Jeanette Contreras portrait

La tercera vacuna trae esperanza

By NCL Director of Health Policy Jeanette Contreras

La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) acaba de aprobar una autorización de uso de emergencia para la vacuna de Johnson & Johnson, la tercera vacuna para combatir el coronavirus en EEUU. Aunque parece que no es tan efectiva como las otras dos, la vacuna de Johnson & Johnson ofrece una protección de 85 por ciento contra casos severos de COVID-19 y 100 por ciento de eficacia para evitar hospitalización y mortalidad, a causa del COVID-19. Con solo una dosis, esta vacuna ofrece protección de 72 por ciento contra el COVID-19 que ultimadamente ayuda controlar la pandemia en la población y alcanzar un nivel de inmunidad necesaria para regresar a la vida normal.

Una ventaja enorme de esta vacuna en términos de administración, es que se puede mantener en refrigeración normal por meses. Las otras vacunas requieren mantenimiento de temperatura súper baja en refrigeradores industriales que solo se encuentran en hospitales grandes. La vacuna de Johnson & Johnson es ideal para distribuir a comunidades rurales y en clínicas comunitarias. La aprobación de esta tercera vacuna, aumenta la disponibilidad y nos da esperanza de poder vacunar a más personas, más rápido con solo una dosis.

Sabemos que la comunidad Latina sufre de una taza de contagio más alta que otros grupos. Latinos constituyen una gran cantidad de empleados en trabajos esenciales con alto riesgo de contagio, como en la producción de comida y en puestos de trabajo de pequeños negocios. Mientras muchos esperan vacunarse, otros tendrán dudas o miedo de vacunarse. La campaña Depende De Ti nos asegura que es normal tener preguntas y ofrece información y respuestas en Español para educar a la comunidad latina.

Campañas educativas como esta son necesaria para combatir información falsa y mitos que circulan en las redes sociales. Se escuchan mitos que las vacunas en general hacen daño o que alteran o cambian el ADN. Sin embargo, está comprobado científicamente por siglos que las vacunas han salvado vidas y nos han protegido. Los Centros para el Control y la Prevención de Enfermedades (CDC, por sus siglas en inglés) tiene una página dedicada a información para derribar los mitos más frecuentes acerca de estas vacunas.

Para alentar a la población a vacunarse, muchas empresas grandes están ofreciendo tiempo pagado o incentivos financieros a los empleados que se vacunan. Por ejemplo, supermercados como Publix les da $125 y Kroger les da $100 a empleados cuando reciben la vacuna completa. Dollar General les aumenta cuatro horas de pago normal a los que se vacunan.

Gracias a la autorización de la nueva vacuna, Presidente Biden afirma que para el fin de mayo habrá vacunas para todos los adultos en EEUU. Las personas que deciden vacunarse, pueden buscar información confiable en el recurso de Telemundo – PlanificaTuVacuna.com para verificar la elegibilidad de acuerdo a las ordenes de cada estado.

Getting more vaccines in arms: Trust and efficiencies

Guest blog by Farah Towfic, PharmD, MBA, director of the U.S. Pharmacopeia COVID-19 Vaccine Handling Toolkit

In the United States, nearly 200 million doses of influenza vaccines are administered annually. Clearly, pharmacists, nurses, physicians, and other healthcare practitioners have demonstrated a successful track record of delivering robust immunization programs for many years. However, the unprecedented scale and speed at which the COVID-19 vaccinations must be delivered to curb the devastating impact of this pandemic has surfaced enormous challenges—which have been further compounded by significant vaccine supply demand.​ Never before have we had to distribute multiple doses to more than 15 billion individuals around the world, with more than 300 million in the U.S. alone.

The pandemic has also recharged the focus on vaccine hesitancy, a challenging and complex issue which, at its core, is about trust based on a person’s experience and perspective. According to the KFF COVID-19 Vaccine Monitor, a growing share of the public is open to getting vaccinated, but many of the same groups that were hesitant in December 2020, when the first COVID-19 vaccines were released, remain hesitant now. When deciding whether to get vaccinated, most people say they will likely turn to pharmacists, doctors, nurses, and healthcare providers as the source for information. The KFF COVID-19 Vaccine Monitor also notes that 85 percent of people trust their own doctor or healthcare provider at least a fair amount for reliable vaccine information.

