May, 27 2020, 12:00am EDT
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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IDF Kills 18 Children in Rafah Hours After US House Approves Billions in Military Aid
"Members of Congress should understand that approving more military aid could subject them to personal liability for aiding and abetting an ongoing genocide in Gaza."
Apr 22, 2024
Hours after the U.S. House approved legislation that would send billions of dollars in additional military aid to Israel, the country's forces killed nearly two dozen people in Rafah, the southern Gaza city where more than half of the enclave's population is sheltering.
Gaza health officials said Sunday that the weekend strikes on Rafah—a former "safe zone" that Israel has been threatening to invade for weeks—killed 22 people, including 18 children. The Associated Pressreported that the first of the Israeli strikes "killed a man, his wife, and their 3-year-old child, according to the nearby Kuwaiti Hospital, which received the bodies."
"The woman was pregnant and the doctors saved the baby, the hospital said," AP added. "The second strike killed 17 children and two women from an extended family."
Israeli forces have killed more than 13,000 children in Gaza since October, but the Biden administration and American lawmakers have refused to back growing international calls to cut off the supply of weaponry and other military equipment even as U.S. voters express support for an arms embargo.
The measure the House approved on Saturday includes $26 billion in funding for Israel, much of which is military assistance.
"Just a day after the House voted to send $14 billion in unconditional military funding to [Israeli Prime Minister Benjamin] Netanyahu's campaign of death and destruction, he bombed the safe zone of Rafah AGAIN, killing 22 Palestinians, of which 18 were CHILDREN!" U.S. Rep. Delia Ramirez (D-Ill.), one of the 58 House lawmakers who voted against the legislation, wrote on social media late Sunday.
"History books will write about today and the past seven months, and how our nation's leaders lacked the courage and moral clarity to stand up to a tyrant," she added. "Shameful."
The military aid package for Israel now heads to the U.S. Senate, which is set to consider the bill early this week. U.S. President Joe Biden, who has continued to greenlight arms sales to Israel amid clear evidence of war crimes, is expected to sign the measure if it reaches his desk.
"Rather than sending more weapons to Israel, Congress should declare an immediate arms embargo on Israel."
U.S. law prohibits "arms transfers that risk facilitating or otherwise contributing to violations of human rights or international humanitarian law," according to a White House memo issued in February. The U.S. State Department has said repeatedly that it has not found Israel to be in violation of international law, a position that runs directly counter to the findings of leading humanitarian organizations and United Nations experts.
The investigative outlet ProPublicareported last week that a "special State Department panel recommended months ago that Secretary of State Antony Blinken disqualify multiple Israeli military and police units from receiving U.S. aid after reviewing allegations that they committed serious human rights abuses" prior to the October 7 Hamas-led attack on southern Israel.
"But Blinken has failed to act on the proposal in the face of growing international criticism of the Israeli military's conduct in Gaza, according to current and former State Department officials," ProPublica noted.
Sarah Leah Whitson, executive director of Democracy for the Arab World Now (DAWN), said in a statement Sunday that senators "should reject sending additional weapons to Israel not only because our laws prohibit military aid to abusive regimes, but because it's extremely damaging to our national interests."
DAWN's advocacy director, Raed Jarrar, added that "at a time when Israel is bracing for International Criminal Court arrest warrants against its leaders, members of Congress should understand that approving more military aid could subject them to personal liability for aiding and abetting an ongoing genocide in Gaza."
"Rather than sending more weapons to Israel," said Jarrar, "Congress should declare an immediate arms embargo on Israel."
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Ahead of Treaty Negotiations, Hundreds March to 'End the Plastic Era'
"As adults who come to Ottawa to negotiate the plastic treaty, you must protect our rights to live in a healthy and safe environment," one young activists said.
Apr 21, 2024
Days before national delegates gather for the fourth and penultimate negotiations to develop a Global Plastics Treaty in Ottawa, Canada, around 500 Indigenous and community representatives, members of civil society and environmental groups, and experts and scientists gathered for a "March to End the Plastic Era" on Sunday.
The protesters, organized under the banner of Break Free From Plastic, called for a treaty that significantly reduces plastic production and centers the frontline communities most impacted by the plastics crisis.
