July, 13 2020, 12:00am EDT
Federal Court Blocks FDA Restriction That Unnecessarily Imposes COVID-19 Risks on Patients Seeking Abortion Care
ACOG Led Coalition of Medical Experts and Reproductive Justice Advocates as Plaintiffs in the Lawsuit
WASHINGTON
A federal district court ruled today that the U.S. Food and Drug Administration (FDA) must temporarily suspend enforcement of a restriction on a medication used for early abortion that subjects patients to COVID-19 risks by forcing them to make an unnecessary trip to their health care provider just to pick up the medication and sign a form. The ruling comes in response to a lawsuit filed by the American Civil Liberties Union on behalf of a coalition of medical experts and reproductive justice advocates, led by the American College of Obstetricians and Gynecologists (ACOG).
At issue in this case is a restriction on an FDA-approved prescription drug, mifepristone, which is used in combination with another drug, misoprostol, to safely and effectively end early pregnancies and treat early miscarriage. Even during the pandemic, the FDA continued to require patients to travel to a hospital, clinic, or medical office to pick up the mifepristone, prohibiting patients who had already been evaluated by a clinician (using telehealth or at a prior in-person visit) from filling their mifepristone prescription by mail. The requirement imposes unnecessary COVID-19 risks and other burdens by forcing patients to travel to one of these clinical settings solely to pick up the medication and sign a form, even though, based on safety data, the FDA already permits patients to swallow the pill later at home.
The court issued a preliminary injunction today that blocks the FDA from enforcing this requirement when mifepristone is used for early abortion care, though the court did not suspend the restriction in cases where the medication is used as part of miscarriage treatment. The injunction will remain in place until at least 30 days after the end of the federal government's declared public health emergency, which the U.S. Department of Health and Human Services has indicated it intends to renew later this month.
The court's ruling is particularly important for communities of color and low-income communities, who make up the majority of impacted patients and who are suffering severe complications and dying from COVID-19 at disproportionately high rates.
"Today's decision means that the Trump administration can no longer force patients to incur unnecessary COVID-19 risks as the price of getting abortion care." said Julia Kaye, staff attorney at the ACLU Reproductive Freedom Project. "Like so many of the administration's actions, its refusal to suspend this irrational restriction during the pandemic -- despite urgent requests from the nation's leading medical authorities -- was particularly dangerous for people of color and low-income communities, who are disproportionately suffering severe harm from COVID-19. We look forward to a day when federal reproductive health care policy is grounded in science, not animus, and this medically baseless requirement is lifted once and for all."
The ruling comes after the FDA ignored requests from leading medical authorities, including ACOG, asking the agency to lift this restriction. By contrast, the FDA and other federal agencies have suspended in-person requirements for other medications during the pandemic. In addition to the plaintiffs in this case, which represent more than 60,000 obstetricians-gynecologists as well as the chairs of obstetrics and gynecology departments at nearly 150 universities, other leading medical groups, including the American Medical Association, filed a brief in support of plaintiffs' request to lift the restriction.
Of the more than 20,000 drug products the FDA regulates, the mifepristone product used to end an early pregnancy or provide miscarriage care is the only medication the FDA requires patients to pick up in-person even though they may self-administer it at home without clinical supervision. When used for purposes other than pregnancy termination, the FDA permits mifepristone to be mailed directly to a patient's home in higher doses and quantities.
The medical community has opposed these restrictions on mifepristone for years, as they have no medical basis. In addition to the case decided today, the ACLU has another case challenging a broader range of FDA restrictions on medication abortion care that was filed prior to the COVID-19 pandemic. More information on that challenge can be found here.
The following are statements from the plaintiffs in this case:
Eva Chalas, M.D., FACOG, FACS, president of ACOG:
"Suspending the REMS requirement for mifepristone for early pregnancy termination represents a necessary step forward in our collective work toward health equity during this unprecedented time of pandemic. Today's ruling represents a victory for patients, who should not have to face the additional burden of increased COVID-19 exposure as a condition of receiving their prescribed mifepristone. It also represents a victory for the dedicated clinicians who are working to provide needed care without unnecessary exposure of patients, their families and the members of the healthcare team, to the novel coronavirus. Nonetheless, we are disappointed that the injunction issued by the Court does not apply to women experiencing miscarriage and the clinicians treating them. We will continue our advocacy to seek removal of these restrictions during the pandemic."
