NCL testimony before ACIP on crucial vaccines

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

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

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

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

February 26, 2021

NCL’s Associate Director of Health Policy Nissa Shaffi testified before the FDA’s Vaccines and Related Biological Products Advisory Committee at the Center for Biologics Evaluation and Research. Read her testimony.

Hana El Sahly, M.D., Chair
Vaccines and Related Biological Products Advisory Committee
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993

RE: Docket No. FDA-2021-N-0173; for Vaccines and Related Biological Products Advisory Committee

Good Afternoon. I am Nissa Shaffi, present today on behalf of the National Consumers League. I have no conflicts of interest to disclose. Our organization extends its gratitude to the Vaccines and Related Biological Products Advisory Committee, for the opportunity to amplify consumer voices regarding the Janssen Biotech COVID-19 vaccine.

For over 120 years, NCL has championed efforts to increase vaccine education, safety, and access for consumers. As consumer advocates, we thank the Food and Drug Administration for their commitment to fostering public trust throughout the development and approval of a vaccine for COVID-19. We have been encouraged by the transparency and opportunities for engagement afforded to the public during this process.

Emergency Use Authorization (EUA)

Consumers are relying on the FDA more than ever for guidance pertaining to treatments for COVID-19, and preserving their confidence in the Agency is of vital importance at this time. Emergency Use Authorization, while not intended to replace randomized clinical trials, has been a critical component to the nation’s pandemic strategy. NCL appreciates the FDA’s recognition of clinical trials as vital to demonstrating the safety and efficacy of a treatment.

Safety and Effectiveness

We are encouraged by reports indicating that the Janssen Biotech vaccine has proven to be effective against hospitalizations and deaths from COVID-19. The added benefit of another vaccine is to decrease virus mutation. Presently, three, far more contagious, variants of COVID-19 spread and could hamper efforts to quell the virus. We are reassured that the Janssen vaccine has demonstrated efficacy against certain variants. As new data is collected, we call on the FDA to perform post-market surveillance to monitor ongoing efficacy.

Health Equity

Vaccine hesitancy and social determinants of health remain critical obstacles in the vaccine rollout process. The Janssen Biotech single-shot vaccine has the potential to increase access for hard-to-reach communities, bringing us closer to herd immunity. This week, we marked a grim milestone, as half a million Americans have now perished from this relentless virus. Amidst this loss, the continued development of vaccines for COVID-19 has provided the nation with much-needed hope and respite.

As the Committee deliberates on the Janssen Biotech COVID-19 vaccine, we request the Agency to also consider the benefit its release would have for historically disadvantaged communities, for which this vaccine would be logistically more accessible than the prior two vaccines.

Thank you to the Committee for your consideration of our views. Through our consumer education work, NCL will continue to support FDA in its efforts to develop a safe, effective, and expedited pathway towards a vaccine for COVID-19.

Sincerely,

Nissa Shaffi
Associate Director of Health Policy
National Consumers League

 

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
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NCL testimony before CDC’s Advisory Committee on Immunization Practices highlights Hep. B vaccine disparities

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

February 24, 2021

NCL’s Associate Director of Health Policy Nissa Shaffi testified before the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices today. Read her testimony.

José R. Romero, MD, FAAP, Chair
Advisory Committee on Immunization Practices
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., Mailstop A27
Atlanta, GA 30329-4027

RE: Docket No. CDC-2021-0008; Advisory Committee on Immunization Practices (ACIP)

Good Afternoon. I am Nissa Shaffi and I will be presenting public comment on behalf of the National Consumers League. For over 120 years, NCL has championed vaccine education and access for consumers who depend on these lifesaving medical interventions. We extend our gratitude to the Advisory Committee on Immunization Practices for the opportunity to serve as a voice for consumers.

