May 2023

Washington, DC — Over the weekend, President Biden reached a deal to avoid default and protect millions of Americans’ health care. Republicans in Congress wanted to rip Medicaid away from 21 million Americans by imposing burdensome paperwork requirements, and they were threatening to default on our debt if they didn’t get their way. President Biden, with the support of Democrats in Congress, held the line insisting they wouldn’t agree to any deal that took health care coverage away from Americans, and the agreement protects Medicaid from any changes whatsoever. In response, Protect Our Care Chair Leslie Dach issued the following statement: 

“President Biden drew a line in the sand and vowed to protect health care coverage in default negotiations, and he did. President Biden and Democratic lawmakers should be commended for protecting the economy from the devastating consequences of a Republican default and stopping the latest GOP plan to slash Medicaid. It should now be clear that Medicaid, like Social Security and Medicare, has the overwhelming support of the American people. 

“Unfortunately, the Republican war on health care continues, and there is no doubt they will continue trying to rip away Medicaid from millions, hike drug and health insurance prices, and remove protections for pre-existing conditions. Republicans and their allies are also in court fighting to take away no cost preventive services, dismantle the Affordable Care Act, revoke reproductive rights, and upend the FDA’s drug approval process. The American people have repeatedly rejected Republican attacks on health care, but sadly, the threats are only growing. 

“While Medicaid was protected in this deal, we must ensure that as lawmakers navigate the appropriations process, vital programs like food assistance and those that promote the health and well-being of people across America are protected as well.”

This week we highlight two federal agencies and their programs to increase health equity by modernizing rules for blood donations and increasing incentives for health providers to ensure that needed care is accessible to all people as well as newly reintroduced, comprehensive federal legislation to address the Black maternal health crisis. Private sector initiatives are complementing  federal and state efforts, with the most recent Asembia Summit explicitly addressing the need for gender equity in care and Black legacy civil rights organizations joining with Biden-Harris Administration officials and calling on health insurers and health associations to take meaningful action to prevent coverage losses and strengthen care quality and affordability. Local programs, the front lines of promoting health equity, often go without recognition, but a Chicago-based group is making a splash now that it is expanding beyond the Chicago area to provide free counseling and classes to cancer patients across the country. Among other research highlighting stark and persistent health disparities, a seminal study funded by the National Institutes of Health (NIH) calculated the staggering economic burden of health disparities for five racial and ethnic minority groups and additional research quantified lives lost and the societal price for failing to achieve health equity.

Protect Our Care is dedicated to making high-quality, affordable and equitable health care a right, and not a privilege, for everyone in America. We advocate for policies that lower health care costs and strengthen coverage, which are critical to expanding access to quality health care and, ultimately, achieving better health outcomes, particularly for people of color, rural Americans, LGBTQI+ individuals, people with disabilities, and more. Our strategies are driven by a broader commitment to tackling systemic inequities that persist due to racism and discrimination and the reality that multi-sector policies are needed to address basic conditions that affect health and related outcomes, particularly for marginalized communities.

INITIATIVES

Fierce Healthcare: Momnibus Act Reintroduced to Congress as Lawmakers Call for Protection of Black Mothers. “Senator Cory Booker and Representatives Lauren Underwood and Alma Adams have reintroduced the bicameral Black Maternal Health Momnibus Act. The Momnibus is comprised of thirteen bills backed by the Black Maternal Health Caucus members. Bills within the act would combat rising maternal mortality rates directly through healthcare reform and indirectly through addressing social determinants of health. Data collected in 2021 showed that maternal mortality rates have reached a nearly 60 year high. If Congress were to pass the act, further funding for improving maternal healthcare for veterans and incarcerated mothers would be unlocked, programs to improve data collection on the crisis would be launched and education programs on maternal vaccinations would expand. Other parts of the bill would convene a task force to address the maternal health crisis. Said task force would direct the investment of funds into programs tackling social determinants of health. Environmental factors leading to poor maternal health outcomes would be addressed through extending eligibility for the special Supplemental Nutrition Program for Women, Infants and Children (WIC) to the postpartum and breastfeeding periods and triggering investment in digital tools to improve maternal health in underserved areas.” [Fierce Healthcare, 5/16/23]

Politico: FDA Relaxes Blood Donation Restrictions on Gay and Bisexual Men. “The FDA on Thursday finalized a long-awaited plan to loosen restrictions on blood donation by men who have sex with men. Currently, men who have sex with men must abstain from sex for three months before giving blood. The new policy still limits people who have certain risk factors — such as a history of non-prescription injection drug use, those who have exchanged sex for money or drugs, or those who previously tested HIV-positive from donating. The final guidelines are consistent with the draft policy issued in January, which proposed to ease restrictions on blood donation from certain men who have sex with men. The FDA says blood donation establishments “may now implement” the new policy, but it is unclear how long it will take for donation centers to revise questionnaires and procedures. The agency did not set a deadline for implementing the revised policy.” [Politico, 5/11/23]

