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Health Advisory Council Newsletter | Summer 2021

NCL Health Policy at Work

Preterm Birth Prevention Alliance

The Preterm Birth Prevention Alliance is excited to share that on August 18 the FDA granted AMAG/Covis’ request for a public hearing to review the proposed grounds for withdrawing 17P from the market. It is a great milestone for the Alliance. In the months leading up to the hearing, the Alliance will continue its advocacy on behalf of women at-risk for preterm birth, and meeting with policymakers across the Administration and in Congress to raise awareness of the upcoming hearing and the risks associated with potential withdrawal of 17P from the market.

On July 20, several members of the Alliance (including 1,000 Days, 2020 Mom, Black Mamas Matter Alliance, Expecting Health, HealthyWomen, Miracle Babies, National Consumers League, and National Partnership for Women & Families) had the opportunity to meet with the White House Domestic Policy Council to brief them on the issue and share our communities’ perspectives. We left this meeting encouraged by their receptivity and galvanized to continue this important work. At their recommendation, we will also be pursuing a meeting with Dr. Stephen Cha, Counselor to the Secretary of HHS, whose portfolio includes FDA issues.

Members of the Preterm Birth Prevention Alliance continued to advocate for the health of moms and babies at a meeting with Madeleine Dean’s office on July 29. During the meeting with Representative Dean’s staff, Alliance members discussed our efforts to preserve access to 17P. We are so encouraged to find an ally and champion of maternal health in Representative Dean, and look forward to continued engagement on this issue with her office. We want to give special thanks to National Partnership for Women & Families, American Association of Birth Centers, HealthyWomen, and 1,000 Days for their partnership in this effort.

Health equity

On June 30, Jeanette Contreras, joined a panel focused on medical racism and health disparities. Jeanette highlighted NCL’s standing priorities in maternal health and women’s reproductive justice. She also lifted up NCL’s efforts to increase vaccine confidence and educate consumers about the role pharmacy benefit managers play in drug pricing. The Honorable Bobby L. Rush (IL-1) helped kickoff the event featuring other leading voices in the health equity space.

To help boost NCL’s health equity priorities, Nissa Shaffi published blogs on the Model Minority Myth and addressing health inequities for LGBTQ communities, in honor of AAPI Heritage Month and Pride Month, respectively. The blogs focused on the need for data disaggregation among racial and ethnic communities and the disproportionate disease burden observed in the LGBTQ community.

On July 1, NCL intern, Spencer Cramer, published his first blog on how the nation needs to treat gun violence as a public health crisis. The piece advocated for investing in robust research and multiple solutions for gun violence as a holistic approach towards health equity.

Vaccines

On April 23, Jeanette Contreras testified before the emergency meeting of the CDC Advisory Committee on Immunization Practices (ACIP) to discuss updates on the recommendations to pause the Janssen COVID-19 vaccine.  NCL commended the momentary pause in distribution of the vaccine enacted out of “an abundance of caution”, following the reports of severe cases of a rare form of blood clots observed in young women. It illustrated the agencies’ swift response to vaccine surveillance data. In July, NCL submitted written comments regarding the cases of Guillain-Barré syndrome (GBS) observed in patients who have received the Janssen vaccine. We are pleased the agencies resumed emergency use of the vaccine and encourage continued transparency.

Additionally, NCL submitted written comments to ACIP in support of an expedited recommendation for the newest class of pneumococcal vaccines, including for the already FDA-approved PCV20 vaccine. A prompt recommendation for this vaccine will ensure that seniors and vulnerable populations can receive needed protection from it as we come out of the COVID-19 pandemic.

NCL also had the opportunity to advocate for our youngest consumers, pediatric populations. On June 10, Nissa Shaffi testified before the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, about the ongoing rollout of COVID-19 vaccines for pediatric populations. The testimony highlighted priorities related to pediatric vaccine uptake and health disparities observed in pediatric COVID-19 cases. Separately, Jeanette Contreras submitted written testimony to ACIP on behalf of NCL and as a mother of two boys, ages 8 and 9, in support of granting emergency use authorization for the COVID-19 vaccine in pediatric populations. The absence of a vaccine for school-aged children will not only lead to continued transmission; as they return to school in the fall, we may see a spike in pediatric cases.

