May, 27 2020, 12:00am EDT
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New Lawsuit Challenges FDA Restriction That Imposes Life-Threatening Risks on Patients Seeking Abortion and Miscarriage Care
ACLU, leading medical experts and reproductive justice advocates ask court to block FDA restriction that subjects patients and clinicians to needless COVID-19 risk.
WASHINGTON
The American Civil Liberties Union (ACLU) filed a lawsuit today on behalf of a coalition of medical experts led by the American College of Obstetricians and Gynecologists (ACOG). The legal action challenges a U.S. Food and Drug Administration (FDA) rule that subjects patients to unnecessary COVID-19 risks as a condition of receiving a medication used for early abortion and miscarriage treatment.
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. Specifically, the FDA requires patients to travel to a hospital, clinic, or medical office to pick up the mifepristone. Because of this restriction, patients who have already been evaluated by a clinician (using telehealth or at a prior in-person visit) cannot fill their mifepristone prescription by mail. Instead, they must incur unnecessary COVID-19 risk and travel to one of these clinical settings to pick up the pill -- even when they will be receiving no in-person medical services at that time and will swallow the pill later at home (as the FDA permits).
"At every other turn during this pandemic, the federal government is trying to make it easier for patients to get the medical care they need without unnecessary health care visits that jeopardize their safety," said Julia Kaye, staff attorney at the ACLU Reproductive Freedom Project. "But when it comes to patients who need to end an early pregnancy or treat a miscarriage, the administration is forcing them to travel to a hospital, clinic, or medical office just to pick up a pill they are already permitted to swallow later at home. This administration apparently would rather subject patients and clinicians to life-threatening medical risks than lift an unnecessary barrier to abortion care."
For years, the medical community has opposed these restrictions on mifepristone as they have no medical basis or patient safety benefit. Despite months of petitioning from leading medical authorities, including the ACOG, the FDA has refused to halt this in-person dispensing requirement even during the COVID-19 pandemic. By contrast, the FDA and other federal agencies have suspended in-person requirements for other medications.
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. When used for purposes other than pregnancy termination, the FDA permits mifepristone to be mailed directly to the patient's home in higher doses and quantities.
The failure to lift this in-person dispensing requirement has particularly severe implications for communities of color and low-income communities, who make up the majority of impacted patients and who are already suffering severe complications and dying from COVID-19 at disproportionately high rates.
The plaintiffs in this case are: ACOG, the Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, SisterSong Women of Color Reproductive Justice Collective, and an individual family medicine physician. The lawsuit is brought by the ACLU and the law firm Arnold & Porter.
Statements from plaintiffs are below:
Eva Chalas, M.D., F.A.C.O.G., F.A.C.S, president of ACOG:
"Our request in this case is simple: The federal government should permit patients seeking safe and effective reproductive health care, which includes care for miscarriage and termination of pregnancy, the same ability to access care and protect themselves from exposure as patients in other contexts are afforded. During the COVID-19 pandemic, the health care community -- from individual physicians to government agencies -- has come together to identify safe, effective ways to provide patients with the care that they need, including through telemedicine. The FDA's decision to maintain medically unnecessary restrictions on mifepristone is a glaring exception, which results in discrimination in access and threatens to harm patients and their clinicians during a time of national crisis. Lifting the barriers to mifepristone will allow women, including those from underserved communities that are disproportionately affected by both COVID-19 and the ongoing maternal health crisis, the ability to obtain necessary and essential evidence-based care without having to risk potential life-threatening exposure."
Monica Simpson, executive director of SisterSong Women of Color Reproductive Justice Collective:
"COVID-19 is causing devastating consequences in every corner of the country, but nowhere more so than in communities of color and Indigenous communities. Because of longstanding disparities in access to and quality of health care and other manifestations of structural racism, Black and Brown people are more likely to have preexisting health conditions that increase the likelihood of severe illness and death from COVID-19. It is unconscionable that the FDA is subjecting women of color, who are disproportionately represented among patients seeking abortion and miscarriage care, to life-threatening viral risks as a condition of obtaining these urgent reproductive health services."