Health Affairs: Looking Back One Year Out From CMS’s New Health Equity Initiative. “In the past year, three revised models and one new model have been announced, all of which have a prominent focus on addressing health equity. One revised model is the Medicare Advantage (MA) Value-Based Insurance Design Model, which builds upon the statutory authority permitting CMS to waive the uniformity requirements with respect to supplemental benefits provided to chronically ill enrollees. Participating plans can provide targeted supplemental benefits such as food, transportation, and housing assistance; reduced copayments; and rewards and incentives in connection with participation in activities that focus on promoting improved health, preventing injuries and illness, and promoting efficient use of health care resources. Beginning in July 2023, [CMS] will collect detailed information from participating plans about the supplemental benefits provided, so that we can assess their use and effectiveness in improving care and outcomes. The second revised model is the ACO Realizing Equity, Access, and Community Health (ACO REACH) Model, which is a revamped and renamed version of the former Global and Professional Direct Contracting Model. [T]he ACO REACH Model is testing a novel “health equity benchmark adjustment,” to remove the disincentive for providers serving disproportionate numbers of underserved beneficiaries to participate in the model. [CMS] also revised the Maryland Primary Care Program, a component of the third model, the Maryland Total Cost of Care Model. In January 2022, the Maryland Primary Care Program began to offer a “Health Equity Advancement Resource and Transformation (HEART)” payment to provide additional support to primary care participants and federally qualified health centers (FQHCs) furnishing enhanced care management services to socioeconomically disadvantaged and complex patients with high clinical risk in counties with high ADI relative to other counties in the state.” [Health Affairs, 5/11/23]

American Journal of Managed Care: Talking About Women’s Health is the First Step to Improving Health Equity. “Panelists at the 2023 Asembia Specialty Pharmacy Summit discussed the myriad of challenges that women face when they encounter the health care system and how these issues can be addressed to provide female patients more agency. Joanne Armstrong, MD, vice president and chief medical officer of women’s health and genomics at CVS/Aetna, began with championing digital tools, saying that although women are the dominant users of digital solutions but only 5% are targeted towards them. She also emphasized the role gender biases play in health disparities, especially for women of color, and why topics predominately experienced by women, such as menstruation, should not be considered taboo. Additionally, discussion around women’s health should extend beyond talking about menstruation and pregnancy to include all aspects of health, including mental health and conditions that predominately impact women, such as lupus and multiple sclerosis. Stephanie Sassman, portfolio leader of women’s health at Genentech, recommended that clinics and government agencies need to establish more partnerships to address major gaps in care for women and normalize discussions around women’s health equity.” [American Journal of Managed Care, 5/9/23]

NBC Chicago: Suburban Group is Beginning Expansion of Cancer Health Equity Initiatives. “Bringing cancer support programs to everyone, regardless of where they live or receive treatment, is Maigenete Mengesha’s mission. Through a partnership with the University of Illinois Cancer Center and the UI Health Mile Square Health Center, Wellness House is offering dozens of programs at the Mile Square location at 1220 S. Wood Street in Chicago. Two-time breast cancer survivor Jeanette Carter lives in Hyde Park and learned about the Wellness House support programs, that are offered completely free of charge, through her doctor, Deborah Manst. Manst urged Carter to try a Mediterranean diet, but Carter wasn’t sure what that meant. She began taking nutrition classes through Wellness House at Mile Square Health Center. In addition to nutrition and exercise classes, Wellness House also offers counseling. They now have a new designation that allows a Wellness House facilitator to expand online counseling sessions beyond the Chicago area, to cancer patients and their families in other states.” [NBC Chicago, 5/17/23]

Legal Defense Fund: Civil Rights Leaders Urge Action as the PHE Ends and Millions are at Risk of Jeopardized Care. “Yesterday, on the final day of the COVID-19 public health emergency designation, civil rights leaders convened at the White House for a joint meeting with the Office of Public Engagement, the Administrator for the Centers for Medicare and Medicaid Services (CMS), senior Biden administration officials, and representatives of health insurers and health associations to discuss concerns related to Medicaid unwinding, the end of the COVID-19 public health emergency, budget negotiations surrounding Medicaid work requirements, changes in Medicare Advantage Plans, and public awareness around cost-savings tied to the Inflation Reduction Act. Following the meeting, the civil rights leaders released a letter outlining key actions for insurers to consider, highlighting the urgent need for unified action. The leaders stated, ‘The lives of millions of vulnerable individuals, particularly Black people and other people of color, rely on the actions and commitments of health insurers and health associations. It is imperative that we work together, raise awareness, and take meaningful action to prevent individuals from being unjustly deprived of healthcare coverage and to ensure that families remain protected and healthcare remains affordable for everyone. We are urging insurers to commit to achieving health access, equity, and affordability for all.’” [Legal Defense Fund, 5/12/23]

