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

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.

2023 Script Your Future Medication Adherence Team Challenge winners

May 16, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, DC —Today, the National Consumers League (NCL) announced the winners of its twelfth annual Script Your Future Medication Adherence Team Challenge, an eight-week intercollegiate competition among health profession student teams and faculty to combat poor medication adherence in the United States, where nearly three out of four patients do not take their medication as directed.

The Challenge, hosted by NCL, returns to university campuses across the country to encourage student competition and innovation. “The Team Challenge was first established in 2011 to nurture adherence-minded values in future generations of health professionals. Since its launch, the campaign has supported close to 2,000 community health events, engaged over 60,000 healthcare providers, and reached 27.5 million consumers and counting. We are very proud of the contribution this effort has made to the public health of all consumers,” said NCL Chief Executive Officer, Sally Greenberg.

This year’s winners are:

  • Lake Erie College of Osteopathic Medicine (LECOM) School of Pharmacy,
  • Temple University School of Pharmacy,
  • Western University School of Health Sciences,
  • University of Charleston School of Pharmacy, and
  • University of Pittsburgh School of Pharmacy.

2023 Medication Adherence Team Challenge Winners

National Award Winner: Lake Erie College of Osteopathic Medicine (LECOM)

Lake Erie College of Osteopathic Medicine’s (LECOM) 2023 Script Your Future efforts were centered around Wellness, Adherence, Lifestyle, and Knowledge (WALK). LECOM students and faculty designed community service events in collaboration with various healthcare professionals across pathways (Erie, Bradenton, Distance Education) and programs (pharmacy, medical, and masters). The unified message promoted the importance of medication adherence, chronic disease state management, reducing disease stigma, smoking cessation, safe drug disposal, and OTC medication safety. To kick off 2023 Script Your Future, a healthcare pledge affirming the importance of interdisciplinary teamwork in improving patient outcomes was distributed and 223 current and future healthcare professional signatures were received. Overall, 817 educational materials were distributed in-person to 260 individuals. Social media, print, and broadcasting efforts reached an estimated 279,360 individuals. Overall, LECOM’s Script Your Future was a successful and impactful campaign that consisted of 159 volunteers, correlating to 273 hours of community service contributed throughout 23 service events that reached 279,779 individuals.

Under-Represented Community Outreach Award Winner: Temple University

Temple University’s main initiative this year was a community baby shower. Students got together and sought donations for diapers, wipes, baby clothes, diaper bags, strollers, car seats, baby bottles, and pacifiers, and advertised the event throughout social media to expectant mothers in the North Philadelphia community. Students connected with larger Philadelphia organizations to get the word out and have expecting mothers register for the event. The event was a great success! There was a panel on general women’s health and gestational diabetes to educate the expecting mothers and students created pamphlets on gestational diabetes and pediatric vaccinations. During the event students displayed safe drug disposal posters and educated the mothers on the importance of keeping medications in places where children and pets cannot reach them. The team was able to help over 50 expectant mothers in the North Philadelphia community.

Media & Communications Award Winner: Western University

In addition to creating TikTok videos, Western’s 2023 team recreated its website with a new, cleaner interface that is easier to use among every age group. A new tinyurl link (www.tinyurl.com/amcphealthhelper) and QR codes to link to the website were created, along with infographics for a variety of chronic diseases. The infographics were visually appealing and easy to read. Additionally, the infographics about COVID-19, high blood pressure, diabetes, and more were available to view in English, Spanish, Vietnamese, Mandarin, and Korean. For this year, the team provided a new translation for its infographics in Tagalog because there is a significant number of Filipino patients within the community. Visitors were able to download these infographics in each language for personal use, all infographics were available in these languages. By informing patients about their disease states, the students were able to help them understand why it is important to continue adhering to their medications. In addition to efforts to promote the TikTok videos and website, the team also collaborated with local pharmacies including Owl Pharmacy, Holt Pharmacy, Ontario Pharmacy, ABC Pharmacy, and Costco Pharmacy in distributing Script Your Future wallet cards. A total of approximately 2,000 wallet cards were distributed, including 1290 in English, 347 in Spanish, 142 in Vietnamese, and 80 in Mandarin.

