NCL comments on Proposed Rule – Fish and Shellfish; Canned Tuna Standard of Identity and Standard of Fill of Container

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November 21, 2023

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831

The National Consumers League recently submitted comments regarding the Proposed Rule, “Fish and Shellfish; Canned Tuna Standard of Identity and Standard of Fill of Container.” We believe that the Proposed Rule, when implemented, will modernize the standard of identity for “canned tuna,” 21 C.F.R. § 161.190 (“canned tuna SOI”), to require an accurate measure and declaration of weight, and to allow for “safe and suitable” ingredients to provide manufacturers with the flexibility to keep up with changing consumer tastes.

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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 nclnet.org.

NCL comments regarding Proposed Rule: Medication Guides: Patient Medication Information Docket No. FDA-2019-N-5959

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November 21, 2023

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831

The National Consumers League recently submitted comments regarding the Proposed Rule, Medication Guides: Patient Medication Information, that we believe will greatly improve the information patients receive with their prescription medicines.

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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 nclnet.org.

NCL applauds President Biden’s landmark AI executive order 

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October 31, 2023

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831

Washington, DC – Yesterday, President Biden signed an executive order to establish the most comprehensive standards to date regarding artificial intelligence (AI). The following statement is attributable to National Consumers League (NCL) Chief Executive Officer Sally Greenberg:

“NCL applauds the Biden Administration for centering consumers and workers in its landmark executive order addressing AI. It is critical that the development of artificial intelligence aligns with our democratic values, preserves civil rights, and protects consumers’ health and safety as well as our privacy. Importantly, the Biden Administration has made clear that there is no exception for AI from the law as it continues to model how policymakers should tackle this issue. While the president’s order is a critical step forward, Congress must pass a robust bill to ensure lasting and comprehensive federal law governing AI.”

As part of the sweeping executive order, federal agencies are to provide clear guidance to landlords, federal benefits administrators, and federal contractors to ensure that AI does not discriminate against consumers and beneficiaries. The president also addressed the potential harms to workers from the use of AI in workplace surveillance, job displacement, union-busting, and discriminatory hiring practices.

NCL has been advocating for consumers and workers in our push for AI regulation, including requiring the labelling of AI-generated content to minimize deception to users.

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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 nclnet.org.

 

NCL statement on PBMs and new GAO report

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September 18, 2023

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831

WASHINGTON, DC – The National Consumers League (NCL) today released a statement following a recently released U.S. Government Accountability Office (“GAO”) report on Medicare Part D rebates.

The following statement is attributable to NCL Chief Executive Officer, Sally Greenberg:

“Investigation after investigation, report after report, and study after study prove that pharmacy benefit managers (“PBMs’) do not provide benefits to consumers. To the contrary, we believe PBMs, who are middlemen, drain billions of dollars that should be going into the pockets of patients and consumers and help them defray their healthcare costs. The evidence mounts that PBMs, which once had a noble purpose, have lost their way and become profit centers unto themselves, adding costs to our drug supply system at the expense of patients. This latest report by GAO underscores that our nation’s seniors – often our most vulnerable patients who rely most on medications – pay the highest price for PBM practices.

“In just one year, GAO found that the PBMs collected almost $50 billion in rebates from prescription drug manufacturers under the Medicare Part D program alone. These savings should go directly to Medicare beneficiaries, but for the nearly 80 of the highest rebated drugs analyzed, GAO found that seniors paid more than $20 billion, while their plan sponsors — often vertically integrated with PBMs — paid only $5.3 billion. PBMs are able to enrich themselves because they control access to prescription drugs, block competition, conduct business in the shadows, and pocket discounts meant for patients. PBMs simply driving up out-of-pocket costs for Medicare beneficiaries to the tune of millions of dollars.

“Congress has an opportunity to enact meaningful PBM reforms to prevent such behavior. We urge our leaders in Congress to closely examine the findings of the GAO report, and put a stop to the practices of PBMs to profit off of vulnerable patients. In doing so, our elected representatives will put money back in the pockets of patients and help them to better afford the medications they need.”

Learn more about NCL’s work to address the PBM problem at nclnet.org/pbms.

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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 nclnet.org.