CHALLENGES

National Institutes of Health: New Study Shows the Economic Burden of Health Disparities Remains High. “The study, funded by the National Institute on Minority Health and Health Disparities (NIMHD), part of the National Institutes of Health,  revealed that in 2018, racial and ethnic health disparities cost the U.S. economy $451 billion, a 41% increase from the previous estimate of $320 billion in 2014. The study also finds that the total burden of education-related health disparities for persons with less than a college degree in 2018 reached $978 billion, about two times greater than the annual growth rate of the U.S. economy in 2018. This study is the first to estimate the total economic burden of health disparities for five racial and ethnic minority groups nationally and for all 50 states and the District of Columbia using a health equity approach. The health equity approach set aspirational health goals that all populations can strive for derived from the Healthy People 2030 goals. It establishes a single standard that can be applied to the nation and each state, and for all racial, ethnic, and education groups. It is also the first study to estimate the economic burden of health disparities by educational levels as a marker of socioeconomic status.” [National Institutes of Health, 5/16/23]

Washington Post: New Study Find Black Communities Faced Waves of Excess Deaths. “America’s Black communities experienced an excess 1.6 million deaths compared with the White population during the past two decades, a staggering loss that comes at a cost of hundreds of billions of dollars, according to two new studies that build on a generation of research into health disparities and inequity. In one study, researchers conclude that the gap in health outcomes translated into 80 million years of potential life lost — years of life that could have been preserved if the gap between Black and White mortality rates had been eliminated. The second report determined the price society pays for failing to achieve health equity and allowing Black people to die prematurely: $238 billion in 2018 alone. The reasons for the excess deaths and resulting economic toll are many, including mass incarceration, but the root is the same, according to the reports published Tuesday in the influential medical journal JAMA: the unequal nature of how American society is structured. That includes access to quality schools, jobs with a living wage, housing in safe neighborhoods, health insurance and medical care — all of which affect health and well-being. Expanding their analysis to a broader population, the researchers concluded that the failure to achieve health equity in 2018 cost the nation $1.03 trillion. That price tag includes the burden experienced by American adults older than 25 who do not have a college degree and by Native American, Asian, Black, Latino and Pacific Islander people.” [Washington Post, 5/16/23]

WAMC: Coalition of Public Health Experts Say Ending the PHE Will Lead to More Dangerous Outcomes for the Most Vulnerable. “Berkshire Health Systems, the county’s largest healthcare provider, is dropping many of its COVID-19 precautions in line with the state. Visitation policies have been expanded, pre-procedure testing will be discontinued, and testing centers in North Adams, Pittsfield, and Great Barrington will close at the end of the month. Even one of the most effective means of limiting the spread of the respiratory illness that has killed millions worldwide is being halted. But not all public health professionals think the concept of returning to normal is possible. A Massachusetts resident, Christine Mitchell, who received her doctorate from the Harvard T.H. Chan School of Public Health, signed on to an open letter from the Massachusetts Coalition for Health Equity calling on the commonwealth to maintain masking requirements for health care institutions. Given how disproportionately the pandemic impacted the most vulnerable at its height, Mitchell says this new chapter of public health policy underscores already deadly themes of ableism and discrimination against people with disabilities. ‘Only 29% of the Massachusetts population have gotten a COVID booster shot,’ said Dr. Lara Jirmanus. ‘And when you take a look at who’s gotten it, you actually find that there are huge inequities in terms of people of color, people according to levels of education. People with lower levels of education have also been less likely to get the vaccine, people with lower income. And that suggests to me that this is also an access issue. It’s about people who are unable to take the day off work to recover from the vaccine.’” [WAMC, 5/11/23]

The Post and Courier: Death Rate of Infants Born to Black Mothers in South Carolina Increased Over 40 Percent from 2017 to 2021. “Although the regional hospital in the city of Orangeburg delivers babies, the birth outcomes in the county are awful by any standard. In 2021, nearly 3 percent of all Black infants in Orangeburg County died before their 1st birthday. Nationally, the average is about 1 percent for Black infants and less than 0.5 percent for White infants. By 2030, the federal government wants infant mortality to fall to 5 or fewer deaths per 1,000 live births. According to annual data compiled by the Centers for Disease Control and Prevention, 16 states have already met or surpassed that goal, including Nevada, New York and California. But none of those states are in the South, where infant mortality is by far the highest in the country, with Mississippi’s rate of 8.12 deaths per 1,000 live births ranking worst. A new study published in the Journal of the American Medical Association found that, over 20 years, Black people in the U.S. experienced more than 1.6 million excess deaths and 80 million years of life lost because of increased mortality risk compared with White Americans. The study also found that infants and older Black Americans bear the brunt of excess deaths and years lost. [A] report published by the state Department of Health and Environmental Control in April shows the rate for non-Hispanic Black babies — who died at a rate nearly 2½ times that of non-Hispanic White infants in South Carolina in 2021 — is growing worse. The death rate among infants born to Black mothers in the state increased by nearly 40 percent from 2017 to 2021.” [The Post and Courier, 5/21/23]