David Chelmow, M.D., president of the Council of University Chairs of Obstetrics and Gynecology:
"The medical community must be able to use all the tools at our disposal, including telehealth care where appropriate, to meet patients' essential medical needs while protecting them from coronavirus. The next generation of health care practitioners must be taught the most safe, effective, and patient-centered care, even during a public health emergency. The FDA's unique restriction on mifepristone prevents clinicians from exercising their medical judgment during this pandemic, limits the ability to provide the optimal medication for miscarriage and abortion care, and needlessly jeopardizes the safety of patients."
Barbara Keber, M.D., F.A.A.F.P., president of the New York State Academy of Family Physicians:
"The COVID-19 crisis has hit New York State particularly hard, with devastating consequences for patients across our state and the family medicine doctors who care for them. The FDA is restricting access to mifepristone in spite of overwhelming medical evidence that it is among the safest drugs in use. There is no medically justifiable reason to restrict use of mifepristone, and certainly not in the current crisis when adhering to these restrictions is only exposing patients and providers to severe and unnecessary medical risk."
In addition to the case filed 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 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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US Voter Registrations Surge as Republicans Try to Limit Ballot Access
One group said it has registered over 100,000 new voters since U.S. President Joe Biden dropped out of the 2024 race.
Jul 26, 2024
The group behind a popular get-out-the-vote technology platform said Friday that it's registered more than 100,000 new U.S. voters since President Joe Biden withdrew from the 2024 presidential race, a surge that came amid mounting Republican efforts to make it harder to register and vote.
Vote.org said that 84% of voters registered in the new wave are under age 35. Nearly 1 in 5 new registrees is 18 years old. Andrea Hailey, the group's CEO, said that "since 2020, we have led the largest voter registration drive in U.S. history," with more than 7.8 million people registered.
After dropping out, Biden endorsed Vice President Kamala Harris to face former Republican President Donald Trump and Sen. JD Vance (R-Ohio) in the November election. The new presumptive Democratic candidate has already earned endorsements from many Democrats in Congress and groups advocating on issues including climate, labor, and reproductive rights.
Vote.org's success comes as Republicans at the federal level are proposing and passing legislation creating obstacles to the ballot box.
Earlier this month, U.S. House Republicans passed Rep. Chip Roy's (R-Texas)
Safeguard American Voter Eligibility (SAVE) Act, which would require proof of American citizenship to vote in federal elections. Republicans claim the bill is meant to fix the virtually nonexistent "problem" of noncitizen voter fraud.
However, Rep. Summer Lee (D-Pa.)
slammed the bill as a "xenophobic attack" meant to silence "Black voices, brown voices, LBGTQIA+ voices, [and] young voices."
Lee said the SAVE Act underscores the need to pass her recently introduced Right to Vote Act, "which would establish the first-ever affirmative federal voting rights guarantee, ensuring every citizen may exercise their fundamental right to cast a ballot."
Earlier this year, U.S. Senate Democrats also reintroduced the John R. Lewis Voting Rights Advancement Act, legislation its sponsors say will "update and restore critical safeguards of the original Voting Rights Act."
Meanwhile, Republican-controlled state legislatures and red-state governors are enacting laws imposing tough restrictions on voter registration, with violations punishable by stiff fines that critics say are meant to dissuade people from registration drives and similar efforts.
Again under the guise of preventing fraud, Republican Florida Gov. Ron DeSantis last year signed legislation limiting voter registration drives, with fines of up to $250,000 for violators.
"These draconian laws and rules are like taking a sledgehammer to hit a flea," Cecile Scoon, an attorney and president of the Florida chapter of the League of Women Voters,
toldThe New York Times in an article published Friday.
Three years after Kansas passed a law making "false representation" of an election official a crime, campaigners say it's become extremely difficult to sign up new voters.
"In 2020, even with the pandemic, we had registered nearly 10,000 Kansans to vote. Now, we haven't been able to register anyone," Davis Hammet, president of the youth voter mobilization group Loud Light, told the Times.
In Louisiana, Republican state lawmakers quietly passed legislation making it easier for election officials to toss out absentee ballots with missing details, limiting how people can mail in other voters' ballots, and restricting the ability to assist people with disabilities with their ballots.
"What we've found is that these measures have a disproportionate impact on voters with disabilities, both Black and white," NAACP Legal Defense Fund senior policy counsel Jared Evans
toldNola.com earlier this week.
