NCL urges DC Council to reject anti-consumer and anti-worker bill

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June 9, 2023

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

Washington, DC – In preparation for a June 8 hearing, NCL submitted a letter to the DC Council urging that the council reject Bill 25-0280, the “Workers and Restaurants are Priorities Act of 2023.” NCL believes this bill is both anti-consumer and anti-worker and it sets a dangerous precedent for carving out an exemption to our DC Consumer Protection Procedures Act (CPPA) for the sole protection of restaurants.

The letter can be found here.

National Consumers League Calls for Stronger Genetic Privacy Protections

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April 7, 2022

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

Washington, D.C. – The National Consumers League (“NCL”) today called on policymakers in Congress and the Biden Administration as well as industry leaders to adopt the organization’s new “Genetic Privacy Rights,” as guideposts for future actions to protect consumers’ genetic data. The group called for legislation, executive actions, and industry practices that protect the “complete confidentiality” of genetic data. The organization further called for the adoption of an “ethical use” standard prohibiting the use of consumers genetic data for military, surveillance, and similar purposes. Finally, given the emerging misuse of genetic data to violate human rights, the group called for protections against Americans’ genetic data being shared with countries deemed “foreign adversaries” of the United States.

“Unlike a password or credit card number, consumers’ DNA cannot be changed even if it has been compromised,” said John Breyault, NCL’s Vice President for Public Policy, Telecommunications and Fraud. “While personal data of all types can be misused to harm consumers, the unique and inalterable nature of genetic data makes special privacy and security protections necessary. As access to genetic data becomes increasingly widespread in both private and governmental contexts, the threats of misuse have only grown.”

The potential for misuse of genetic data has been highlighted by the activities of foreign adversaries of the United States. For example, entities associated with the Chinese government have made it a priority to collect genetic data of American citizens to help build more effective surveillance technologies. The Russian government has also sought to collect genetic data to build “genetic passports” that experts believe could be used to build lists of individuals’ genetic traits and health risks.

“Clear rules of the road that give consumers’ genetic data the utmost legal protection is urgently needed,” said Breyault. “Consumers should be confident that when they share their genetic data with health care providers or private entities, that data will not be shared for purposes beyond which it was provided or with entities that are not committed to the ethical use of that data.”

The full list of NCL’s proposed genetic privacy rights is available here. A roadmap of potential legislative, executive, and industry actions is available here.

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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 support for investigation of anti-competitive practices in the live event ticketing industry

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

 

April 1, 2022

 

The Honorable Jonathan Kanter

Assistant Attorney General

Antitrust Division

United States Department of Justice

950 Pennsylvania Avenue, NW

Washington, DC 20530-0001

 

RE: National Consumers League support for investigation of anti-competitive practices in the live event ticketing industry

 

Dear Assistant Attorney General Kanter,

On March 15, 2022, Senators Richard Blumenthal and Amy Klobuchar urged the Department of Justice (“the Department”) to investigate the state of competition in the live-event marketplace, including potential violations of Live Nation-Ticketmaster’s updated consent decree.[1] The National Consumers League, America’s oldest consumer advocacy organization, supports Senator Blumenthal’s and Senator Klobuchar’s request for the Department to take action on the issue of live entertainment marketplace competition.

As the Department is aware, just one company, Live Nation Entertainment (“LNE”), controls roughly 80% of the primary ticketing market following Live Nation’s vertical

integration with Ticketmaster.[2] In the Department of Justice’s own words, Ticketmaster benefits from “high barriers to other companies successfully, substantially, and profitably entering or attempting to expand in the market for primary ticketing services to major concert venues.”[3] There is no indication that the Live Nation-Ticketmaster merger (and further monopolistic actions since 2010) have reduced these barriers to entry.[4]