Interprofessional Award Winner: University of Charleston

The University of Charleston School of Pharmacy (UCSOP) took a broad approach to interprofessional collaboration and included students studying political science and public health. These students were onsite during the West Virginia Rural Health Day and WVA Pharmacy Day at the Capital events. Political Science students were able to give advice to pharmacy students on presenting material and information to legislators and state leaders. Students focused efforts on increasing community influence around the importance of healthy lifestyles, medication adherence, and the confidence in vaccines. To broaden the effort further, the University of Charleston Nursing Program, University of Charleston Athletic Trainers and Exercise Undergraduates, along with various undergraduate students who could share knowledge on health topics participated in various events. In addition to UC associates, the team collaborated with several community partners, such as the West Virginia Pharmacists Association, West Virginia Rural Health Association, West Virginia Collegiate Recovery Network, American Foundation for Suicide Awareness, The American Heart Association, Mt. Olivet Baptist Church, and West Virginia local and state representatives. In working with these organizations, the team was able to broaden the number of community members influenced by its campaign efforts.

Technology Innovation Award: University of Pittsburgh

The Pitt Pharmacy team created innovative technologies where students had the ability to learn about cardiovascular emergencies in real time. Students ran simulations with simman. This “patient” can have a range of health concerns, from a heart attack to atrial fibrillation. Students learned how cardiac disorders are treated and performed simulations as instructors for future pharmacy students. In addition, student organizations hosted events with virtual reality technology where students could “treat” patients for these cardiovascular events.

Owen Hott, a student involved in the University of Pittsburg technology committee, stated, “As the head of the technology and innovation committee, Script Your Future was a great experience that allowed me to work with new people, come up with awesome ideas, and to play a part in a national campaign to empower patients. Part of my future goals as a pharmacist is to make sure that patients are as knowledgeable about their own health as their health providers. It’s all too often that I see issues that could have been avoided if anyone had spent the time to teach patients about their conditions rather than just sending them off with their medications, and I’m glad I was able to contribute to the cause!”

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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.

Script Your Future launches eleventh annual student competition for innovations in medication adherence

January 18, 2022

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

Washington, DC—Today marks the launch of the eleventh annual Script Your Future Medication Adherence Team Challenge, a two-month-long intercollegiate competition among pharmacy student teams and faculty for creating solutions to raise awareness about medication adherence as a critical public health issue. The Challenge, hosted by the National Consumers League (NCL), is returning to university campuses across the country building on a decade of successful student competition and innovation. 

The Challenge is an integral part of Script Your Future, a campaign launched by NCL and its partners in 2011 to combat the problem of poor medication adherence in the United States, where nearly three out of four patients do not take their medication as directed. In addition to medication adherence, in 2022 teams will counsel patients on vaccine confidence and safe drug disposal. 

Both faculty and student participants from last year’s awarded teams have reflected on their experiences in the Script Your Future program: 

“The Script Your Future Team Challenge was a great way for our pharmacy students to collaborate with other health professional students and positively impact our community by being a part of the COVID-19 response efforts, vaccinating thousands of individuals against COVID-19, addressing vaccine hesitancy, as well as providing patient education regarding medication adherence. We appreciate the opportunity the Challenge offered our students, and we are looking forward to participating again this year!”  

—Lisa Hong, PharmD, Associate Professor, Loma Linda University School of Pharmacy 

“Participating in Script Your Future was a refreshing experience and helped me and my students step outside of our frustration with the COVID-19 pandemic and do something about it. It was wonderful to have the opportunity to work with colleagues and students from other programs toward a single goal. Everyone, especially the students, really stepped up and thought outside the box to achieve the goals of Script Your Future.”  