NCL remains committed to educating consumers on the value and safety of immunizations. During the COVID-19 pandemic immunization rates have dropped drastically, which means that our work is needed more than ever. Even under ordinary circumstances, vaccines are underutilized in adult populations, especially among racial and ethnic minority communities.

Health disparities contribute largely to the burden for Hepatitis B infection, with Asian/Pacific islanders and non-Hispanic black communities having the highest rates of HBV-related death. Despite vaccine recommendations, there is an estimated prevalence for chronic HBV infection in the US of nearly 1.6 million persons (range 1.2–2.5 million).

NCL is concerned that the updated guidance for those over 60 years of age with diabetes getting vaccinated only upon shared decision making with their providers will not address the health disparities that persist. The populations at greatest risk for HepB infection are those that are more likely to lack access to health care and not have a primary care medical home. NCL would like to see the CDC support a large-scale education and outreach campaign to raise awareness of the risk of HepB in older adults and call for increased HepB screening in high-risk communities across the country.

NCL similarly shared its disappointment in response to ACIP’s 2019 recommendations for the pneumococcal vaccine to be administered for those over 65 years of age with shared decision making based on the rationale that childhood vaccinations had dramatically reduced the spread of this disease. However, pneumococcal disease continues to result in an estimated 150,000 hospitalizations per year. And adults over age 65 remain at increased risk for pneumococcal disease.

In light of the drop in childhood immunizations induced by the pandemic, the CDC may want to issue caution statements to providers that herd immunity may have diminished compared to years prior for many of the diseases we target with the most commonly recommended vaccines. As a commitment to our advocacy, NCL continues to reaffirm that vaccines save lives and will continue to support increased immunizations for preventable diseases.

In closing, we encourage ACIP to maintain effective public messaging and strong vaccine recommendations to instill vaccine confidence, so that the American public feels safe and informed in their decisions to vaccinate across the lifespan.

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

 

Sincerely,

Nissa Shaffi
Associate Director of Health Policy
National Consumers League

 

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
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NCL applauds Florida’s popular vote to raise state minimum wage

For immediate release: November 13, 2020

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

Washington, DC –The National Consumers League (NCL) applauds Florida voters who, on November 3, overwhelmingly approved a ballot measure—Amendment 2—to raise the state’s minimum wage to $15 an hour. The amendment was adopted with more than 61 percent of voters weighing voting for the measure.  This is an amendment to the state constitution that scales up the minimum wage to $15 by 2026, up from its paltry current $8.56 an hour.

The following statement is attributable to Sally Greenberg, NCL executive director:

With this vote, Florida joins seven other states in the process of raising their minimum wages to $15 an hour. And Florida is the first state to raise the minimum wage to $15 an hour via ballot measure and amendment to the constitution. We are very pleased that Florida voters so decisively supported this measure despite Republican leadership in Florida opposing the measure and refusing to bring it to the state legislature.  Florida Governor Ron DeSantis has been a vocal opponent, claiming it is ‘going to cause big, big upheavals for the restaurant industry.’ Yet the people of Florida disagree. They want increases in the minimum wage.

NCL notes that while working people in Florida will be the beneficiaries, workers in other states deserve the same increases. That is why NCL strongly supports federal legislation—passed by the House last year—to raise the minimum wage to $15 in every state from the paltry $7.25 an hour last raised by Congress in 2009.

This is a particularly gratifying vote given, that Donald Trump’s allies in Florida opposed the measure, while Trump won the election in the state of Florida by 51 percent to Joe Biden’s 47.9 percent. But that is not unusual. Minimum wage increases are typically popular among the electorate. Since 2000, states have held 21 referendums on the minimum wage, and all have passed, according to a tally kept by Ballotpedia. Public opinion surveys have shown broad support; a 2019 Pew survey found that two-thirds of Americans supported raising the federal minimum wage to $15 an hour.

