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Health Advisory Council Newsletter | Spring 2021

NCL Health Policy at Work

CBD education and advocacy

In congressional outreach, NCL signed onto a joint letter in opposition to new House legislation, HR 841, which would put consumers at further risk if enacted. The bill requires FDA to allow all hemp-derived ingredients in dietary supplements and provides no exclusions (e.g., the bill is not limited to CBD, there is no exception for THC, and no prohibition of self-determination of GRAS, or products that are generally regarded as safe, for hemp-based compounds).

During National Consumer Protection Week, the Consumers for Safe CBD campaign released a PSA featuring NCL Director of Health Policy Jeanette Contreras, who shares an important reminder with consumers about the potential dangers of CBD, or cannabidiol.

Maternal health

NCL is making strides to address the dismal state of maternal health in the United States. On April 20, NCL launched the Preterm Birth Prevention Alliance alongside 14 fellow advocates who are passionate about standing up for the needs of moms and babies, and reducing the risk of preterm birth, a leading cause of infant death in the United States. and one that disproportionately affects people of color. The Preterm Birth Prevention Alliance shares a concern about the proposed market withdrawal of 17P, the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth.

Collectively, the Alliance is calling for FDA to grant a public hearing to hear directly from women facing prematurity, and the providers who treat them, about their real-world experience. We are also urging FDA to review additional research methods to further study 17P—while maintaining patient access. To learn more about the issue and the Preterm Birth Prevention Alliance, visit pretermbirthalliance.org.

NCL is proud to support the Black Maternal Health Momnibus, a package of 12 bills intended to comprehensively address the maternal health crisis that disproportionately impacts Black, Indigenous, and women of color in this country. NCL applauded the resolution introduced by Representative Alma Adams, (NC-12), Representative Lauren Underwood (IL- 14), and Senator Cory Booker (D-NJ) designating April 11-17, 2021 as national Black Maternal Health Week. NCL also applauded a provision within the American Rescue Plan that allows states to extend Medicaid coverage to women for up to one year after childbirth. This provision to expand postpartum care is vital to improving maternal health outcomes for our most vulnerable moms.

Women’s health

NCL maintains its commitment to advocating for increased access to contraception. In an *opinion piece by NCL Executive Director, Sally Greenberg, she argues that contraception is an essential part of health care and that the full array of FDA-approved contraceptives should be fully covered by insurance. NCL also applauds the FDA for moving to increase access to the abortion pill, Mifepristone. As of April 12, the FDA will temporarily allow Mifepristone to be dispensed by mail for the duration of the COVID-19 public health emergency. Patients are now able to obtain a safe and effective abortion pill through a telemedicine consult, without risking exposure to COVID-19 with an in-person visit.

COVID-19

In March, NCL’s Executive Director, Sally Greenberg, moderated a discussion with the Cancer Support Community and the American Clinical Laboratory Association. The web briefing provided stakeholders with an in-depth overview of the state of COVID-19 testing and industry efforts to facilitate genomic sequencing to help identify COVID-19 variants.

In continued efforts to educate consumers about COVID-19, NCL featured a guest blog by Farah Towfic, PharmD, MBA, director of the U.S. Pharmacopeia (USP) COVID-19 Vaccine Handling Toolkit to discuss how USP was able to provide solutions to the operational challenges of delivering vaccines, which helps healthcare practitioners vaccinate more people in their communities quickly and safely.

Vaccine safety and confidence

In efforts to counteract vaccine safety disinformation, NCL, joined by nine patient and consumer advocacy organizations, sent a joint letter to the U.S. Small Business Administration (SBA), expressing concerns regarding Paycheck Protection Program (PPP) monies granted to the leading American anti-vaccine groups. The organizations collectively demanded that the SBA claw back nearly a million dollars worth of PPP loans from some of the most virulent anti-vaccine groups — each of which has spread misleading information about the coronavirus.

NCL continued its regulatory advocacy to increase the safety and confidence in vaccines. On February 24, NCL’s Associate Director of Health Policy Nissa Shaffi testified before the Centers for Disease Control and Prevention (CDC) Advisory Committee of Immunization Practices (ACIP). NCL’s testimony highlighted racial and ethnic disparities in Hepatitis B vaccinations. On April 23, Jeanette Contreras testified before the CDC ACIP in support of lifting a temporary pause on the administration of the Johnson & Johnson vaccine and recognized that the vaccine surveillance systems in place are working as they should to ensure the safety of the American people.

On February 26, Nissa Shaffi testified before the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), Vaccine and Related Biological Products Advisory Committee (VRBPAC). NCL testified in support of the responsible Emergency Use Authorization (EUA) of the Janssen Biotech COVID-19 vaccine, pointing to the benefit the vaccine’s one-shot dose would have for rural and medically underserved communities.

To further address vaccine hesitancy and COVID myths, NCL’s Director of Health Policy, Jeanette Contreras, published a Spanish-language blog urging consumers to welcome the newly available Johnson & Johnson vaccine as an additional safe and effective way to curb this pandemic.

Pharmacy benefit managers (PBMs) driving up Rx costs

NCL is taking up a call to action to address the unfair disadvantage consumers face at pharmacy counters at the hands of pharmacy benefit managers, or PBMs. In a statement on the Senate confirmation hearing of HHS Secretary Xavier Beccera, NCL encouraged Beccera to continue critical efforts to help drive down consumer out-of-pocket costs of medicines at the pharmacy counter. Consumers are unaware of what drives the high cost of prescription drugs and they shouldn’t have to, states Sally Greenberg — the system needs to deliver affordable, accessible, safe and effective medications without any entities taking an unfair or hidden profit. Through this work, NCL aims to educate consumers about the role PBMs play in raising costs for their prescription medications via rebates and cost savings that unfortunately do not transfer to patients. NCL is also asking policymakers to act. Stay tuned for more from us on this, and let’s continue the conversation.

Script Your Future Medication Adherence Team Challenge

On April 2, NCL completed its 10th Annual Script Your Future Medication Adherence Team Challenge. The Team Challenge is a competition designed to engage health profession students and faculty across the nation by encouraging teams to develop creative initiatives to raise public awareness about the importance of medication adherence and vaccine confidence. Over the past eight weeks, students from 27 schools of pharmacy have successfully coordinated COVID-19 vaccine clinics, directly counseled thousands of patients, produced informational videos on Anti-Microbial Resistance awareness, and hosted campus-wide Script Your Future events. NCL will announce Team Challenge winners in June. We thank our generous partners for your enduring support of Script Your Future by serving as reviewers this year!

*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings.

Health Advisory Council Newsletter | Spring 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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