NCL statement regarding efforts to ban menthol tobacco products

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) commends the Food and Drug Administration (FDA) for its efforts to ban menthol cigarettes and flavored cigars. The FDA states it will work to keep menthol flavored tobacco products off the market by enforcing a potential ban against manufacturers, distributors, wholesalers, importers, and retailers. The ban on menthol-flavored tobacco products is a historic measure to address health disparities present in vulnerable communities as a result of unfair marketing practices.

Menthol cigarettes continue to be heavily advertised, widely available, and priced cheaper in Black communities. Tobacco manufacturers have long deployed tactics that lure and entice young people with their menthol-flavored tobacco products, consequently contributing to a gateway for children to initiate cigarette smoking.

“For generations, tobacco companies have disproportionately targeted communities of color with advertisements of highly addictive menthol flavored tobacco products”, said NCL Executive Director, Sally Greenberg. The sales resulting from these predatory marketing practices have ravaged vulnerable communities, particularly African American youth. We applaud this Administration’s effort to protect consumers, particularly from the most marginalized areas of society, from the adverse effects of menthol-flavored tobacco products.

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About the National Consumers League

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.

Jeanette Contreras portrait

PBMs profit while consumers foot the bill. Policymakers must act

By NCL Director of Health Policy Jeanette Contreras

As consumers, when we go to the pharmacy for our medications, we expect a fair price. However, there’s growing evidence that pharmacy benefit managers — or PBMs — have been impeding the savings that should be going to consumers. Consumers deserve  to share in the cost savings, and we need policymakers to step in and help make that happen.

We previously wrote about our disappointment in how PBMs have evolved from once honest brokers to becoming profit driven and greedy, now taking savings away from consumers and patients.

One avenue PBMs use to pocket savings is through pharmaceutical rebates. PBMs negotiate with companies to lock in discounts for drugs in order to secure the drugs’ placement on a list (formulary). PBMs have notoriously leveraged formularies to give greatest access to the drugs that pay the PBMs the largest rebates, leaving less expensive drugs off-limits to consumers.

A recent Senate Finance Committee report found that rebates to PBMs have significantly increased since 2013 (some as high as 70 percent). But these discounts fail to lower the patients’ out-of-pocket costs for necessary treatments, such as insulin. For one product, the manufacturer offered the PBM a 56 percent rebate – which means more than half of the savings for insulin are going to a company that doesn’t even make the lifesaving medication.

Insulin is expensive. Forbes recently reported that newer versions cost patients between $175 and $300 a vial. The story points out diabetes patients need multiple vials, the cost of which add up quickly; the total annual value of rebates and discounts for PBMs is likely to be more than $5,000 per patient. As a result, consumers lose, paying more than many of them can afford for lifesaving drugs.

Another way PBMs profit is by avoiding competition, which would drive value and savings for consumers. Three main PBMs accounted for about 60 percent of all U.S. prescription claims in 2019. And when it comes to insulin, with so few industry players, it’s no surprise that consumers again find themselves on the losing end.

We’re pleased to see that some policymakers in the states are taking steps to address these issues. In New Jersey, the state is shaking things up by creating alternatives to how it contracts with PBMs — which is, in turn, increasing competition and benefitting consumers. New Jersey residents are saving  a bundle (to the tune of $2.5 billion over five years).

In New Hampshire, a recent study shows that the state can expect to save an estimated $17.8-$22.2 million annually thanks to legislation that will utilize a similar competitive PBM contract process.

While this is encouraging news, there is still more work to be done to bring to light the role of PBMs. Policymakers need to step in to ensure PBMs deliver savings to patients as they were originally intended to do. We’re encouraging state and federal action to review the role PBMs play in driving up costs and to address the many loopholes they use to increase profits.

Consumers — not PBMs — should come first at the pharmacy counter. Reach out to your elected officials. Share this story on social media to help raise awareness. And stay tuned as we continue the conversation.

Jeanette Contreras portrait

Expanded Medicaid coverage for postpartum care

By NCL Director of Health Policy Jeanette Contreras

The COVID-19 pandemic has enlightened us to how the social determinants of health adversely impact maternal outcomes in low-income, medically underserved communities. Year after year, the United States continues to have the highest maternal mortality ratio among wealthy countries. In efforts to address this disparity, the American Rescue Plan Act includes a provision that allows states to expand Medicaid coverage to women for up to one year after childbirth.

The dismal maternal and infant mortality rates are directly correlated with the health disparities that disproportionately afflict black, indigenous, and women of color. A 2019 report from the Centers for Disease Control and Prevention (CDC) found that Black women were 3.3 times more likely than white women to die from pregnancy-related complications and Native American and Alaska Native women were 2.5 times more likely than white women to die within a year after childbirth.

Medicaid has traditionally been seen as a safety net for low-income pregnant women and children, providing health coverage that funds more than four in ten births in the U.S. each year. Under federal law, Medicaid must cover pregnant women with incomes up to 138 percent of the Federal Poverty Level (FPL) through 60 days postpartum. Each year, over 1.6 million women across the U.S. are effectively placed at risk for becoming uninsured when that 60-day coverage period ends.

Women who live in states that expanded Medicaid under the Affordable Care Act (ACA) are eligible to continue their health coverage through Medicaid. Additionally, the Families First Coronavirus Response Act, which passed last year, provides states with a 6.2 percent increase to the Federal Medical Assistance Percentage (FMAP) rate to cover new enrollees eligible under the ACA Medicaid expansion as long as the Public Health Emergency is in place or at least throughout 2021. However, the women living in the 14 states that have yet to expand Medicaid would find themselves uninsured.

