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Health Advisory Council Newsletter | Winter 2021 | Member Updates

America’s Health Insurance Plans (AHIP)

American Society of Health-System Pharmacists (ASHP)

Biotechnology Innovation Organization (BIO)

Brian Isetts, University of Minnesota College of Pharmacy

Consumers for Quality Care (CQC)

Consumer Healthcare Products Association (CHPA)

Eli Lilly and Company

Food and Drug Administration (FDA) – Center for Drug Evaluation and Research (CDER)

Food and Drug Administration – Office of Women’s Health (OWH)

Healthcare Distribution Alliance (HDA)

HealthyWomen

United States Pharmacopeia

America’s Health Insurance Plans (AHIP)

Health insurance providers continue to take decisive action to support their members amid the COVID-19 crisis, ensuring that Americans have access to diagnostic testing, treatment, and COVID-19 vaccination. AHIP recently released a dedicated resource page on COVID-19 vaccines, which highlights everything health insurance providers are doing, from providing access to FDA-approved vaccines to educating Americans about the need for vaccines. AHIP is also partnering with the Ad Council on a national COVID-19 vaccine education effort to increase confidence in vaccination against COVID-19. Developed in partnership with COVID Collaborative, the initiative will reach key audiences across the country through research-driven creative campaigns, strategic media placements, community outreach and trusted messenger engagement–representing one of the largest public education efforts in history.

The Modern Medicaid Alliance, of which AHIP is a founding member, announced new COVID-19 data now available on its Medicaid Dashboard. In addition to providing the latest, most comprehensive Medicaid enrollment research and polling for all 50 states plus the District of Columbia, the recently updated Dashboard now includes a new feature dedicated to demonstrating COVID-19’s impact on Medicaid at the national and state levels. The new COVID-19 data finds that enrollment in Medicaid and the Children’s Health Insurance Program (CHIP) increased by nearly 6 percent nationwide from December 2019 to June 2020. An additional 5.03-10.25 million people are projected to enroll in the Medicaid program through December 2022 as a result of the COVID-19 crisis, according to modeling from Health Management Associates (HMA).

To learn more about health insurance providers actions to support Americans amid the COVID-19 crisis, AHIP, or the Modern Medicaid Alliance, contact Nicole Eynard at neynard@ahip.org

American Society of Health-System Pharmacists (ASHP)

ASHP has developed new COVID-19 resources that are open to the public: a Vaccine FAQ developed jointly with the American Nurses Association, and a new resource guide on the security, storage, and handling of the COVID-19 vaccines currently authorized by the FDA. This guide serves as a current reference document to support our members and other providers who are serving on the front lines of the vaccine rollout. To access additional resources and information, ASHP invites you to visit ASHP’s COVID-19 microsite.

Biotechnology Innovation Organization (BIO)

BIO continues to raise awareness and advance policies that address antimicrobial resistance (AMR), a public health crisis that puts modern medicine at risk. Antibiotic-resistant infections are a growing problem, particularly for public health responses to pandemics such as COVID-19, for which secondary bacterial and fungal infections can have deadly consequences. BIO is working on policies that both ensure a sustainable pipeline of new antibiotics as well as patient access to these medicines. Alongside organizations like the National Consumers League and their important work on medication adherence via Script Your Future, BIO hopes to help make a difference. Learn more about BIO’s initiative Working to Fight AMR, which issued its latest Superbug Bulletin in December explaining the latest developments and challenges in the AMR market.

In addition to our AMR work, BIO has been working hard to educate the public on COVID-19 vaccines, with a goal of increasing vaccination acceptance across communities. BIO recently launched CovidVaccineFacts.org to address key issues and answer commonly asked questions about COVID-19 vaccine development, safety, administration, and more. Through their site, BIO is sharing educational content that you can use to support your own organizations’ vaccine outreach. BIO will continue populating the website with new questions and answers throughout 2021.

BIO is partnering with the nonprofit sector on its COVID efforts, and via the site BIO will be sharing nonprofit partner organizations’ events and resources. Our partners include: The National Hispanic Coalition on Aging, BlackDoctor.Org, the COVID-19 Prevention Network, LULAC and the National Black Church Initiative, among others. Visit CovidVaccineFacts.org here and be sure to check out BIO’s partners page to learn how you can be a fact spreader using BIO’s advocate toolkit. If your non-profit organization is doing innovative work to drive vaccine acceptance within Communities of Color, please connect with us!

