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Reinstating in-person mifepristone administration requirements is harmful to patients and providers
In May 2020, the American College of Obstetricians and Gynecologists (ACOG), along with other organizations and physicians (Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, SisterSong Women of Color Reproductive Justice Collective, Honor MacNaughton, MD), filed a civil action against the US Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) challenging the requirements of in-person mifepristone dispensing, which was one of the 3 restrictions placed on the medicine as part of mifepristone’s risk evaluation and mitigation strategy (REMS). The requirements, which also include provider certification and patient signatures on specified consent forms, specifically target dosages of mifepristone for use related to abortions and miscarriages but do not apply when prescribing mifepristone for other medical conditions, even with higher doses. During the pandemic, the FDA suspended the REMS requirements for many other medications, including those more toxic than mifepristone. Additionally, the HHS activated a “telemedicine exception” that allows physicians to use telemedicine to satisfy mandatory requirements for prescribing controlled substances, including opioids, while minimizing the patient’s and provider’s risk of exposure to COVID-19 with in-person appointments. Notably, mifepristone for abortion and miscarriage management was excluded from this relaxation of the REMS requirement.
On July 13, 2020, a Federal District Court concluded that the in-person requirements were a “substantial obstacle” for women seeking abortions during the COVID-19 pandemic and granted a preliminary injunction to temporarily stop the FDA’s enforcement of the in-person requirements for mifepristone. We wrote about what that decision meant for ObGyns and urged clinicians to advocate to make the injunction permanent (OBG Manag. 2020;32(12):13-14, 23, 38. doi: 10.12788/obgm.0034.)
From there, however, the FDA worked to reverse that decision, which included applications to the District Court and to the Supreme Court for a stay of the injunction. If successful, this would suspend the injunction while the case was pending. In October, after the Supreme Court deferred review of the application (preferring a review by the lower courts), the District Court upheld the injunction of the in-person requirements citing the worsening pandemic crisis.
In-person requirement re-instated
On January 12, 2021, the United States Supreme Court granted the stay of the District Court’s injunction, which allowed the federal government to enforce the in-person requirement for mifepristone once again. The decision came down to a vote of 6 to 3. As is typical for decisions on stay orders, the court did not release a majority opinion explaining the reasoning behind this decision. In a concurring opinion, Chief Justice John Roberts wrote that the decision was not a judgment of if the requirements for in-person dispensing of mifepristone imposed an undue burden on women seeking an abortion. Instead, the Chief Justice explained that the decision came down to if a District Court could order the FDA to change their regulations based on “the court’s own evaluations of the COVID-19 pandemic,” maintaining that the court could not overrule “the politically accountable entities with the ‘background, competence, and expertise to assess public health.’”1 No other justices joined his opinion.
A worrisome pattern of a conservative supermajority
In her dissent, Justice Sonia Sotomayor criticized the government’s “statistically insignificant, cherry-picked data” and argued that the government did not provide any explanation from an FDA or HHS official explaining why mifepristone’s in-person requirement is more important than the in-person requirements of other drugs that have been waived during the pandemic.2 Therefore, she explained, there is “no reasoned decision” by any health official anywhere on which they can base the decision to grant the stay.
This ruling was the Supreme Court’s first major decision on reproductive health since the confirmation of Justice Amy Coney Barrett and may be an insight into future decisions of the new conservative supermajority on abortion and reproductive health issues. Particularly worrisome is what this decision could mean for stays in abortion cases that dictate whether or not the regulation is enforced during an active case. Even if cases are ruled in favor of patients and abortion providers, if the courts continue to allow enforcement of abortion restrictions during litigation, this could result in permanent closure of abortion clinics and prevent many individuals from accessing safe and legal abortion.
Looking toward the future
In the setting of almost 29 million cases of COVID-19 and more than 526,000 deaths, this stay order requires women seeking a medication abortion to make an appointment at a clinic, risking possible exposure to COVID-19, in order to access mifepristone.3,4 The Biden administration can and should remove the FDA requirement for in-person delivery of mifepristone, which would mitigate the effects of the stay order and allow women to obtain medication abortions during the pandemic.
Take action
- Contact your local ACLU (find them here) or lawyer in your area for assistance navigating the legal landscape to prescribe mifepristone after this stay order
- Minimize a patient’s wait time for mifepristone administration by blocking time in your weekly schedule for patients seeking abortion care
- Work with other providers and health care professionals in your area to submit petitions to the FDA
- FDA v American College of Obstetricians and Gynecologists, 592 US __ (2021)(Roberts, CJ, concurring).
- FDA v American College of Obstetricians and Gynecologists, 592 US __ (2021)(Sotomayor, J, dissenting).
- COVID data tracker. Centers for Disease Control and Prevention website. https://covid.cdc.gov/covid-data-tracker. Accessed March 9, 2021.
- Fulcer IR, Neill S, Bharadwa S, et al. State and federal abortion restrictions increase risk of COVID-19 exposure by mandating unnecessary clinic visits. Contraception. 2020;102:385-391.
