decision, agreed to do so During December.
Discussion in this case
Celal Gunes/Anadolu, via Getty Images
The Biden administration asked the judge to reverse the appeals court's decision, stating that the medical association and its physician members had not shown that they may have suffered injuries as a result of the FDA's actions, and that these alleged injuries were not covered by the FDA. He argued that this can be traced back to the mitigation measures. Mifepristone rules.
Attorney General Elizabeth Preloger said in court that the doctors challenging the changes were not prescribing the drugs and that members were forced to perform abortions on women who showed up to emergency rooms with ongoing pregnancies. said that not a single case had been confirmed. in the documents.
But lawyers for medical groups represented by the Alliance Defending Freedom argued that their members not only oppose abortion, but also “complicity in the process.”
“For decades, the FDA has directed women harmed by abortion pills to emergency rooms, many of whom sought treatment from defendant physicians,” the attorneys wrote. . “The FDA is now being asked to account for the harm caused, but it cannot claim that FDA-directed treatments are themselves somehow speculative.”
If the Supreme Court agrees with the Department of Justice that doctors do not have a proper basis for filing a lawsuit in federal court, it will decide whether the FDA acted within the law when it changed the rules for the use of mifepristone. It would likely order the case dismissed without making a decision. .
However, if the judge reaches the legal issues raised in the case, the Justice Department and Danko asked the court to find that FDA's actions in 2016 and 2021 were legal.
The agency relied on “vast medical evidence” about mifepristone's use over decades when it determined the 2016 change was safe, Preloger wrote. In any case, she said the district court was wrong to second-guess Congress' decision to give FDA authority.
“To the government's knowledge, this case does not allow courts to limit access to FDA-approved drugs by second-guessing FDA's expert judgment about the conditions necessary to ensure safe use of drugs.” This is the first time that we have restricted the
Pharmaceutical companies and former FDA commissioners say a ruling upholding the 5th Circuit Court of Appeals could undermine the FDA's drug approval process and could lead to permanent legal challenges to approval decisions. warned the court.
If the lower courts' approach were left in place, “courts could replace the FDA's scientific expertise with amateur analysis, and the courts would be able to replace the FDA's scientific expertise with amateur analysis,” would overturn its approval and terms of use,” one group said. Former commissioners and acting commissioners made statements to the court in briefs.
“The resulting uncertainty threatens the incentives for pharmaceutical companies to make the time-consuming and costly investments necessary to develop new drugs, and ultimately reduces patient access to critical treatments that prevent suffering and save lives. the researchers said.
A number of drug companies and executives separately emphasized the importance of drug companies being able to rely on the courts to respect the FDA's scientific judgment.
“If courts are able to overturn these decisions years later in a process that lacks scientific rigor, the resulting uncertainty will create intolerable risks and reduce incentives for investment regardless of the drug in question. ,” they said in the document. simple. “This ends up hurting the patient.”
But lawyers for the Medical Association Against Abortion Rights and its members argue that the FDA has not provided a “satisfactory explanation” for its decision to lift the in-person dispensing requirement, and that the studies relied on by the FDA do not. There is a serious problem.”
The associations argued that the removal of the in-person requirement in 2021 eliminated the opportunity for health care workers to test for ectopic pregnancies and other conditions. In 2016, the FDA removed the “non-study interrelated safety measures” that investigated changes in their entirety, they continued.
Americans United for Life, a group that supports the Hippocratic Medical Alliance, claimed They argued that the FDA facilitates access to abortion pills without medical supervision, increasing health and safety risks to women and impeding their care.
Summarize this content to 100 words Washington – The Supreme Court is scheduled to convene Tuesday to hear arguments. Cases involving commonly used abortion drugs and recent actions by the Food and Drug Administration to increase drug availability.At the center of the legal battle is mifepristone, a pill taken along with other drugs to terminate early pregnancies. Approved by the FDA in 2000, more than 5 million patients have taken mifepristone, and studies cited in court filings show mifepristone is safe and effective, according to the FDA. It has been shown thatIn recent years, the FDA has taken a series of steps to make mifepristone more accessible, including allowing mifepristone to be taken up to the 10th week of pregnancy and being delivered by mail without an in-person doctor's visit. ing. These actions, taken in 2016 and 2021, came under legal scrutiny after anti-abortion rights doctors and physician association groups argued that the FDA violated the law when it relaxed rules. is subject to.
The Supreme Court is Federal Court of Appeals Judgment The agency's actions were found to be illegal. A ruling overturning these changes could limit access to mifepristone nationwide, even in states with laws protecting abortion access. Since the High Court issued its order last April, access to mifepristone has remained unchanged while the legal proceedings in the case continue. maintain availability. The relief will remain in place until the Supreme Court issues its ruling, expected by the end of June.
Mifepristone (Mifeprex) and misoprostol, two drugs used in medication abortions, at the Women's Reproductive Clinic in Santa Teresa, New Mexico, on June 17, 2022.
Robin Beck/AFP via Getty Images
Arguments in the case come less than two years after the Supreme Court ruled in June 2022 that: Relaxing the constitutional right to abortion and sends the matter back to the state. And this dispute isn't the only abortion dispute the justices are expected to consider within the next month. second case Federal law includes whether emergency room doctors in states that ban abortions will be required to treat pregnant patients whose lives are at risk.