"It's clear that their goal is to make it harder to vote, harder for specific communities to vote especially," Evans added. "What they don't realize is that these laws hurt white voters, too."
In Nebraska, Republican Secretary of State Bob Evnen last week
ordered county election offices to stop registering voters with past felony convictions who have not received official pardons. The move came after the state's unicameral Legislature passed a bill granting voting eligibility to felons immediately after they have completed their sentences instead of waiting two years.
"We refuse to accept thousands of Nebraskans having their voting rights stripped away," ACLU of Nebraska legal and policy fellow Jane Seu said in a statement. "We are confident in the constitutionality of these laws, and we are exploring every option to ensure that Nebraskans who have done their time can vote."
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"You thought Project 2025 was just a threat after the election? It's actually happening *right now,*" said one climate campaigner.
Jul 26, 2024
Climate and environmental defenders on this week implored U.S. senators to block a permitting reform bill introduced this week by Sens. Joe Manchin and John Barrasso that campaigners linked to Project 2025, a conservative coalition's agenda for a far-right overhaul of the federal government.
Common Dreamsreported Monday that Manchin (I-W.Va.) and Barrasso (R-Wyo.)—respectively the chair and ranking member of the Senate Energy and Natural Resources Committee—introduced the Energy Permitting Reform Act of 2024.
The Natural Resources Defense Council (NRDC) noted that although the proposal "includes several positive reforms for the accelerated development of transmission projects," it also advocates "limiting opportunities for communities to challenge projects, loosening oversight for drilling and mining projects, extending drilling permits and fast-tracking [liquified natural gas] permits, and several other provisions friendly to fossil fuel giants."
"This dangerous bill doesn't deserve a floor vote."
These are nearly identical policies to what's proposed in Project 2025's Mandate for Leadership. The plan, which was spearheaded by the Heritage Foundation, calls for "unleashing all of America's energy resources," including by ending federal restrictions on fossil fuel drilling on public lands; limiting investments in renewable energy; and rolling back environmental permitting restrictions for new oil, gas, and coal projects, including power plants.
While Manchin has been trying—and failing—to pass fossil fuel-friendly permitting reform legislation for years, Brett Hartl, director of public affairs at the Center for Biological Diversity, said that his "Frankenstein legislation is taken straight from Project 2025, and it's the biggest giveaway in decades to the fossil fuel industry."
Hartl said the bill "deprives communities of the power to defend themselves and gives that power to Big Oil by making it harder for communities to challenge polluting projects in court," and "prioritizes the profits of coal barons over public health."
"And it mandates oil and gas extraction in our oceans," he continued. "The insignificant crumbs thrown at renewable energy do nothing to address the climate emergency."
"Monday was the hottest day in recorded history," Hartl noted. "It's shocking that as the climate emergency continues to break records around us, the Senate continues to fast-track the fossil fuel expansion that is killing us. This dangerous bill doesn't deserve a floor vote."
Hartl added that "to preserve a livable planet," Senate Majority Leader Chuck Schumer (D-N.Y.) "must squash this legislation now."
Manchin—who has said this will be his last term in office—has been a steadfast supporter of the fossil fuel industry, partly because his family owns a coal company. The senator says his permitting reform bill "will advance American energy once again to bring down prices, create domestic jobs, and allow us to continue in our role as a global energy leader."
However, Allie Rosenbluth, Oil Change International's U.S. manager, warned Thursday that "this bill is yet another dangerous attempt by Sen. Manchin to line the pockets of his fossil fuel donors, sacrificing communities and our climate along the way."
"Don't be fooled: The Energy Permitting Reform Act is another dirty deal to fast-track fossil fuels above all else," she continued. "It would unleash more drilling on federal lands and waters, unnecessarily rush the review of proposed oil and gas export projects, and lift the Biden administration's pause on new LNG exports."
"We urge Congress to reject this proposal and commit to action that protects frontline communities from the impacts of fossil fuel development and the climate crisis," Rosenbluth added.
"Don't be fooled: The Energy Permitting Reform Act is another dirty deal to fast-track fossil fuels above all else."
NRDC managing director of government affairs Alexandra Adams said Wednesday that "this bill is a giveaway for the oil and gas industry that will ramp up drilling and environmental destruction at a time when we need to be putting a hard stop to fossil fuels."