—Erin Gysbers, PA-C, Didactic Director, Assistant Professor, Loma Linda University 

“I am extremely proud of the efforts of our team to achieve vaccination rates as high as 96 percent in our community. This is just a small testament to what we are all capable of in contributing to keep our communities safe and I am excited for future efforts.”  

—Joseph Velasco, PharmD Class of 2022, Loma Linda University School of Pharmacy  

“The Script Your Future Team Challenge has given me the opportunity to create numerous online resources to help patients with their medication adherence and to increase their COVID-19 vaccine confidence. This experience challenged me to work creatively with our WesternU’s AMCP Research and Education committee to not only create helpful infographics, but to widen the accessibility of these resources through QR codes and a texting service. These electronic tools gave patients improved access to our helpful resources on our very own WesternU AMCP Health Helper website. We also expanded onto social media and physically delivered our resources to pharmacies, local communities, and schools in Pomona, California. Participating in this program has been an experience that will resonate through my future career.” 

—Andrew Pham, PharmD Class of 2024, Western University of Health Sciences College of Pharmacy  

As the nation continues to navigate the COVID-19 pandemic, Script Your Future teams are encouraged to build their campaigns centering around vaccine confidence to help address hesitancy and mitigate further spread of the coronavirus. Teams are encouraged to tailor their outreach towards chronic health issues including cardiovascular disease, hypertension, diabetes, and respiratory illnesses. Challenge administrators also welcome the inclusion of other disease groups that would benefit from medication adherence-related interventions. Teams are also encouraged to integrate messaging on the importance of safe drug disposal. Patient counseling on this topic will help patients to know how to properly and safely dispose of their medications after they are no longer needed.  

Through March 28, inter-professional teams—including student pharmacists, nurses, doctors, and others—will implement creative approaches to outreach in their communities to raise awareness and improve understanding about medication adherence. At the end of the Challenge, teams submit entries for review by national partner organizations, and winners are recognized for their efforts to improve medication adherence. 

Last year, Team Challenge student health professionals were met with unique circumstances, hurdles, and obstacles as they navigated the historic COVID-19 pandemic, which resulted in school closures, event cancelations, and a host of other challenges. In spite of this, more than 5,000 future healthcare professionals and volunteers from 78 participating health professions schools participated. Collectively, the teams directly counseled close to 150,000 patients and vaccinated over 134,000 consumers, nationwide. Since the Team Challenge began in 2011, more than 18,800 future healthcare professionals have participated, reaching nearly 26 million consumers. 

Last year’s national award winner was University of Charleston School of Pharmacy. Other schools winning category-specific honors included: University of the Sciences School of Pharmacy; Loma Linda School of Pharmacy; Howard University College of Pharmacy; Wilkes University Nesbitt School of Pharmacy; University of Pittsburgh School of Pharmacy; and Western University College of Pharmacy. Additional participating schools received finalist and runner-up status across a variety of award categories. 

The Team Challenge is sponsored by the American Pharmacists Association (APhA), the National Association of Chain Drug Stores (NACDS) Foundation, and the National Community Pharmacists Association (NCPA). 

To learn about previous winners, visit Script Your Future’s online home. 

For more information on the Challenge, visit the Team Challenge community website. 

Tweet along with us during the Team Challenge using #SYFchallenge, and follow the campaign @IWillTakeMyMeds. 

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About 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.

About Script Your Future

Script Your Future is a campaign of the National Consumers League (NCL), a private, non-profit membership organization founded in 1899. NCL’s mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information about the Script Your Future campaign, visit ScriptYourFuture.org. For more information on NCL, please visit nclnet.org.

