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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Nobel Prize for mRNA Researchers Shows Power of Public Funding for Vaccines, Campaigners Say
"Public funding delivers incredible medical advances and that should be a priority for all countries, but pharmaceutical companies cannot be trusted to share technology with the world."
Oct 02, 2023
Scientists Katalin Karikó and Drew Weissman were awarded the Nobel Prize in Physiology or Medicine on Monday for research that paved the way for the messenger RNA vaccines against Covid-19—critical work that, as campaigners quickly pointed out, benefited from substantial U.S. government funding.
Dr. Mohga Kamal-Yanni, policy co-lead for the People's Vaccine Alliance, said in a statement that "this award challenges the claim that it was solely big pharmaceutical companies who saved the world from Covid-19."
"Just like the Oxford-AstraZeneca vaccine, Karikó and Weissman's groundbreaking work on mRNA vaccines received a huge amount of public funding," said Kamal-Yanni. "Pharmaceutical companies have refused to share mRNA technologies with developers and researchers in developing countries."
The Nobel Prize committee credited Karikó and Weissman with fundamentally changing "our understanding of how mRNA interacts with our immune system."
"The laureates contributed to the unprecedented rate of vaccine development during one of the greatest threats to human health in modern times," the committee said.
As The Washington Postsummarized, the pair "discovered how to chemically tweak messenger RNA, turning basic biology into a technology ready to change the world when the pandemic struck. Their discovery is incorporated into the coronavirus vaccines made by Moderna and Pfizer and its German partner, BioNTech, which have now been given billions of times."
But the Post and other major outlets covering Karikó and Weissman's Nobel prize-winning contributions did not emphasize—or even mention—that some of the scientists' work was funded by the National Institutes of Health. Karikó and Weissman patented their findings in 2006 and later licensed the patents to Moderna and BioNTech, Pfizer's coronavirus vaccine partner.
According to an analysis by Knowledge Ecology International (KEI), Weissman "appears as the principal investigator on a total of 42 projects funded by the National Institutes of Health (NIH) between 1998 and 2020, representing $18,323,060 in costs."
"Karikó was the principal investigator of four projects funded by the NIH between 2007 and 2011, totaling $1,234,462 in costs," KEI observed. "In other words, the United States government funded and has certain rights over at least some of the foundational Karikó and Weissman patents directed to mRNA discoveries."
"As governments discuss how to prepare for the next pandemic, they should learn from the story of mRNA."
Throughout the pandemic and into the present, vaccine makers such as Pfizer and Moderna have opposed global calls to share their vaccine recipes and technology with the world, fiercely clinging to their monopoly control over production and using that control to force governments into one-sided contracts favorable to the pharmaceutical industry—even though their vaccines were developed with massive public support.
A
study published in The BMJ earlier this year estimated that the U.S. government pumped nearly $32 billion into the development, production, and purchase of mRNA coronavirus vaccines.
The Biden administration, meanwhile, has declined to use its ownership of key patents or the leverage provided by public funding to force pharmaceutical companies to do everything they can to ensure the equitable distribution of lifesaving vaccine technology.
Kamal-Yanni of the People's Vaccine Alliance said Monday that "fortunately, Weissman is helping a WHO-backed mRNA program which aims to develop mRNA technology in lower-income countries, even while pharmaceutical companies refuse to share their know-how."
"As governments discuss how to prepare for the next pandemic, they should learn from the story of mRNA," said Kamal-Yanni. "Public funding delivers incredible medical advances and that should be a priority for all countries, but pharmaceutical companies cannot be trusted to share technology with the world."
Peter Maybarduk, director of the Access to Medicines program at Public Citizen, echoed that message, saying in a statement that "today's Nobel must ring as a call for equity and health justice, and a call to change a massively unjust pharmaceutical industry."
"Moderna, Pfizer, and BioNTech still largely control the available vaccines and in some countries have significantly increased their price, despite the billions in public funding on which the vaccines rely," said Maybarduk. "By supporting initiatives to share science and technology, and by funding vaccine infrastructure, governments can help blunt the effects of disease, and bring a coda of justice to a terribly unjust time."
This story has been updated to include a statement from Public Citizen.
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Defying Calls to Appoint Barbara Lee, Newsom Chooses Laphonza Butler to Fill Feinstein's Seat
Butler previously served as the head of a major SEIU local. But she also represented Uber as it fought efforts to classify drivers as employees.
Oct 02, 2023
California Gov. Gavin Newsom announced late Sunday that he will appoint Laphonza Butler, president of the Democratic Party-aligned reproductive rights group
EMILY's List, to fill the U.S. Senate seat left vacant by the death of long-serving Sen. Dianne Feinstein last week.
Newsom's selection rebuffs calls from progressives and some Democratic lawmakers—including the head of the Congressional Black Caucus—to nominate Rep. Barbara Lee (D-Calif.) to fill the vacancy. Lee is one of three prominent Democrats running for Feinstein's seat in 2024.
Feinstein had planned to step down at the end of her term in January 2025.
Newsom pledged to fill any early vacancy with a Black woman, but he signaled last month that it would not be Lee, who is running against Reps. Katie Porter (D-Calif.) and Adam Schiff (D-Calif.).
"I don't want to get involved in the primary," Newsom told NBC, stressing that his selection would be an interim pick. "It would be completely unfair to the Democrats that have worked their tail off. That primary is just a matter of months away. I don't want to tip the balance of that."
In a statement late Sunday, Newsom said that "as we mourn the enormous loss of Senator Feinstein, the very freedoms she fought for—reproductive freedom, equal protection, and safety from gun violence—have never been under greater assault. Laphonza will carry the baton left by Senator Feinstein, continue to break glass ceilings, and fight for all Californians in Washington, D.C."