By Elizabeth G. Taylor, Executive Director of the National Health Law Program, Juliet Choi, President and CEO of the Asian & Pacific Islander American Health Forum (APIAHF), and Leslie Dach, Chair of Protect Our Care

Last week, Arkansas released updated Medicaid enrollment data that serves as a dire warning for the rest of the nation: 72,802 people who rely on Medicaid lost their insurance coverage in April — 40 percent of whom were infants or children. About 80 percent of Arkansans who lost coverage were disenrolled from Medicaid because they did not meet Arkansas’ paperwork requirements like completing renewal forms properly, not because of a determination that they no longer qualify for Medicaid.

This comes as Republicans in Washington passed legislation to impose even more paperwork requirements in Medicaid nationwide — threatening coverage for 21 million people. The devastating outcomes of both these initiatives are by design and reflect a broader national trend: Republicans are using bureaucracy and paperwork to kick people off their health care coverage. 

Congress passed bipartisan legislation at the beginning of the COVID-19 pandemic to protect access to Medicaid by ensuring no one could be disenrolled during the public health emergency. This provision expired on April 1, 2023, and an estimated 15 million people nationwide – including millions of people of color – are at risk of losing coverage as states begin the massive task of determining who on their Medicaid rolls remains eligible. Every state is working to re-evaluate their Medicaid rolls and has a year to do so, but Republican-led states like Arkansas are moving at breakneck speed to throw people off of coverage.

Republicans in Congress continue to impose barriers to coverage for millions of Americans, including by passing partisan legislation in the House of Representatives, jeopardizing Medicaid coverage for an estimated 21 million people by imposing additional work reporting requirements. Introducing more red tape for beneficiaries as states are already overwhelmed with the unprecedented and complex redetermination process would be nothing short of disastrous. 

By seeking to impose work requirements nationwide, House Republicans want to export Arkansans’ misery to the rest of America. In 2018, when Arkansas implemented a less extreme version of work reporting requirements, over 18,000 people (or one in four subject to these requirements) lost their coverage in just seven months; adding red tape quickly takes health care away from people who rely on it. And since two-thirds of families who count on Medicaid include people who already work and the vast majority of others are caregivers, students, or physically unable to work, it’s clear that work reporting requirements are about reducing Medicaid enrollment, not about promoting work.

As representatives of leading civil rights, health equity, and health care organizations, we strongly oppose any barriers to accessing health care. Throwing people off their Medicaid will exacerbate racial and ethnic disparities in access to care. People of color make up a greater portion of those on Medicaid  — a direct result of deep-rooted historical discrimination in employment, housing and education, as well as other forms of structural racism. While people of color make up 35% of Arkansans under age 65, they comprise 44% of people who count on Medicaid. The same is true of nutrition assistance and income support programs like SNAP and TANF. We are deeply concerned with proposals to take nutrition support away from households if they are not able to navigate a complex bureaucratic system to document they are working or prove they are exempt. 

Public officials in states across the country have an obligation to minimize coverage losses as the redetermination process continues rather than pursuing new, harmful proposals. Lawmakers in Washington should reject Speakers McCarthy’s default bill and its burdensome work reporting requirements. No one should lose their health care coverage, nutrition assistance or income support due to paperwork or red tape. Medicaid is proven to save lives, help people from all backgrounds stay healthy, keep rural hospitals and other safety net providers open, boost local economies, and support needed preventive care. It must be protected and strengthened, not gutted through an anti-working poor agenda.

FOR IMMEDIATE RELEASE
Monday, May 22, 2023
Contact: Jack Cardinal, (781) 960-5208, [email protected]
Anne Shoup, [email protected]

Campaign Launches With Full Page New York Times Ad
And Weeklong Digital Ad Campaign

Washington, DC — Community Catalyst Action Fund and Protect Our Care are launching an ad campaign ahead of a day of action tomorrow to oppose any cuts to Medicaid and SNAP in a final deal on the Republican’s debt default plan. The effort is backed by dozens of other leading health justice organizations, and patient and provider advocate groups. 

The ad campaign kicked off with a joint ad in The New York Times and a weeklong digital ad campaign from Community Catalyst Action Fund. 

You can see the joint NYT ad here, which reads: The Republican default plan could take health care and food support away from millions of people and families. Tell them: No cuts to Medicaid or SNAP. 

The digital ads from Community Catalyst Action Fund will run throughout the week and target key lawmakers.