Monica Simpson, executive director of SisterSong Women of Color Reproductive Justice Collective:
"The FDA's medically unjustified requirement has long stood in the way of communities of color getting the reproductive health care we need -- and now, during the pandemic, it is putting us at unnecessary risk for COVID-19. Today's ruling recognized the simple truth that people should not be forced to choose between getting the care they need and protecting their health. This Administration should stop spending its time trying to make it harder for people of color to get the medical care we need, and instead trust us to make our own reproductive decisions and remove barriers that violate or prohibit our human right to self-determination."
David Chelmow, M.D., president of the Council of University Chairs of Obstetrics and Gynecology:
"As Chairs of Ob-Gyn departments at medical schools and hospitals across the country, we know how critical it is for patients to get the care they need without making unnecessary trips to their medical providers. Today, science prevailed over politics and the federal court ruled that patients are now able to access early abortion care during the pandemic without unnecessary risk. We are disappointed that the Court did not grant the same access to patients needing mifepristone for miscarriage care. We ask the FDA to listen to the medical experts and lift these baseless restrictions once and for all."
Jason Matuszak, M.D., FAAFP, President of New York State Academy of Family Physicians:
"In New York, we learned early on how critical it is to avoid unnecessary travel. Yet the FDA has insisted, with no medical justification, on requiring patients to come in person to a physician's office just to pick up a pill they are already permitted to self-administer at home. We are grateful that, as a result of today's ruling, medication abortion patients will no longer have to expose themselves to unnecessary medical risk just to get the care they need."
The American Civil Liberties Union was founded in 1920 and is our nation's guardian of liberty. The ACLU works in the courts, legislatures and communities to defend and preserve the individual rights and liberties guaranteed to all people in this country by the Constitution and laws of the United States.
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'All States Will Be Impacted' by US Supreme Court's Idaho Abortion Case
"At its core, this Supreme Court decision will reflect who we are becoming as a society."
Apr 24, 2024
Less than a month after a key abortion pill hearing, the right-wing U.S. Supreme Court on Wednesday heard arguments for another major reproductive rights case—one out of Idaho that could impact healthcare for pregnant women and people across the country.
Idaho is among the over 20 states that have tightened restrictions on abortion since the high court's right-wing majority reversedRoe v. Wade nearly two years ago with Dobbs v. Jackson Women's Health Organization. Since August 2022, abortions have been banned in the state except for reported cases of rape or incest or when "necessary to prevent the death" of the pregnant person.
"If the court does not uphold emergency abortion care protections, this ruling will have devastating consequences for pregnant people."
Before Idaho's near-total ban on abortion took effect, U.S. District Judge B. Lynn Winmill barred enforcement of it to the extent that it conflicts with the Emergency Medical Treatment and Labor Act (EMTALA), a 1986 federal law requiring emergency departments that accept Medicare to provide "necessary stabilizing treatment" to any patient with an emergency medical condition.
The Biden administration argues that such care includes abortion; Idaho's Republican policymakers—backed by the far-right Christian Alliance Defending Freedom—disagree. The U.S. Supreme Court in January paused Winmill's order and agreed to hear arguments in Moyle v. United States and Idaho v. United States.
As The New York Timesreported Wednesday:
In a lively argument, questions by the justices suggested a divide along ideological lines, as well as a possible split by gender on the court. Justice Amy Coney Barrett, a conservative, appeared skeptical that Idaho's law, which bars doctors from providing abortions unless a woman's life is in danger or in specific nonviable pregnancies, superseded the federal law.
The argument also raised a broader question about whether some of the conservative justices, particularly Justice Samuel A. Alito Jr., may be prepared to embrace language of fetal personhood, that is, the notion that a fetus would have the same rights as a pregnant woman.
Also noting Barrett's apparent alignment with the three liberal women on the court, Law Dork's Chris Geidner predicted "it comes down to" Chief Justice John Roberts and fellow right-winger Brett Kavanaugh.
"Already, we see women miscarrying and giving birth to stillborn infants in restrooms and in their cars after hospitals have turned them away, and medical professionals put in impossible positions by extremist lawmakers," said MomsRising executive director and CEO Kristin Rowe-Finkbeiner, citing Associated Pressreporting from last week.
"Of all the horrors SCOTUS unleashed with its appalling, dangerous, massively unpopular ruling overturning Roe v. Wade, the threat that pregnant people—most of whom are moms—will be denied emergency medical care is among the worst," she asserted. "An adverse ruling in this case will mean emergency rooms can deny urgently needed care to people experiencing serious pregnancy complications that can destroy their health, end their fertility, and take their lives."
