Nearly seven months have passed since the decision in the U.S. Supreme Court case Dobbs v. Jackson Women’s Health Organization eliminated the federal right to abortion care. In a grim anniversary, Sunday also marks what would have been fifty years since the Roe v. Wade decision—but instead the day falls amid the first year without its protections.
As abortion access is increasingly restricted and even outright banned in many states, more attention is being placed on the promise of medication abortion care. Medication abortion is extremely safe and effective, and now makes up over half of all abortions in the United States. Despite the safety and popularity of medication abortion, however, unnecessary barriers to it still remain.
Since The Century Foundation’s 2021 report outlining the safety and efficacy of medication abortion care, and barriers to accessing it, key changes have been made to the regulations governing its dispensation—while during this same period the country’s landscape of abortion access has been decimated. This commentary will provide an update on access to medication abortion access post-Roe, and how to preserve and expand it.
FDA Takes a Step in the Right Direction
Earlier this month, the U.S. Food and Drug Administration (FDA) finalized its long-awaited changes to the onerous restrictions that regulate mifepristone, one of the two drugs used in the most common regimen for medication abortion care. These regulations, known as risk evaluation and mitigation strategy (REMS), are meant for drugs that pose serious safety concerns; yet they are applied to mifepristone, which, given its overwhelming safety, does not meet these criteria. Rather than eliminating the REMS restrictions entirely—a move that would be supported by decades of evidence of the drug’s safety—the FDA modified the regulations concerning dispensing mifepristone, but kept some burdensome requirements in place.
The primary change the FDA made allows for pharmacies (both mail-order and brick-and-mortar) to dispense the medication rather than mandating that health care providers stock and dispense the drug themselves, as was previously required. For the most part, this change allows mifepristone to be accessed similarly to most prescription drugs: patients will still need to obtain prescriptions, but will then be able to receive the medication directly from a pharmacy instead of from their prescribing provider. This is a welcome and crucial change; combined with last year’s decision to make permanent the pandemic-era allowance for telehealth provision of mifepristone, these REMS modifications represent progress toward increasing access to medication abortion care.
Patients will still need to obtain prescriptions, but will then be able to receive the medication directly from a pharmacy instead of from their prescribing provider.
Still, to make the medication abortion truly accessible, so much more is needed. In addition to maintaining burdensome requirements such as the patient agreement form, the REMS modifications also instituted a certification requirement for individual pharmacies, creating an unnecessary step that may limit access. The FDA is requiring this despite the fact that there is already ample evidence that mifepristone can be safely administered by pharmacies like any other prescription medication: Canada has been doing so since 2017 without any impact on the drug’s safety.
To be sure, the removal of physician-only dispensing requirements is an important step to increasing access to medication abortion care—but it also falls well short of both the evidence behind mifepristone’s safety and the severity of the abortion access crisis we now face.
Barriers Left in Place Impact More Than Abortion Care
In addition to altering the REMS for mifepristone, the FDA refused a request made through the citizen petition process, which allows individuals and organizations to ask for the agency to make changes to its policies. This petition, submitted by the American College of Obstetricians and Gynecologists on behalf of itself and nearly fifty other organizations, asked that the FDA work with one of mifepristone’s manufacturers to add miscarriage management to the drug’s label as one of its intended usages. The petition also requested that the FDA use discretion in enforcing the REMS to allow for treatment of miscarriage—as well as eliminating the REMS entirely. While the FDA’s decision was not an unexpected outcome, denying this request is a disappointing development for the health and wellbeing of people who will suffer pregnancy loss.
While mifepristone’s label does not currently include miscarriage as an indication, mifepristone in combination with misoprostol is the most effective drug regimen for miscarriage management. Yet, with the existing restrictions surrounding mifepristone, this treatment is rarely made available to patients.
Miscarriage is incredibly common: it is estimated that 10 percent to 15 percent of known pregnancies end in miscarriage, but the actual proportion for all pregnancies may be closer to half. In addition to potential health complications, miscarriage can have serious negative mental health impacts, particularly when it is not actively treated. This risk is higher for certain communities, including Black patients, who are also at greater risk of experiencing pregnancy loss due to the complex effects of systemic racism, discrimination in health care, and disparities in health care access.