In fact, anticompetitive behavior in the live-event marketplace is so egregious that the Department was forced to obtain an updated consent decree with LNE in 2020.[5] Although the modified final judgement was a welcome act, consumers still suffer due to many of LNE’s business practices.[6] Since the announcement of the updated consent decree, Live Nation has continued to eliminate marketplace competitors, including an acquisition that received the Department’s approval.[7]

As a result of toxic market practices, concert attendees, sports fans, theater enjoyers, and other live-event goers must endure punishing hidden fees. In 2018, the Government Accountability Office found that on average, purchasers paid an additional 27% of the ticket’s original value in fees.[8] Recent media reports have found fees as high as 78% of the ticket’s starting price.[9] This is after consumers must contend with scalpers employing illegal ticket-buying “bot” software and other unscrupulous methods in order to even secure their tickets.[10]

The unfortunate state of the live entertainment marketplace warrants an investigation by the Department—with specific attention to LNE’s compliance with the updated consent decree. The harmful impacts of LNE’s near-monopoly are unacceptable. We urge the Department to conduct a thorough investigation of these practices and, if necessary, take action to ensure market health and consumer protection.

Sincerely,

Sally Greenberg

Executive Director

National Consumers League

 

[1] United States Senator Richard Blumenthal. Blumenthal & Klobuchar Urge DOJ Action to Restore Competition in the Concert & Live Entertainment Market. (March 2022). https://www.blumenthal.senate.gov/newsroom/press/release/blumenthal-and-klobuchar-urge-doj-action-to-restore-competition-in-the-concert_live-entertainment-market

[2] United States Government Accountability Office. Event Ticket Sales: Market Characteristics and Consumer Protection Issues. (April 2018). Pg. 4. https://www.gao.gov/assets/gao-18-347.pdf

[3] United States Department of Justice. Competitive Impact Statement, United States of America v. Live Nation Entertainment, Inc., No. 1:10-cv-00139 (D. D.C. Jan. 25, 2010). https://www.justice.gov/atr/case-document/competitive-impact-statement-209

[4] The Hollywood Reporter. Live Nation Accused of Shutting Out Venues That Don’t Use Ticketmaster. (January 2022). https://www.hollywoodreporter.com/business/business-news/live-nation-ticketmaster-class-action-1235070131/; Ticket News. Ticketmaster Resale Returns to Broker-Focused Conferences Despite Past Controversy. (July 2021). https://www.ticketnews.com/2021/07/ticketmaster-resale-returns-to-broker-focused-conferences-despite-past-controversy/

[5] United States Department of Justice. Justice Department Will Move to Significantly Modify and Extend Consent Decree with Live Nation/Ticketmaster. (December 2019). https://www.justice.gov/opa/pr/justice-department-will-move-significantly-modify-and-extend-consent-decree-live

[6] Variety. John Oliver Blasts Ticketmaster in Scathing Broadside Against Ticket Prices, Fees, Secondary Market. (March 2022). https://variety.com/2022/music/news/john-oliver-ticketmaster-prices-fees-secondary-market-1235204410/

[7] Complete Music Update. Ticketmaster gets approval for deal to buy Rival. (April 2020). https://completemusicupdate.com/article/ticketmaster-gets-approval-for-deal-to-buy-rival/

[8] United States Government Accountability Office. Event Ticket Sales: Market Characteristics and Consumer Protection Issues. (April 2018). https://www.gao.gov/products/gao-18-347

[9] The Guardian. John Oliver rips Ticketmaster and live music costs: ‘One of the most hated companies on earth’ (March 2022). https://www.theguardian.com/tv-and-radio/2022/mar/14/john-oliver-ticketmaster-live-music-costs

[10] United States Federal Trade Commission. Cracking down on ticket bots that leave you out in the cold. (January 2021). https://consumer.ftc.gov/consumer-alerts/2021/01/cracking-down-ticket-bots-leave-you-out-cold#:~:text=Ticket%20bots%20may%20also%20be,the%20tickets%20for%20higher%20prices

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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 joins LGBTQ+ coalitions to address credit issues for transgender and nonbinary community

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March 17, 2022

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

Washington, DC— The National Consumers League has joined efforts with LGBTQ, consumer, and legal advocacy groups to address credit-related problems encountered by transgender and nonbinary consumers.