Brian Isetts, University of Minnesota College of Pharmacy

Brian Isetts would like to share that profession of Pharmacy is mobilizing to address the country’s failing COVID-19 vaccination response, as explained here: Feds to Start Using Pharmacies to Ramp up Administration of Vaccines, at: https://www.medscape.com/viewarticle/943677.

Consumers for Quality Care (CQC)

For more than three years, Consumers for Quality Care (CQC) has worked to shine a light on the serious problems that consumers are facing when it comes to accessing quality, affordable health care. The ongoing COVID-19 pandemic and economic pain that it has caused millions of Americans has only made these disparities greater in our country.

From fighting anti-consumer Medicaid waivers, to speaking out against harmful administration proposals like the NBPP, we have been working tirelessly to ensure that consumers are at the forefront of the health care debate and that is something we will continue to do moving forward as we demonstrate to policymakers the importance of quality care for all. To learn more about CQC’s recent work, check out the links; open letter to President-elect Joe Biden, growing coalition, comments to CMS over a dangerous Medicaid proposal, and consumer stories.

Consumer Healthcare Products Association (CHPA)

The 2020 Coronavirus Aid, Relief, and Economic Securities (CARES) Act provided consumers with a number of health-related benefits, including renewed eligibility for over-the-counter (OTC) medicines as qualified expenses under Health Savings Accounts (HSAs) and Flexible Spending Arrangements (FSAs), and it granted eligibility for feminine care products for the first time, as well. For more than ten years, CHPA has been leading a broad coalition of stakeholders to regain these HSA/FSA benefits for consumers and since the CARES Act passed, CHPA has been educating Americans about the new benefits through our campaign, www.TaxFreeOTC.org. Using web, digital display ads, PR, and social media strategies, we have reached more than 150 million consumers to educate them about these new benefits. Learn more at www.TaxFreeOTC.org.

Eli Lilly and Company

Eli Lilly would like to report that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for Lilly’s investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg, for the treatment of recently diagnosed, mild to moderate COVID-19 illness in high-risk patients. Read more, here: Bamlanivimab for COVID-19 | Eli Lilly and Company.

Food and Drug Administration (FDA) – Office of Women’s Health

CDER’s Office of Communications has a new director, James-Denton (JD) Wyllie. He has been with the organization for six months. You’ll find his bio on our website at the following link: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/james-denton-jd-wyllie. Our former director, Chris Shreeve, retired in August 2020.

Food and Drug Administration (FDA) – Office of Women’s Health

The FDA Office of Women’s Health (OWH) hosted a public meeting to discuss potential sex (biological) and gender (psychosocial) differences in use and responses to cannabidiol (CBD) and other cannabinoids on November 19, 2020. Presentations addressed patient and healthcare provider perspectives on CBD and other cannabinoid use, sex differences in the effects of CBD and other cannabinoids, use of CBD and other cannabinoids in pregnancy, and government agency perspectives on CBD research and evaluation. The meeting recording can be accessed here.

There are also two recent posts on the OWH blog: Knowledge and News on Women. In recognition of Diabetes Awareness Month this past November, OWH Director Dr. Kaveeta Vasisht and guest blogger Dr. Susan Mayne-Center for Food Safety and Nutrition (CFSAN) Director at FDA, shared how healthy eating habits play a major role in diabetes management. Exciting new changes to the Nutrition Facts label were shared, read the blog post in its entirety here. OWH kicked off the new year encouraging women to make their health a priority throughout 2021. Resources and additional information can be found in the January blog post here.

The FDA is also hosting a virtual public meeting from February 2-3, 2021: Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials. Click the link for additional details and registration information: https://www.fda.gov/drugs/news-events-human-drugs/scientific-and-ethical-considerations-inclusion-pregnant-women-clinical-trials-public-meeting. If you are not subscribed to the OWH newsletter, the subscription option is located at the top of the OWH homepage, www.fda.gov/womens.

Healthcare Distribution Alliance (HDA)

Allied Against Opioid Abuse (AAOA) recently partnered with the National Hispanic Medical Association (NHMA) to release a new suite of resources to help educate the Hispanic community about the rights, risks and responsibilities associated with prescription opioids. The toolkit was developed by an advisory committee of NHMA members and features three downloadable and printable resources available in both Spanish and English. Along with the toolkit resources, AAOA released an informational Spanish-language video providing key insights on safe prescription opioid use from NHMA physicians. The partnership between AAOA and NHMA aims to increase awareness among Hispanics about prescription opioid safety, safe storage and disposal and alternative pain management options by providing resources for healthcare providers to easily share with their patients. We encourage you to share the resources and video with your networks. For more information about how your organization can collaborate with AAOA, please contact Lee Lynch (llynch@reservoircg.com).