Providing patients with their choice of treatment, including management with medication, can mitigate negative mental and physical health outcomes. Providing effective treatment for miscarriage both completes the pregnancy loss process more quickly and reduces the risk that later, unplanned interventions will be needed.
Every person experiencing pregnancy loss deserves access to the treatment of their choice. But despite the fact that mifepristone is part of the most effective medication regimen, the REMS restrictions severely limit its availability. Adding miscarriage management to the label of mifepristone is critical in expanding access to appropriate and timely pregnancy loss treatment.
Adding miscarriage management to the label of mifepristone is critical in expanding access to appropriate and timely pregnancy loss treatment.
Additionally, even beyond miscarriage management, many health conditions require treatment with medications that are also used for abortion care. Since the Dobbs decision and subsequent proliferation of abortion bans, access to this care has been jeopardized. Patients in need of treatment for chronic conditions—including autoimmune disorders and gastric ulcers—have already been denied necessary and often life-saving medication because of fear of criminalization.
Future Threats to Medication Abortion Access
Unfortunately, there is reason to believe that access to medication abortion care may become even more limited in the months to come. A lawsuit filed in Texas last November seeks to undo FDA’s approval of mifepristone entirely. The case argues that the agency exceeded their authority in their use of an accelerated process to approve the drug in 2000. The group that filed the suit, Alliance Defending Freedom (ADF), is an extremist Christian advocacy organization that has made its name in cases representing anti-abortion and anti-LGBQT interests and has long sought to reverse FDA’s approval of mifepristone (this is the same group that wrote the Mississippi law that led to the Dobbs decision overturning Roe v. Wade).
This lawsuit represents the latest attempt by organizations on the right to cherry-pick judges sympathetic to their causes, colloquially known as forum shopping. In the case of the Texas lawsuit, the judge is Trump-appointee Matthew Kacsmaryk, who previously represented the conservative legal advocacy group First Liberty Institution. Just last month he ruled—in an opinion riddled with legal errors—that the Title X federally funded family planning program can no longer provide contraception to Texas minors without parental consent. Forum shopping is made particularly easy for cases brought to this court, given that Judge Kacsmaryk automatically receives nearly every case filed there.
There is of course a wealth of data on both mifepristone’s safety—including that it is safer than medications like Tylenol and Viagra—as well as evidence of FDA’s adherence to appropriate protocols when it originally approved the drug over twenty years ago. The fact that this case has found a likely sympathetic judge in Kacsmaryk, however, means that the faulty basis of ADF’s claims may not matter.
Alarmingly, as part of this same lawsuit, ADF also requested revival of the 150-year old Comstock Act. Passed in 1873, this law banned the mailing of “obscene, lewd, and/or lascivious” materials, including contraceptives, abortifacients, sexual health information, and obscene literature. Although subsequent court cases removed the language on contraception, other portions of the antiquated law remain on the books. These provisions have remained unenforced, though, since the ruling in Roe v. Wade.
Fortunately, the federal government has already weighed in. The Department of Justice’s Office of Legal Counsel issued a comprehensive memo last month making clear that the Comstock Act does not prohibit the mailing of medication used for abortion care. And just this week, the FDA urged Judge Kacsmaryk to reject the lawsuit; the agency submitted a filing that made clear both that the suit’s claims have no basis and that reversing the drug’s approval would reduce abortion services and create risks for abortion seekers.
Despite the lack of credibility to ADF’s claims in their Texas lawsuit, the case could threaten the availability of medication abortion care—in the states where it is not already banned since the Dobbs decision. Of course, access to medication abortion care alone will never be sufficient; people seeking abortion care need access to the method of their choosing, and many need procedural care from an abortion facility. But with almost half of all states having banned abortion or being likely to do so, pregnant people in the United States cannot afford to have the most common form of abortion care made even more limited. The Biden–Harris administration has committed to restoring and safeguarding abortion access, and has made some key steps to do so. More can be done, though, and this includes eliminating the REMS restrictions entirely, and ensuring that access to mifepristone is not further decimated by anti-abortion extremists.