If we are going to mitigate the impact of this pandemic, we need to help build and maintain trust in COVID-19 vaccines. As an independent, nonprofit, scientific organization, U.S. Pharmacopeia (USP) has been dedicated—for more than 200 years—to improving global health and building trust in medicine through public standards and related programs that help ensure the quality, safety, and benefit of our drugs. With our shared goals to provide patient access to quality medicines, USP is proud to be a founding member of the National Consumers League (NCL) Health Advisory Council. The Council’s informative communication and opportunities for engagement provide critical perspectives that help shape and inform USP’s strategic focus and initiatives. The Health Advisory Council also demonstrates the power of collaboration—which is a cornerstone of USP’s work.

By working together with stakeholders, partners in industry and the U.S. government, we are able to identify the COVID-19 vaccine operational challenges and also provide solutions. One of these solutions is the recently released USP COVID-19 Vaccine Handling Toolkit, which addresses gaps that slow getting shots in arms and helps healthcare practitioners safely deliver vaccines in a variety of settings.

As millions of additional doses of COVID-19 vaccines are released, the USP COVID-19 Vaccine Handling Toolkit is helping doctors, nurses, pharmacists, and other healthcare practitioners create operational efficiencies to vaccinate more people in their communities quickly and safely, all the while maintaining quality. It includes strategies in three key areas:

  • Preparation and labeling to support different practitioners preparing and administering vaccines including how to maximize the number of doses per vial and enabling pre-drawing of vaccines in advance of large immunization events.
  • Storing, handling, and transporting the vaccine to mass vaccination clinics, nursing and long-term care facilities, and more.
  • Waste prevention and disposal to support settings in preventing vaccine waste and addressing gaps for vaccine administrators in proper disposal of ancillary supplies, such as syringes.

“Using the strategies from the USP Vaccine Handling Toolkit for pre-drawing syringes and streamlining our processes and workflow we increased shots in arms by 50% per day,” says Patricia W. Slattum, Pharm.D., Ph.D., BCGP, a vaccine administrator with the Virginia Medical Reserve Corp and Virginia Commonwealth University.

More than 40 independent expert volunteers along with U.S. government representatives developed this toolkit that enables healthcare practitioners to benefit from consistent, scientific-based strategies developed by independent experts that close efficiency gaps across states and territories.

The USP COVID-19 Vaccine Handling Toolkit is one of several initiatives USP is undertaking to support quality and build trust in COVID-19 vaccines, treatments, and preventatives. For example, our Hand Sanitizer Toolkit, launched in spring 2020, is being used by many around the world to ensure quality preparation of this essential COVID-19 preventative.

As the nation’s pioneer consumer organization, that leads the charge on the importance of adherence to live-savings medicines, NCL plays a pivotal role in helping to build trust in vaccines. USP values the opportunity to share the COVID-19 Vaccine Handling Toolkit with NCL and looks ahead to future opportunities to partner with NCL and other stakeholders in the patient advocacy community.

As more is learned about COVID-19 vaccines, additional information will be shared in the future. We encourage NCL’s readers to sign-up for updates at www.usp.org/covid-vaccine-handling​.

About USP
USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. Through our standards, advocacy, and education, USP helps increase the availability of quality medicines, supplements, and food for billions of people worldwide.

NCL encourages HHS nominee Becerra to continue efforts to help lower consumer out-of-pocket costs at the pharmacy counter

March 1, 2021
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC—The National Consumers League is encouraging the Department of Health and Human Services (HHS) nominee Xavier Becerra to continue critical efforts to help drive down consumer out-of-pocket costs of medicines at the pharmacy counter.

Last week, Becerra testified before the Senate HELP Committee as his confirmation hearings were underway. If confirmed, Becerra would play a critical role in helping consumers pay no more than necessary for the medications they need by addressing the role pharmacy benefit managers (PBMs) play in determining what consumers pay and why.

NCL Executive Director Sally Greenberg weighed in with the following statement:

“PBMs have repeatedly promised to lower costs for patients, but unfortunately we’ve not seen this in action. When it comes to prescription drug access and affordability, we should all be on the side of consumers, rather than middlemen corporations. The challenges posed by COVID-19 serve as a daily reminder of the importance of standing up for individuals and families that don’t have the knowledge or patience to understand why they’re subjected to PBM schemes. If confirmed, Attorney General Becerra will have the opportunity to continue working on this issue and helping to ensure PBMs uphold their promise to consumers. Everyone in the health care system needs to work to reduce costs for consumers, who are burdened by high costs across the board. We look forward to joining with him to get to the heart of why out-of-pocket costs are rising and, most importantly, what can be done about it.”

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
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Jeanette Contreras portrait

Vaccine recommendations for those who recovered from COVID-19

By NCL Director of Health Policy Jeanette Contreras

As the United States prepares for the release of a third COVID-19 vaccine, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) meets to discuss further implementation considerations that will inform guidance for the vaccine rollout. At its March 1 meeting, ACIP dedicated a portion of the discussion to whether those who’ve recovered from the virus should still be vaccinated.