Script Your Future Medication Adherence Team Challenge

For ten years, Script Your Future teams have conducted community outreach, teaching patients to take their medications as directed by their providers. This year’s Team Challenge National Awards, announced in June, went to the University of Charleston School of Pharmacy (UCSOP) and the University of the Sciences, Philadelphia College of Pharmacy participating. Congratulations to all the teams who were awarded stipends for their participation in the Team Challenge!

Last year, we included vaccine confidence as a metric for the competition. We’re so excited to share that due to the inclusion of vaccine confidence in the Script Your Future campaign, this year’s teams collectively inoculated more than 134,000 patients against COVID-19 and other routine immunizations! Through their strategic and diligent patient outreach via mass vaccination sites, our teams made their communities safer, one interaction at a time, culminating in over 280,000 patient interactions, nationwide.

COVID-19

NCL continues to educate consumers on vaccine confidence during the COVID-19 pandemic. On May 19, Jeanette Contreras, published her second Spanish-language blog to educate consumers about the availability of at-home COVID tests and the role of testing in the continued response to the pandemic. On June 23, Nissa Shaffi, published a blog in support of CDC recommendations that COVID-19 vaccines are safe for pregnant and lactating persons. The blog explores vaccine hesitancy regarding maternal immunizations and serves as a call to action for everyday immunization advocates to encourage vaccine confidence in their communities.

On August 18, NCL released a statement in support of government and employer mandates requiring vaccination. Employer mandates are proving to be an effective measure to nudge reluctant people to get the COVID-19 vaccine. Additionally, vaccine mandates should be implemented in collaboration with labor unions, and provide workers with paid leave to get the vaccine and to potentially recover from side effects resulting from vaccination.

Prescription drug prices

NCL continues its efforts to educate consumers about the role PBMs play in the rising costs for prescription medications. On July 19, Sally Greenberg penned an op-ed, featured in the Morning Consult, on the need for swift implementation of regulations that would direct PBMs to pass along negotiated savings to consumers at the pharmacy counter.

On July 26, Sally Greenberg penned an op-ed, featured in The Hill, on how a loophole in the ACA allows health plans to cover prescription drugs as an Essential Health Benefit (EHB), but not count a patient’s out-of-pocket costs toward reaching their annual deductible or out-of-pocket cost maximum. NCL calls on Congress to clarify that any service covered by a health plan is defined as an EHB, so patients’ out-of-pocket payments for Rx drugs are always counted towards their maximum requirement.

On June 30, NCL Executive Director, Sally Greenberg, moderated a panel on access to contraceptives as intended by the ACA. The panel featured experts in the women’s health space, as well as a patient who shared her personal testimony regarding contraceptive use.

CBD education and advocacy

On June 9, NCL released a statement expressing concerns with the Hemp Access and Consumer Safety Act (S. 1698), which mandates that the FDA regulate CBD as a dietary ingredient. This legislation would only further incentivize CBD manufacturers to seek fast-track approval as a dietary supplement and forego rigorous clinical trials needed for the development of FDA-approved medicines.

As a member of the Collaborative for CBD Science & Safety, NCL signed onto a joint statement on the release of the “Cannabis Administration & Opportunities Act” discussion draft as it impacts cannabinoid science and the regulation of CBD-containing products. NCL looks forward to engaging with policymakers to develop policy recommendations that ensure the quality and safety of CBD and CBD-containing products available for consumer use. During National Mental Health Awareness Month, the Consumers for Safe CBD campaign released a PSA featuring Jeanette Contreras, NCL Director of Health Policy, to warn consumers about turning to unregulated over-the-counter CBD products that claim to help ease anxiety and depression.

New resources on the PBM problem

NCL continues efforts to address the unfair disadvantage consumers face at pharmacy counters at the hands of pharmacy benefit managers, or PBMs. Our new webpage provides resources to further explain the complicated and obscure PBM system, including an explainer video and glossary of key terms to help consumers better understand this complex issue. As Congress returns from summer recess and healthcare legislation will be a top priority, we look forward to working with them to advocate for meaningful reforms to help lower consumer out-of-pocket costs. Please feel free to share these resources with your audiences and learn more at nclnet.org/pbms.

Health Advisory Council Newsletter | Summer 2021

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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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