"Delegates must act like our lives depend on it—because they do," Daniela Duran Gonzales, senior legal campaigner with the Center for International Environmental Law, said in a statement. "Our climate goals, the protection of human health, the enjoyment of human rights, and the rights of future generations all rest on whether the future plastics treaty will control and reduce polymers to successfully end the plastic pollution crisis."
"Short-sighted business interests must be out of the room because the only way to achieve equitable livelihoods is when we have a healthy planet."
The official meeting of the Intergovernmental Negotiating Committee (INC) to craft a "international legally binding instrument on plastic pollution, including in the marine environment," will run from April 23 to 29 in the Canadian capital.
Break Free From Plastic called the negotiations a "make or break" moment for the treaty, which is supposed to be completed in late 2024 in Busan, South Korean. However, civil society groups have expressed concern that oil-producing countries and the plastics industry will water down the agreement and steer it toward waste management and recycling, which has been revealed to be a false solution to plastic pollution knowingly promoted by the industry for decades.
The last round of negotiations concluded in late 2023 in Nairobi, Kenya, with little progress made after 143 fossil fuel and chemical lobbyists attended.
Salisa Traipipitsiriwat of Thailand, who is the senior campaigner and Southeast Asia plastics project manager for the Environmental Justice Foundation, said ahead of Sunday's march that it was "crucial for world leaders to step up and put the people and planet at the forefront."
"Short-sighted business interests must be out of the room because the only way to achieve equitable livelihoods is when we have a healthy planet," Traipipitsiriwat added.
On Sunday, marchers gathered for a press conference at 10:30 am ET before marching at around 11:30 am from Parliament Hill to the Shaw Center, were negotiations will begin on Tuesday. Crowds began to disperse around 1:30 pm. Participants carried large banners with messages including, "End the plastic era," "End multigenerational toxic exposure," and pointing out that 99% of plastics came from fossil fuels. The gathering featured live music and art, including a giant tap pouring out plastics and a "Plastisaurus rex" with the message "Make single-use plastic extinct."
(Photo: Break Free From Plastics)
"Now's the time to be bold and push for a treaty that cuts plastic production and holds polluters accountable," Julie Teel Simmonds, a senior attorney at the Center for Biological Diversity, said in a pre-march statement. "I'm inspired to be joining so many advocates in Ottawa, standing up against the enormous harm the fossil fuel and petrochemical industries are causing to people's health and the planet. I hope to see countries showing ambition this week, and I urge them to remember what's at stake for future generations."
Civil society groups have compiled several demands for an ambitious and effective treaty. These are:
- Centering human rights, especially those of Indigenous communities, young people, and workers most impacted by plastic pollution;
- Protecting the rights of Indigenous peoples throughout the treaty process;
- Dealing with plastics across their entire lifecyle;
- Reducing production as a "nonnegotiable" part of the treaty;
- Eliminating toxic chemicals and additives from plastics;
- Bolstering reuse systems for plastics that are non-toxic;
- Prioritizing first prevention, then reuse, recycling, recovery, and disposal when managing plastic waste;
- Ending "waste colonialism" by strengthening regulations for trading plastics;
- Guaranteeing a "just transition" for people employed across the plastics lifecycle;
- Including "non-party" provisions in the treaty;
- Establishing a mechanism to fund countries so they can fully implement the treaty; and
- Enshrining conflict-of-interest policies as a protection against plastics industry lobbying.
The coalition emphasized the need to tackle the problem of plastic from cradle to grave.
"Plastic doesn't just become pollution when it's thrown away," said Jessica Roff, the U.S. and Canada plastics and petrochemicals program manager for the Global Alliance for Incinerator Alternatives. "Plastic is pollution, from the moment the fossil fuels are extracted from the ground to the eternity of waste it spawns."
Chrie Wilke, global advocacy manager for the Waterkeeper Alliance, said "Clearly the crux of the plastic pollution crisis is too much plastic being produced. There is no way to recycle our way out of this. We must face the fact that plastic and petrochemicals, at current production levels, endanger waterways, communities, and fisheries across the globe. Cutting production and implementing non-plastic alternatives and reuse systems is essential."