To date, there are more than 28 million confirmed cases of COVID-19, and experts estimate that the true number of individuals infected, yet not clinically confirmed, to be triple that amount, pushing the total prevalence to approximately 100 million. A recent study by the National Institutes of Health (NIH) indicates that those who’ve recovered will have a certain amount of natural immunity to the virus for up to eight months after infection, which is in line with the findings of a major British study published in early February, in which 88 percent of participants who previously tested positive for COVID-19 still had antibodies after six months.

Considering that the demand is greater than the supply, it is a difficult task to make recommendations for the equitable distribution of vaccines. For example, Spain issued recommendations that patients wait six months after diagnosis to get vaccinated if an individual is under age 55 with no major health complications. People over 55, or those with health risks that make them vulnerable to reinfection, are exempt from this delay and encouraged to be vaccinated.

Additionally, early studies are showing that immunity in individuals who had recovered and received one shot may be equal to or even exceed those not infected who had received two doses. According to the University of Maryland School of Medicine, a single dose of the Moderna or Pfizer mRNA vaccines would elicit an immune system response sufficient to provide comparable immunity to two doses in a non-infected person. On February 12, France became the first country to issue guidance recommending that people who have already recovered from COVID-19 only need to receive one dose of a vaccine, between 3 and 6 months after their infection.

Early research like this is informing public health policies in other countries. But the United States is known all over the world for its scientific rigor and reliance on randomized clinical trial data as a gold standard. In a recent blog, NIH Director Dr. Francis Collins reassures us that, should other studies support these early results, the experts at the Food and Drug Administration (FDA) and CDC will certainly consider whether one dose is enough.

The implementation of a one-dose vaccine would help to increase supply, however, the emergence of COVID-19 variants presents new challenges for curbing this pandemic. Current CDC guidance states that even if you’ve recovered from COVID-19, you should get vaccinated. Arming yourself with a vaccine will keep you and your family safe, and ultimately help to stave off new COVID-19 variants.

NCL testimony before FDA on Janssen Biotech COVID-19 vaccine

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

February 26, 2021

NCL’s Associate Director of Health Policy Nissa Shaffi testified before the FDA’s Vaccines and Related Biological Products Advisory Committee at the Center for Biologics Evaluation and Research. Read her testimony.

Hana El Sahly, M.D., Chair
Vaccines and Related Biological Products Advisory Committee
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993

RE: Docket No. FDA-2021-N-0173; for Vaccines and Related Biological Products Advisory Committee

Good Afternoon. I am Nissa Shaffi, present today on behalf of the National Consumers League. I have no conflicts of interest to disclose. Our organization extends its gratitude to the Vaccines and Related Biological Products Advisory Committee, for the opportunity to amplify consumer voices regarding the Janssen Biotech COVID-19 vaccine.

For over 120 years, NCL has championed efforts to increase vaccine education, safety, and access for consumers. As consumer advocates, we thank the Food and Drug Administration for their commitment to fostering public trust throughout the development and approval of a vaccine for COVID-19. We have been encouraged by the transparency and opportunities for engagement afforded to the public during this process.

Emergency Use Authorization (EUA)

Consumers are relying on the FDA more than ever for guidance pertaining to treatments for COVID-19, and preserving their confidence in the Agency is of vital importance at this time. Emergency Use Authorization, while not intended to replace randomized clinical trials, has been a critical component to the nation’s pandemic strategy. NCL appreciates the FDA’s recognition of clinical trials as vital to demonstrating the safety and efficacy of a treatment.

Safety and Effectiveness

We are encouraged by reports indicating that the Janssen Biotech vaccine has proven to be effective against hospitalizations and deaths from COVID-19. The added benefit of another vaccine is to decrease virus mutation. Presently, three, far more contagious, variants of COVID-19 spread and could hamper efforts to quell the virus. We are reassured that the Janssen vaccine has demonstrated efficacy against certain variants. As new data is collected, we call on the FDA to perform post-market surveillance to monitor ongoing efficacy.

Health Equity

Vaccine hesitancy and social determinants of health remain critical obstacles in the vaccine rollout process. The Janssen Biotech single-shot vaccine has the potential to increase access for hard-to-reach communities, bringing us closer to herd immunity. This week, we marked a grim milestone, as half a million Americans have now perished from this relentless virus. Amidst this loss, the continued development of vaccines for COVID-19 has provided the nation with much-needed hope and respite.