NCL welcomes FDA heightened concerns related to CBD products

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December 29, 2022 [Updated]

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 703-298-2614

Washington, D.C. – The National Consumers League (NCL), the nation’s oldest consumer advocacy organization, is welcoming of the FDA’s heightened concern and attention to consumer safety risks in the CBD or cannabidiol consumer product market.

“The FDA’s continued engagement and work in the CBD consumer product market is critical to protecting consumer safety – the agency’s increased attention to CBD products is welcome news,” said Sally Greenberg, NCL’s Chief Executive Officer.

In 2019, in response to the proliferation of unreviewed and untested CBD products, NCL identified the need for greater education among consumers about CBD and better enforcement of regulations in the CBD marketplace. NCL created Consumers for Safe CBD to address this need, champion the rights of consumers, and call on government and industry to do better – to ensure safety and promote a pathway for new products through clinically tested scientific research.

Since then, action has been taken on the state and federal levels to increase access to cannabinoids beyond CBD, which is why NCL is now shifting its focus to cannabis more broadly with the establishment of Cannabis Consumer Watch. Cannabidiol (CBD) is a chemical compound found in cannabis plants. It is one of the main ingredients in cannabis, but unlike THC, it does not cause a high or have psychoactive effects.

“NCL called on the FDA to develop regulations for the CBD marketplace. We also asked the CBD industry to ensure safety and promote a pathway for new products through clinically tested scientific research,” said Greenberg.

The 2018 Farm Bill legalized hemp cultivation in the U.S., which led to significant growth in the CBD marketplace.

“Since 2019, NCL and other groups like the Consumer Federation of America and Community Anti-Drug Coalitions of America have been asking the FDA to step in and address the CBD marketplace – which is currently a ‘Wild West,’ with myriad unsubstantiated claims made by many in the industry about the so-called benefits of CBD products for everything from sleep disorders to cancer to pain relief, without regard to safe dosages,” Greenberg noted. “We want the agency to establish a regulatory framework for the legal sale of appropriate cannabis and cannabis-derived products. Some industry members have been asking for rules of the road as well. Any regulatory framework FDA recommends for cannabis-derived products must prioritize consumer safety and address the safety risks the agency has identified.”

There is only one FDA-approved drug on the market that employs CBD as its active ingredient – Epidiolex – a medication to treat a rare form of childhood epilepsy. That drug has undergone the rigorous FDA approval process and thus has substantiated therapeutic benefits that outweigh the risks which can be managed by prescribing physicians.

Cannabis Consumer Watch will continue to work to educate consumers about the potential dangers of CBD in an unregulated market and encourage the FDA to take strong, effective, and prompt action to protect the public from the potential harms posed by unregulated, untested CBD.

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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 https://nclnet.org.

NCL comments on pediatric COVID-19 vaccines before CDC’s Advisory Committee on Immunization Practices

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Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242

Washington, DC—Today, June 24, 2021, NCL Director of Health Policy Jeanette Contreras, submitted written testimony to the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices in support of pediatric COVID-19 vaccines. Her comments appear below.

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- 2021-0060; rescheduled from June 18; new docket no. CDC-2021-0034

Good afternoon. My name is Jeanette Contreras, and today I am representing the National Consumers League (NCL), which for over 120 years has championed the overwhelming safety and efficacy of vaccines and promoted vaccine education. Consumer access to these lifesaving medical interventions is critical. I am also speaking today as a mother of two boys, ages 8 and 9. I appreciate the opportunity to provide public comment before this advisory committee.

The U.S. has reached a tragic 600,000 deaths as a result of COVID-19. The virus continues to spread and mutate around the world. Sadly, 330 children and adolescents are among the 600,000 deaths. Although preexisting medical conditions clearly predispose children to severe disease, healthy children are also at risk for severe COVID-19 and multisystem inflammatory syndrome (MIS-C). Though MIS-C is a rare condition associated with COVID-19, Black and Hispanic children are disproportionately affected, making up 64% of the cases observed in children 1-14 years of age.

