Listen Live: Supreme Court hears abortion pill arguments as justices weigh access to widely used drug
Washington — The Supreme Court is convening Tuesday to hear arguments in a
This case deals with a frequently used medication for inducing abortion.
Recent measures taken by the Food and Drug Administration have aimed to streamline the process of obtaining medication.
The focal point of the legal dispute involves the medication mifepristone, which is used with another drug to end a pregnancy in its early stages. The FDA has approved mifepristone since 2000, and according to the agency, over 5 million patients have used it. Studies referenced in court documents have demonstrated its safety and effectiveness.
In the last few years, the FDA has implemented a sequence of measures to increase the availability of mifepristone. This includes permitting it to be taken up to 10 weeks into a pregnancy and providing it through mail delivery without requiring an in-person visit with a doctor. These actions, which were enacted in 2016 and 2021, have faced legal examination as a group of doctors and medical organizations opposed to abortion rights have alleged that the FDA broke the law by easing these regulations.
A federal appeals court has made a decision deeming the agency’s actions as illegal. If this ruling is upheld, it could restrict the availability of mifepristone in all states, including those with laws that protect access to abortion.
There have been no changes to the availability of mifepristone while legal proceedings have been ongoing since the high court’s ruling in April.preserving its availability
The relief will continue until the Supreme Court makes its decision, which is anticipated by the end of June.
ROBYN BECK/AFP via Getty Images
Arguments in the case are taking place less than two years after the Supreme Court ruled in June 2022 to
Remove the legal protection of abortion rights. –
The matter will be sent back to individual states. In the coming month, the Supreme Court will also address additional cases related to abortion besides this dispute.second case
This pertains to the question of whether doctors in emergency rooms are legally obligated to perform abortions in states where they are prohibited, in cases where the patient’s life is in danger.
The recent ruling by the court is in response to recent evidence showing an increase in medication-induced abortions in the U.S. after the Supreme Court’s decision to reverse Roe v. Wade.
New research from the Guttmacher Institute, a pro-choice organization, published last week in the medical journal JAMA, revealed a significant increase in the number of self-administered abortions using pills in the six months following the reversal of Roe. These medication abortions made up 63% of all abortions within the U.S. healthcare system in 2023, up from 53% in 2020.
The dispute over mifepristone
The FDA’s actions regarding mifepristone were contested in court in November 2022, more than 20 years after the drug was introduced in the U.S. The plaintiffs, a coalition of medical organizations that oppose abortion, filed a lawsuit in federal court in Texas. They specifically challenged the FDA’s original approval in 2000 and its subsequent modifications in 2016 and 2021.
The FDA took several steps, including extending the time frame in which mifepristone can be used from seven weeks to 10 weeks during pregnancy, decreasing the number of in-person visits from three to one, expanding the range of health care providers who can prescribe the drug, and eliminating the mandatory in-person prescription requirement.
The groups, represented by the organization Alliance Defending Freedom which advocates conservative legal views, alleged that the FDA lacked the power to sanction the sale of mifepristone and did not sufficiently assess the drug’s safety or effectiveness.
The federal judge overseeing the case, U.S. District Judge Matthew Kacsmaryk, agreed that the FDA’s 2000 approval and subsequent actions were likely unlawful. He
hindered the initial measure taken by the FDA
Permitting the sale of the drug in the United States.
delayed action for the first time in its history
However, Kacsmaryk issued a temporary halt on his decision for a period of seven days, following interventions from both a federal appeals court and the Supreme Court. Ultimately, the Supreme Court postponed any action, marking the first instance of such a delay in its history.maintained access to mifepristone while legal proceedings continued.
Months later, the U.S. Court of Appeals for the 5th Circuit
The FDA’s 2000 approval was maintained.
The court ruled against recent changes made by the agency for the abortion pill, stating that they were in violation of the law. However, the Supreme Court’s previous order in April 2023, which aimed to protect access to the pill, overrides this decision.