As the Committee deliberates on the Janssen Biotech COVID-19 vaccine, we request the Agency to also consider the benefit its release would have for historically disadvantaged communities, for which this vaccine would be logistically more accessible than the prior two vaccines.

Thank you to the Committee for your consideration of our views. Through our consumer education work, NCL will continue to support FDA in its efforts to develop a safe, effective, and expedited pathway towards a vaccine for COVID-19.

Sincerely,

Nissa Shaffi
Associate Director of Health Policy
National Consumers League

 

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
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NCL testimony before CDC’s Advisory Committee on Immunization Practices highlights Hep. B vaccine disparities

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

February 24, 2021

NCL’s Associate Director of Health Policy Nissa Shaffi testified before the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices today. Read her testimony.

José R. Romero, MD, FAAP, Chair
Advisory Committee on Immunization Practices
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., Mailstop A27
Atlanta, GA 30329-4027

RE: Docket No. CDC-2021-0008; Advisory Committee on Immunization Practices (ACIP)

Good Afternoon. I am Nissa Shaffi and I will be presenting public comment on behalf of the National Consumers League. For over 120 years, NCL has championed vaccine education and access for consumers who depend on these lifesaving medical interventions. We extend our gratitude to the Advisory Committee on Immunization Practices for the opportunity to serve as a voice for consumers.

NCL remains committed to educating consumers on the value and safety of immunizations. During the COVID-19 pandemic immunization rates have dropped drastically, which means that our work is needed more than ever. Even under ordinary circumstances, vaccines are underutilized in adult populations, especially among racial and ethnic minority communities.

Health disparities contribute largely to the burden for Hepatitis B infection, with Asian/Pacific islanders and non-Hispanic black communities having the highest rates of HBV-related death. Despite vaccine recommendations, there is an estimated prevalence for chronic HBV infection in the US of nearly 1.6 million persons (range 1.2–2.5 million).

NCL is concerned that the updated guidance for those over 60 years of age with diabetes getting vaccinated only upon shared decision making with their providers will not address the health disparities that persist. The populations at greatest risk for HepB infection are those that are more likely to lack access to health care and not have a primary care medical home. NCL would like to see the CDC support a large-scale education and outreach campaign to raise awareness of the risk of HepB in older adults and call for increased HepB screening in high-risk communities across the country.

NCL similarly shared its disappointment in response to ACIP’s 2019 recommendations for the pneumococcal vaccine to be administered for those over 65 years of age with shared decision making based on the rationale that childhood vaccinations had dramatically reduced the spread of this disease. However, pneumococcal disease continues to result in an estimated 150,000 hospitalizations per year. And adults over age 65 remain at increased risk for pneumococcal disease.

In light of the drop in childhood immunizations induced by the pandemic, the CDC may want to issue caution statements to providers that herd immunity may have diminished compared to years prior for many of the diseases we target with the most commonly recommended vaccines. As a commitment to our advocacy, NCL continues to reaffirm that vaccines save lives and will continue to support increased immunizations for preventable diseases.

In closing, we encourage ACIP to maintain effective public messaging and strong vaccine recommendations to instill vaccine confidence, so that the American public feels safe and informed in their decisions to vaccinate across the lifespan.

Thank you for your consideration of our views on this important public health issue.

 

Sincerely,

Nissa Shaffi
Associate Director of Health Policy
National Consumers League

 

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
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Preventing the spread of COVID-19: Testing & genetic sequencing efforts in response to emerging variants

With growing concerns regarding the impact of emerging COVID-19 variants, testing and genetic sequencing are critical components of broader return-to-work, return-to-school, and public health surveillance efforts.

Addressing health inequity: A critical step towards a successful national vaccine rollout strategy

Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

The COVID-19 vaccines have provided much needed doses of hope as consumers eagerly wait for their shots. However — due to competing pressures of managing inadequate supplies, complex state-managed distribution plans, emerging viral variants, and unaddressed health disparities — the national vaccine rollout has fallen short of its intended goals.

To date, more than 40 million have received at least one dose of a COVID-19 vaccine, and 16+ million people are currently fully-vaccinated. On average, providers around the country are administering 1.6 million doses per day. According to experts, 70 to 90 percent of the population will need to be vaccinated if we are to achieve herd immunity and return to normal everyday activities.

The delays in the vaccine rollout have been attributed to variations among states and territories, which have been expected to set their own distribution plans and eligibility criteria. All states have made the vaccine available for healthcare workers, and nearly 43 states and the District of Columbia have expanded their eligibility to include occupation-based vaccination programs. These include members of the non-medical essential workforce, like grocery store employees and police officers.