Though there is reason to be concerned about the increase in cases of myocarditis or pericarditis following the second shot of the Pfizer and Moderna vaccines, consumers should be reassured that the safety monitoring system, Vaccine Adverse Event Reporting System (VAERS), is working as intended. Federal health officials are investigating the rare cases of which the most common symptoms reported were chest pain, elevated cardiac enzymes, ST or T wave changes, dyspnea and abnormal echocardiography or imaging. We applaud the Centers for Disease Control and Prevention (CDC) for releasing clinical guidance to providers alerting them to consider myocarditis and pericarditis in adolescents or young adults with acute chest pain, shortness of breath, or palpitations. So far, 80 percent of patients reported have made a full recovery.

We commend the coordinated efforts of the U.S. Food and Drug Administration and CDC to monitor the safety and efficacy of the vaccine. The COVID-19 vaccine has been administered safely to over 150 million Americans, and we are on target to reach herd immunity by October, with at least 70% of Americans vaccinated. Given the remarkable evidence of safety and efficacy of the COVID-19 in adults, parents should be assured that the vaccine will keep their children safe.

Our children are vaccinated for measles, rubella, polio, diphtheria, typhoid, and other routine childhood vaccines that have for decades prevented deadly illnesses that historically killed millions of children. Today, thanks to vaccine adherence, these illnesses have virtually been eradicated and far rarer than COVID-19. Unfortunately, uptake for routine pediatric immunizations have declined during the pandemic. It is essential we ensure that children are up to date with their vaccines. We are excited that data show the COVID-19 vaccine can safely be co-administered along with routine pediatric vaccinations. As we consider future educational outreach campaigns to increase vaccine confidence, we should encourage families to seek recommended immunizations for their children along with the COVID-19 vaccine.

As states lift public health emergency protocols across the country, too many of our children remain unnecessarily unprotected. According to the American Academy of Pediatrics, as of June 10, over 4 million children have tested positive for COVID-19 since the onset of the pandemic. About 14,500 new child cases were reported last week. We are only beginning to understand the long-term health effects associated with COVID-19, which include extreme fatigue, rapid heart rate, memory loss, gastrointestinal problems and other symptoms that are lasting months after infection. There is a need to collect more data on the long-haul effects on children, and to provide assistance to families who are struggling to find care for their children. We urge the CDC to provide guidance to providers and patients on what to look for when treating children who were previously infected with COVID-19.

As I dropped my 8-year-old at camp yesterday, I was telling him how beginning July 1 we won’t need to wear masks. He asked me “is that because everybody will be vaccinated- except me?” My husband and I are vaccinated, but our family is still at risk of being infected by any of the emerging variants. And when school-aged children return to the classroom in the fall, we may face a spike in pediatric cases.

Through our education and outreach efforts, the National Consumers League will continue to support efforts to vaccinate the nation across lifespan. The absence of a COVID-19 vaccine for pediatric populations will lead to continued transmission and leave children at risk for infection. To achieve meaningful herd immunity, we will need to ensure that children have access to a safe and effective COVID-19 vaccine, and also consider the unique disparities that children of color experience in the face of the pandemic.

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

Sincerely,

Jeanette Contreras, MPP
Director of Health Policy
National Consumers League

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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.

National Consumers League applauds the awarding of the prestigious Iqbal Masih Child Labor Award for the Elimination of Child Labor to Norma Flores López and the International Labour Organization

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June 11, 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), America’s pioneering consumer and worker advocacy organization and a leader in the fight to reduce child labor globally, welcomes the awarding of the Iqbal Masih Child labor Elimination Award to the Norma Flores López and the International Labor Organization on Thursday.

Iqbal Masih, for whom the award was named, was sold into slavery in his native Pakistan as a rug weaver at age 4, and escaped his captors at age 10. He became a prominent voice against child labor before he was murdered for his activism at age 12.

Norma Flores López, who is a member of NCL’s Board of Directors, works closely with NCL on the Child Labor Coalition (CLC), which NCL founded and has co-chaired since 1989. The following statement is attributable to NCL Executive Director Sally Greenberg:

Norma began working in U.S. fields as a small child, and as a teenager began to speak out against the exploitation of farmworker children – something NCL and the CLC has combatted for decades. She has been a tireless advocate against child labor and has shared her experiences and expertise at numerous international conferences, in newspapers, and on television news magazines, including 60 minutes. Today, Norma heads the CLC’s Domestic Issues Committee, helping us to develop strategies to equalize protections for children who have entered work at early ages. We’re so pleased that Norma’s passion and commitment for protecting children has been recognized with this prestigious award. NCL also works closely with the International Labour Organization, and applauds its recognition as a leading player in the fight against child labor.