"We cannot afford to roll back so many of our bedrock environmental and community legal protections and offer a blank check to the oil and gas industry," she stressed. "We need new solutions for permitting if we are going to meet our clean energy potential and address the climate challenge. But this is not it."
"This bill would altogether be a leap backward on climate, health, and justice if passed into law," Adams added. "The Senate should reject it and look toward alternative solutions already being considered."
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'Nothing To Eat': War-Torn Sudan Faces Mass Famine as Military Delays Aid
Both parties in Sudan's civil war are to blame for a looming mass famine, experts say, and the military's blocking of U.N. aid at a border crossing with Chad exacerbates the problem.
Jul 26, 2024
Sudan's military is blocking United Nations aid trucks from entering at a key border crossing, causing severe disruptions in aid in a country that experts fear may be on the brink of one of the worst famines the world has seen in decades, The New York Timesreported Friday.
The border city of Adré in eastern Chad is the main international crossing into the Darfur region of Sudan, but the Sudanese Armed Forces (SAF), the state's official military, which is engaged in a civil war with a paramilitary group called the Rapid Support Forces (RSF), has refused to issue permits for U.N. trucks to enter there, as it's an RSF-controlled area.
U.S. and international officials have issued increasingly alarmed calls for steady aid access to help feed the millions of severely malnourished people in Darfur and other areas of Sudan.
Last week, Linda Thomas-Greenfield, the United States ambassador to the U.N., said that the SAF's obstruction of the border was "completely unacceptable."
Both warring parties in Sudan continue to perpetrate brazen atrocities, including starvation of civilians as a method of warfare. This piece focuses on the SAF's ongoing obstruction of essential aid. The situation is catastrophic. The policy is criminal. https://t.co/FKhqQh3EI9.
— Tom Dannenbaum (@tomdannenbaum) July 26, 2024
The Sudanese who've made it out of the country and into Adré reported dire and unsafe conditions in their home country.
"We had nothing to eat," Bahja Muhakar, a Sudenese mother of three, told the Times after she crossed into Chad, following a harrowing six-day journey from Al-Fashir, a major city in Darfur. She said the family often had to live off of one shared pancake per day.
Another mother, Dahabaya Ibet, said that her 20-month-old boy had to bear witness to his grandfather being shot and killed in front of his eyes when the family home in Darfur was attacked by gunmen late last year.
Now the mothers and their families are refugees in Adré, where 200,000 Sudanese are living in an overcrowded, under-resourced transit camp.
In addition to those that have made it out of the country, there are 11 million people internally displaced within Sudan, most of whom have become displaced since the civil war began in April 2023.
An unnamed senior American official told the Times that the looming famine in Sudan could be as bad as the 2011 famine in Somalia or even the great Ethiopian famine of the 1980s.
In April, Reutersreported that people in Sudan were eating soil and leaves to survive, and The Washington Postcalled it a nation in "chaos," reporting that World Food Program trucks had been "blocked, hijacked, attacked, looted, and detained."
In late June, a coalition of U.N. agencies, aid groups, and governments warned that 755,000 people in Sudan faced famine in the coming months.
The U.S. last week announced $203 million in additional aid to Sudan—part of a $2.1 billion pledge that world leaders made in April, which some countries have not yet delivered on.
Some officials including Thomas-Greenfield, who has dubbed the situation in Sudan "the worst humanitarian crisis in the world," have called for the U.N. Security Council to allow aid delivery into the country even in the absence of SAF approval; it's believed that Russia would veto such a measure.
Sudan's civil war has seen a great deal of international interference. Amnesty International on Thursday published an investigatory briefing showing that weapons from Russia, China, Serbia, Turkey, Yemen, and the United Arab Emirates (UAE) had been identified in the country. And The Guardian on Friday reported that the passports of Emirati citizens had been found among wreckage in Sudan, indicating the UAE may have troops or intelligence officers on the ground, though the UAE denied the accusation.
The International Service for Human Rights on Friday warned that both the SAF and RSF were engaged in wrongful killings and arrests, especially targeted at lawyers, doctors, and activists. The group called for an immediate cease-fire.
The SAF and Sudanese government figures have cast doubt on international experts' claims about famine in the country.
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