The letter  to the major credit reporting companies, notes that transgender and nonbinary consumers face a myriad of issues after they change their names — with serious consequences for their financial and personal lives. The transgender and nonbinary community have reported to the Consumer Financial Protection Bureau that they cannot get Experian, Equifax and TransUnion to correct their credit reports.

Some issues reported are that their credit report fragments into two or more unconnected files upon their name change or are not there at all. Many times their credit scores drop by hundreds of points, precluding them from accessing banking services, mortgages, auto financing, employment, and rental housing. Transgender and nonbinary consumers find that even when they were able to contact and persuade a customer service representative at one of the Big Three credit bureaus to manually fix their report, a new upload of data reverts their credit histories back to fragmented or incomplete files. Some have even reported serious fallout after their credit histories reflected their “deadname” or former name, thereby outing them as transgender to potential employers, rental agents, car dealerships, or financial institutions.

The letter asks the credit reporting industry to:

  • Utilize consumers’ full 9-digit Social Security numbers in matching algorithms to ensure credit information is associated with the correct credit file.
  • Facilitate name changes by having clear procedures to update a consumer’s name on their credit report when presented with a legal name change order and ensure that staff are sufficiently trained in those procedures and are able to provide culturally competent service to transgender and nonbinary consumers.
  • Reduce the burden on transgender and nonbinary consumers to submit name-change documentation to each credit reporting agency by instituting a “one-stop” system that allows a consumer to submit a single request to have the legal name on their report updated, and ensures the request is communicated to all consumer reporting agencies.
  • Prevent the occurrence and recurrence of fragmented credit files by creating procedures to detect when a consumer changes their legal name with a creditor, to associate the new name with their credit file, and to consolidate a consumer’s credit information in their current and previous names in a single credit file — as the industry presently does when cisgender women and other consumers change their last names.
  • Prevent the disclosure of transgender and nonbinary consumers’ deadnames to landlords, employers, and underwriters by disclosing only a consumer’s current legal name in reports provided to credit report 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 www.nclnet.org.

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

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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.

 

NCL testimony before ACIP on crucial vaccines

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February 24, 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, February 24, 2022, NCL submitted comments to the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices in support of new recommendations for the influenza, pneumococcal, and tick-borne encephalitis vaccines. NCL comments appear below.

February 24, 2022
Grace M. Lee, MD, MPH, 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-2022-0015

Dear Chairwoman:

Founded in 1899 by the renowned social reformer Florence Kelley, the National Consumers League (NCL) has long championed vaccines as lifesaving medical interventions. 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 increased access and vaccine confidence. 122 years later, we are honored to persist in our fight to protect consumers from vaccine preventable illnesses and we extend our gratitude to the Advisory Committee on Immunization Practices (ACIP) for the opportunity to present public comment.

Tick-borne Encephalitis (TBE) Vaccine

During the pandemic, Americans are spending more time in nature and participating in outdoor activities. The majority of TBE virus infections are acquired in forested areas through activities such as camping, hiking, fishing, and bicycling; and case numbers peak when ticks are most active, during early and late summer. In addition, incidence rates and severity of disease are highest in people aged ≥50 years.

NCL applauds the FDA for its approval of Pfizer’s TBE vaccine last year as an important step in making a vaccine more accessible for TBE, and preventing illness from tick bites. It is critical that access to this vaccine is expanded so that individuals and families feel safe and protected from TBE when outdoors. Being that there is no specific treatment for TBE, the preventive measure of vaccination is a significant means for keeping Americans healthy.