Alexa Kolbi-Molinas, deputy director of the ACLU Reproductive Freedom Project, similarly stressed that under a decision that favors the Idaho GOP, "pregnant people will suffer severe, life-altering health consequences, and even death."
"We're already seeing the devastating impact of this case play out in Idaho, where medical evacuations to transport patients to other states for the care they need have dramatically spiked since the Supreme Court allowed state politicians to block emergency abortion care," she noted.
The has also been an exodus of healthcare providers. Pointing out that those who violate Idaho's ban face five years in prison, The Guardianreported Wednesday that "between 2022, when Roe was overturned, and 2023, about 50 OB-GYNs moved out of the state."
As Republican lawmakers in various states have ramped up attacks on reproductive freedom since Dobbs, states that still allow abortions have seen an influx of "healthcare refugees." A Planned Parenthood spokesperson confirmed in January that about 30% of its abortion patients in Nevada—which borders Idaho—are from other states.
"With several of Nevada's bordering states enforcing abortion bans, pushing many people seeking care to our state, we've seen firsthand the devastation that anti-abortion policies are already wreaking,"
Reproductive Freedom for All director of Nevada campaigns Denise Lopez said Tuesday. "The Supreme Court must not allow us to spiral further into this healthcare crisis."
If the high court rules in favor of Idaho's Republican lawmakers, she warned, "all states will be impacted, even in places like Nevada with more than 4 in 5 voters supporting reproductive freedom."
Destiny Lopez, acting co-CEO of the Guttmacher Institute, declared that "at its core, this Supreme Court decision will reflect who we are becoming as a society: Are we okay with requiring pregnant individuals who face severe complications to suffer life-threatening health consequences rather than granting them access to abortion? Are we okay with forcing doctors to choose between violating federal law by not providing emergency abortion care or violating state law if they do?"
"If the court does not uphold emergency abortion care protections, this ruling will have devastating consequences for pregnant people—particularly Black and Brown folks, immigrants, people with lower incomes, those without health insurance, and LGBTQ+ communities—while further emboldening extremists," she emphasized.
Arguments in the case have sparked multiple demonstrations, from a weekend rally in Boise, Idaho to a Wednesday gathering outside the U.S. Supreme Court in Washington, D.C., where Women's March organized a die-in to highlight the potential consequences of the forthcoming ruling.
"It's a horrifying time to be someone who needs critical abortion care in America right now," said Women's March executive director Rachel O'Leary Carmona. "The GOP is chipping away at women's bodily autonomy and livelihoods one illegitimate court case at a time—from fast-tracking a case on the authorization of a medication that's been safely administered for decades last month, to now bringing the fate of emergency abortion care to a Supreme Court captured by their radical, anti-choice agenda."
"We know what these cases really are: They're part of a series of efforts by Christian nationalist politicians to do anything they can to control women's bodies and cut back women's decisions about their healthcare, their family planning, and their lives," she added.
Similar warnings about far-right Christian nationalist attacks on a range of rights have dominated political contests this cycle—including the race for the White House. In November, Democratic President Joe Biden, who supports access to abortion care, is set to face former Republican President Donald Trump, who brags about appointing three of the six justices who reversed Roe.
The case has renewed arguments for considering changes to the country's top court, which over the past few years has not only seen plummeting levels of public trust but also been rocked by repeated ethics scandals.
"Idaho's abortion ban is a direct consequence of the court's radical decision to overturn Roe v. Wade and allow partisan state legislatures to determine Americans' access to abortion care," said Stand Up America managing director of policy and political affairs Brett Edkins. "If the Supreme Court once again sides with anti-abortion extremists, it will be further proof that this court is radically out of touch with the American people and must be reformed."
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Biden Signs TikTok Ban—Among the 'Stupidest and Most Authoritarian' Tech Bills
One critic said that "the bill doesn't touch the homegrown spyware U.S. companies churn out" and "also strikes at the First Amendment right to receive information."
Apr 24, 2024
Digital rights defenders on Wednesday slammed the passage of a U.S. foreign aid package containing a possible nationwide TikTok ban as unconstitutional, xenophobic, and ill-advised during an election year in which President Joe Biden desperately needs as many young votes as possible.
Biden signed the $95 billion bill late Wednesday morning after senators voted 79-18 the previous evening to approve the package, which includes tens of billions of dollars in U.S. military assistance for Ukraine, Taiwan, and Israel—which is waging a genocidal war against Palestinians in Gaza.