Tags: abortion access, roe v. wade, medication abortion
Roe Day without Roe Underscores Need to Safeguard Access to Medication Abortion Care
Nearly seven months have passed since the decision in the U.S. Supreme Court case Dobbs v. Jackson Women’s Health Organization eliminated the federal right to abortion care. In a grim anniversary, Sunday also marks what would have been fifty years since the Roe v. Wade decision—but instead the day falls amid the first year without its protections.
As abortion access is increasingly restricted and even outright banned in many states, more attention is being placed on the promise of medication abortion care. Medication abortion is extremely safe and effective, and now makes up over half of all abortions in the United States. Despite the safety and popularity of medication abortion, however, unnecessary barriers to it still remain.
Since The Century Foundation’s 2021 report outlining the safety and efficacy of medication abortion care, and barriers to accessing it, key changes have been made to the regulations governing its dispensation—while during this same period the country’s landscape of abortion access has been decimated. This commentary will provide an update on access to medication abortion access post-Roe, and how to preserve and expand it.
FDA Takes a Step in the Right Direction
Earlier this month, the U.S. Food and Drug Administration (FDA) finalized its long-awaited changes to the onerous restrictions that regulate mifepristone, one of the two drugs used in the most common regimen for medication abortion care. These regulations, known as risk evaluation and mitigation strategy (REMS), are meant for drugs that pose serious safety concerns; yet they are applied to mifepristone, which, given its overwhelming safety, does not meet these criteria. Rather than eliminating the REMS restrictions entirely—a move that would be supported by decades of evidence of the drug’s safety—the FDA modified the regulations concerning dispensing mifepristone, but kept some burdensome requirements in place.
The primary change the FDA made allows for pharmacies (both mail-order and brick-and-mortar) to dispense the medication rather than mandating that health care providers stock and dispense the drug themselves, as was previously required. For the most part, this change allows mifepristone to be accessed similarly to most prescription drugs: patients will still need to obtain prescriptions, but will then be able to receive the medication directly from a pharmacy instead of from their prescribing provider. This is a welcome and crucial change; combined with last year’s decision to make permanent the pandemic-era allowance for telehealth provision of mifepristone, these REMS modifications represent progress toward increasing access to medication abortion care.
Still, to make the medication abortion truly accessible, so much more is needed. In addition to maintaining burdensome requirements such as the patient agreement form, the REMS modifications also instituted a certification requirement for individual pharmacies, creating an unnecessary step that may limit access. The FDA is requiring this despite the fact that there is already ample evidence that mifepristone can be safely administered by pharmacies like any other prescription medication: Canada has been doing so since 2017 without any impact on the drug’s safety.
To be sure, the removal of physician-only dispensing requirements is an important step to increasing access to medication abortion care—but it also falls well short of both the evidence behind mifepristone’s safety and the severity of the abortion access crisis we now face.
Barriers Left in Place Impact More Than Abortion Care
In addition to altering the REMS for mifepristone, the FDA refused a request made through the citizen petition process, which allows individuals and organizations to ask for the agency to make changes to its policies. This petition, submitted by the American College of Obstetricians and Gynecologists on behalf of itself and nearly fifty other organizations, asked that the FDA work with one of mifepristone’s manufacturers to add miscarriage management to the drug’s label as one of its intended usages. The petition also requested that the FDA use discretion in enforcing the REMS to allow for treatment of miscarriage—as well as eliminating the REMS entirely. While the FDA’s decision was not an unexpected outcome, denying this request is a disappointing development for the health and wellbeing of people who will suffer pregnancy loss.
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While mifepristone’s label does not currently include miscarriage as an indication, mifepristone in combination with misoprostol is the most effective drug regimen for miscarriage management. Yet, with the existing restrictions surrounding mifepristone, this treatment is rarely made available to patients.
Miscarriage is incredibly common: it is estimated that 10 percent to 15 percent of known pregnancies end in miscarriage, but the actual proportion for all pregnancies may be closer to half. In addition to potential health complications, miscarriage can have serious negative mental health impacts, particularly when it is not actively treated. This risk is higher for certain communities, including Black patients, who are also at greater risk of experiencing pregnancy loss due to the complex effects of systemic racism, discrimination in health care, and disparities in health care access.