The day of action is an opportunity for local, state and community partners and advocates to engage policymakers in a discussion about the impact that these cuts would have on people and families in their communities, many of whom are already struggling to make ends meet. It is also a moment to remind policymakers that Medicaid is also one of the best ways to prevent medical debt, which impacts more than 40 percent of households and will only worsen if Congress continues to give tax breaks to the wealthy while cutting key programs for families and people with low incomes. Due to racism and other forms of oppression, cuts to Medicaid deepen health inequity of already systematically excluded communities, which is why there is Tri-Caucus led effort to speak out against these proposals.

“It is shameful and wrong that some are willing to hold our economy hostage to advance an agenda of taking affordable health care and food away from millions of people,” said Emily Stewart, executive director of Community Catalyst and Community Catalyst Action Fund. “Our message to Congress is clear: No cuts to Medicaid, SNAP or TANF. It is unconscionable to take away health care and food away from those who need it while protecting tax cuts for the wealthy and massive corporations.”

“Republicans are threatening to default on our nation’s debt in order to push their radical agenda of ripping away health care and other vital support from millions of Americans,” said Protect Our Care Chair Leslie Dach. “They have fully reginited their war on health care and food assistance, fighting to slash programs that keep families, people with disabilities, parents and caregivers healthy, at work and out of poverty in order to protect tax breaks for the wealthiest people and corporations. People across political parties, no matter where they live, overwhelmingly oppose this MAGA agenda and are raising their voices in opposition.”

Sherrell Bird knows all too well the impact that these cuts would have on people in the community, as the executive director of SOWEGA Rising, a nonprofit focused on building community power in her hometown of Albany, Georgia, and its surrounding communities. She is one of many that are organizing events and advocacy in their communities. “People are facing health and economic hardships every day in our community and it’s past time that politicians start putting us first, rather than doing the bidding of the wealthiest among us,” she shared. “Taking health care and food away is not the direction we should be going as a country — it is dangerous, it is unfair, and it must stop.” 

# # # 

About Community Catalyst Action Fund: Community Catalyst Action Fund builds the power of people to create a health system rooted in race equity and health justice, and a society where health is a right for all. We strengthen the health justice and advocacy movement to achieve community-led political and policy wins that put people over profits. Learn more here.

About Protect Our Care: Protect Our Care is a nonprofit organization that is leading the fight for better health care at lower costs.

FOR PLANNING PURPOSES:
Contact: [email protected], 646-359-4422

House Republicans Continue To Double Down on Their Efforts to Rip Away Lifesaving Care

New York, NY — Today, at 11:30 AM EST, U.S. Representative Pat Ryan (NY-18) will join Protect Our Care New York and executive director of The Hudson Valley National Center for Veteran Reintegration Kevin Keaveny to discuss House Republicans’ “Default on America Act,” legislation, and its impact on health care for millions of veterans across the country. 

Today, Protect Our Care unveiled a new report detailing exactly how veteran’s health care would be impacted if the Republican Default on America Act were to become law. The report found that under the GOP bill, millions of veterans, including the 225,400 who receive their health care services in New York, would face: 

• An over-22 percent slash to health care funding
• 30 million fewer outpatient visits
• 81,000 jobs lost across the Veterans Health Administration
• A backlog of 134,000 claims
• $565 million in cuts earmarked for major construction projects, including critical upgrades to clinics and hospitals

Speakers will discuss the report, and how the Republican plan would gut resources for the Veterans Administration and disproportionately harm veterans of color, disabled veterans, low-income veterans, and veterans facing homelessness in New York and across the United States.

Speakers will also discuss proposed cuts to Medicaid and other vital services, including mental health and substance use treatment, maternal care, cancer research and more.  

PRESS CALL:

WHO:
U.S. Representative Pat Ryan (NY-18)
Kevin Keaveny, Hudson Valley National Center for Reintegration
Nate Jackson, Protect Our Care New York

WHAT: Virtual Press Conference

WHEN: Thursday, May 18 at 11:30 AM EST

WHERE: Register to join the Zoom event (Registration required) 

Washington, DC — Today, House Speaker Kevin McCarthy told reporters that work reporting requirements are a red line in debt ceiling negotiations. Already, House Republicans have passed a radical bill to cut Medicaid and rip coverage away from 21 million Americans — disproportionately impacting people of color, rural Americans, and people with disabilities. In response, Protect Our Care Chair Leslie Dach issued the following statement: 

“President Biden did the right thing taking Medicaid cuts off the table in debt negotiations. Adding paperwork requirements may be a red line for McCarthy, but it means cutting off a vital lifeline for 21 million people who count on Medicaid — which is the exact result MAGA Republicans want. There is no room for work reporting requirements in Medicaid, SNAP, or TANF. 