Jeanette Contreras portrait

La tercera vacuna trae esperanza

By NCL Director of Health Policy Jeanette Contreras

La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) acaba de aprobar una autorización de uso de emergencia para la vacuna de Johnson & Johnson, la tercera vacuna para combatir el coronavirus en EEUU. Aunque parece que no es tan efectiva como las otras dos, la vacuna de Johnson & Johnson ofrece una protección de 85 por ciento contra casos severos de COVID-19 y 100 por ciento de eficacia para evitar hospitalización y mortalidad, a causa del COVID-19. Con solo una dosis, esta vacuna ofrece protección de 72 por ciento contra el COVID-19 que ultimadamente ayuda controlar la pandemia en la población y alcanzar un nivel de inmunidad necesaria para regresar a la vida normal.

Una ventaja enorme de esta vacuna en términos de administración, es que se puede mantener en refrigeración normal por meses. Las otras vacunas requieren mantenimiento de temperatura súper baja en refrigeradores industriales que solo se encuentran en hospitales grandes. La vacuna de Johnson & Johnson es ideal para distribuir a comunidades rurales y en clínicas comunitarias. La aprobación de esta tercera vacuna, aumenta la disponibilidad y nos da esperanza de poder vacunar a más personas, más rápido con solo una dosis.

Sabemos que la comunidad Latina sufre de una taza de contagio más alta que otros grupos. Latinos constituyen una gran cantidad de empleados en trabajos esenciales con alto riesgo de contagio, como en la producción de comida y en puestos de trabajo de pequeños negocios. Mientras muchos esperan vacunarse, otros tendrán dudas o miedo de vacunarse. La campaña De Ti Depende nos asegura que es normal tener preguntas y ofrece información y respuestas en español para educar a la comunidad latina.

Campañas educativas como esta son necesaria para combatir información falsa y mitos que circulan en las redes sociales. Se escuchan mitos que las vacunas en general hacen daño o que alteran o cambian el ADN. Sin embargo, está comprobado científicamente por siglos que las vacunas han salvado vidas y nos han protegido. Los Centros para el Control y la Prevención de Enfermedades (CDC, por sus siglas en inglés) tiene una página dedicada a información para derribar los mitos más frecuentes acerca de estas vacunas.

Para alentar a la población a vacunarse, muchas empresas grandes están ofreciendo tiempo pagado o incentivos financieros a los empleados que se vacunan. Por ejemplo, supermercados como Publix les da $125 y Kroger les da $100 a empleados cuando reciben la vacuna completa. Dollar General les aumenta cuatro horas de pago normal a los que se vacunan.

Gracias a la autorización de la nueva vacuna, presidente Biden afirma que para el fin de mayo habrá vacunas para todos los adultos en EEUU. Las personas que deciden vacunarse, pueden buscar información confiable en el recurso de Telemundo – PlanificaTuVacuna.com para verificar la elegibilidad de acuerdo a las órdenes de cada estado.

Script Your Future launches tenth annual student competition for innovations in medication adherence

February 1, 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—Today marks the launch of the tenth annual Script Your Future Medication Adherence Team Challenge, a two-month-long intercollegiate competition among health profession student teams and faculty for creating solutions to raise awareness about medication adherence as a critical public health issue. The Challenge, hosted by the National Consumers League (NCL), is returning to university campuses across the country after nine years of successful student competition and innovation.

The Challenge is an integral part of Script Your Future, a campaign launched by NCL and its partners in 2011 to combat the problem of poor medication adherence in the United States, where nearly three out of four patients do not take their medication as directed.

“Today’s medications are better than ever at treating and curing people, but these treatments can only work if patients know the importance of taking their prescriptions as directed. It takes all members of the health team to make that happen,” said Sally Greenberg, NCL Executive Director. “For 10 years, our Script Your Future Medication Adherence Team Challenge has galvanized student health professionals to explore creative, interprofessional approaches, in encouraging medication adherence. To usher Script Your Future into the next era of improving adherence, we have implemented two new components to the Team Challenge: technology innovation and vaccine adherence. We have been blown away by the ingenuity of our student teams, and we look forward to how they will contribute to their communities in this year’s Team Challenge.”

