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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Apr 26, 2024
The United Nations' top humanitarian affairs officials on Friday called for an immediate deescalation of hostilities in Sudan, where rival factions in the military government have been fighting for a year and where an attack on the city of El Fasher is reportedly imminent.
About 800,000 people in the city, the capital of North Darfur state, are in "extreme and immediate danger," U.N. aid operations director, Edem Wosornu, told the U.N. Security Council earlier this week, as she reported that clashes between the Rapid Support Forces (RSF), a paramilitary group, and the Sudanese Armed Forces (SAF) are nearing El Fasher.
Fighting between the two groups has intensified in recent weeks, forcibly displacing an estimated 40,000 people.
The U.N. Office for the Coordination of Humanitarian Affairs said Friday that the security situation in North Darfur has left more than a dozen aid trucks with relief supplies for 122,000 people stranded in neighboring Northern state, unable to proceed into the only capital city in Darfur that is not controlled by RSF.
"A patchwork of armed actors, including the Darfur Joint Protection Forces, the SAF, and the RSF control different parts of the El Fasher area," Human Rights Watch reported this week. "Tense calm alternating with episodic fighting has prevailed for months."
Since April 14, when RSF began to push into El Fasher, at least 43 people—including women and children—have been killed due to fighting between the SAF and RSF.
"Civilians are trapped in the city, afraid of being killed should they attempt to flee," said Seif Magango, spokesperson for the U.N. high commissioner for human rights, Volker Türk. "This dire situation is compounded by a severe shortage of essential supplies as deliveries of commercial goods and humanitarian aid have been heavily constrained by the fighting, and delivery trucks are unable to freely transit through RSF-controlled territory."
The lack of humanitarian aid in North Darfur has pushed the state toward a famine, with one child dying of starvation every two hours, according to a February report by Doctors Without Borders.
In December, the U.S. State Department announced an $85 million sale of radar and other military equipment to the United Arab Emirates (UAE), which The New York Times reported last year has been covertly supporting the RSF.
U.S. Rep. Ilhan Omar (D-Minn.) proposed a joint resolution to block arms sales to the UAE in January, in light of its support for the paramilitary group.
Omar was among several lawmakers who wrote to President Joe Biden and Secretary of State Antony Blinken earlier this week, urging them to "deliver urgently-needed humanitarian assistance" and to help end the hostilities.
Sudanese-Australian writer Yassmin Abdel-Magied urged Americans on Friday to pressure lawmakers and the White House to take more action.
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OCHA called on the warring parties to "take constant care to spare civilians and civilian objects in the conduct of military operations."
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The Tennessee win "is breaking the brains of Republicans in that region. They're truly astonished that workers might not trust their corporate overlords with their working conditions, pay, health, and retirement," Thom Hartmann wrote in a Friday opinion piece.
"The problem for Republicans is that unions represent a form of democracy in the workplace, and the GOP hates democracy as a matter of principle."
"The problem for Republicans is that unions represent a form of democracy in the workplace, and the GOP hates democracy as a matter of principle," he argued. "Republicans appear committed to politically dying on a number of hills that time has passed by. Their commitment to gutting voting rolls and restricting voting rights, their obsession with women’s reproductive abilities, and their hatred of regulations and democracy in the workplace are increasingly seen by average American voters as out-of-touch and out-of-date."
Just before voting began in Chattanooga, GOP Govs. Kay Ivey of Alabama, Brian Kemp of Georgia, Tate Reeves of Mississippi, Henry McMaster of South Carolina, Bill Lee of Tennessee, and Greg Abbott of Texas claimed that "unionization would certainly put our states' jobs in jeopardy" and the UAW is "making big promises to our constituents that they can't deliver on."
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"Workers at our plant are ready for this moment," Mercedes employee Jeremy Kimbrell said last week. "We are ready to vote yes because we are ready to win our fair share. We are going to end the Alabama discount and replace it with what our state actually needs. Workers sticking together and sticking by our community."
As workers gear up for the election, the Alabama House of Representatives on Tuesday voted 72-30 for a bill that would withhold future economic incentive money from companies that voluntarily recognize unions rather than holding secret ballots. The state Senate previously passed a version of the legislation but now must consider it with the lower chamber's amendments.
The Associated Pressnoted that "Georgia Gov. Brian Kemp signed similar legislation on Monday" and that Tennessee already has one on the books.
