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.

Jeanette Contreras portrait

How to protect consumers from PBM greed

By NCL Director of Health Policy Jeanette Contreras

The rising cost of health care is a sore point for all consumers and nowhere is it more glaring than at the pharmacy counter. However, consumers are largely unaware that Pharmacy Benefit Managers – or PBMs – are the middlemen working behind the scenes with very little competition and accountability. There are now just three PBMs that account for about 77% of all equivalent prescription claims. This lack of competition allows PBMs to easily manipulate the price and make it impossible for consumers to get a fair deal.

There is plenty of blame to go around when it comes to the rising cost of prescription drugs. But PBMs ultimately control which medicines we get (and don’t get) and how much we pay out of pocket for them. That’s exactly why the Federal Trade Commission (FTC)– whose mission is to protect consumers and competition – has requested public comments on the ways these large, middlemen companies are affecting drug affordability and access.

I recently led a discussion with key experts to discuss this issue. NCL’s Executive Director Sally Greenberg, Former FTC Policy Director David Balto, and HIV + Hepatitis Policy Institute Executive Director Carl Schmid, shared their insights with us.

David Balto explained, “There are three things needed for a market to really function effectively – you need to have choice (competition); second, transparency – that is you know what you’re getting and what the benefit of the bargain is; and third, that there’s no conflict of interest. In the PBM market, PBMs fail on all three grounds.”

PBMs initially came into existence to streamline how consumers get their medicines and were intended to lower costs. However, as Sally Greenberg pointed out, “The fact that PBMs have the influence and decision-making authority they do should be concerning for all consumers. PBMs have the power to negotiate discounts with drug manufacturers, they work with insurance companies to determine which drugs will ultimately be covered, and they work with pharmacists to reimburse them for dispensing drugs. All along the way, they’ve found ways to profit – and all along the way this impedes the savings that should be going to consumers.”

Carl Schmid shared more about how this impacts patients, “We’re now seeing the creation of specialty drugs or specialty tier (on formularies). This is a term created totally by the PBMs…now it’s just any new drug – all HIV drugs, all Hepatitis drugs, all cancer drugs – they’re all specialty drugs these days and they put them in the highest tier. And this not only creates higher out-of-pocket costs for patients, but it’s also discriminatory.”

These unfair PBM practices lead to unnecessarily high out-of-pocket costs for prescriptions while PBMs continue to find ways to game the system to their benefit. The FTC wants to hear from consumers and patients who have been negatively impacted by these PBM practices.

Watch the full discussion here to learn more about the PBM problem. Then share your story with the FTC here.

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.

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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 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.

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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 leads effort to encourage FDA to adopt safer standards for OTC hearing aids

March 10, 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 – Today, National Consumers League (NCL), along with 29 not-for-profit, public health organizations from across the country, sent a letter to the U.S. Food and Drug Administration (FDA) regarding the agency’s ongoing process to establish regulations that will soon allow hearing aids intended for adults with perceived mild to moderate hearing loss to be sold over-the-counter (OTC) without any involvement of a medical professional. As the FDA finishes developing its final OTC hearing aid regulation, we urge the agency to include stronger measures to better protect consumers affected by this new category of medical devices.  

We applaud the FDA for its efforts to provide increased access and affordability through the creation of this new category of hearing aids. At the same time, the FDA must ensure these devices are safe, particularly given that many consumers will purchase OTC hearing aids without knowing their clinical level of hearing loss and not having any support from a medical professional. In addition to hearing loss, many OTC hearing aid users may also have other medical challenges impeding their ability to recognize and/or react to loud or uncomfortable sounds produced by these hearing aids. Under such circumstances, the need to ensure OTC hearing aids fulfill their intended purpose without risking unintended harm cannot be understated. 

The letter states: “To ensure the safety of consumers, we believe the FDA should implement the recommendations of the nation’s leading associations of hearing care professionals, including the American Academy of Otolaryngology-Head and Neck Surgery, American Academy of Audiology, American Speech-Language-Hearing Association, and International Hearing Society. These associations are urging the FDA to lower the maximum sound output to 110 decibels and establish an amplification (or gain) limit of 25 decibels. These associations, as well as respected entities like the World Health Organization and the Centers for Disease Control and Prevention, have made clear that allowing sounds to enter the ears of consumers at the proposed levels can cause serious and permanent hearing damage within mere seconds.” 

Importantly, these recommendations will not have any impact on the FDA’s goal of providing increased access to affordable hearing devices, compromise the effectiveness of OTC hearing aids, or discourage innovation—they will only make them sufficiently safe for consumers with mild to moderate hearing loss.  

Read the full letter HERE. Learn more about the issue here: OTC Hearing Aids- Gain and Output 

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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.

 

Why we need more Black health professionals in the workforce

By NCL Health Policy Associate Milena Berhane

A lack of diversity in the health care workforce has been a persistent issue in the United States, posing significant implications to health equity, particularly for the Black or African American community.

An estimated five percent of physicians identify as Black, despite making up 13 percent of the U.S. population. A recent study utilizing U.S. Census Bureau information found that the proportion of Black physicians in the United States has only increased by four percent in more than a century — from 1900-2018. This study also reported that the percent of Black male physicians has remained relatively stagnant since 1940. Diversity issues also exist in other health care professions, with an estimated 7.8 percent of nurses, 3.8 percent of dentists, and 2.5 percent of physical therapists being Black.

The education, testing, application, and interviewing process required to pursue a career in health care is rigorous and costly. In addition to a four-year degree, candidates are also required to take standardized exams, pay expensive application fees, and pay for travel to interview. Most medical students expect to spend up to $10,000 for the application process. Once accepted to a health professional program, the tremendous monetary and time costs of schooling are immense obstacles for many. Medical school attendees accumulate an average $200,000 of student loans by the time they are finished with their programs.

Due to generations of systemic racism in our country, Black Americans are less resourced — financially and in terms of social capital — than their white counterparts. The rigorous process of applying to and remaining in health professional programs creates a pipeline that excludes disadvantaged students from the ability to pursue careers in clinical care.

The barriers to enter the workforce have further negative impact on communities and health equity. Black patients face a variety of issues that can influence their ability to access medical care, including medical mistrust caused by historical unethical medical mistreatment faced by Black Americans, dismissal of health concerns that Black patients express to health care providers, and others. Time and time again, Black patients have shared their experiences of medical providers ignoring their health concerns, and therefore being undertreated and going undiagnosed for their conditions. In addition, research indicates that Black patients report poorer patient-provider communication and shared decision-making. These issues lead to Black patients receiving lower quality care from medical providers, further worsening health conditions that could be treated.

Racial bias and a lack of culturally competent medical care in the healthcare system has led to poorer health outcomes for Black patients. Black Americans of all ages already face higher rates of hypertension, asthma, diabetes, and other health issues due to systemic racism and how it has affected the environments they live in, the food they have access to, their education prospects, income, etc. These inequities compiled with a culturally incompetent and bias medical system leaves Black Americans with little ability to receive proper medical treatment and improve their health and well-being. Although medical schools are attempting to teach the importance of culturally competent care, it is crucial that Black patients are also able to access healthcare providers that look like them and come from their communities.

Clearly, the current make up of racial diversity of the health care workforce has failed to keep up with the demographic shifts in the United States. Although public health efforts are important in addressing and improving health equity, inequities within the medical system must be addressed simultaneously. The COVID-19 pandemic has only highlighted and exacerbated health inequities. Increasing the amount of Black health professionals across the United States is a critical step in ensuring better health outcomes for Black patients and their overall well-being.

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.

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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.