Friday night, a federal judge in Texas issued a devastating ruling in abortion access—one which attempts to ban mifepristone (part of the most common regimen for medication abortion care) from the market nationwide. Almost immediately after, a federal judge in Washington issued a contradictory order, barring the Food and Drug Administration (FDA) from changing the status quo in mifepristone’s availability (although, notably, this order applies only to the seventeen states and DC who are plaintiffs in the suit). These two rulings mean a lot of questions remain—and litigation is not yet over. This commentary highlights five of the main takeaways as they stand now.
First and foremost, though, it is critical to remember that mifepristone is still available: the decision attempting to eliminate its approval is not in effect, as the judge stayed his own ruling until this coming Friday. Individuals seeking abortion can find the current status of laws in their state here.
1. The ruling out of Texas is based in politics, not science.
The plaintiff in this first case, Alliance for Hippocratic Medicine, is actually composed of a number of anti-abortion groups who incorporated shortly before filing the suit in federal court in Amarillo, Texas; they are represented by Alliance Defending Freedom (ADF), an extremist Christian advocacy group known for their anti-abortion and anti-LGBT interests. Their claim is that the FDA overstepped their authority in the original approval of mifepristone over twenty years ago. The lawsuit hinges on this and other false claims about the risks of mifepristone. Yet, as we know from decades of evidence, that mifepristone and medication abortion care in general is incredibly safe, and it has been well-established that the FDA followed appropriate protocols in its process to approve mifepristone.
Yet, as we know from decades of evidence, that mifepristone and medication abortion care in general is incredibly safe, and it has been well-established that the FDA followed appropriate protocols in its process to approve mifepristone.
The evidence base of mifepristone’s safety was just reaffirmed in 2021, when the FDA made the decision to loosen the risk evaluation and mitigation strategy (REMS) that governs its administration. Although evidence supports a full removal of the REMS entirely—these restrictions are meant for dangerous medications, a criterion not met by mifepristone—these recent changes marked a step in the right direction. One key change was the permanent removal of in-person dispensation requirements, which had been temporarily lifted during the COVID-19 Public Health Emergency. Research since the implementation of telehealth provision of medication abortion care has demonstrated that it is just as safe as in-person care and that the mailing of the pills does not delay care.
The ruling to remove mifepristone’s approval goes beyond ignoring the evidence base that demonstrates the safety of abortion. It relies on dangerous anti-abortion rhetoric that, alarmingly, gives a nod to the notion of so-called “fetal personhood.” The sixty-seven-page order from notoriously anti-abortion Judge Kacsmaryk cites debunked claims and attempts to give legitimacy to some of the most extreme views of the movement. It even attempts to revive the long dormant Comstock Act, a 150-year-old anti-obscenity law, which could have disastrous impacts on wider abortion access.
2. If mifepristone’s approval is rescinded, the impact will be widespread—and disproportionately felt.
Unlike the state bans that have proliferated since Dobbs, this decision has the potential to impact abortion seekers nationwide—even in states generally considered “friendly” to abortion rights. That does not mean, though, that all communities will feel the effects equally. As with all restrictions and bans on abortion, marginalized groups will bear the brunt of the effects. People living on low incomes, young people, immigrants, and Black and indigenous and other people of color already face additional barriers to accessing care, and this will be compounded if access is further limited by this ruling. Rural areas and states with few brick-and-mortar abortion providers will be hit particularly hard if the ruling is enacted and mifepristone is removed from the market. In addition, in a state like Georgia, where abortion is banned after six weeks, reduced access to medication abortion care would make it even harder for patients to get care in that limited window.
Unlike the state bans that have proliferated since Dobbs, this decision has the potential to impact abortion seekers nationwide—even in states generally considered “friendly” to abortion rights.