With his signature on Senate Bill 362, "Kemp's aim is to thwart future organizing attempts by workers at automotive plants in Georgia, such as those operated by Hyundai Motor Group," according toThe Atlanta Journal-Constitution.
As the newspaper detailed:
Georgia has been a right-to-work state since 1947, when Congress passed the Taft-Hartley Act, allowing workers to refuse to join a union or pay dues, even though they may benefit from contracts negotiated by a union with their employer. Just 5.4% of workers in the state belonged to a union in 2023, according to the U.S. Bureau of Labor Statistics.
But the National Labor Relations Act of 1935, also known as the Wagner Act, protects the right for workers to form a union and collectively bargain for better wages and working conditions.
The new Georgia law is expected to be challenged in court, labor experts have said.
Acting U.S. Labor Secretary Julie Su told the AP on Thursday that she is not sure if the department will challenge the laws, given the National Labor Relations Board's responsibilities, but she stressed that "there are federal standards beneath which no worker should have to live and work."
In terms of joining a union, "that choice belongs to the worker, free from intervention, either by the employer or by politicians, free from retaliation and threats," Su said. "And what we are seeing is that workers who were thought to be too vulnerable to assert that right are doing it, and they're doing it here in the South."
The U.S. labor chief also slammed "unacceptable" union-busting efforts by companies and suggested that protecting the right to unionize is part of President Joe Biden's "promise to center workers in the economy."
"He has said he's the most pro-worker, pro-union president in history, and we are going to make good on that promise. And that includes making sure that workers have the right to join a union," Su said of the president.
Biden's commitment to workers and unionizing rights has caught the attention of GOP leaders. The governors' joint statement nodded to the UAW's January endorsement of the president, who is seeking reelection in November, and South Carolina's leader attacked the administration earlier this year.
During his January State of the State speech, McMaster declared that "we will not let our state's economy suffer or become collateral damage as labor unions seek to consume new jobs and conscript new dues-paying members. And we will not allow the Biden administration's pro-union policies to chip away at South Carolina's sovereign interests. We will fight. All the way to the gates of hell. And we will win."
News From the Statesreported Friday that "of all the foreign-owned automakers in South Carolina, BMW would be the most likely mark in the near term if enough of its workers show interest. The massive plant near Greer—the manufacturer's only U.S. production facility—employs some 11,000 people, twice the number of workers at Volkswagen in Tennessee and Mercedes in Alabama. It has operated in the Upstate for nearly 30 years and is in the process of adding electric vehicle lines."
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Biden's February directive states that "the recipient country will facilitate and not arbitrarily deny, restrict, or otherwise impede, directly or indirectly, the transport or delivery of United States humanitarian assistance."
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Observers say these attacks—which include the infamous " Flour Massacre" and the drone strikes that killed seven World Central Kitchen staffers—were deliberate, which Israel denies.
The blocking of humanitarian aid is a key component of the International Court of Justice (ICJ) genocide case against Israel brought by South Africa and supported by more than 30 nations. On January 26, the ICJ issued a preliminary ruling that found Israel is "plausibly" committing genocide in Gaza and ordered it to prevent future genocidal acts. Critics argue Israel has ignored the order.
According to Lynch:
The paper was cleared by 10 USAID officials, underscoring its widespread backing of the findings. But Sonali Korde, the agency's deputy assistant administrator and head of the Bureau for Humanitarian Affairs, signed off on the document with the phrase INFO, bureaucratic shorthand for passing it up the chain of command without committing to its conclusions. Blinken is required to formally certify to Congress in the coming weeks whether Israel complies with the White House determination.
Last month, the Biden administration
said that Israel's use of U.S.-supplied weapons complies with international law, an assessment lambasted by many observers including Palestinian American political analyst Yousef Munayyer, who called it "absolutely scandalous."
Palestinian and human rights advocates and more than two dozen congressional Democrats have challenged the Biden administration's claim that Israel is using U.S.-supplied weapons in compliance with domestic and international law, pointing to the use of 2,000-pound bombs—which can wipe out an entire city block—in densely populated areas and other potentially illegal actions. In December, Biden acknowledged that Israel's bombing was "indiscriminate."
Critics including progressive members of Congress have called for an arms embargo on Israel. However, Biden this week signed the biggest-ever U.S. aid package for Israel and has
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