As the nation continues to navigate the COVID-19 pandemic, Script Your Future teams are encouraged to build their campaigns centering around vaccine confidence to help address hesitancy and mitigate further spread of the coronavirus. Teams are encouraged to tailor their outreach towards chronic health issues including cardiovascular disease, hypertension, diabetes, and respiratory illnesses. Challenge administrators also welcome the inclusion of other disease groups that would benefit from medication adherence-related interventions.

The Challenge is sponsored by the American Pharmacists Association (APhA), the National Association of Chain Drug Stores (NACDS) Foundation, and the National Community Pharmacists Association (NCPA).

Through April 2, inter-professional teams—including student pharmacists, nurses, doctors, and others—will implement creative outreach approaches in their communities to raise awareness and improve understanding about medication adherence. At the end of the Challenge, teams submit entries for review by national partner organizations, and winners are recognized for their efforts to improve medication adherence.

Last year, Team Challenge student health professionals were met with unique circumstances, hurdles, and obstacles as they navigated the historic COVID-19 pandemic, which resulted in school closures, event cancelations, and a host of other challenges. To adhere to social distancing guidelines, dedicated teams pivoted their campaigns and made an impact in other ways. Ultimately, however, more than 80 teams submitted applications; the competition saw engagement from nearly 2,900 future healthcare professionals and volunteers, who hosted more than 250 events in 14 states. Collectively, the teams directly counseled close to 12,000 patients and introduced Script Your Future messaging to more than 430,000 consumers, nationwide.

Since the Team Challenge began in 2011, more than 21,000 future healthcare professionals have directly counseled nearly 87,000 patients and nearly 26 million consumers.

Last year’s national award winner was University of the Sciences: Philadelphia College of Pharmacy. Other schools winning category-specific honors included: Howard University College of Pharmacy; St. Louis College of Pharmacy; Lake Erie College of Osteopathic Medicine School of Pharmacy (LECOM); University of Pittsburgh School of Pharmacy; and Western University College of Pharmacy. Additional participating schools received finalist and runner-up status across a variety of award categories.

To learn about previous winners, visit Script Your Future’s online home.

For more information on the Challenge, visit the Challenge Community website.

Tweet along with us during the Challenge using #SYFchallenge, and follow the campaign @IWillTakeMyMeds.

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About 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.

About Script Your Future

Script Your Future is a campaign of the National Consumers League (NCL), a private, non-profit membership organization founded in 1899. NCL’s mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information about the Script Your Future campaign, visit ScriptYourFuture.org. For more information on NCL, please visit nclnet.org.

Ensuring completion of series for the COVID-19 vaccine

Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

After 10 dark months and over 350,000 lives lost, there is finally light at the end of the tunnel in the fight against COVID-19. Developing a vaccine for COVID-19 in such a short timeframe was made possible by dedicated efforts on the part of scientists, public health experts, and private and public partnerships. It is truly a triumphant medical achievement.

Now health care providers face another summit to scale—ensuring compliance for the vaccine to encourage efficacy and herd immunity. The leading vaccines for COVID-19, Pfizer BioNTech, and Moderna, will require two doses to ensure efficacy. Evidence has shown that when a vaccine involves multiple doses, nearly 50 percent of patients fail to return for a second dose. Clearly, aside from the distribution and administration, ensuring completion of series for the vaccine will be a critical logistical challenge.

It is estimated that 75 to 85 percent of the population will need to be vaccinated in order to reach herd immunity. That’s a lot of people. And if we account for the odds of those who will receive the vaccine and do not complete their series, we’ve got a long road ahead before the pandemic is behind us.