“For Republicans who have mounted a decades-long war on American health care, these so-called work requirements serve the same purpose as the GOP ongoing efforts to repeal or sabotage the ACA — deny people the health coverage they need in order to protect tax breaks for billionaires. The American people have repeatedly rejected Republican efforts to slash American health care, and President Biden and congressional Democrats must stand firm against the GOP’s latest scheme to deny care to millions of Americans.” 

Less than a month ago, a federal judge in Texas issued a ruling revoking authorization for mifepristone, a safe and effective medication essential for reproductive care that was approved by the FDA more than 20 years ago. Not only did this ruling risk barring the use of mifepristone for safe and legal abortions for millions of American women, disproportionately harming low-income individuals, women of color, and those without regular access to a nearby health care provider – it also laid the groundwork for any judge to be able to overrule the evidence-based and scientific FDA medication approval process, throwing the entire system into chaos. 

The Supreme Court has stayed Judge Matthew Kacsmaryk’s ruling for now, allowing mifepristone to remain on the market for now, but the case is still in motion. The Fifth Circuit Court of Appeals is poised to rule on the merits of the case shortly. Read Protect Our Care’s statement on the SCOTUS order here.

23 states and 253 members of Congress – joined by physicians, health care experts, and legal experts – overwhelmingly agree that this case is built on unfounded legal arguments supported by anecdotes and cherry-picked studies. If Judge Matthew Kacsmaryk’s ruling stands, the consequences for patients would be disastrous. 

Fifth Circuit Appeal

Former FDA Officials 5th Circuit Amicus Brief: The Texas Ruling Threatens Patients’ Access to Critical Drugs That Prevent Suffering and Save Lives. A group of six former FDA officials, including David Kessler, Jane Henney, Margaret Hamburg, Michael A Friedman, Joshua Shafstein, Stephen Ostroff, and Norman “Ned” Sharpless, filed an amicus brief in support of the FDAt “In reviewing an administrative agency’s action based on the agency’s evaluation of scientific evidence, such as FDA drug approval decisions, courts have emphasized that they will uphold the action as long as it is within a zone of reasonableness and meets the standard of rationality required by the Administrative Procedure Act. In this case, instead of reviewing FDA’s approval of mifepristone and subsequent modifications to its conditions of use under this firmly established standard, the district court substituted its own opinions about FDA’s evaluation of the scientific data for the expert judgments of FDA clinicians and scientists, and on that basis overturned FDA’s approval of mifepristone. This unprecedented order turns Congress’s desired regulatory scheme on its head and opens the door to constant legal challenges of drug approvals. If allowed to stand, the district court’s order would threaten the incentives for drug companies to undertake the time- consuming and costly investment required to develop new drugs and provide patients access to critical remedies that prevent suffering and save lives.” [Former FDA Officials Brief, 5/2/23]

Amicus Brief By 23 States And The District Of Columbia: Overturning FDA Approval Has Devastating Consequences For The Industry And The Public. A coalition of 23 states—including New York, Arizona, California, Colorado, Connecticut, Delaware, Hawai‘i, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, North Carolina, Oregon, Pennsylvania, Rhode Island, Vermont, Washington, and Wisconsin—and the District of Columbia filed an amicus brief in support of an appeal: “In this case, allowing the district court to unilaterally substitute its judgment for the FDA’s determinations—in defiance of the scientific evidence and in a manner that unduly burdens rather than assures safe access—contravenes the mandate of the FDA and undermines the integrity of the FDA-approval process, with devastating consequences for the industry and the public. Providers and patients in amici States rely on the availability of thousands of FDA-approved drugs to treat or manage a range of medical conditions experienced by their residents, including asthma, HIV, infertility, heart disease, diabetes, and more. […] These harmful outcomes would cause ripple effects across the entire health system. In many amici States, the same facilities providing abortion also offer other critical services, such as pre- and post-natal care, family planning, cancer screening, and other critical forms of preventative health care. Delays resulting from increased demand for abortion procedures (in lieu of medication abortions) will obstruct access to all care offered at those facilities, inevitably resulting in higher rates of unintended pregnancy and sexually transmitted infections, barriers to early detection and treatment for breast, ovarian, and testicular cancers and chronic diseases, and worsened overall health outcomes. Underserved groups, including women of color, low-income women, people with disabilities, and LGBTQ individuals, will be hardest hit. And increasingly poor overall health outcomes will impose substantial costs on amici States and local governments. By contrast, in amici States’ experience, the alleged strains on the health care system purportedly caused by the FDA’s regulatory decisions, which the district court accepted as fact, have simply never materialized.” [New York et al. Brief, 5/1/23]

