Jeanette Contreras portrait

Leaders in Congress support safe OTC hearing aid standards

By NCL Director of Health Policy Jeanette Contreras

Mild to moderate hearing loss is a difficult reality that millions of Americans struggle with, which is why the availability of over-the-counter (OTC) hearing aids is exciting for those who are impacted by hearing loss. While making OTC hearing aids more accessible is a promising step for consumers, we at NCL would be remiss if we didn’t underscore our concerns around the Food and Drug Administration’s (FDA) proposed OTC hearing regulations as they currently exist.

In December of last year, NCL was one of hundreds of organizations who submitted a comment to FDA’s public docket on the issue; and last month we submitted a letter voicing our concerns to the FDA that was supported by 29 not-for-profit, public health organizations across the country. These organizations collectively represent the concerns of millions of consumers, patients, and individuals impacted by hearing loss.

We want to reiterate our enthusiasm for OTC hearing aids, but as the gold standard of safety in our country, it is imperative that the FDA make sure these devices are safe for consumers and do not worsen a problem they are intended to mitigate. As written, the draft regulations would allow for a maximum sound output level of 120 dBA – equivalent to the volume of a chainsaw or fire engine siren. This is concerning, as exposure to sounds at 120 dB can be dangerous in as little as nine seconds according to the CDC. This is why NCL, along with other leading consumer and healthcare voices, encourage the FDA to follow the recommendations of hearing care professionals, including the American Academy of Otolaryngology–Head and Neck Surgery that recommend a maximum output of 110 dB and a gain limit of 25 dB. Without a limit on gain, OTC hearing aids users will be able to amplify sounds to dangerous levels, and far beyond what Congress authorized when it said these devices must be limited to adults with moderate hearing loss or less.

The safety parameters we are recommending would in no way compromise the efficacy of OTC hearing aids intended for individuals with perceived mild to moderate hearing loss. In fact, a recent study concluded that commercially-available hearing aids programmed according to parameters typical of those used for individuals with mild to moderate hearing loss yield effective output and gain levels and are within the recommended limits specified by leading hearing care organizations and medical experts.

Importantly, the FDA has already cleared several hearing aids for adults with perceived mild to moderate hearing loss that were found to be safe and highly effective during clinical trials. While these devices were authorized under a different category of hearing aids, these devices limit the maximum output to 115 dB or below and gain to 30 dB or less, lower than the amplification limits currently proposed by the FDA. At the very least, the FDA should incorporate these amplification limits in the final OTC hearing aid regulation.

Finally, as we await finalized guidance from the FDA, we applaud leaders in Congress who are standing behind consumers in supporting safe and effective amplification limits. Last month, Congresswoman Betty McCollum (D-MN) and Congresswoman Rosa DeLauro (D-CT) sent a letter to the FDA echoing their safety concerns. The letter states, “[The proposed rule] hurts consumers and patients in two ways. First, it means individuals suffering from greater levels of hearing loss could put off a needed visit with a licensed hearing professional. Doing so could lead to worsening their existing symptoms, delaying an accurate diagnosis and treatment, and even creating irreparable damage to their hearing. Secondly, it means those with perceived mild-to-moderate hearing loss would be exposed to harmful levels of noise that could result in further damage to their long-term hearing. In order to avoid these concerns, FDA should impose a gain limit of 25 dB and an overall output limit of 110 dB.”

Similar to the countless other experts that have also weighed in, we believe that establishing safe amplification limits would not reduce the efficacy of these devices or limit the advancement of innovative technologies. We thank Congresswomen McCollum and DeLauro for being a voice for consumers and patients on this important issue. To learn more about gain and output and how to protect yourself from hearing loss, check out our infographic.

NCL Briefing: measuring the 340B program’s impact on charitable care and operating profits for covered entities

Join the National Consumers League for a panel discussion with experts from Health Capital Group, the Community Oncology Alliance, and Johns Hopkins on this new white paper, which analyzes 340B’s impact on hospital profit margins and charitable care spending and attempts to quantify the amount of program benefits accruing to covered entities, contract pharmacies and patients.