One of the bill's provisions would force ByteDance, TikTok's Chinese parent company, to sell the app to a non-Chinese company within a year or face a federal ban. Approximately 170 million Americans use TikTok, which is especially popular among members of Gen-Z and small-to-medium-sized businesses, and contributes tens of billions of dollars to the U.S. economy annually.
"Whether it's dressed up as a ban or a forced sale, the bill targeting TikTok is one of the stupidest and most authoritarian pieces of tech legislation we've seen in years," Fight for the Future director Evan Greer said in a statement.
Jenna Leventoff, senior policy counsel at the ACLU, called the provision "nothing more than an unconstitutional ban in disguise."
"Banning a social media platform that hundreds of millions of Americans use to express themselves would have devastating consequences for all of our First Amendment rights, and will almost certainly be struck down in court," she added.
Jameel Jaffer, executive director of the Knight First Amendment Institute at Columbia University, said:
The First Amendment means that the government can't restrict Americans' access to ideas, information, or media from abroad without a very good reason for it—and no such reason exists here. Repackaging the government's reasons for the ban in the language of "national security" does not change the analysis. There's no national security exception to the First Amendment, and creating such an exception would make the First Amendment a dead letter.
Proponents of the possible ban attempted to spin it as something else and pointed to precedents including the 2020 forced sale of the popular LGBTQ+ dating app Grindr, formerly owned by a Chinese company.
"I want to be very clear: This is not a 'TikTok ban,'" Sen. John Fetterman (D-Pa.), who voted to approve the bill, said in a statement. "I have no interest in banning TikTok. This bill will simply make TikTok safer by separating it from the Chinese Communist Party so that the data of 170 million Americans—many of whom are children—is protected."
Senate Commerce Committee Chair Maria Cantwell (D-Wash.) said before Tuesday's vote that "Congress is acting to prevent foreign adversaries from conducting espionage, surveillance, maligned operations, harming vulnerable Americans, our servicemen and women, and our U.S. government personnel."
"Banning TikTok without passing real tech regulation will just further entrench monopolies like Meta and Google, without doing anything to protect Americans from data harvesting or government propaganda."
However, Kate Ruane, who directs the Center for Democracy & Technology's Free Expression Project, asserted that "Congress shouldn't be in the business of banning platforms. They should be working to enact comprehensive privacy legislation that protects our private data no matter where we choose to engage online."
Greer said that "not only is this bill laughably unconstitutional and a blatant assault on free expression and human rights, it's also a perfect way to derail momentum toward more meaningful policies like privacy and antitrust legislation that would actually address the harms of Big Tech and surveillance capitalism."
Greer continued:
Banning TikTok without passing real tech regulation will just further entrench monopolies like Meta and Google, without doing anything to protect Americans from data harvesting or government propaganda.
We could be months away from another Trump administration, and top Democrats are busy expanding mass surveillance authority and setting the precedent that the government can ban an entire social media app based on vague 'national security' concerns that haven't been explained to the public.
Some critics questioned the wisdom of Biden signing off on a potential ban of the most popular social media app among many young users during an election year in which many younger voters are disappointed in the president's record on climate, student debt relief, the Gaza genocide, and more.
One user of X, the social platform formerly known as Twitter, said earlier this year that signing the bill would demonstrate a "comical level of political malpractice, the equivalent of seeing the rake on the ground and purposefully stepping on it."
Moments after Biden signed the bill, TikTok CEO Shou Zi Chew
vowed, "We aren't going anywhere."
"The facts and the Constitution are on our side and we expect to prevail again," he said, referring to the three times when federal judges blocked efforts to ban TikTok.
TikTok CEO Shou Chew responds to the bill that could ban the app: “Make no mistake, this is a ban, a ban of TikTok and a ban on you and your voice.”
“Rest assured, we aren’t going anywhere.”
pic.twitter.com/qElI8JvY0D
— philip lewis (@Phil_Lewis_) April 24, 2024
In the most recent case, U.S. District Court Judge Donald Molloy ruled last December that a Montana law that would have banned the app "violates the Constitution in more ways than one" and had a "pervasive undertone of anti-Chinese sentiment."
It is unclear who would buy TikTok. Analysts estimate the platform is worth upward of $100 billion, placing it out of reach for all but the biggest U.S. tech titans and, ironically, setting up possible antitrust challenges from the very administration that ultimately forced the sale.