Amicus Brief By 253 Members of Congress: The Texas Ruling Poses A Serious Health Risk & Would Erect Additional Barriers To Health Care. “[T]he district court’s stay of the U.S. Food and Drug Administration’s September 28, 2000 Approval of mifepristone and other challenged agency actions has no basis in law, threatens the Congressionally mandated drug approval process, and poses a serious health risk to pregnant individuals by making abortion more difficult to access […] [T]he district court’s order not only misapplies the law but also threatens to harm members of the public, many of whom rely on the availability of mifepristone for reproductive care—and many more of whom rely on the integrity of FDA’s drug approval process for continued access to life-improving and lifesaving drugs. Congress intended to—and did—vest authority in FDA to evaluate and ensure the safety and efficacy of drugs in the United States, and amici call on this Court to give due weight to that intent.  […] By curtailing access to the most common method of medication abortion, the district court’s order would erect additional barriers to health care for vulnerable populations. Reduced abortion access is also associated with higher rates of poverty, and lower educational attainment for both children and parents. The unavailability of mifepristone will have an especially acute impact on Black maternal health. In 2020, maternal death rates were 62 percent higher in abortion-restriction states than in abortion access states.” [253 Members of Congress Brief, 5/1/23]

Former DOJ Officials Amicus Brief in Alliance for Hippocratic Medicine v. FDA. “In this brief, former high-ranking officials from both major parties, who hold opposing views on the moral and jurisprudential aspects of abortion, argue the District Court wrongly assumed that the FDA has the authority under the Food, Drug & Cosmetic Act to consider unrelated laws when it reviews applications for approval of new drugs. FDA’s role is to determine the safety and efficacy of drugs based on scientific evidence and not to purport to enforce laws over which they do not have enforcement authority. Amici also demonstrate how the court’s interpretation of the Comstock Laws from 1873—federal anti-vice law that criminalizes the mailing of abortion drugs when intended for use in unlawful abortions—was wrong and its rejection of DOJ’s interpretation of those laws misplaced.” [Former DOJ Officials Brief, 4/13/23]

Motion To Stay

Amicus Brief By 240 Members of Congress: Texas Ruling Second-Guessed Scientific Determinations with Cherry-Picked Anecdotes To Upend the Status Quo. “The district court appears to have second-guessed FDA’s scientific determinations with cherry-picked anecdotes and studies, and on that basis, imposed a remedy that could significantly upend the status quo. […] the district court’s misguided stay under Section 705 of the Administrative Procedure Act will reduce access to abortion, exacerbating an already significant reproductive health crisis,” write the lawmakers, adding: “The consequences of the district court’s remedy could extend far beyond mifepristone, for it undermines the science-based, expert-driven process that Congress designed for determining whether drugs are safe and effective. […] Its perilous consequences reach far beyond mifepristone. Providers and patients rely on the availability of thousands of FDA-approved drugs to treat or manage a range of medical conditions, including asthma, HIV, infertility, heart disease, diabetes, and more.” [240 Members of Congress Brief, 4/11/23]

Former FDA Officials Supreme Court Amicus Brief: This Ruling Puts the Country on a Dangerous Path Towards a Piecemeal Regulatory Scheme Congress Already Rejected in 1938. “Courts lack the expertise to step into FDA’s shoes by second-guessing FDA’s experts on the safety and efficacy of drugs. Assuming that role would require in expert judges to learn how to do what FDA’s expert pharmacologists, toxicologists, chemists, epidemiologists, physicians, and data scientists have spent lifetimes training to do. Getting it wrong can lead to catastrophic consequences—measured not in dollars, but in human lives— and deprive patients of life-saving medication they depend upon. FDA’s modern authority over drug approvals evolved in response to a series of public health crises that occurred over the last century. In response to these crises, Congress steadily expanded and centralized FDA’s authority over drug approvals to give FDA more discretion to protect public health. Congress codified FDA’s accelerated approval authority in 2012, when it passed the Food and Drug Administration Safety and Innovation Act.” [Former FDA Officials SCOTUS Brief, 4/17/23]

Pharmaceutical Companies 5th Circuit Amicus Brief: Texas Ruling Will Shatter the FDA’s Gold Standard Approvals Method. ““[T]he opinion identified no errors in FDA’s scientific judgment or calculations. Instead, the court proffered its own, competing analysis, which lacked any evidence that could support the type of rigorous scientific decision-making with which FDA is tasked. The court cast aside not only the voluminous scientific evidence FDA considered at the time of approval, but also nearly a quarter century of subsequent data showing safe and effective use of the drug. In its place, the court relied on personal stories told by plaintiffs and cherry-picked, unreliable publications—many of which were not even submitted to FDA. The court then ruled that FDA was required to refuse to approve the NDA based on the court’s own non-scientific assessment of this alternative, incomplete record.” [Pharmaceutical Companies, Executives, And Investors Brief, 4/11/23]