(Photo: Ben Powless/Survival Media Agency)
Activists also emphasized the environmental justice implications of plastic pollution, and how some communities and groups are more burdened than others, both from the dangers of the production process and from waste disposal.
"Children and youth like me suffer the most and are recognized as a vulnerable group," said Aeshnina 'Nina' Azzahra, the founder of River Warrior Indonesia. "My playground and my future are at risk. We all want our environment to be plastic-free, but please don't put your burden on the other side of the world—this is NOT fair. As adults who come to Ottawa to negotiate the plastic treaty, you must protect our rights to live in a healthy and safe environment."
Jo Banner, co-founder and co-directer of The Descendants Project, said:"Frontline community members, such as myself, are participating in these treaty negotiations with heavy hearts as our communities back home are struggling with sickness and disease caused by the upstream production of plastic."
"Although our hearts are heavy, they are full with passion urging negotiators to aim for an ambitious treaty that caps plastic production," Banner added. "Areas such as my hometown, located in the heart of Louisiana's Cancer Alley, need a strong treaty now. There is no more time to waste."
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'Obvious Evidence of Genocide': Mass Grave Discovered in Gaza's Nasser Hospital
Palestinian rescue workers said they found hundreds of bodies, some with their hands bound and others with their skin, organs, or heads removed.
Apr 21, 2024
Palestinian civil defense discovered hundreds of bodies buried by Israeli forces in a mass grave inside the complex of Khan Younis' Nasser Medical Complex on Saturday.
Rescue workers said they had removed at least 200 bodies as of 12:00 pm local time on Sunday, and they estimated that at least another 200 remained, Middle East Eye reported.
"We found corpses without heads, bodies without skins, and some had their organs stolen," the director-general of the Government Media Office said in a statement shared by Quds News Network.
"Following the mass graves at Al-Shifa hospital, it looks like Israel is a voracious death machine turning hospitals in Gaza into graveyards."
The Israel Defense Forces (IDF) withdrew from Khan Younis on April 7. While they occupied the city, they stormed the Nasser Medical Complex in February, arresting several doctors, damaging the structure with shelling, and rendering it unable to function as a hospital.
Al Jazeera reporter Hani Mahmoud said the bodies found in the Nasser grave included children, young men, and older women. Rescues said that some of the bodies they found had been buried with their hands tied behind their backs, according to Middle East Eye.
"Our teams continue their search and retrieval operations for the remaining martyrs in the coming days as there are still a significant number of them," Palestinian emergency services said in a statement shared with Al Jazeera.
The news came as the U.S. House of Representatives voted on Saturday to send another $26 billion to Israel, including for military aid.
"These mass graves are obvious evidence of genocide and the most unthinkable war crimes. And yet, the House just signed off on $26 billion in weapons to fuel the genocidal Israeli military, while Israel threatens a full scale ground invasion to massacre Palestinians in Rafah," the U.S. Campaign for Palestinian Rights said on social media.
This is not the first mass grave that has been discovered near a Gaza Strip hospital since Israel began its devastating bombardment and invasion following Hamas' deadly October 7 attack on southern Israel. When the IDF withdrew from the al-Shifa hospital earlier this month, Palestinian journalist Hossam Shabat reported seeing hundreds of dead bodies outside the hospital, many that had had their hands and legs bound and their bodies run-over by bulldozers. Al Jazeera reported that several mass graves were found near al-Shifa.
"Following the mass graves at Al-Shifa hospital, it looks like Israel is a voracious death machine turning hospitals in Gaza into graveyards. Wake up world!" Palestinian politician and activist Hanan Ashrawi wrote on social media.
Muhammad Shehada, the communications chief for Euro-Med Human Rights Monitor, expressed shock that there was not more media coverage of the Nasser grave.
"I CANNOT find a single headline in any mainstream media about this!" Shehada wrote on social media. "Imagine it was Ukraine? or Israel?"
Over the weekend, the the Gaza Health Ministry reported that the death toll from Israel's war on Gaza surpassed 34,000, though this is likely an undercount since several people remain trapped beneath rubble.
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