While vaccine hesitancy among some Americans remains a problem, it’s becoming less of a concern as more and more people are getting vaccinated. COVID-19 has further exposed both vulnerabilities in our infrastructure and social determinants of health — conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect their overall health — that threaten to impede access. Throughout the rollout, vulnerable communities have experienced barriers in booking vaccine appointments due to limited access to broadband, phones, and accessible, affordable transportation.

Vaccine hesitancy and social determinants of health remain the primary obstacles in the rollout process. Going forward, addressing health disparities will be a critical strategy in realizing a successful national response, because — without health equity — the virus will continue to ravage the most vulnerable communities. The National Consumers League supports comprehensive strategies to address the glaring disparities in health and access that COVID-19 has exposed.

NCL applauds White House efforts to expand vaccine rollout

For immediate release: February 22, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org(412) 945-3242 or Taun Sterling, tauns@nclnet.org(202) 207-2832

Washington, DC—The National Consumers League (NCL) strongly supports the White House’s latest efforts to ramp up supplies to help expedite the national vaccine rollout plan. The Biden Administration has unveiled plans to mobilize federally-organized distribution channels to ensure Americans get as many shots in arms as possible. President Biden has promised to increase vaccine supply capacity to inoculate 100 million people within the first 100 days of his presidency. The ultimate goal is to have 300 million vaccines (600 million doses) in supply by this summer, which means that at least 50 percent of the population can be partially vaccinated by June. At this rate, we can expect that nearly 90 percent of the population will be fully vaccinated by December.

To meet these demands, the President has invoked the Defense Production Act to ramp up production of vaccines and personal protective equipment (PPE). The Administration has also partnered with the Federal Emergency Management Agency (FEMA), to set up vaccination sites around the country. To help expand capacity and access to vulnerable communities, President Biden has galvanized Federally Qualified Health Centers (FQHCs) in the national response. As of February 15, FQHCs will receive supplies of the vaccines to reach individuals most at risk during the pandemic. Community pharmacies have also been engaged in rollout efforts to broaden access to historically disadvantaged communities, located farther from health services.

NCL appreciates the confidence this administration has placed in community health centers and pharmacies as a critical component in the national COVID-19 response.

“NCL has long recognized the vital role that pharmacists and other health professions play in our nation’s public health, through our decade of hosting the public health outreach campaign, Script Your Future,” said NCL Associate Director of Health Policy Nissa Shaffi. “We commend the Administration’s efforts to augment access to vaccines by leveraging federal and community resources. These newly-forged relationships will bring the nation closer to reaching herd immunity and making strides in achieving health equity.”

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

NCL supports the Black Maternal Health Momnibus

For immediate release: February 16, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org(412) 945-3242 or Taun Sterling, tauns@nclnet.org(202) 207-2832

Washington, DC—The National Consumers League (NCL) is proud to support the Black Maternal Health Momnibus Act introduced last week by Representatives Lauren Underwood (D-IL) and Alma Adams (D-NC), Senator Cory Booker (D-NJ), and members of the Black Maternal Health Caucus. The Momnibus includes 12 bills intended to comprehensively address the maternal health crisis that disproportionately impacts Black, Indigenous, and women of color in this country.

Among other measures, the Momnibus calls for improvements to data collection and quality measures to help policymakers better understand the causes of maternal mortality in the United States. NCL has long supported policies to improve maternal health outcomes and advocated for increased access to healthcare for vulnerable populations. NCL’s founders supported early studies on the causes of infant mortality at the Hull House in Chicago in the 1890’s.

“It’s inexcusable for a nation as advanced and well-resourced as the United States to have the highest pregnancy-related death rate in the developed world. Our current healthcare system is failing to protect black women, who are three to four times more likely than white women to die from pregnancy-related complications,” said NCL Director of Health Policy Jeanette Contreras.

“We must also recognize the association between institutional racism and adverse birth outcomes among Black, Indigenous, and women of color,” said Contreras. The Momnibus provides investments to address the social determinants of health that create inequality, such as access to housing, transportation, and adequate nutrition. The legislation also provides funding to the community-based organizations whose work is integral to the support system shown to be effective at improving maternal health outcomes. The legislation further ensures that our most vulnerable moms have access to quality care throughout the pregnancy and during the critical first year of the infant’s life.

“NCL strongly supports the proposal to extend Medicaid and CHIP coverage to 12-months for postpartum care to mothers,” said Contreras. “As well as the legislation’s investments in diversifying the perinatal workforce—critical to providing culturally competent care to Black, Indigenous, and women of color. We enthusiastically call on Congress to support the passage of this comprehensive legislation to address the escalating maternal mortality crisis in this country.”

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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.