NAACP Legal Defense Fund 5th Circuit Amicus Brief: Texas Ruling Directly Undermines the Supreme Court and the Public Interest. “Because the district court’s opinion will impact the availability of mifepristone in all 50 states, it is contrary to the minimal assurances provided for in Dobbs. Justice Kavanaugh’s concurrence emphasized that the Dobbs decision ‘does not prevent the numerous States that readily allow abortion from continuing to readily allow abortion’ and that all states ‘may evaluate the competing interests and decide how to address this consequential issue.’ Rather than leave it to individual states to ‘readily allow abortion,’ as encouraged by Justice Kavanaugh, the district court’s order disallows the two-step medication abortion option entirely. The Supreme Court opined thirty years ago that ‘[t]he ability of women to participate equally in the economic and social life of the Nation has been facilitated by their ability to control their reproductive lives.’ Increased abortion access has had a demonstrably positive economic impact on women, and on Black women, in particular. A review of the data from 2020 among states that report racial and ethnic data on abortion patients indicates 39 percent identify as non-Hispanic Black, and among those aged 15-44 there were 24.4 abortions per 1,000 non-Hispanic Black women. When people can decide if, when, and how many children to have, they are able to make conscious determinations about other aspects of their lives.” [NAACP Legal Defense And Educational Fund Brief 4/11/23]

American College of Obstetricians and Gynecologists 5th Circuit Amicus Brief: The District Court Relied on Biased and Flawed Studies to Justify Ruling. “Without any form of the evidentiary hearing and in complete disregard to the overwhelming body of evidence proving that mifepristone is safe, the District Court’s order (the “Order”) purports to suspend the use of treatment essential to amici’s patients, in order to further its own ideological agenda and that of Appellees. The decision is rife with medically inappropriate assumptions and terminology. It disregards decades of unambiguous analysis supporting the use of mifepristone in miscarriage and abortion care. It relies on pseudoscience and on speculation, and adopts wholesale and without appropriate judicial inquiry the assertions of a small group of declarants who are ideologically opposed to abortion care and at odds with the overwhelming majority of the medical community and the FDA.” [Medical and Public Health Societies Brief, 4/11/23]

Doctors for America 5th Circuit Amicus Brief: Banning the Use of Mifepristone Would Endanger the Health of Patients. “An injunction reversing the approval of mifepristone would remove the availability of an evidence-based treatment that is the safest and best option for many patients. As physicians describe… the removal of mifepristone would undermine their ability to provide safe and effective management of early pregnancy loss.” [Doctors for America Brief, 2/13/23]

Washington, DC — Today, Representative Lauren Underwood (D-IL-14) introduced the Black Maternal Health Momnibus Act of 2023, which is a package of 13 bills to address critical drivers of maternal mortality. Black women are three times more likely to die from pregnancy-related complications than White women in the United States. Maternal mortality in the United States is higher than in any high-income nation. An estimated 80 percent of these deaths are preventable, and the problem is getting worse: recent CDC data show a 40 percent increase in maternal deaths between 2020 and 2021, making passing the Momnibus legislation and requiring Medicaid to provide 12 months of postpartum coverage more urgent than ever before. In response, Protect Our Care Chair Leslie Dach released the following statement:

“It is unacceptable that the United States loses more moms to preventable pregnancy-related deaths than any other high-income country, and this problem has only worsened over the past 30 years. This tragedy disproportionately befalls Black, Indigenous, and rural families. The Black Maternal Health Momnibus Act is essential legislation that addresses the leading causes of poor maternal health outcomes, and it will save lives and help end the maternal health crisis. Protect Our Care commends Representatives Underwood and Adams and Senator Booker for their tireless leadership to improve the pregnancy, birthing, and postpartum experience in America. Congress should pass this legislation without delay.” 

White House Confirms President “Will Not Accept Proposals that Take Away People’s Health Coverage”

Washington, DC — Over the weekend, President Biden committed to protecting health care for millions of Americans as Republicans are seeking to rip away coverage for as many as 21 million people who rely on Medicaid through their extreme “Default on America Act.” 

President Biden told reporters Medicaid is off the table while the White House confirmed “he will not accept proposals that take away peoples’ health coverage.” The President reinforced this commitment today. A record 92 million people in America are covered by Medicaid – mostly seniors, children, and people with disabilities – but the GOP is seeking serious cuts to Medicaid and 22 percent cuts to research for cancer cures, veterans health care, and other vital health care programs. Republicans have proposed bureaucratic reporting requirements, which will only result in millions losing coverage. Read more about how Republicans are demanding health care cuts here. 

In response, Protect Our Care Chair Leslie Dach issued the following statement:

“President Biden made it very clear that he is not going to let Republicans hold our economy and the American people hostage in exchange for millions of people losing their health care. If the GOP gets their way, 21 million Americans risk  losing their health care coverage because of bureaucratic barriers and red tape. This would disproportionately harm people with disabilities or behavioral health disorders, caregivers, people of color, and rural Americans.  By standing up to GOP health care sabotage, President Biden is standing up for the American people. If Republicans truly cared about working families, they wouldn’t continue to put support for tax cuts for the wealthy before ensuring every American has affordable health care.”