Pneumococcal Vaccine

While we are encouraged that ACIP recommendations increase access to the pneumococcal vaccine for adults ages 19-64 with underlying health conditions, we were disappointed that ACIP did not lower the overall age recommendation to include adults aged 50 and older. Moreover, there is a lot of confusion about which vaccine or combination of vaccines is needed for complete immunization. Confusion about the pneumococcal vaccine can cause vaccine hesitancy among patients, and makes it difficult for providers to make informed decisions for their patients. We would like the CDC to provide clearer recommendations to help increase the rate of vaccine uptake; including physician and patient education. NCL will continue to encourage consumers to ask their healthcare provider about being fully protected against pneumococcal disease.

Influenza Vaccine

Protecting older adults from influenza is now critically important as COVID-19 continues to plague the nation. We are pleased that ACIP is considering recommendations for preferential use of enhanced seasonal influenza vaccines (e.g., high-dose, adjuvant, and recombinant) over standard vaccines in adults aged 65 and older. Updating decades old recommendations will prevent hundreds of thousands of outpatient/ER visits, hospitalizations, and deaths due to influenza each winter. During the 2018-2019 flu season, an estimated 35.5 million people got sick with influenza and 34,200 people died.

Because of the pandemic, more Americans have come to understand how vaccines work and value the protection that they offer to prevent infectious disease. However, millions of people have missed their routine shots during the shutdown. It is important that we seize this moment to educate consumers about their recommended immunizations across lifespan. NCL will continue working to ensure equitable access to vaccines and instill vaccine confidence in consumers. We look forward to clear recommendations by ACIP on the use of vaccines. We appreciate your consideration of our views on this important public health topic.

Sincerely,

Jeanette Contreras, MPP
NCL 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.

 

Testimony at CDC advisory committee on Moderna COVID-19 vaccine approval

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

Washington, DC—Today, February 4, 2022, NCL Health Policy Associate Milena Berhane provided oral testimony to the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices in support of the approval of Moderna’s COVID-19 vaccine and pediatric COVID-19 vaccines. Her comments appear below.

February 4, 2022

Thank you, Dr. Lee. My name is Milena Berhane, and today I am representing the National Consumers League. Since NCL’s founding in 1899 by social reformer Florence Kelley, we have advocated for the critical role immunizations play in the preservation and improvement of public health. We extend our gratitude to this Committee for the opportunity to present public comments.

An estimated 890,000 Americans have died from COVID-19 during this pandemic that has persisted in the U.S. for the past two years. The COVID-19 virus continues to threaten the health and safety of many, especially vulnerable populations such as the elderly and immunocompromised groups. The currently available COVID-19 vaccines have worked to save lives, and avoid preventable illness, hospitalizations, and deaths in our communities.

The National Consumers League commends the FDA and the CDC on the approval of the Moderna COVID-19 vaccine, which will continue to be a key tool in the public health response to this pandemic. This vaccine has been, and will continue to be, a safe and effective measure to protecting Americans 18 years of age and older.

America’s families are hopeful that the Pfizer COVID-19 vaccine will be granted Emergency Use Approval for children under 5 years of age. Hospitalization of children under 5 years of age has soared, further evidence of the need for expanding vaccine access to children in this age group. Vaccinating children under the age of 5 will protect them from illness, but also protect their families, caretakers, and teachers from contracting COVID-19 as well.

We are also concerned about the widespread drop-in routine childhood immunization rates during the pandemic. According to CDC data released last May, over 11.7 million children have missed doses of their recommended vaccines.  We are particularly worried that our nation’s most vulnerable children, those who qualified for the Vaccines for Children program, are getting caught up at a much slower rate than children with commercial insurance.

The National Consumers League recognizes the extreme importance of immunizations in protecting the health and safety of all Americans, and will continue its efforts to increase vaccine confidence and uptake across lifespan. We look forward to the upcoming recommendations by this committee regarding these COVID-19 vaccines.

Thank you.

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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 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.

NCL testimony before FDA on Janssen Biotech COVID-19 vaccine

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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

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

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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

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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