This article was updated on January 23 at 12:08 p.m. PST.
“The FDA’s policy imposes an unnecessary, unjustifiable, irrational and undue burden on women seeking an abortion during the current pandemic,” says Justice Sotomayor in yesterday’s decision.
On Tuesday, six members of the Supreme Court granted a Trump administration request to reinstate an FDA rule requiring patients seeking medication abortion to make an unnecessary in-person visit to their health care provider just to pick up the medication and sign a form. Justices Sotomayor, Kagan and Breyer dissented from the Court’s decision and would have denied Trump’s request.
Justice Sotomayor joined by Justice Kagan wrote a scathing dissent, castigating the majority for callously forcing patients to expose themselves and others to COVID-19 for no medical benefit.
“The FDA’s policy imposes an unnecessary, unjustifiable, irrational and undue burden on women seeking an abortion during the current pandemic,” said Justice Sotomayor. She concluded by calling on the government—presumably the Biden-Harris administration—to reconsider this policy and, fittingly, cited Justice Ruth Bader Ginsburg:
“Maintaining the FDA’s in-person requirements for mifepristone during the pandemic not only treats abortion exceptionally, it imposes an unnecessary, irrational, and unjustifiable undue burden on women seeking to exercise their right to choose. One can only hope that the Government will reconsider and exhibit greater care and empathy for women seeking some measure of control over their health and reproductive lives in these unsettling times. See Gonzales, 550 U. S., at 172 (Ginsburg, J., dissenting) ‘[Women’s] ability to realize their full potential. . . is intimately connected to their ability to control their reproductive lives.’”
Justices Sotomayor, Kagan and Breyer join many in opposition of the majority decision—which places patients at needless risk and directly contradicts medical science, say experts.
“It is disgraceful and frankly frightening that instead of listening to expert medical and scientific consensus about the safety of medication abortion and the risks imposed by these unwarranted restrictions, the Supreme Court chose to listen to politicians with an anti-science, anti-abortion agenda,” says Dr. Jason Matuszak, president of New York State Academy of Family Physicians. “It’s past time for the FDA to eliminate these baseless restrictions—not only during the pandemic, but for good.”
The decision reverses a Maryland federal court ruling from last July that suspended an FDA requirement that patients make in-person visits to medical providers to get the abortion pill. U.S. District Court Judge Theodore Chuang ruled the FDA requirement of in-person visits during the pandemic imposed a “substantial obstacle” to abortion health care that is likely unconstitutional. Judge Chuang’s order had allowed doctors to mail mifepristone to their patients. Tuesday evening’s Supreme Court decision reversed Judge Chuang’s order.
“The Court’s ruling rejects science, compassion and decades of legal precedent in service of the Trump administration’s anti-abortion agenda,” says Julia Kaye, staff attorney at the ACLU Reproductive Freedom Project. “It is mind-boggling that the Trump administration’s top priority on its way out the door is to needlessly endanger even more people during this dark pandemic winter—and chilling that the Supreme Court allowed it. The Biden-Harris administration must right this wrong on day one and hold firm to its commitment to support both evidence-based regulations and reproductive freedom.”
Politically Motivated Restrictions on Abortion Pill Defy Science and Endanger Women
Approved by the FDA for use during the first 10 weeks of gestation, medication abortion uses two types of pills: mifepristone, which interrupts the flow of the hormone progesterone that sustains the pregnancy; and misoprostol, which causes contractions to expel the contents of the uterus. This combination of pills is 95 percent effective and is an extremely safe way to end an early pregnancy. In fact, medication abortion today accounts for over 60 percent of abortions in the first 10 weeks, according to the Guttmacher Institute.
Despite the safety of medication abortion, when the FDA approved the drug in 2000, it placed it in the Risk Evaluation and Mitigation Strategy (REMS) drug safety program. Under this restriction, the FDA prohibited retail pharmacies from stocking and distributing mifepristone, instead requiring doctors to register with the drug manufacturer and distribute the medication themselves in person to patients, who then take most of the pills at home.
Whereas the REMS program is meant to restrict dangerous drugs, mifepristone is in fact an extremely safe drug—six times safer than Viagra, which is not similarly restricted.
The Trump administration has suspended all kinds of in-person requirements for medications that are far less safe than mifepristone, including for opioid drugs like fentanyl and OxyContin, but they have appealed all the way to the Supreme Court—twice—to maintain the requirement of in-person visits to receive mifepristone. Requiring patients to travel to doctors—often traveling long distances to reach the nearest clinic—exposes them to needless COVID-19 risks relating to transportation, childcare, and other interpersonal contact.
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This FDA restriction—and Trump’s refusal to waive it during the pandemic—is based on politics, not medical evidence, says Dr. Eva Chalas, president of American College of Obstetricians and Gynecologists:
“Despite the administration’s claims, the facts in this case remain clear: Mifepristone is a safe, effective medication for termination of pregnancy, and its use should not expose patients or clinicians to added risk of COVID-19 infection. We are gravely disappointed that our members and their patients will now be faced with an unnecessary increase in risk of exposure to COVID-19 as the virus rages across the country. Access to reproductive health care should not come with a caveat.”