HealthyWomen

As the trusted digital resource for women 35-64, HealthyWomen enables and empowers women to make informed choices regarding their health through real, attainable, and action-oriented editorial coverage. And as the world learns more about the COVID-19 vaccines, HealthyWomen is on the frontline ensuring we have the best information for our audience. The COVID-19 Vaccine Education and Equity Project is a coalition of 100+ patient, health care provider, public health and relevant trade organizations (including the American Pharmacists Association, Consumer Brands Association, National Association of Chain Drug Stores, National Association of Convenience Stores, etc.) that have come together to advance public education around COVID-19 vaccines. Pfizer has provided initial funding to support the project, which was convened by HealthyWomen, the Alliance for Aging Research, and the National Caucus and Center on Black Aging. Please visit https://covidvaccineproject.org/ for more information.

United States Pharmacopeia (USP)

U.S. Pharmacopeia has released a new COVID-19 Vaccine Handling Toolkit that provides critical information to pharmacists, doctors, nurses, nurse practitioners, health profession students, physician assistants, and others handling COVID-19 vaccines. These resources can facilitate operational efficiencies that help accelerate delivery and support safe handling of COVID-19 vaccines while maintaining quality and ultimately the public’s trust. Visit www.usp.org/covid-vaccine-handling to download the toolkit or to learn more.

HAC Newsletter Winter 2021

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NCL health policy updates

Member updates

Member spotlight: U.S. Pharmacopeia (USP)

December meeting summary

Winter 2020 HAC Meeting

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PBPA Commends HHS Funding to Support Maternal and Infant Health

The Preterm Birth Prevention Alliance (PBPA), a coalition of maternal and women’s health advocates dedicated to improving preterm birth outcomes in the United States and addressing its disproportionate impact on women of color, applauds the U.S. Department of Health and Human Services (HHS) for awarding nearly $350 million to states across the country to improve support for safe pregnancies and healthy babies.

“For far too long, U.S. maternal health care has lagged behind that of other developed countries, particularly for women of color,” noted Sally Greenberg, Executive Director of the National Consumers League. “This additional funding will enable local health departments and nonprofits to better address the health care needs of the most vulnerable mothers and their babies.”

The funding, awarded by HHS’ Health Resources and Services Administration (HRSA), will support home visiting services, increase access to doulas, address infant mortality and maternal illness, and improve data reporting on maternal mortality.

“Maternal health care in the U.S. has consistently failed women of color,” Greenberg continued.  “We applaud HHS for this additional funding that will help to improve the maternal health for all mothers and babies, especially women of color and those most at-risk.”

The funding announcement follows the release of a report by the U.S. Commission on Civil Rights which found that Native American women are more than two times more likely to die from pregnancy-related complications than white women in the U.S. This disparity was further exacerbated for Black women in the U.S., who are three to four times more likely to die from pregnancy-related complications than white women.

“In addition to expanding programs to support maternal health, we must increase representation from racially and ethnically diverse groups in research and clinical trials, particularly those studying treatment options to prevent maternal morbidity and mortality,” said Greenberg.  “The need for the additional HHS funding and the report from the Commission on Civil Rights clearly illustrate how critical representative research and real world evidence are to ensuring all mothers and their babies have the same opportunity for the best possible health outcomes.”

Diverse research for a diverse America: The value of equitable, real-world research

August 12, 2021/in Blog, Health, Prevention Blog Post

By Sally Greenberg, NCL Executive Director

While the COVID-19 pandemic has led to hardship for all Americans, it is clear that people of color have been disproportionately burdened. Across the health care continuum, addressing this disparity has become part of the broader conversation about the history of systemic racism and the underlying social determinants of health that negatively affect the mental, physical, and economic health of individuals and entire communities.

The pandemic has underscored persistent health disparities, and there is growing recognition that representation in research and clinical trials can have a profound impact on health outcomes. A lack of representation from racially and ethnically diverse groups in research and clinical trials have typically led to gaps in data, missing the opportunity to assess the full impact of various treatments and drugs across a range of populations. The collection and use of real-world research and data to inform the potential use, risks, and benefits of medical products and treatments can ultimately lead to better health outcomes, particularly for those who have been underrepresented in the past.