Even in communities where in-person abortion care is available, clinics will not be able to meet an increased demand, on top of the influx of patients already experienced post-Dobbs. Many clinics provide procedural abortion care only on certain days of the week (with many providers traveling between clinics—or even states) due to a shortage of abortion providers nationwide. Regardless of its availability (which is far from guaranteed), individuals who choose medication abortion over procedural care do so for a range of reasons, and deserve access to the method of their choice.
3. Mifepristone is not the only option for medication abortion.
Mifepristone, though, is only one of two drugs used most commonly in medication abortion care in the United States. The other drug used in the FDA-approved protocol, misoprostol, is far less restricted; rather than being indicated for medication abortion, it is prescribed for the treatment and prevention of gastric ulcers. It is prescribed off-label (a legal and common practice in medicine in which medications are prescribed for something other than their narrow FDA-approved use) for other uses, including medication abortion care and miscarriage management.
Misoprostol can also be used alone, without mifepristone, for medication abortion care. In fact, in most parts of the world, where (the more costly and highly regulated) mifepristone is often unavailable, misoprostol alone is the standard—and it’s safe and effective. Misoprostol-only regimens have been well-studied for years in the international context, and a recent study has provided insight into outcomes in the United States as well. Research on self-managed abortion using misoprostol alone, in June 2020, found a high rate of effectiveness and a low rate of serious adverse events.
Providers are already preparing for a switch to a misoprostol-only regimen. But this won’t be possible everywhere: in Ohio, a 2011 law requiring adherence to the FDA-approved protocol will prohibit clinics from offering misoprostol alone.
Despite the safety of misoprostol-only abortion care, there is no reason—and no excuse—for prohibiting the use of mifepristone. Currently, over 98 percent of medication abortions in the U.S. are done using a combination of mifepristone and misoprostol—and one judge in Texas should not be able to eliminate access to that standard of care.
4. The independence of the FDA is being threatened by judicial “forum shopping.”
Beyond the disastrous implications for abortion care, this ruling signals an even broader crisis: if the FDA’s scientists and experts can be overruled in court, other safe and necessary medications could be in jeopardy. Although the immediate impact—and focus—will be on mifepristone, the enactment of the Texas ruling would set a dangerous precedent.
Even further, the case sheds light on an alarming exploitation of the workings of federal court. The only reason the plaintiffs were able to obtain this ruling was because of an extreme example of forum shopping: cherry picking not only a jurisdiction but a specific judge known to be hostile to reproductive health and rights. Since nearly all cases filed in this division are received by Judge Kacsmaryk, ADF (with its dark money backing) was able to bring a case without legitimate merit, knowing it was likely to be ruled in their favor. This alarming tactic has already seen wins from conservative extremists seeking to block minors’ access to family planning services.
5. With conflicting rulings, what’s next for mifepristone?
The Department of Justice has already announced its appeal of the ruling in AHM vs. FDA, which will take the case to the Fifth Circuit—an appellate court known to be hostile to abortion rights.
But the ruling out of Texas was not the only decision to be issued this past Friday. Democratic attorneys general had also filed a case in federal court in Washington State challenging the FDA’s application of the REMS restrictions as unnecessary. The ruling, released Friday night, directly contradicts that of Kacsmaryk by ordering the FDA to maintain the status quo in the approval of mifepristone. With both of these conflicting orders, the Supreme Court may decide to review the cases together if they reach the highest court.
Even if the order undoing mifepristone’s removal is allowed to go into effect, though, the next steps for mifepristone itself are not entirely clear—because this is an entirely unprecedented move. Never before has a court ruled to take an FDA-approved medication off the market after decades of use. There has been some speculation from experts about how the FDA could use its discretion in enforcement, but how the agency will proceed remains to be seen.
Never before has a court ruled to take an FDA-approved medication off the market after decades of use.
Now more than ever, the Biden–Harris administration must build on its actions to safeguard abortion access and explore every possible avenue to expand access. Medication abortion care, both with mifepristone and with misoprostol alone, are safe and effective. No matter the courts’ rulings, people will continue to need and to have abortions—whether in clinics, via telehealth, or by self-managing—and our policies should support individuals in accessing care in the setting of their choosing.