Abortion Pill Ruling Falls Particularly Hard on Minority and Low-Income Women
The ruling has particularly negative impacts on low-income people and people of color, who are more vulnerable to COVID-19, says Monica Simpson, executive director of SisterSong Women of Color Reproductive Justice Collective:
“With today’s ruling, the Supreme Court told people of color that unnecessary risk of exposure to a virus that is disproportionately killing our communities is a fair price to pay for access to abortion. Black, Brown and Indigenous folks should not have to endure yet another form of state violence while we are fighting for our lives in this pandemic. It’s up to the Biden-Harris administration to not only undo this damage they are inheriting, but also take bold affirmative action to advance reproductive justice.”
Sung Yeon Choimorrow, executive director of National Asian Pacific Women’s Forum, agrees: “Asian American and Pacific Islander women and other women of color are disproportionately harmed by restrictions on abortion, just as we have disproportionately suffered the health and economic effects of COVID-19. The Court’s decision to single out safe and effective abortion care for restrictions with no medical benefit has a direct cost to the AAPI community. Trump’s determination to pack judicial benches with ideological allies is having immediate negative consequences on our lives and our wellbeing.
“We hope that the Biden administration will move swiftly to lift these outdated restrictions permanently and expand access to this essential health care. People should be able to get the care and information they need to have an abortion on their own terms, whether that is at a clinic or in their home, and without fear of punishment,” says Choimorrow.
Sotomayor and Kagan Dissent
In dissent, Justice Sotomayor, joined by Justice Kagan, said the majority opinion was flagrantly wrong. They noted government policy allowing patients to access the health care they need from their homes because in-person health care during the COVID-19 pandemic poses a significant risk to patients’ health—“yet the government has refused that same grace to women seeking medication abortion,” wrote Sotomayor.
She continued, “Due to particularly severe health risks, vastly limited clinic options, and the 10-week window for obtaining a medication abortion, the FDA’s requirement that women obtain mifepristone in person during the COVID-19 pandemic places an unnecessary and undue burden on their right to abortion.”
And on top of that, many medical offices have closed or dramatically reduced their open hours during the pandemic, she noted.
Sotomayor argued that this policy particularly endangers minority and low-income populations, who are “more likely to live in intergenerational housing, so patients risk infecting not just themselves, but also elderly parents and grandparents,” making the in-person medical visit a significant deterrent for women to seeking medication abortion.
Sotomayor also noted the district court’s finding that the in-person visit requirement can cause women to miss the 10-week window for a medication abortion. Sotomayor condemned the majority’s response that women can just get a surgical abortion as “callous,” describing in detail this “far more invasive” procedure:
“Medication abortion involves taking two pills and the equivalent of an early miscarriage. When a woman undergoes surgical abortion, she requires local anesthesia and sometimes sedation, her cervix is stretched with dilating rods, a tube is inserted through her cervix into her uterus, and, depending on the particular procedure, various medical tools are used to remove fetal tissue from her uterus. On top of this, surgical abortions carry all the same (and likely greater) risks of exposure to COVID–19 as do medication abortion’s in-person requirements.”
Sotomayor sums up, “Together, patients’ health vulnerabilities, public transportation risks, susceptible older family members at home, and clinic closures and reduced services pose substantial, sometimes insurmountable, obstacles for women seeking medication abortions during the COVID–19 pandemic.”
Calls for Biden-Harris to Reverse Trump Policy and End FDA Restriction on Abortion Pill
As a practical matter, the Supreme Court ruling shuts down new online abortion clinics like Just the Pill in Minnesota and Choix in California, and blocks online pharmacies such as Honeybee Health and American Mail Order Pharmacy from shipping mifepristone to patients.
The Gynuity Health Project’s TelAbortion study that provides medication abortion via the mail as part of research exception to the FDA restriction will continue, but patients may face new barriers like ultrasounds and other tests that could require in-person visits to a medical clinic, said Tara Shochet, co-director of the TelAbortion Project. “The ruling means additional hurdles and barriers to accessing medical abortion and it means putting people health in jeopardy during a pandemic.”
Not everyone thinks that the FDA restriction requires doctors to hand the abortion pill to patients in-person. The organization Plan C, which advocates for medication abortion, argues that the FDA requires only that the clinician “distribute” the medication to their patients, which Plan C says they can do do by mail. Most advocates and doctors, however, believe that an in-person visit is required.
The Biden-Harris administration could in the coming weeks issue guidance lifting the mifepristone in-person requirement during the COVID-19 public health emergency, as the government has with many other medications during the pandemic. Medical professionals and activists are now calling for the Biden administration to to do just that, and to go farther: End the FDA restriction on the abortion pill altogether.
“I urge the next administration to follow the science and lift these onerous and outdated requirements,” says Dr. Daniel Grossman director of Advancing New Standards in Reproductive Health. “This Supreme Court ruling puts people’s health and lives at risk. There is no reason during a pandemic to require patients seeking medication abortion care to be seen in person when telemedicine is equally safe and effective. There is no benefit to patients receiving the medications in person—especially given the fact that the FDA allows them to take the pills at home.”
Kirsten Moore, director of the Expanding Medication Abortion Access Project, agrees. “All eyes now turn to the Biden-Harris administration. We urge them to direct the FDA to follow the science and immediately lift these restrictions during the pandemic and conduct a full review of the REMS. Twenty years of science and experience tell us that it shouldn’t be this hard to get medication abortion care.”
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