Child Labor Coalition welcomes the reintroduction of the Children’s Act for Responsible Employment and Farm Safety 2022 (CARE Act)

March 31, 2022

Media contact: National Consumers League –  Katie Brown, katie@nclnet.org, (202) 207-2832

Washington, D.C.—The Child Labor Coalition (CLC), representing 38 groups engaged in the fight against domestic and global child labor, applauds Rep. Lucille Roybal-Allard (D-CA) and Rep. Raúl Grijalva (D-AZ) for introducing the Children’s Act for Responsible Employment and Farm Safety (CARE). The legislation, introduced on Cesar Chavez Day, would close long-standing loopholes that permit children in agriculture to work for wages when they are only age 12. The bill would also ban jobs on farms labeled “hazardous” by the U.S. Department of Labor if workers are under the age of 18. The children of farm owners, working on their parents’ farms, would not be impacted by the CARE Act.

“Today, I am re-introducing the Children’s Act for Responsible Employment and Farm Safety (CARE Act) with my friend and co-lead Congressman Raúl M. Grijalva to protect the rights, safety, and future of [children who work on farms],” said Congresswoman Roybal-Allard, Thursday.

“I’m proud to co-lead this important legislation with Rep. Roybal-Allard to protect the children of farmworkers. Farmworkers remain some of the most exploited, underpaid, and unprotected laborers in our nation. They and their children deserve legal protections, better working conditions, and higher workplace standards to protect their health and safety. It’s past time we updated our antiquated labor laws to give children working in agriculture the same protections and rights provided to all kids in the workforce,” said Rep. Grijalva.

“Children working for wages on farms are exposed to many hazards—farm machinery, heat stroke, and pesticides among them—and they perform back-breaking labor that no child should have to experience,” said CLC co-chair Sally Greenberg, the executive director of the National Consumers League, a consumer advocacy organization that has worked to eliminate abusive child labor since its founding in 1899. “Current child labor law discriminates against children who toil in agriculture. It’s time these dangerous exemptions end. We applaud Rep. Roybal-Allard and Rep. Grijalva’s leadership in re-introducing CARE.”

“Ending exploitive child labor on American farms is long overdue and this legislation will result in healthier, better educated farmworker children and help end the generational poverty that afflicts many farmworker families,” said Reid Maki,Coordinator, Child Labor Coalition and Director of Child Labor Advocacy, National Consumers League. The CARE Act has been endorsed by 200 national, regional, and state-based organizations, noted Maki.

“Children as young as 12 are being hired to do backbreaking work on US farms, at risk of serious injuries, heat stroke, pesticide poisoning, and even death,” said Margaret Wurth, senior children’s rights researcher at Human Rights Watch, a CLC member. “Existing US child labor laws are woefully out of date and put child farmworkers at unacceptable risk,” Wurth said. “Congress should act swiftly to adopt the CARE Act and ensure that all children are protected equally.”

The CLC’s strategy for child labor on U.S. farms is guided by its Domestic Issues Committee Chair Norma Flores López who worked in the fields as a young girl. “Decades ago, my family and I were crowding into the back of a pickup truck with our few belongings, and starting our two-day journey towards the fields of Indiana, Michigan, or Iowa. What awaited me, starting at the age of 12, were long hours of back-breaking work earning low wages. I was one of the faces you see in photographs from the fields, hidden behind a bandana.  Fast forward more than 25 years, and we are still fighting for young girls –and boys — who are enduring exploitation, harvesting the fruits and vegetables we eat. The same reality that I once lived awaits the approximately 300,000 children who work on American farms today,” said Flores López, who also serves as Chief Programs Officer of Justice for Migrant Women and was the 2021 recipient of the U.S. Department of Labor Iqbal Masih Award.

“For too long, children laboring in U.S. agriculture have been denied the protections they deserve to ensure their health and well-being. Too often, kids working on commercial farms are subjected to dangerous, unhealthy, work that’s detrimental to their education and far too often results in harm or even death. The CARE Act would address this problem and give children working on farms the same protections as children working in other industries,” said Bruce Lesley, president of the First Focus Campaign for Children, a bipartisan children’s advocacy organization.

In addition to raising the minimum age at which children could work in agriculture, CARE would increase minimum fines for employers who violate agricultural child labor laws when those violations lead to serious injury, illness, or death of minors. The legislation would also strengthen regulations that protect minors from pesticide exposure and improve analysis of child labor health impacts.