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Israel's War on Gaza Has Helped Fuel 'Near Breakdown of International Law': Amnesty
"What we saw in 2023 confirms that many powerful states are abandoning the founding values of humanity and universality enshrined in the Universal Declaration of Human Rights," Amnesty's secretary-general said.
Apr 24, 2024
Government aggression and the rise of Big Tech are threatening the rules-based international order and global human rights, Amnesty International warned in its annual State of the World's Human Rights report, released Wednesday.
The organization expressed particular alarm over Israel's war on Gaza and the inability or unwillingness of its allies to rein in the government of Prime Minister Benjamin Netanyahu from bombing civilian populations, displacing more than 1.9 million people, and restricting the flow of aid into the besieged Gaza Strip. This and other conflicts, such as Russia's invasion of Ukraine, had led to a "near breakdown of international law," Amnesty said.
"For millions the world over, Gaza now symbolizes utter moral failure by many of the architects of the post-World War Two system; their failure to uphold the absolute commitment to universality, our common humanity, and to our 'never again' commitment," Amnesty International's secretary-general Agnès Callamard wrote in the preface to the report.
"One country, one government is allowed to annihilate international law, to put its middle finger in the eye of international law."
Amnesty wrote that Israel had made a "mockery" of some of the key tenants of international humanitarian law such as proportionality and distinction by targeting civilization populations and infrastructure such as refugee camps, hospitals, bakeries, and United Nations schools. As of the end of 2023, Israel had killed 21,600 Palestinians, a third of them children. At present, the death toll has surpassed 34,200, though that is likely an undercount as many remain buried beneath rubble.
Amnesty International researcher Budour Hassan toldDeutsche Welle that it was "utterly disappointing" that "one country, one government is allowed to annihilate international law, to put its middle finger in the eye of international law, and go on as if nothing has happened, normalizing the abnormal, normalizing the atrocities that have been happening, so that the crime that was an atrocity two days ago would become normal."
Hassan said there were things that the international community could do to try to stop the violence, such as cutting off weapons sales to Israel and Palestinian armed groups.
"It's just that the international community has proven desperately unwilling and incapable of upholding these norms," Hassan added, saying that, by failing to act, it could be "signing a death sentence to the whole international order."
In particular, Amnesty criticized the U.S. for spending months vetoing U.N. Security Council resolutions calling for a cease-fire, as well as European Union countries like Germany and the U.K. that called out their opponents' human rights abuses but continued to back Israel.
"What we saw in 2023 confirms that many powerful states are abandoning the founding values of humanity and universality enshrined in the Universal Declaration of Human Rights,” Callamard said.
In addition to Israel and its Western allies, Amnesty also pointed to Russia and its ongoing invasion of Ukraine, as well as China's human rights abuses against the Uyghur and financial backing of the Myanmar military, which killed at least 1,000 civilians in 2023.
"We have here three very large countries, superpowers in many ways, sitting on the Security Council that have emptied out the Security Council of its potentials, and that have emptied out international law of its ability to protect people," Callamard toldThe Associated Press of the U.S., Russia, and China.
In addition to state actors, Amnesty International sounded the alarm about the growing power of large technology companies, and, in particular, the rollout of artificial intelligence. The human rights group said that both new and existing technologies were making it easier for governments to target vulnerable groups like women, minorities, and members of the LGBTQ community. For example, the New York City Police Department informed Amnesty that it used facial recognition technology to keep tabs on Black Lives Matter activists, while Israel used it in the West Bank to help control Palestinian movement. The organization warned of how under-regulated technologies could exacerbate the scapegoating of marginalized groups as many countries hold elections in 2024.
"Big Tech's surveillance business model is pouring fuel on this fire of hate, enabling those with malintent to hound, dehumanize, and amplify dangerous narratives to consolidate power or polling," Callarmard said. "It's a chilling specter of what's to come as technological advances rapaciously outpace accountability."
Callarmard called for reforms to the U.N. Security Council so that no country could use its veto power to obstruct action and for better governmental regulation of developing technologies.
The silver lining is that ordinary people around the world continue to demonstrate for human rights, both their own and others. Amnesty cited the international movement for a cease-fire in Gaza; abortion rights protests in the U.S., El Salvador, and Poland; and the Fridays for Future youth movement to phase out fossil fuels and address the climate emergency.
"People have made it abundantly clear that they want human rights; the onus is on governments to show that they are listening," Callamard said.
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