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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.

June 10 testimony before FDA’s Vaccines and Related Biological Products Advisory Committee

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

Washington, DC—Today, June 10, 2021, NCL’s Associate Director of Health Policy Nissa Shaffi, testified before the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, about the ongoing rollout of COVID-19 vaccines for pediatric populations. Her testimony appears below:

Arnold Monto, M.D., Acting 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-0458; for Vaccines and Related Biological Products Advisory Committee

Good afternoon. My name is Nissa Shaffi, and I am representing the National Consumers League (NCL). I have no conflicts of interests regarding today’s remarks.

The National Consumers League was founded in 1899, by the renowned social reformer Florence Kelley. General Secretary Kelley’s support of vaccinations played a key part in mitigating a critical smallpox outbreak towards the end of the 19th century, and her stalwart advocacy for immunizations has informed NCL’s bedrock principles for vaccine education, confidence, and safety.

122 years later, we are honored to persist in our pursuit to advance vaccines as vital public health interventions, and we extend our gratitude to the Vaccines and Related Biological Products Advisory Committee for the opportunity to present comment during this public hearing session.

Emergency Use Authorization (EUA)

NCL appreciates that the FDA recognizes that Emergency Use Authorization is not intended to replace the rigor of full approval, and that randomized clinical trials are critically important for the definitive demonstration of safety and efficacy of a treatment.

The diligent review and public engagement that went into the EUA process for the COVID-19 vaccines currently available have helped our nation reach key milestones in immunizations.

As our adult populations have benefitted from these critical public health efforts, we are energized to extend that momentum towards our youngest citizens. Through our education and outreach of consumers, we support FDA in its efforts to develop a safe, effective, and expedited pathway towards a COVID-19 vaccine via an EUA to help prevent the spread of the virus in pediatric populations.

Safety and Effectiveness

We have great trust in the FDA’s safety monitoring systems and call on the Agency to perform ongoing post-market surveillance to ensure the vaccine’s continued safety and efficacy.

As we’ve observed with recent vaccine safety concerns, consumers rely heavily on public health agencies to communicate and respond to any potential adverse events regarding the COVID-19 vaccine. We call on the FDA to continue to sustain its robust interagency collaboration as we endeavor to vaccinate the nation.

Pediatric Population Vaccine Uptake

Although children are at a lower risk of COVID-19 compared to adults, and tend to experience milder symptoms, pediatric populations now account for 22% of new COVID cases, compared to 3% last year. As with adults, children and adolescents with underlying chronic health conditions are at higher risk for COVID-19-related hospitalization and death.

The absence of a vaccine for pediatric populations will lead to continuing transmission that will consistently put children at risk for infection.

Furthermore, vaccine uptake for routine pediatric immunizations have declined dramatically during the pandemic. It is essential for public health officials, advocates, and parents to ensure that children are up to date with their vaccines, and that children eligible for the COVID-19 vaccine receive their shots. Data shows that the COVID-19 vaccine currently available for children ages 12-15 is safe and effective, and has been recommended to be co-administered along with routine pediatric vaccinations.

Health Disparities

While COVID-19 has impacted the entire country, it has largely devastated communities of color. Children of color, specifically Black and Hispanic youth, have been especially vulnerable. This has been even more apparent with the prevalence of Multisystem inflammatory syndrome in children, a rare but serious COVID-19-associated condition, that has been observed in children 1- 14 years of age, 64% of which were reported to be Black or Hispanic.

To achieve meaningful herd immunity, we will need to ensure that children have access to a safe and effective COVID-19 vaccine, and also consider the unique disparities that children of color experience in the face of the pandemic.