Tags: abortion access, medication abortion, mifepristone
Five Key Takeaways on Mifepristone, after Two Competing Rulings
Friday night, a federal judge in Texas issued a devastating ruling in abortion access—one which attempts to ban mifepristone (part of the most common regimen for medication abortion care) from the market nationwide. Almost immediately after, a federal judge in Washington issued a contradictory order, barring the Food and Drug Administration (FDA) from changing the status quo in mifepristone’s availability (although, notably, this order applies only to the seventeen states and DC who are plaintiffs in the suit). These two rulings mean a lot of questions remain—and litigation is not yet over. This commentary highlights five of the main takeaways as they stand now.
First and foremost, though, it is critical to remember that mifepristone is still available: the decision attempting to eliminate its approval is not in effect, as the judge stayed his own ruling until this coming Friday. Individuals seeking abortion can find the current status of laws in their state here.
1. The ruling out of Texas is based in politics, not science.
The plaintiff in this first case, Alliance for Hippocratic Medicine, is actually composed of a number of anti-abortion groups who incorporated shortly before filing the suit in federal court in Amarillo, Texas; they are represented by Alliance Defending Freedom (ADF), an extremist Christian advocacy group known for their anti-abortion and anti-LGBT interests. Their claim is that the FDA overstepped their authority in the original approval of mifepristone over twenty years ago. The lawsuit hinges on this and other false claims about the risks of mifepristone. Yet, as we know from decades of evidence, that mifepristone and medication abortion care in general is incredibly safe, and it has been well-established that the FDA followed appropriate protocols in its process to approve mifepristone.
The evidence base of mifepristone’s safety was just reaffirmed in 2021, when the FDA made the decision to loosen the risk evaluation and mitigation strategy (REMS) that governs its administration. Although evidence supports a full removal of the REMS entirely—these restrictions are meant for dangerous medications, a criterion not met by mifepristone—these recent changes marked a step in the right direction. One key change was the permanent removal of in-person dispensation requirements, which had been temporarily lifted during the COVID-19 Public Health Emergency. Research since the implementation of telehealth provision of medication abortion care has demonstrated that it is just as safe as in-person care and that the mailing of the pills does not delay care.
The ruling to remove mifepristone’s approval goes beyond ignoring the evidence base that demonstrates the safety of abortion. It relies on dangerous anti-abortion rhetoric that, alarmingly, gives a nod to the notion of so-called “fetal personhood.” The sixty-seven-page order from notoriously anti-abortion Judge Kacsmaryk cites debunked claims and attempts to give legitimacy to some of the most extreme views of the movement. It even attempts to revive the long dormant Comstock Act, a 150-year-old anti-obscenity law, which could have disastrous impacts on wider abortion access.
2. If mifepristone’s approval is rescinded, the impact will be widespread—and disproportionately felt.
Unlike the state bans that have proliferated since Dobbs, this decision has the potential to impact abortion seekers nationwide—even in states generally considered “friendly” to abortion rights. That does not mean, though, that all communities will feel the effects equally. As with all restrictions and bans on abortion, marginalized groups will bear the brunt of the effects. People living on low incomes, young people, immigrants, and Black and indigenous and other people of color already face additional barriers to accessing care, and this will be compounded if access is further limited by this ruling. Rural areas and states with few brick-and-mortar abortion providers will be hit particularly hard if the ruling is enacted and mifepristone is removed from the market. In addition, in a state like Georgia, where abortion is banned after six weeks, reduced access to medication abortion care would make it even harder for patients to get care in that limited window.
Even in communities where in-person abortion care is available, clinics will not be able to meet an increased demand, on top of the influx of patients already experienced post-Dobbs. Many clinics provide procedural abortion care only on certain days of the week (with many providers traveling between clinics—or even states) due to a shortage of abortion providers nationwide. Regardless of its availability (which is far from guaranteed), individuals who choose medication abortion over procedural care do so for a range of reasons, and deserve access to the method of their choice.