###

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 applauds federal funding for maternal health in 2022 appropriations

March 18, 2022

Media contact: National Consumers League –  Katie Brown, katie@nclnet.org, (202) 207-2832

Washington, DC— The National Consumers League applauds the passage of the 2022 omnibus appropriations act. The appropriations bill, signed into law, includes over $1 billion in federal funding to support critical maternal health provisions needed to address the nation’s alarming maternal mortality rates.

We are pleased that many provisions of the Black Maternal Health Momnibus Act of 2021 were included in the FY 2022 appropriations bill. The new law provides a significant increase in funding for the CDC’s safe motherhood & infant health programs. This additional support will help to identify drivers of maternal death rates in the states and expand evidence-based programs and interventions at hospitals and birthing facilities across the nation. The bill also includes a significant funding increase to the Maternal and Child Health Block Grant, which will assist state and local health entities in providing the essential health and social services that our most vulnerable birthing people and babies need.

Provisions from the Maternal Health Quality Improvement Act were also included in the fiscal year 2022 omnibus appropriations bill. These provisions provide funding that supports health professional schools to train future health care professionals about perceptions and biases in maternal health, which currently contribute to inequities in maternal health outcomes. In addition to racial bias, it is critical to invest in diversifying and expanding the perinatal workforce to include nurses, doulas, behavioral health professionals, and other practitioners. In a recent blog post, NCL Health Policy Associate Milena Berhane discusses the importance of diversifying the workforce and the negative impacts of racial bias on the quality of care for racial and ethnic minorities.

We recognize that perinatal suicides, which occur during pregnancy or up to one year postpartum, are a leading cause of maternal mortality in the United States. We are pleased that this appropriations act provides increased federal funding for maternal mental health programs. The additional funding will be critical in expanding access to community-based treatment and recovery services for pregnant people and new mothers who struggle with mental health or behavioral health conditions. The spending bill also funds additional necessary mental health resources, by increasing funding for the 24/7 maternal mental health hotline that is available to pregnant people and new mothers.

NCL applauds Congress for providing funding for critical maternal health provisions within the FY22 Omnibus bill. We will continue to advocate for the passage of additional maternal health provisions in future legislation and spending bills until we end the maternal mortality crisis in our nation.

###

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.

New We Can Do This! podcast episode featuring conversation with feminist Karen Mulhauser tackles reproductive rights, women’s history, and today’s challenges

For immediate release: February 9, 2022
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Katie Brown, katie@nclnet.org, (202) 207-2832

Washington, DC—The National Consumers League (NCL), the nation’s pioneering worker and consumer advocacy organization, has released “A woman’s right to choose: Equal access to health care threatened,” a new episode in its  We Can Do This! podcast series. Hosted by NCL Executive Director Sally Greenberg, the episode features a conversation with Karen Mulhauser, longstanding champion for women’s rights. Mulhauser served as the first appointed executive director of the National Abortion Rights Action League (NARAL) in 1974, shortly after the 1973 Roe v. Wade case was decided by the Supreme Court, securing the right to abortion. After leading NARAL, Mulhauser’s work took many directions, including empowering women to register and vote, and the founding of Every Woman Vote 2020.

“With NCL’s long history in advocacy for safe, effective access to health care, we welcome Karen Mulhauser’s perspective on the historical fight for a woman’s right to choose. Mulhauser gives us an intimate view into why these protections are so important and so fragile,” said Greenberg.

An excerpt of Karen’s interview: “One in three women have an abortion. … My story is one that when I was in college and got pregnant unintentionally, I self-induced, and for decades I didn’t talk about that. But part of what I think needs to happen is that people have to tell their stories. … We are losing our democracy, and that’s why I’m building a voter initiative for this. In my long years of life, this is the most important election of my life. And I want to do whatever I can to mobilize as many people as possible.”

This episode contains sensitive topics. Listener discretion is advised.

This episode is now available on nclnet.org and on Apple Podcasts and Google Podcasts.

NCL’s We Can Do This! Podcast | Episode 16 

“A woman’s right to choose: Equal access to health care threatened”

Episode description: The National Consumers League believes in equal health care access for all, and that includes a woman’s right to choose. With the looming possibility of Roe v. Wade being overturned and new laws adopted in states around the country restricting women’s access to abortion and other reproductive services, we sat down with pioneering abortion rights champion  — Karen Mulhauser  — NARAL’s first Executive Director, for a historical perspective on abortion. Mulhauser discusses her personal story, political organizing and her work to secure rights and protections for women.

### 

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 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.

###

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.