In May 2020, the American College of Obstetricians and Gynecologists (ACOG), along with other organizations and physicians (Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, SisterSong Women of Color Reproductive Justice Collective, Honor MacNaughton, MD), filed a civil action against the US Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) challenging the requirements of in-person mifepristone dispensing, which was one of the 3 restrictions placed on the medicine as part of mifepristone’s risk evaluation and mitigation strategy (REMS). The requirements, which also include provider certification and patient signatures on specified consent forms, specifically target dosages of mifepristone for use related to abortions and miscarriages but do not apply when prescribing mifepristone for other medical conditions, even with higher doses. During the pandemic, the FDA suspended the REMS requirements for many other medications, including those more toxic than mifepristone. Additionally, the HHS activated a “telemedicine exception” that allows physicians to use telemedicine to satisfy mandatory requirements for prescribing controlled substances, including opioids, while minimizing the patient’s and provider’s risk of exposure to COVID-19 with in-person appointments. Notably, mifepristone for abortion and miscarriage management was excluded from this relaxation of the REMS requirement.
On July 13, 2020, a Federal District Court concluded that the in-person requirements were a “substantial obstacle” for women seeking abortions during the COVID-19 pandemic and granted a preliminary injunction to temporarily stop the FDA’s enforcement of the in-person requirements for mifepristone. We wrote about what that decision meant for ObGyns and urged clinicians to advocate to make the injunction permanent (OBG Manag. 2020;32(12):13-14, 23, 38. doi: 10.12788/obgm.0034.)
From there, however, the FDA worked to reverse that decision, which included applications to the District Court and to the Supreme Court for a stay of the injunction. If successful, this would suspend the injunction while the case was pending. In October, after the Supreme Court deferred review of the application (preferring a review by the lower courts), the District Court upheld the injunction of the in-person requirements citing the worsening pandemic crisis.
In-person requirement re-instated
On January 12, 2021, the United States Supreme Court granted the stay of the District Court’s injunction, which allowed the federal government to enforce the in-person requirement for mifepristone once again. The decision came down to a vote of 6 to 3. As is typical for decisions on stay orders, the court did not release a majority opinion explaining the reasoning behind this decision. In a concurring opinion, Chief Justice John Roberts wrote that the decision was not a judgment of if the requirements for in-person dispensing of mifepristone imposed an undue burden on women seeking an abortion. Instead, the Chief Justice explained that the decision came down to if a District Court could order the FDA to change their regulations based on “the court’s own evaluations of the COVID-19 pandemic,” maintaining that the court could not overrule “the politically accountable entities with the ‘background, competence, and expertise to assess public health.’”1 No other justices joined his opinion.
A worrisome pattern of a conservative supermajority
In her dissent, Justice Sonia Sotomayor criticized the government’s “statistically insignificant, cherry-picked data” and argued that the government did not provide any explanation from an FDA or HHS official explaining why mifepristone’s in-person requirement is more important than the in-person requirements of other drugs that have been waived during the pandemic.2 Therefore, she explained, there is “no reasoned decision” by any health official anywhere on which they can base the decision to grant the stay.
This ruling was the Supreme Court’s first major decision on reproductive health since the confirmation of Justice Amy Coney Barrett and may be an insight into future decisions of the new conservative supermajority on abortion and reproductive health issues. Particularly worrisome is what this decision could mean for stays in abortion cases that dictate whether or not the regulation is enforced during an active case. Even if cases are ruled in favor of patients and abortion providers, if the courts continue to allow enforcement of abortion restrictions during litigation, this could result in permanent closure of abortion clinics and prevent many individuals from accessing safe and legal abortion.
Looking toward the future
In the setting of almost 29 million cases of COVID-19 and more than 526,000 deaths, this stay order requires women seeking a medication abortion to make an appointment at a clinic, risking possible exposure to COVID-19, in order to access mifepristone.3,4 The Biden administration can and should remove the FDA requirement for in-person delivery of mifepristone, which would mitigate the effects of the stay order and allow women to obtain medication abortions during the pandemic.
Take action
- Contact your local ACLU (find them here) or lawyer in your area for assistance navigating the legal landscape to prescribe mifepristone after this stay order
- Minimize a patient’s wait time for mifepristone administration by blocking time in your weekly schedule for patients seeking abortion care
- Work with other providers and health care professionals in your area to submit petitions to the FDA
In May 2020, the American College of Obstetricians and Gynecologists (ACOG), along with other organizations and physicians (Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, SisterSong Women of Color Reproductive Justice Collective, Honor MacNaughton, MD), filed a civil action against the US Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) challenging the requirements of in-person mifepristone dispensing, which was one of the 3 restrictions placed on the medicine as part of mifepristone’s risk evaluation and mitigation strategy (REMS). The requirements, which also include provider certification and patient signatures on specified consent forms, specifically target dosages of mifepristone for use related to abortions and miscarriages but do not apply when prescribing mifepristone for other medical conditions, even with higher doses. During the pandemic, the FDA suspended the REMS requirements for many other medications, including those more toxic than mifepristone. Additionally, the HHS activated a “telemedicine exception” that allows physicians to use telemedicine to satisfy mandatory requirements for prescribing controlled substances, including opioids, while minimizing the patient’s and provider’s risk of exposure to COVID-19 with in-person appointments. Notably, mifepristone for abortion and miscarriage management was excluded from this relaxation of the REMS requirement.