Existing efforts to improve inclusion

Efforts to expand diversity and representation in medical research are underway in Congress. Policymakers are encouraging the incorporation of Real World Evidence (RWE) in drug development through the recent Cures 2.0 draft legislation released by Reps. Diana Degette (D-CO-1) and Fred Upton (D-MI-6). While the status quo limits us from effectively reaching underserved populations, the proposed legislation would allow studies that include RWE for some drugs after they have been approved. At the heart of this issue is a growing appreciation that the same therapy can affect different populations in different ways, which is why Cures 2.0 supports collecting data that more accurately reflects the unique experiences and needs of patients across diverse populations.

Recognizing the potential for RWE in maternal health

The lack of representative research in the field of maternal health is undeniable, and its implications are staggering. The dismal state of maternal care in the United States reflects how our health care system has failed women of color, including by not adequately studying treatment options to prevent maternal morbidity and mortality. The need for RWE is clear when you consider the persistent disparities in health outcomes that plague minority communities.

Preterm birth and its disproportionate impact on women of color is a stark illustration of the need to make progress on representative research in maternal health. Preterm birth is the second-largest contributor to infant death in America today. Despite the tremendous physical, emotional, and financial toll that preterm birth continues to take on our country — disproportionately so on women and families of color — not enough therapeutic tools currently exist to prevent it.

Today, “17P,” the only FDA-approved treatment to help reduce the likelihood of spontaneous, recurrent preterm birth in the United States is at-risk of being withdrawn from the market in all its forms, including the branded product and five generic versions. Unfortunately there is conflicting evidence from two different clinical trials, one representative of a diverse U.S. population and another studied in a largely white population in Europe. It’s not a straightforward comparison. If 17P is withdrawn, the women most affected by preterm birth, predominantly women of color, would be left without an FDA-approved treatment option.

The FDA is considering the path forward, including additional data collection through leveraging RWE from past patient use. The success of the first (approval) trial for 17P in the impacted communities signals the importance of RWE. Continued access to 17P is, at its core, a matter of health equity. Black women must not yet again be left vulnerable to a system that historically has overlooked them.

PRETERM BIRTH PREVENTION ALLIANCE APPLAUDS FDA’S GRANTING OF HEARING FOR THE ONLY FDA-APPROVED THERAPIES TO REDUCE RECURRENT PRETERM BIRTH

WASHINGTON, DC, August 26, 2021 –

Preterm Birth Prevention Alliance a coalition of maternal and women’s health advocates dedicated to improving preterm birth outcomes in the United States and addressing its disproportionate impact on women of color, commends the U.S. Food and Drug Administration (FDA) for granting a public hearing to discuss 17P, the only FDA-approved class of branded and generic treatments to reduce preterm birth in indicated patients.

We appreciate the FDA’s willingness to hear directly from individuals facing prematurity and the providers who treat them about their experiences with 17P,” said National Consumer League’s Executive Director Sally Greenberg. “It is an important step towards better understanding variations in efficacy across diverse populations and ensuring all women have an equal chance at the best possible outcomes.”

Last week, the FDA agreed to grant Covis Pharma, the manufacturer of the branded 17P product Makena its request for a public hearing to discuss 17P. Hydroxyprogesterone caproate—or “17P”—has been approved since 2011 and is the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth in the United States. In 2020, the FDA proposed withdrawing 17P in all its forms, including the branded product and its five generic versions, based on conflicting efficacy data from two studies composed of vastly different populations, one predominantly inclusive of women in the U.S. most vulnerable to preterm birth and one not.

“Mothers and birthing people deserve access to the best possible treatments to prevent preterm birth. We cannot achieve birth equity if we study pregnant women as a monolith,” said Blythe Thomas, Initiative Director of 1,000 Days. “It is only by systematically researching the real-world, post-market impact of 17P on individuals from a variety of racial and ethnic backgrounds, while maintaining access for all affected, that we can reduce disparities in maternal and infant health.”

While the hearing date has not yet been set, the Alliance looks forward to sharing the perspectives of affected individuals and their physicians with the agency once the hearing is scheduled and will continue to advocate for at-risk moms and babies of all races and ethnicities.