Providing patients with their choice of treatment, including management with medication, can mitigate negative mental and physical health outcomes. Providing effective treatment for miscarriage both completes the pregnancy loss process more quickly and reduces the risk that later, unplanned interventions will be needed.
Every person experiencing pregnancy loss deserves access to the treatment of their choice. But despite the fact that mifepristone is part of the most effective medication regimen, the REMS restrictions severely limit its availability. Adding miscarriage management to the label of mifepristone is critical in expanding access to appropriate and timely pregnancy loss treatment.
Additionally, even beyond miscarriage management, many health conditions require treatment with medications that are also used for abortion care. Since the Dobbs decision and subsequent proliferation of abortion bans, access to this care has been jeopardized. Patients in need of treatment for chronic conditions—including autoimmune disorders and gastric ulcers—have already been denied necessary and often life-saving medication because of fear of criminalization.
Future Threats to Medication Abortion Access
Unfortunately, there is reason to believe that access to medication abortion care may become even more limited in the months to come. A lawsuit filed in Texas last November seeks to undo FDA’s approval of mifepristone entirely. The case argues that the agency exceeded their authority in their use of an accelerated process to approve the drug in 2000. The group that filed the suit, Alliance Defending Freedom (ADF), is an extremist Christian advocacy organization that has made its name in cases representing anti-abortion and anti-LGBQT interests and has long sought to reverse FDA’s approval of mifepristone (this is the same group that wrote the Mississippi law that led to the Dobbs decision overturning Roe v. Wade).
This lawsuit represents the latest attempt by organizations on the right to cherry-pick judges sympathetic to their causes, colloquially known as forum shopping. In the case of the Texas lawsuit, the judge is Trump-appointee Matthew Kacsmaryk, who previously represented the conservative legal advocacy group First Liberty Institution. Just last month he ruled—in an opinion riddled with legal errors—that the Title X federally funded family planning program can no longer provide contraception to Texas minors without parental consent. Forum shopping is made particularly easy for cases brought to this court, given that Judge Kacsmaryk automatically receives nearly every case filed there.
There is of course a wealth of data on both mifepristone’s safety—including that it is safer than medications like Tylenol and Viagra—as well as evidence of FDA’s adherence to appropriate protocols when it originally approved the drug over twenty years ago. The fact that this case has found a likely sympathetic judge in Kacsmaryk, however, means that the faulty basis of ADF’s claims may not matter.
Alarmingly, as part of this same lawsuit, ADF also requested revival of the 150-year old Comstock Act. Passed in 1873, this law banned the mailing of “obscene, lewd, and/or lascivious” materials, including contraceptives, abortifacients, sexual health information, and obscene literature. Although subsequent court cases removed the language on contraception, other portions of the antiquated law remain on the books. These provisions have remained unenforced, though, since the ruling in Roe v. Wade.
Fortunately, the federal government has already weighed in. The Department of Justice’s Office of Legal Counsel issued a comprehensive memo last month making clear that the Comstock Act does not prohibit the mailing of medication used for abortion care. And just this week, the FDA urged Judge Kacsmaryk to reject the lawsuit; the agency submitted a filing that made clear both that the suit’s claims have no basis and that reversing the drug’s approval would reduce abortion services and create risks for abortion seekers.
Despite the lack of credibility to ADF’s claims in their Texas lawsuit, the case could threaten the availability of medication abortion care—in the states where it is not already banned since the Dobbs decision. Of course, access to medication abortion care alone will never be sufficient; people seeking abortion care need access to the method of their choosing, and many need procedural care from an abortion facility. But with almost half of all states having banned abortion or being likely to do so, pregnant people in the United States cannot afford to have the most common form of abortion care made even more limited. The Biden–Harris administration has committed to restoring and safeguarding abortion access, and has made some key steps to do so. More can be done, though, and this includes eliminating the REMS restrictions entirely, and ensuring that access to mifepristone is not further decimated by anti-abortion extremists.
Tags: abortion access, roe v. wade, medication abortion