The Justice Department and Danco Laboratories — the maker of Mifeprex, the brand-name version of mifepristone — asked the Supreme Court to review the 5th Circuit’s ruling, and it
Consented to do it. in December.
of “phone argument”
The points made in the “phone dispute” case.
On March 26, 2024 in Washington, D.C., a crowd gathered outside the Supreme Court to listen to oral arguments for the case FDA v. Alliance for Hippocratic Medicine. They awaited their turn in line, eager to hear the discussions.
DREW ANGERER/AFP via Getty Images
The Biden administration is requesting the justices to overturn a ruling made by the appeals court. They argue that the medical associations and their physicians have not provided evidence of potential harm from the FDA’s actions and that any harm that is claimed is directly linked to the FDA’s relaxation of restrictions on mifepristone.
According to Solicitor General Elizabeth Prelogar, the physicians opposing the changes have not prescribed the medication and have not found an instance where a patient was required to undergo an abortion against their will after showing up at an emergency room with a continuing pregnancy. The court was informed of this in the documents submitted.
The attorneys of the medical organizations, represented by the Alliance Defending Freedom, contended that their clients are opposed not just to abortion, but also to participating in it.
The lawyers stated that for many years, the FDA has instructed women who have experienced harm from abortion drugs to go to emergency rooms. As a result, these women have sought treatment from the doctors involved. However, now that the FDA is being held responsible for the harm caused, they cannot argue that the treatment option they recommended is uncertain.
If the Supreme Court concurs with the Justice Department’s argument that the physicians lack sufficient grounds to file a lawsuit in a federal court, then the case would be dismissed without ruling on whether the FDA’s change of regulations for the use of mifepristone was lawful.
However, if the judges consider the legal matters brought up in the case, both the Department of Justice and Danco have encouraged the court to determine that the FDA’s actions in 2016 and 2021 were justified.
Prelogar stated that the agency considered a significant amount of medical evidence spanning many years when making the decision that the 2016 modifications to the use of mifepristone would be safe. She also noted that the district court was incorrect in questioning the FDA’s authority to make these determinations as granted by Congress.
According to the authorities, this particular instance represents the initial occurrence in which a court has hindered access to a FDA-approved medication by questioning the FDA’s professional assessment on the necessary conditions for ensuring the drug’s safety.Prelogar stated.
Both pharmaceutical companies and previous leaders of the FDA have expressed concerns to the court that upholding the 5th Circuit’s ruling could potentially weaken the agency’s procedure for approving drugs and result in ongoing legal disputes over its decisions.
A group of former FDA commissioners and acting commissioners argued that if the lower court’s approach is upheld, it would grant courts the power to replace the FDA’s scientific knowledge and nullify the agency’s approval and regulations for drugs, even if they have been on the market for many years. They expressed their concerns in a written statement to the court.
“They stated that the resulting lack of clarity could jeopardize the motivation for pharmaceutical companies to invest the necessary time and resources in developing new drugs. Ultimately, this could impede patients’ access to essential treatments that alleviate pain and save lives.”
Several pharmaceutical companies and executives emphasized the significance of the courts upholding the FDA’s scientific evaluations in order for drug companies to have confidence.
“According to a brief, if a court is able to reverse previous rulings in the future without following proper scientific procedures, the resulting uncertainty will pose significant risks and weaken the motivation for making investments, regardless of the specific drug in question. Ultimately, this will have a negative impact on patients.”
However, attorneys representing the medical organizations and their constituents who are against abortion have contended that the FDA did not provide a sufficient justification for its choice to remove the in-person dispensing mandate. They also criticized the studies that the agency used as the basis for its decision, citing significant issues with them.
The decision to remove the in-person visit requirement in 2021 was criticized by healthcare organizations for removing the chance to detect ectopic pregnancies and other health conditions. The associations also noted that the FDA made this change in 2016 without conducting sufficient studies on the overall impact of these alterations.
The organization Americans United for Life, who supports the Alliance for Hippocratic Medicine, stated that the FDA has supported the availability of abortion pills without proper medical oversight, resulting in higher health and safety hazards for women and disruptions to their healthcare.
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Source: cbsnews.com