Under the American Rescue Plan, for the next five years, states have the option to extend Medicaid and the Children’s Health Insurance Program (CHIP) eligibility to pregnant individuals for 12 months postpartum. Though each state’s Medicaid program is different, the inclusion of this provision incentivizes states to extend health care to mothers during the most vulnerable time in their lives. This increased access to health care will pave the way towards improving health disparities for our most at-risk women and infants beyond the pandemic.

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 De Ti Depende 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 órdenes de cada estado.

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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Welcoming FDA’s call for better science, more research on CBD

In 2019, in response to the growing retail market of untested, unapproved cannabidiol (CBD) products, NCL identified the need for greater consumer education and increased regulation at the federal level. NCL and its partners — Consumer Federation of America and the Community Anti-Drug Coalitions of America — created Consumers for Safe CBD to help raise awareness of the unregulated CBD marketplace, champion the rights of consumers, and call on government and industry to do more to protect consumers. This year, we will continue to work with key stakeholders to encourage safe CBD food and beverage products and promote a pathway for new therapeutic products through clinically-tested scientific research.

We’ve come a long way since our launch, and FDA is making progress. Newly former FDA Commissioner Stephen Hahn and Principal Deputy Commissioner Amy Abernethy recently called for better science, more data, and increased testing to determine the risks and benefits associated with CBD. We are encouraged by the commitments outlined in the FDA statement and look forward to continued collaboration with the Biden Administration and the new leadership at the agency to make the CBD marketplace fair, safe, and healthy for consumers.

Read more about the FDA’s comments on the Consumers for Safe CBD here and sign up for CBD updates from our Consumers for Safe CBD campaign here.

Letter to Congress: NCL calls for confirmation of Becerra as Health Secretary

January 22, 2021

Dear Chairman Grassley and Ranking Member Wyden:

The National Consumers League (NCL) is America’s pioneering consumer advocacy organization, representing consumers and workers on marketplace and workplace issues since our founding in 1899. NCL has long advocated for equitable access to affordable quality health care for all. Today, NCL continues to work tirelessly to ensure the nation’s COVID-19 response meets the needs of the communities hardest hit by the pandemic.

As such, we call on the Senate to act expeditiously to confirm the appointment of Attorney General Xavier Becerra to serve as Secretary of the U.S. Department of Health and Human Services (HHS). AG Becerra’s appointment to Secretary of HHS is welcomed by advocates across the health care spectrum. As a nation in the midst of a public health crisis, there has never been a more critical time for bipartisanship. AG Becerra’s speedy confirmation would be a positive step forward to setting aside political ideology and working across the aisle to serve the American people.

AG Becerra is a proven champion for increasing access to health care in low-income minority communities, which are being disproportionately affected by the coronavirus. As Attorney General of California, AG Becerra’s stalwart leadership helped to preserve key consumer health care protections enacted by the Affordable Care Act. We anticipate that Attorney General Becerra will lead the HHS pandemic response with the same health equity and social justice principles he’s employed throughout his career.

NCL strongly supports the nomination of Attorney General Xavier Becerra as the next HHS Secretary and urges this Committee to report his nomination favorably to the Senate. NCL is encouraged this Committee has already begun the nomination process by sending its initial questionnaire to the nominee, and hopes this is an indicator that the diligent work to confirm AG Becerra’s appointment to HHS will commence without delay.

Sincerely,

Sally Greenberg
Executive Director
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.

National Consumers League applauds Congress for surprise billing protections for consumers

For immediate release: December 22, 2020

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 welcomes the inclusion of long-needed surprise billing protections in the COVID Relief Omnibus Spending Bill.

Surprise billing happens when a patient’s insurance doesn’t cover a procedure provided by an out-of-network physician, something patients don’t know or realize when they get a procedure. An estimated one in five emergency visits and one in six inpatient admissions will trigger a surprise bill, which can run into the thousands of dollars.

Medical debt disproportionately drives people into bankruptcy. Bill collectors and hospitals often layer on fees, interest, and penalties, driving the original costs way up. A 2019 study published in the American Journal of Public Health found that 530,000 bankruptcies filed annually are because of debt accrued as a result of treatment for medical illness.

This statement is attributable to NCL Executive Director Sally Greenberg:

“We greatly appreciate the bipartisan leadership of Senators Maggie Hassan (D-NH) and Bill Cassidy (R-LA) in getting the surprise billing language over the finish line. We also thank House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Greg Walden (R-OR), Senate Health Committee Chairman Lamar Alexander (R-TN), and Ranking Member Patty Murray (D-WA) for their early leadership on this issue. This is a shining example of working across the aisle for the betterment of consumers.

Consumers can breathe a huge sigh of relief because under the bill—including the cost of an air ambulance—consumers will be ‘held harmless’ when exposed to out-of-network costs. Once this bill is law, consumers can expect that fees charged will be far more affordable and predictable at in-network rates. We are grateful to Congress for recognizing surprise billing as a predatory practice from which consumers need protection. The committee leadership not only helped to pass a bill but launched an investigation.

After two years of debate and discussion on how health care providers and health plans will negotiate these extra costs, it was agreed that patients should be taken out of the middle of dispute resolution processes. Now, we finally have a workable system for protecting consumers.”

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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.