States where legislatures have declined or been unwilling to pass minimum wage have seen victories on the ballot, including Arizona, Missouri, Montana, Colorado, and Ohio, while state legislatures in California, Connecticut, Illinois, Maryland, Massachusetts, New Jersey, New York, and DC’s City Council have all adopted increased minimum wage legislation.

Below are links to NCL’s statement on minimum wage and NCL’s “We Can Do This!” podcast episode with Fight for $15 Director Diana Ramirez.

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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 statement on vaccine for COVID-19

For immediate release: November 12, 2020

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

Washington, DC –The National Consumers League (NCL) welcomes the very hopeful news that a coronavirus vaccine with a reported efficacy rate of 90 percent may be approved and rolled out in the next few months. NCL has historically advocated for vaccines because they have overwhelming effectiveness and safety profiles, preventing billions of often debilitating and deadly diseases across the globe—from small pox to measles to polio. The clinical evidence on the coronavirus vaccine—developed by Pfizer Inc. and partner BioNTech SE—though incomplete at the moment, is very promising.

“We applaud the unprecedented cooperation by public and private entities, along with concerted coordination among scientists, doctors, and researchers that has gone into developing a vaccine to combat this terrible pandemic, which has killed over 237,000 Americans, struck 10 million people, and only shows signs of worsening over the winter months,” said NCL Executive Director Sally Greenberg. “As this vaccine moves closer to being cleared for widespread use and the safety data verified, we are grateful to the companies and government officials who urgently prioritized the development of an effective and safe vaccine to combat the scourge of COVID-19. We are also encouraged that other companies are in the later stages of reviewing their own COVID-19 vaccines, which use different technologies to fight the virus but hopefully will be effective and safe as well.”

The FDA will be reviewing the safety data in the next few weeks on the Pfizer vaccine and will then determine to whom the first doses will be directed. Pfizer has said the vaccine could become available before the end of the year and that the company can produce 50 million doses globally—equivalent to reaching 25 million people because two doses are required for maximum protection from the virus. The most vulnerable populations are likely to receive the first batch of vaccines.

NCL cautioned consumers that during this period, people should maintain all the safety practices for preventing spread of the virus—wearing masks and practicing social distancing and keeping social gatherings to a minimum.

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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 testified before FDA Vaccines and Related Biological Products Advisory Committee

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) testified before the Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration (FDA). For over 120 years, NCL has advocated on behalf of consumers who depend on vaccines as lifesaving medical interventions. NCL extended its gratitude to the Vaccines and Related Biological Products Advisory Committee for all they do to protect public health and for the opportunity to speak before the Committee.

In its testimony, NCL highlighted the following priorities: the deployment of Emergency Use Authorizations; the safety and effectiveness of the vaccine; and the inclusion of diversity in clinical trials. These three concerns align directly with NCL’s efforts to enhance vaccine confidence and uptake, especially in the context of COVID-19.

Safety and Effectiveness:

NCL trusts that the FDA will release a vaccine only upon careful consideration of its safety and effectiveness. Post-market surveillance of the vaccine is imperative to determining the ongoing efficacy of the vaccine. Implementing the release of a vaccine on such a magnificent scale will involve precise coordination that traverses all levels of government and consumers will rely on public health agencies to communicate and respond to any potential adverse events regarding the COVID-19 vaccine.

Emergency Use Authorization (EUA):

There has never been a more critical time for consumers to have confidence in the Food and Drug Administration. The FDA is entrusted with ensuring the safety, efficacy, and security of the treatments needed to treat and prevent the spread of the virus.

Throughout the pandemic, consumers have received conflicting information from the Administration on various COVID-19 treatments. NCL is aware that developing a vaccine for COVID-19 is a time-sensitive priority, however, we are concerned that consumers may believe that the FDA is hastily approving investigational tests and drugs.

NCL appreciates that the FDA recognizes that EUA is not intended to replace randomized clinical trials and that clinical trials are critically important for the definitive demonstration of safety and efficacy of a treatment. Through our education and outreach of consumers, we support the FDA in its efforts to develop a safe, effective, and expedited pathway towards a COVID-19 vaccine.