"An advocate for women and girls, a second-generation fighter for working people, and a trusted adviser to Vice President [Kamala] Harris," Newsom added, "Laphonza Butler represents the best of California, and she'll represent us proudly in the United States Senate."
Shortly following news of the governor's decision, journalists
noticed that EMILY's List removed the final line of Butler's bio that said she lives in Maryland with her partner and daughter. Newsom's office confirmed to California reporter Ashley Zavala that Butler moved to the Washington, D.C. area for her role at EMILY's List but owns a home in California, and will reregister to vote in the state before she is sworn in.
Prior to her stint at EMILY's List, which works to elect pro-choice Democrats, Butler served as president of Service Employees International Union (SEIU) Local 2015, the nation's largest home care and nursing home workers union.
But CalMattersnoted Sunday that "despite her previous career, organized labor is likely to split on Butler."
"Many felt betrayed when she represented Uber in 2019 as the company tried to broker a deal that would avoid classifying their drivers as employees," the outlet reported.
Butler also worked as director of public policy for Airbnb.
Politicoreported that "Newsom is making his appointment without putting limitations or preconditions on his pick running for the seat in 2024. That means Butler could decide to join the sprawling and competitive field of Democratic contenders seeking to succeed Feinstein, with special elections now layered on top of the March primary and November runoff."
In a letter to Newsom earlier Sunday, Congressional Black Caucus Chair Steven Horsford (D-Nev.) urged Newsom to appoint Lee to fill the vacant U.S. Senate seat, arguing that her "unparalleled legislative record, longstanding leadership in the Democratic Party, and deep commitment to justice and equality cannot be equaled."
"Barbara Lee has diagnosed a sickness in this country: greed," Horsford wrote. "And, as a former mental health professional, she has a solution: eradicate poverty, exterminate corporate welfare, and end austerity for working families. She is the only person with the courage, vision, and record to eradicate poverty, face down the fossil fuel industry, defend our democracy, and tirelessly advance the progressive agenda."
Lee, for her part, wrote in a social media post that she looks forward to working with Butler to "deliver for the Golden State."
"I am singularly focused on winning my campaign for Senate," Lee wrote. "CA deserves an experienced senator who will deliver on progressive priorities. That's exactly what I'm running to do."
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'Out-of-Step With American Values': Newsom Vetoes Key Labor Bills
The California governor on Saturday rejected bills that would have given unemployment insurance to striking workers and OSHA protections to domestic employees.
Oct 01, 2023
California Gov. Gavin Newsom vetoed too important pieces of labor rights' legislation on Saturday: one that would have given unemployment insurance to striking workers and another that would have extended protections to domestic employees.
Newsom's vetoes come as both California and the nation have seen a number of high profile strikes this year, including by Hollywood writers and actors.
"This veto tips the scales further in favor of corporations and CEOs and punishes workers who exercise their fundamental right to strike," California Labor Federation leader Lorena Gonzalez Fletcher said in a statement. "At a time when public support of unions and strikes are at an all-time high, this veto is out-of-step with American values."
Senate Bill 799, which passed in September, would have offered unemployment insurance to workers on strike for 14 days or more. It came while both the Screen Actors Guild-American Federation of Television and Radio Artists (SAG-AFTRA) and the Writers Guild of America (WGA) were out on strike in the first writer and actor double-feature work stoppage in 60 years.
In a statement, Newsom said he was vetoing the bill for economic reasons, arguing that the state's unemployment insurance had been governed by the same financial structure since the 1980s, was "vulnerable to insolvency," and already expected to be almost $20 billion in debt by the end of the year.
"Now is not the time to increase costs or incur this sizable debt," Newsom said.
However, The Sacramento Beepointed out that Newsom's veto might have been made politically easier by the fact that the WGA ended its strike Wednesday after reaching a tentative deal with the studios.
Democratic State Sen. Anthony Portantino, who introduced the bill, said he thought the summer's labor actions only showed how necessary the bill was.
"I am disappointed in the Governor's veto," he tweeted. But he said the fight wasn't over.
"The need continues and so will efforts to make this law in CA," he said.
Also on Saturday, Newsom delivered another blow to the state labor movement when he vetoed SB 686 to give domestic workers protections under the state's Occupational Safety and Health Administration (OSHA).
"I'm deeply disappointed that the governor doesn't recognize the inherent worth and dignity of those women who care for our homes and families by vetoeing SB 686," tweeted the bill's author Sen. MarÃa Elena Durazo. "That measure would've insured that domestic workers have the same occupational health and safety protections as others."
This is the second time that Newsom has vetoed a Durazo bill along similar lines, the Los Angeles Timesreported. The last was in 2020.
Newsom argued then and now that it is not possible to regulate private homes like businesses. For example, the bill would have required homes that asked cleaners to use bleach to provide eyewash stations.
"I am particularly concerned given that approximately 44% of the households that employ domestic workers are low-income themselves, that this bill creates severe cost burdens and penalties for many people who cannot afford them," he wrote in his veto message.
The bill was backed by the California Domestic Workers Coalition and immigrant rights groups like the Instituto de Education Popular del Sur de California.
Nancy Zuniga, a program manager for that group and a supporter of the bill, said she was inspired by her mother who is still cleaning homes at 63, though Zuniga hopes she can retire.
"If we don’t protect domestic workers, what condition will she be in when she reaches that moment?" she asked the LA Times. "A lot of them will do this until they pass."
According to a 2020 report from the University of California, Los Angeles, 85% of domestic workers live with muscular and skeletal injuries.
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