The court's review also follows new research showing that medical abortions have increased in the United States since the Supreme Court overturned Roe v. Wade.a research has been published The medical journal JAMA on Monday revealed that the number of self-administered abortions using the pill has increased in the six months since the high court overturned Roe's decision. A study released last week by the Guttmacher Institute, an organization that supports abortion rights, found that medication abortions Accounts for 63% of all abortions in the U.S. healthcare system in 2023, up from 53% in 2020.Controversy surrounding MifepristoneThe challenge to the FDA's efforts regarding mifepristone was filed in November 2022 by a group of physician organizations opposed to abortion rights, more than 20 years after the drug became available in the United States. The group, led by the Hippocratic Medical Alliance, went to federal district court in Texas to challenge the FDA's initial approval in 2000 and recent changes in 2016 and 2021. As part of these actions, the FDA will allow mifepristone to be taken until 10 weeks of pregnancy instead of 7, reduce the number of required in-person visits from three to one, and encourage more healthcare providers to administer the drug. and eliminated the requirement for face-to-face prescriptions.
The group, represented by the conservative legal group Alliance Defending Freedom, says the FDA lacks the authority to approve mifepristone for sale and has not adequately reviewed the drug's safety and effectiveness. insisted.The federal judge overseeing the case, U.S. District Judge Matthew Kaksmarik, agreed that the FDA's 2000 approval and subsequent actions were likely illegal.he Blocked FDA's initial action allow the drug to be sold in the United StatesBut Mr. Kaczmarik put the verdict on hold for a week, and the Federal Court of Appeals and Supreme Court intervened.In the end, the high court maintained access He was put on mifepristone while the legal process continued. A few months later, the U.S. Court of Appeals for the Fifth Circuit decided Supported FDA approval in 2000 However, the agency said recent changes violate the law. However, the Court of Appeal's decision is preempted by the Supreme Court's early April 2023 order protecting access.The Department of Justice and Danko Laboratories (maker of Mifeprex, the brand-name version of Mifepristone) have asked the Supreme Court to reconsider the Fifth Circuit's decision, agreed to do so During December. Discussion in this case
View of tulips near the Supreme Court on March 22, 2024 in Washington, DC.
Celal Gunes/Anadolu, via Getty Images
The Biden administration asked the judge to reverse the appeals court's decision, stating that the medical association and its physician members had not shown that they may have suffered injuries as a result of the FDA's actions, and that these alleged injuries were not covered by the FDA. He argued that this can be traced back to the mitigation measures. Mifepristone rules. Attorney General Elizabeth Preloger said in court that the doctors challenging the changes were not prescribing the drugs and that members were forced to perform abortions on women who showed up to emergency rooms with ongoing pregnancies. said that not a single case had been confirmed. in the documents.
But lawyers for medical groups represented by the Alliance Defending Freedom argued that their members not only oppose abortion, but also “complicity in the process.”“For decades, the FDA has directed women harmed by abortion pills to emergency rooms, many of whom sought treatment from defendant physicians,” the attorneys wrote. . “The FDA is now being asked to account for the harm caused, but it cannot claim that FDA-directed treatments are themselves somehow speculative.”If the Supreme Court agrees with the Department of Justice that doctors do not have a proper basis for filing a lawsuit in federal court, it will decide whether the FDA acted within the law when it changed the rules for the use of mifepristone. It would likely order the case dismissed without making a decision. . However, if the judge reaches the legal issues raised in the case, the Justice Department and Danko asked the court to find that FDA's actions in 2016 and 2021 were legal.The agency relied on “vast medical evidence” about mifepristone's use over decades when it determined the 2016 change was safe, Preloger wrote. In any case, she said the district court was wrong to second-guess Congress' decision to give FDA authority.”To the government's knowledge, this case does not allow courts to limit access to FDA-approved drugs by second-guessing FDA's expert judgment about the conditions necessary to ensure safe use of drugs.” This is the first time that we have restricted thePharmaceutical companies and former FDA commissioners say a ruling upholding the 5th Circuit Court of Appeals could undermine the FDA's drug approval process and could lead to permanent legal challenges to approval decisions. warned the court.
If the lower courts' approach were left in place, “courts could replace the FDA's scientific expertise with amateur analysis, and the courts would be able to replace the FDA's scientific expertise with amateur analysis,” would overturn its approval and terms of use,” one group said. Former commissioners and acting commissioners made statements to the court in briefs. “The resulting uncertainty threatens the incentives for pharmaceutical companies to make the time-consuming and costly investments necessary to develop new drugs, and ultimately reduces patient access to critical treatments that prevent suffering and save lives. the researchers said.A number of drug companies and executives separately emphasized the importance of drug companies being able to rely on the courts to respect the FDA's scientific judgment.“If courts are able to overturn these decisions years later in a process that lacks scientific rigor, the resulting uncertainty will create intolerable risks and reduce incentives for investment regardless of the drug in question. ,” they said in the document. simple. “This ends up hurting the patient.”But lawyers for the Medical Association Against Abortion Rights and its members argue that the FDA has not provided a “satisfactory explanation” for its decision to lift the in-person dispensing requirement, and that the studies relied on by the FDA do not. There is a serious problem.”The associations argued that the removal of the in-person requirement in 2021 eliminated the opportunity for health care workers to test for ectopic pregnancies and other conditions. In 2016, the FDA removed the “non-study interrelated safety measures” that investigated changes in their entirety, they continued.Americans United for Life, a group that supports the Hippocratic Medical Alliance, claimed They argued that the FDA facilitates access to abortion pills without medical supervision, increasing health and safety risks to women and impeding their care.
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melissa quinn
Melissa Quinn is a political reporter for CBSNews.com. She has written for media outlets including the Washington Examiner, Daily Signal, and Alexandria Times. Melissa covers U.S. politics with a focus on the Supreme Court and federal courts.
https://www.cbsnews.com/news/supreme-court-abortion-pill-arguments-mifepristone/ The Supreme Court will hear abortion pill case today as justices consider access to widely used drug