Diversity in Clinical Trials:

Finally, to mitigate the disproportionate disease burden experienced by people of color during the pandemic, NCL requests that clinical trials for the COVID-19 vaccine are inclusive and consist of diverse subjects. People of color are significantly underrepresented in clinical trials and undertreated in medical settings. This phenomenon will prove to be a challenge when encouraging vaccine uptake. Ensuring adequate representation in clinical trials would foster vaccine confidence across all demographics.

In closing, to stem the tide of deaths from these vaccine-preventable diseases, NCL submits these comments for review by the Committee to ensure that consumers are afforded with safe and effective vaccines to combat the pandemic.

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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.

Fighting for crucial consumer, worker protections and fair outcomes in coronavirus environment

March 27, 2020: A message to our online community about how we are working hard to ensure crucial protections for consumers and workers in this time of uncertainty.

Sally Greenberg discussing CBD on Capitol Hill

Coronavirus update: Fighting for crucial protections, fair outcomes

A message to our online community

In this critical time, as our nation is gripped by the COVID-19 virus, we want you to know that we remain 100% committed to doing everything we can to help stop the spread of the virus and to fight for consumer and worker protections in this rapidly changing economy.

Although we are now doing so remotely in order to maintain our safety and the safety of our loved ones, NCL staff continues to work behind the scenes to ensure that the interests of consumers and workers are not forgotten in the rush to pass legislation and make executive branch decisions.

Below we’ve highlighted what’s happening and hope that you agree that our work – and your support – are more important than ever.

Pushing Congress to protect passengers in COVID-19 relief legislation

The pandemic has reduced passenger air traffic to a trickle, putting the airlines in deep economic distress. A strong, well-functioning, and safe airline industry is essential to our country. That said, NCL does not believe that giving a blank check to the industry is in consumers’ best interest. That’s why NCL led a coalition of consumer and air passenger advocates to call on Congress to include strong passenger protections in the COVID-19 relief bill. We will continue to advocate for reforms to the airline’s business practices, like excessive fees and shrinking seats, in the weeks and months to come.

Fighting COVID-19 scams

We are actively reaching out to consumers to educate them about how to spot coronavirus-related scams. We are already seeing reports of scammers using this moment of national emergency to sell bogus coronavirus “cures” and target seniors with phony investment scams. That’s why we issued a statement applauding Attorney General William Barr’s order to all U.S. Attorneys to ramp up efforts to shut down COVID-19 scams and are continuing to alert our readers about emerging trends.

We are also using our Consumers for Safe CBD platform (4safeCBD.org) to highlight false product claims made by unscrupulous CBD manufacturers who are using the crisis to promote their products .

Healthcare in the new environment

In response to a request for help from FDA, NCL is supporting the agency’s efforts to expose bogus coronavirus tests, treatments, and cures. In addition, we signed onto a letter as part of our adult vaccine coalition to ask for ZERO CO-PAYs for all Medicare Part D vaccines, which could include COVID-19 vaccines when they become available. With safety as a paramount concern, NCL is supporting the American Nurses Association’s call to action to increase Personal Protective Equipment (PPE) for nurses.

Crucial worker protections

NCL persists in its fight for worker protections and joined a letter opposing the exclusion of immigrants from the omnibus relief package. We also signed onto an effort to ensure the Postal Service can remain fully functional during this crisis and beyond. The USPS is predicting that an economic recession could pose a “serious threat to the near-term viability of the Postal Service,” and has asked Congress to give USPS more than $7 billion each year for the next two years.

NCL joined allies at farmworker organizations in expressing concerns related to exposure of the largely uninsured, financially fragile farmworker community to COVID-19 and asking political leaders to be mindful of the unique concerns, considerations, and risks confronting farmworkers.