While both the Pfizer BioNTech and Moderna vaccines were found to be 95 percent effective, require two doses, and use similar mRNA vaccine technology, they differ in timelines. The Pfizer BioNTech vaccine requires two doses that are spaced three weeks apart, and Moderna’s vaccine requires two doses that are spaced four weeks apart. Coordinating efforts to ensure that patients get the correct vaccine in a timely manner, will be a massive undertaking.

There are multiple barriers to address in order to enhance vaccine compliance to end the pandemic. The vaccine is expected to induce flu-like symptoms and may deter some patients from getting their second dose if they aren’t warned about what to expect. Common side effects of the vaccine include headache, fever, chills, soreness at the site of delivery, and fatigue, but patients will need transparency about all potential side effects.

All patients who receive the COVID-19 vaccine will be given vaccine cards (see below). These cards will help track the type of vaccine administered, the dosage, date, and other information pertinent to providers and patients to ensure the completion of a series. Similar to contact tracing, massive follow up will be required via text messages, along with other interventions to remind patients of their upcoming second dose.

Source: CNN

The Food and Drug Administration (FDA) has issued a statement on the importance of properly adhering to FDA-issued vaccine guidelines. The vaccines have been issued with specified dosages and are scheduled at timed intervals. Individuals are instructed against reducing the number of doses (only taking one shot), extending the length of time between their booster vaccines, or changing guidance that is not rooted in evidence-based science, as it will directly impact the efficacy of the vaccine. Until new data is released by scientists and manufacturers of the COVID-19 vaccine regarding changes in dosage or schedules, FDA encourages continued adherence to its current issued guidance.

Vaccine hesitancy will surely further complicate matters. A study conducted by the Kaiser Family Foundation revealed that African Americans are increasingly skeptical of a COVID-19 vaccine. The findings allude to generational distrust of government and medical institutions by people of color, specifically, African Americans, where vaccine hesitancy has been influenced by lived experiences with discrimination and systemic racism. A successful vaccination plan will not only consider the herculean task of distribution and administration but should provide credible outreach within communities of color to foster confidence in the COVID-19 vaccine.

The National Consumers League continues to educate consumers on the importance of vaccine safety and compliance through our advocacy and engagement with the FDA. Our best line of defense against the pandemic is vaccine confidence and adherence. We encourage all who are able to get vaccinated for their own health and the health of their loved ones and community.

NCL testified before CDC committee on COVID-19 vaccine recommendations

For immediate release: December 22, 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) testified before the Centers for Disease Control and Disease Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) this weekend on the equitable distribution of the Moderna vaccine and recommendations for consumer education on vaccine safety. In its testimony, NCL applauds the transparency and access afforded to the public throughout the COVID-19 vaccine approval process.

Equitable distribution:

NCL is encouraged that the Food and Drug Administration (FDA) has approved the Moderna vaccine and that the U.S. government will lead distribution efforts. Due to its ease of transport and storage, the Moderna vaccine stands to readily ship to rural and hard to reach communities. NCL calls on federal health officials at the helm of distribution to facilitate access to the Moderna vaccine to medically underserved areas.

Safety and efficacy:

NCL expressed its trust in the FDA and CDC’s robust inter-agency collaboration to continue ongoing, post-market surveillance of adverse events among recipients of the COVID-19 vaccine and to inform consumers of any additional safety recommendations. NCL urged the CDC to educate consumers about potential reactions and side effects, as this transparency will further encourage the compliance necessary to achieve herd immunity. The vaccine is expected to induce flu-like symptoms after the initial dose and this may deter some patients from getting their second dose if they aren’t warned about what to anticipate.

Vaccine adherence:

NCL encouraged the CDC to conduct culturally competent and inclusive public messaging about vaccine safety to ensure that communities of color and persons with limited English proficiency are informed and feel empowered in their decisions to vaccinate. Adding to the complexity of administering the vaccine, public health officials will need to ensure the completion of two doses in a series. This stands to create additional challenges because evidence has shown that when a vaccine involves multiple doses, nearly 50 percent of patients fail to return for a second dose.