Thank you to the Committee 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

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 concerned as Senate bill puts consumers at risk from unregulated CBD

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

Washington, DC—On May 19, Senators introduced the Hemp Access and Consumer Safety Act (S. 1698) which directs the U.S. Food and Drug Administration (FDA) to regulate hemp-derived cannabidiol (CBD) products as dietary ingredients or supplements. The National Consumers League (NCL) has long been concerned about the risks posed to consumers by unapproved cannabis-derived products. There is little research on the health and safety of CBD products, and as such the NCL does not support any legislation that would bypass the FDA’s regulatory authority and rigorous scientific review.

Currently, manufacturers and distributors of products containing CBD can petition the FDA for review and approval of a new ingredient as a dietary supplement (21 U.S.C. 350b). This approval process requires manufacturers and distributors to submit scientific data showing that the product is generally regarded as safe (GRAS). “Not only is there insufficient data to designate CBD products as GRAS, the FDA needs further data to determine safe dosage and concentration levels in order to set manufacturing and labeling requirements that ensure consumer safety,” said Jeanette Contreras, NCL Director of Health Policy.

As demonstrated in a white paper published by NCL, companies selling CBD products often focus their research efforts on weak and inexpensive studies, and then use the results for marketing purposes. “Current studies have not enhanced our scientific understanding of CBD, and policymakers should focus on incentivizing further clinical studies to bring new proven medical treatments to patients,” said Contreras. By mandating the FDA to regulate CBD as a dietary ingredient, S. 1698 would only further incentivize CBD manufacturers to forego rigorous clinical trials and the development of FDA-approved medicines. Easier approval as a dietary supplement will disincentivize real scientific research into any potential health benefits or risks of CBD products.

Under S. 1698, CBD manufacturers that make unwarranted claims of treating medical issues will seek expedited approval for their products as dietary supplements, rather than as drugs. We should be encouraging the development of new cannabis-derived medicines that have gone through the rigorous processes of randomized controlled trials and FDA approval. Considering the lack of existing research on CBD, this bill classifying CBD products as dietary supplements would irresponsibly lead to increased consumption of these products and limit the future development of cannabis-derived FDA approved treatments—while putting consumers at risk.

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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.

NCL supports the Protecting Seniors through Immunizations Act of 2021

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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 delighted to support the Protecting Seniors through Immunizations Act of 2021 (H.R. 1978/S. 912), introduced by Senators Mazie Hirono (D-HI), Tim Scott (R-SC), Sheldon Whitehouse (D-RI), and Shelley Moore Capito (R-WV), and Representatives Ann Kuster (D-NH) and Larry Bucshon (R-IN). The bill would expand access to immunizations for seniors by eliminating cost sharing for vaccines covered under Medicare Part D.

The legislation would eliminate out-of-pocket costs for all vaccines recommended by Centers for Disease Control and Prevention (CDC) and covered under Medicare Part D. This would apply to crucial immunizations such as the Shingles and tetanus, diphtheria, and pertussis, or Tdap, vaccines, along with future vaccinations. Currently all CDC recommended vaccines are covered with no out-of-pocket costs under private insurance, Medicaid, and Medicare Part B. Unfortunately, Medicare beneficiaries must often pay out-of-pocket costs of up to $160 for vaccines covered under Part D.

“As healthcare costs continue to skyrocket, policymakers should support legislation that eliminates financial barriers for Medicare beneficiaries to get their CDC recommended vaccines,” said NCL Director of Health Policy Jeanette Contreras. “Research shows that higher cost-sharing means fewer seniors will elect to receive their vaccines. By eliminating out-of-pocket costs for immunizations, older Americans will be better protected from vaccine preventable illnesses.”

More than 50,000 American adults die from vaccine-preventable diseases every year. Among other provisions, this bill would increase education about vaccines for Medicare beneficiaries and would authorize a study to find ways to boost adult vaccination rates. These steps are important at a time when misinformation regarding vaccine safety is spreading rampantly throughout society. Improving access to and utilization of vaccinations will enhance overall health outcomes and help to address existing racial and socioeconomic health disparities.

“Vaccines are amongst the most effective public health measures at our disposal. Routine immunizations can prevent diseases that have the potential to cause severe disease and wreak havoc on our most vulnerable communities,” said Contreras. “We urge Congress to pass the Protecting Seniors Through Immunization Act, to ensure greater equity in access to vaccines, in turn protecting the most vulnerable members in society from unnecessary and easily preventable illness and death.”

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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.