Looking ahead

NCL remains actively engaged in working to properly ensure that relief packages address the interests of consumers and workers. We are very pleased that Congress will be providing cash assistance to our most vulnerable, and we continue to push for salary and benefit protections, particularly for those workers in the most seriously impacted industries.

In the coming days, stay tuned for news of our Trumpeter Awards Dinner, which we will host in October. We will be sending out a Save the Date and announcing our award recipients shortly.

Best wishes for staying safe and healthy, from all of us at NCL.

Sally Greenberg
Executive Director
National Consumers League

NCL: #NeverMoreRelevant

Capitol Hill briefing alerts lawmakers to public health ramifications of CBD proliferation

Lawmakers need to be aware of the threats to public health posed by the proliferation of unregulated, untested CBD products currently widely available in the marketplace. There is a great deal of work to be done in Washington to better understand the healing potential of CBD, while also protecting consumers from the dangers of what is currently an anything-goes market environment.

That was the compelling message participants took from a congressional staff briefing last week on “The Future of Cannabis as a Drug.” Expert speakers, including National Consumers League Executive Director Sally Greenberg, issued a two-pronged call for action: to intensify clinical research into new medical treatments containing CBD, while encouraging the Food and Drug Administration (FDA) to proactively regulate non-medical, over-the-counter CBD products that are frequently mislabeled and contain potentially harmful ingredients.

The briefing featured opening remarks by U.S. Representatives Scott Peters (D-CA) and Cathy McMorris Rodgers (R-WA) and was moderated by Ron Manderscheid, Executive Director of the National Association of County Behavioral Health and Developmental Disability Directors and the National Association for Rural Mental Health. “We would like to have more understanding and more confidence in CBD products,” Rep. Peters explained. “You should know what you’re getting”.

Attendees received eye-opening data about the ways in which readily-available CBD products—sold in the form of oils, lotions, food additives, and more—have the potential to make consumers ill. Few realize, for example, that an independent study found 70 percent of the top-selling CBD products contain substances such as pesticides, arsenic, and toxic mold.

NCL’s Greenberg previewed upcoming academic research that will place a spotlight on the questionable science being utilized by CBD and cannabis companies, often in partnership with academia, to lend legitimacy to these products and short-cut the regulatory approval process. “Not only are these products untested, but they are inaccurately labeled,” said Greenberg. “We want FDA to do what it’s supposed to do, and what we as consumers expect it to do.”

NCL launched Consumers for Safe CBD to warn the public of the potential health and safety risks associated with unregulated and unlawfully marketed CBD products.

Susan Audino, a board member of the Center for Research on Environmental Medicine in Maryland, shared her findings on the lack of quality controls currently in the CBD marketplace and how product marketing is accelerating faster than the science used to substantiate claims of enhanced health and well-being. “We even trust McDonald’s to inform us of the number of calories in a Big Mac,” said Audino. “When it comes to cannabis, we are not afforded that same safety and assurance.”

James Werline, a pharmacist and the father of a daughter with a severe form of epilepsy, spoke to the promise and importance of CBD-related research. The only CBD medication currently approved by the FDA is used to prevent seizures caused by rare forms of childhood epilepsy. Angelique Lee-Rowley, Vice President, Global Chief Ethics and Compliance Officer at Greenwich Biosciences, discussed the importance of clinical research into new CBD treatments and shed light on the restrictions pharmaceutical companies have in educating consumers on product efficacy versus the retail and online marketers who have few boundaries in the claims they can make.

“We are on the verge of a major breakthrough,” said Rep. McMorris Rogers. “We want to be encouraging those breakthroughs. I am committed to helping with those developments.”

The briefing served to alert congressional staff to the seriousness of this issue. By 2022, the CBD marketplace is expected to reach $1.8 billion in sales, more than triple what it was just four years earlier. As the commerce expands, so do—without adequate consumer protections—the threats to health and safety.