3. Mifepristone is not the only option for medication abortion.
Mifepristone, though, is only one of two drugs used most commonly in medication abortion care in the United States. The other drug used in the FDA-approved protocol, misoprostol, is far less restricted; rather than being indicated for medication abortion, it is prescribed for the treatment and prevention of gastric ulcers. It is prescribed off-label (a legal and common practice in medicine in which medications are prescribed for something other than their narrow FDA-approved use) for other uses, including medication abortion care and miscarriage management.
Misoprostol can also be used alone, without mifepristone, for medication abortion care. In fact, in most parts of the world, where (the more costly and highly regulated) mifepristone is often unavailable, misoprostol alone is the standard—and it’s safe and effective. Misoprostol-only regimens have been well-studied for years in the international context, and a recent study has provided insight into outcomes in the United States as well. Research on self-managed abortion using misoprostol alone, in June 2020, found a high rate of effectiveness and a low rate of serious adverse events.
Providers are already preparing for a switch to a misoprostol-only regimen. But this won’t be possible everywhere: in Ohio, a 2011 law requiring adherence to the FDA-approved protocol will prohibit clinics from offering misoprostol alone.
Despite the safety of misoprostol-only abortion care, there is no reason—and no excuse—for prohibiting the use of mifepristone. Currently, over 98 percent of medication abortions in the U.S. are done using a combination of mifepristone and misoprostol—and one judge in Texas should not be able to eliminate access to that standard of care.
4. The independence of the FDA is being threatened by judicial “forum shopping.”
Beyond the disastrous implications for abortion care, this ruling signals an even broader crisis: if the FDA’s scientists and experts can be overruled in court, other safe and necessary medications could be in jeopardy. Although the immediate impact—and focus—will be on mifepristone, the enactment of the Texas ruling would set a dangerous precedent.
Even further, the case sheds light on an alarming exploitation of the workings of federal court. The only reason the plaintiffs were able to obtain this ruling was because of an extreme example of forum shopping: cherry picking not only a jurisdiction but a specific judge known to be hostile to reproductive health and rights. Since nearly all cases filed in this division are received by Judge Kacsmaryk, ADF (with its dark money backing) was able to bring a case without legitimate merit, knowing it was likely to be ruled in their favor. This alarming tactic has already seen wins from conservative extremists seeking to block minors’ access to family planning services.
5. With conflicting rulings, what’s next for mifepristone?
The Department of Justice has already announced its appeal of the ruling in AHM vs. FDA, which will take the case to the Fifth Circuit—an appellate court known to be hostile to abortion rights.
But the ruling out of Texas was not the only decision to be issued this past Friday. Democratic attorneys general had also filed a case in federal court in Washington State challenging the FDA’s application of the REMS restrictions as unnecessary. The ruling, released Friday night, directly contradicts that of Kacsmaryk by ordering the FDA to maintain the status quo in the approval of mifepristone. With both of these conflicting orders, the Supreme Court may decide to review the cases together if they reach the highest court.
Even if the order undoing mifepristone’s removal is allowed to go into effect, though, the next steps for mifepristone itself are not entirely clear—because this is an entirely unprecedented move. Never before has a court ruled to take an FDA-approved medication off the market after decades of use. There has been some speculation from experts about how the FDA could use its discretion in enforcement, but how the agency will proceed remains to be seen.
Now more than ever, the Biden–Harris administration must build on its actions to safeguard abortion access and explore every possible avenue to expand access. Medication abortion care, both with mifepristone and with misoprostol alone, are safe and effective. No matter the courts’ rulings, people will continue to need and to have abortions—whether in clinics, via telehealth, or by self-managing—and our policies should support individuals in accessing care in the setting of their choosing.1
Notes
Tags: abortion access, medication abortion, mifepristone