###

ABOUT THE PRETERM BIRTH PREVENTION ALLIANCE

The Preterm Birth Prevention Alliance (PBPA) is a coalition of maternal and women’s health advocates who share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P, the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth. Formed in 2021 by the National Consumers League, the 15 partners in the PBPA seek to improve preterm birth outcomes in the United States by maintaining access to safe, FDA-approved treatment options and advocating for more diverse medical research that adequately represents the experiences of women and newborns of color. Women of color need a seat at the table. To learn more, visit www.pretermbirthalliance.org

LEADING PATIENT ADVOCATES LAUNCH PRETERM BIRTH PREVENTION ALLIANCE TO PROTECT CRITICAL ACCESS TO THE SOLE FDA-APPROVED CLASS OF THERAPIES TO REDUCE RECURRENT PRETERM BIRTH

WASHINGTON, DC, April 20, 2021 – Today, the National Consumers League (NCL), along with a coalition of patient advocacy organizations dedicated to advancing the health of mothers and infants, announced the launch of the >Preterm Birth Prevention Alliance.

Members of the Alliance are joining forces in an effort to preserve patient access to the only Food & Drug Administration-approved class of treatments for pregnant women who have previously had an unexpected, or spontaneous, preterm birth. Together, Alliance members seek to ensure that the Food & Drug Administration (FDA) hears concerns from the full range of stakeholders about the potential risks and impact of withdrawal for at-risk pregnant women and their providers.

For the fifth year in a row, the U.S. preterm birth rate has increased (to 10.2 percent of births), and preterm birth and its complications were the second largest contributor to infant death across the country. Preterm birth also represents a significant racial health disparity, with Black women in America experiencing premature delivery at a rate 50 percent higher than other racial groups throughout the country.

However, in 2020, the FDA >proposed withdrawing hydroxyprogesterone caproate, commonly called “17P” or “17-OHPC”, the only FDA-approved class of branded and generic treatments to help prevent the risk of preterm birth in women with a history of spontaneous preterm birth. The FDA is currently determining whether to hold a hearing on the status of 17P, based on conflicting efficacy data from two studies composed of vastly different patient populations, one inclusive of women in the U.S. most vulnerable to preterm birth and one not.

“We’re fighting for a more inclusive healthcare system that gives everyone an equal chance to have the best outcomes possible,” said Sally Greenberg, executive director of the National Consumers League. “We don’t believe that removing 17P from the market without gaining a better understanding of who could benefit the most from its use is in the best interests of patients, nor their healthcare providers, particularly as there are no other approved treatment options available.”

To date, 14 organizations have joined NCL to advocate for the health interests of at-risk pregnant women and infants, including: 1,000 Days; 2020 Mom; American Association of Birth Centers; Black Mamas Matter Alliance; Black Women’s Health Imperative; Expecting Health; Healthy Mothers, Healthy Babies Montana; HealthyWomen; Miracle Babies; National Birth Equity Collaborative; National Black Midwives Alliance; National Partnership for Women & Families; Sidelines High-Risk National Support Network; and SisterReach.

“As a trained obstetrician and gynecologist, I know firsthand the impact of preterm birth on Black women and birthing people. I also know that racism – not race – is the driving factor leading the disproportionate impact of preterm birth on Black women and birthing people thereby exacerbating systemic inequities in maternal and infant health. To achieve birth equity, which is the assurance of the conditions of optimal births for all people with a willingness to address racial and social inequities in a sustained effort, we must work to protect and uphold a standard of care for spontaneous, recurrent preterm births and ensure it remains accessible and affordable for all who stand in need,” added Dr. Joia Crear Perry, founder and president of the National Birth Equity Collaborative.

The Preterm Birth Prevention Alliance is calling for the FDA to grant a public hearing to fully consider all of the data, additional research methods, and stakeholder perspectives before deciding whether to withdraw approval of this critical class of therapies. The health of America’s moms and babies warrants the utmost care and consideration.

###

ABOUT THE PRETERM BIRTH PREVENTION ALLIANCE

The Preterm Birth Prevention Alliance is a coalition of maternal and women’s health advocates who share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P, the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth. Formed in 2021 by the National Consumers League, we seek to improve preterm birth outcomes in the United States by maintaining access to safe, FDA-approved treatment options and advocating for more diverse medical research that adequately represents the experiences of women and newborns of color. Women of color need a seat at the table. To learn more, visit www.pretermbirthalliance.org.

Initial support for the Preterm Birth Prevention Alliance is provided by Covis Pharma.

MEDIA CONTACT:

Carol McKay, carolm@nclnet.org

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