On July 13, 2020, a Federal District Court concluded that the in-person requirements were a “substantial obstacle” for women seeking abortions during the COVID-19 pandemic and granted a preliminary injunction to temporarily stop the FDA’s enforcement of the in-person requirements for mifepristone. We wrote about what that decision meant for ObGyns and urged clinicians to advocate to make the injunction permanent (OBG Manag. 2020;32(12):13-14, 23, 38. doi: 10.12788/obgm.0034.)
From there, however, the FDA worked to reverse that decision, which included applications to the District Court and to the Supreme Court for a stay of the injunction. If successful, this would suspend the injunction while the case was pending. In October, after the Supreme Court deferred review of the application (preferring a review by the lower courts), the District Court upheld the injunction of the in-person requirements citing the worsening pandemic crisis.
In-person requirement re-instated
On January 12, 2021, the United States Supreme Court granted the stay of the District Court’s injunction, which allowed the federal government to enforce the in-person requirement for mifepristone once again. The decision came down to a vote of 6 to 3. As is typical for decisions on stay orders, the court did not release a majority opinion explaining the reasoning behind this decision. In a concurring opinion, Chief Justice John Roberts wrote that the decision was not a judgment of if the requirements for in-person dispensing of mifepristone imposed an undue burden on women seeking an abortion. Instead, the Chief Justice explained that the decision came down to if a District Court could order the FDA to change their regulations based on “the court’s own evaluations of the COVID-19 pandemic,” maintaining that the court could not overrule “the politically accountable entities with the ‘background, competence, and expertise to assess public health.’”1 No other justices joined his opinion.
A worrisome pattern of a conservative supermajority
In her dissent, Justice Sonia Sotomayor criticized the government’s “statistically insignificant, cherry-picked data” and argued that the government did not provide any explanation from an FDA or HHS official explaining why mifepristone’s in-person requirement is more important than the in-person requirements of other drugs that have been waived during the pandemic.2 Therefore, she explained, there is “no reasoned decision” by any health official anywhere on which they can base the decision to grant the stay.
This ruling was the Supreme Court’s first major decision on reproductive health since the confirmation of Justice Amy Coney Barrett and may be an insight into future decisions of the new conservative supermajority on abortion and reproductive health issues. Particularly worrisome is what this decision could mean for stays in abortion cases that dictate whether or not the regulation is enforced during an active case. Even if cases are ruled in favor of patients and abortion providers, if the courts continue to allow enforcement of abortion restrictions during litigation, this could result in permanent closure of abortion clinics and prevent many individuals from accessing safe and legal abortion.
Looking toward the future
In the setting of almost 29 million cases of COVID-19 and more than 526,000 deaths, this stay order requires women seeking a medication abortion to make an appointment at a clinic, risking possible exposure to COVID-19, in order to access mifepristone.3,4 The Biden administration can and should remove the FDA requirement for in-person delivery of mifepristone, which would mitigate the effects of the stay order and allow women to obtain medication abortions during the pandemic.
Take action
- Contact your local ACLU (find them here) or lawyer in your area for assistance navigating the legal landscape to prescribe mifepristone after this stay order
- Minimize a patient’s wait time for mifepristone administration by blocking time in your weekly schedule for patients seeking abortion care
- Work with other providers and health care professionals in your area to submit petitions to the FDA
- FDA v American College of Obstetricians and Gynecologists, 592 US __ (2021)(Roberts, CJ, concurring).
- FDA v American College of Obstetricians and Gynecologists, 592 US __ (2021)(Sotomayor, J, dissenting).
- COVID data tracker. Centers for Disease Control and Prevention website. https://covid.cdc.gov/covid-data-tracker. Accessed March 9, 2021.
- Fulcer IR, Neill S, Bharadwa S, et al. State and federal abortion restrictions increase risk of COVID-19 exposure by mandating unnecessary clinic visits. Contraception. 2020;102:385-391.
- FDA v American College of Obstetricians and Gynecologists, 592 US __ (2021)(Roberts, CJ, concurring).
- FDA v American College of Obstetricians and Gynecologists, 592 US __ (2021)(Sotomayor, J, dissenting).
- COVID data tracker. Centers for Disease Control and Prevention website. https://covid.cdc.gov/covid-data-tracker. Accessed March 9, 2021.
- Fulcer IR, Neill S, Bharadwa S, et al. State and federal abortion restrictions increase risk of COVID-19 exposure by mandating unnecessary clinic visits. Contraception. 2020;102:385-391.