Equitable allocation:

NCL applauds ACIP’s recommendations to prioritize vaccinations for health care workers and long-term care facility residents in Phase 1a. Now that there are two approved vaccines, NCL calls on ACIP to prioritize recommendations to vaccinate the approximately 87 million non-healthcare essential workers unable to work from home—such as bus drivers and grocery workers—who are at higher risk of exposure. Racial and ethnic minorities make up more than 40 percent of the essential workforce and are the backbone of many essential industries. The pandemic has illustrated that low-income minority communities experience more severe COVID-related illness requiring hospitalization and are at higher risk for death.

Persons who recovered from COVID-19:

Lastly, over 18 million individuals in the U.S. have been infected with the coronavirus. It is expected that individuals who recover will acquire some natural immunity to COVID-19. Individuals who recover from the coronavirus want to know if they are protected from reinfection and for how long. We call on the CDC to expedite developing vaccine recommendations for persons who’ve recovered from COVID-19.

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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.

CMS Proposed Rule Ignores Data & Bipartisan Support for the Value of Copay Assistance Programs

By NCL Director of Health Policy Jeanette Contreras

Americans love getting a discount. As consumers, we like to shop to save without compromising the quality of the products we buy. But in healthcare, the stakes are higher at the checkout counter. Patients not only want a discount, they depend on it to afford necessary, sometimes lifesaving, medication to treat their health condition.

Despite what we know about the value and impact of copay assistance programs, a new policy from the Centers for Medicare & Medicaid Services (CMS) could put a barrier between these critical programs and the patients who need them most.

Manufacturer copay assistance programs include discounts, coupon cards, and vouchers which many of our friends, family members, and neighbors use to afford their prescriptions. Studies have shown that without these financial support systems, many patients couldn’t afford their medicines.

The CMS proposal, which has yet to be finalized, would require manufacturers to guarantee that this assistance goes directly to patients—and if manufacturers do not, they would be required to include the value of the copay assistance in Medicaid Best Price and Average Manufacturer Price (AMP) calculations. That would be fine but there’s a  problem.

CMS has a separate policy that was already finalized earlier this year: the Notice of Benefit and Payment Parameters (NBPP) Rule for 2021. In part, the NBPP allows health insurance companies and pharmacy benefit managers (PBMs) to use policies that stop copay assistance from counting towards a patient’s out-of-pocket burden—sometimes called copay accumulator adjustment programs.

NCL criticized HHS for permitting health plans to use these so-called copay accumulator adjustment programs.

“Removing this cost-sharing assistance will force those patients to pay thousands of dollars more in unexpected costs at the pharmacy. These new costs could push some to forego those medications, leading to worsened health outcomes. This could compromise medication adherence and will lead to increased health care costs over time.” – NCL Executive Director Sally Greenberg

Separate studies conducted by the Centers for Disease Control and Prevention (CDC) and IQVIA show that out-of-pocket costs can contribute substantially to reduced adherence or to patients not taking their medication altogether. This is counterproductive because if patients do not take their meds as directed, it means higher costs in other parts of the healthcare system stemming from increased hospitalizations, ER visits, and long-term health issues.

If the data doesn’t convince CMS, voters should. Weeks before the presidential election, we can clearly see widespread support for the value of copay assistance regardless of political affiliation. According to a new National Hemophilia Foundation national survey, more than 80 percent of registered voters believe the government should require copay assistance to be applied to patients’ out-of-pocket costs. Even lawmakers agree that CMS should stop this policy before it launches. A bipartisan group of 36 members of the U.S. House of Representatives sent a letter to CMS urging the agency to not finalize the “contentious line extension section or the Medicaid best price change as currently defined in the notice of proposed rulemaking.”

Clearly, copay assistance is critical to Americans. We hope CMS reevaluates the potentially harmful consequences of this new rule on patients and pulls back this counterproductive proposal.

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.