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Leadership: Board of Directors and Staff

National Consumers League Board of Directors

The National Consumers League, a private, nonprofit membership organization, is governed by a board of directors with experience in consumer protection and advocacy, law, business, labor, and public affairs. Headquartered in Washington, DC, NCL has affiliated members from every state and collaborates with an extensive nationwide consumer action network. Organizational affiliations are provided for identification purposes only. Board members serve on an individual basis.

Officers

Joan Bray – Chair

Retired Senator, Missouri Senate

Jon Leibowitz – Vice Chair

Federal Trade Commission, retired

Richard Fiesta – Treasurer

Alliance for Retired Americans

Sharon White-Páez – Secretary

Potomac Waves Media

Directors

Jenny Backus

Backus Consulting, LLC

Debra Berlyn

Consumer Policy Solutions

Dr. Marvin L. J. Blye

The Blye Group

Kirstin Downey

Honolulu Civil Beat

Norma Flores López

Justice for Migrant Women

Ashley Harrington

Consultant

Pastor Herrera, Jr.

California State University-Northridge

Andrea LaRue

NVG, LLC

Cleo Manuel Stamatos

Consumer Mom, LLC

Rod Markham

Avuetech

Bob Russo

Consumers League of New Jersey

Sarah Sattelmeyer

The Pew Charitable Trusts

Wendy Weinberg

Office of the Attorney General for the District of Columbia

Maureen Thompson

CFP Board

NCL Staff

Executive Director

Sally Greenberg - Executive Director, National Consumers League

Sally Greenberg joined the National Consumers League as Executive Director on October 1, 2007. The League’s focus is on five key priority areas: fraud, child labor, LifeSmarts, health care, especially the safe use of medications and medication adherence, and food safety and nutrition. Sally has testified numerous times before Congress on consumer protection issues, including on product safety, fraud, excessive fees on car rentals, consumer rip-offs in calling cards and in support of protections for farmworker children. Sally is our primary spokesperson on a variety of issues.

Sally came to NCL from Consumers Union, where she worked from 1997-2007 on product liability and food safety issues, along with auto and product safety. Previously, Sally worked at the U.S. Department of Justice Foreign Claims Settlement Commission and prior to that, she spent a decade serving as the Eastern States Civil Rights Counsel for the Anti-Defamation League, based in Boston. Sally started her career as a legislative correspondent for Senator Gaylord Nelson (D-WI). She went on to spend four years as legislative assistant for Congressman Toby Moffett (D-CT).

Sally was president of the Women’s Bar Association of Massachusetts and the Women’s Bar Foundation, and served on several gubernatorial commissions in Massachusetts. Sally served for many years on the board of directors of the Alliance for Justice, and HALT, an organization whose mission is the protection of the rights of consumers in their interactions with lawyers and the legal system. Sally is a member of the Reagan-Udall Foundation Board, a nonprofit established by Congress to support the mission of the FDA and help equip the agency with the highest caliber regulatory science and technology. She also serves on the board of the Keystone Center, which helps leaders in health, energy, environment and education battle contentious issues with a consensus-based approach. Sally also served for over a decade on the board of directors of Trillium Asset Management

Communications & Marketing

Carol McKay - Vice President of Communications

Carol McKay joined the staff of the National Consumers League as Assistant Director of Communications in September 2000. At NCL, Carol works closely with policy staff, the executive director, and the development team to oversee all aspects of marketing and communications for the organization. Carol manages print and online publications, media relations, and consumer public education campaigns on a variety of issues, ranging from health to fraud to child labor. Carol coordinates public relations for NCL’s programs including LifeSmarts, NCL’s work in fraud prevention and education, and child labor. Her department also serves the internal communications needs of the organization. In addition to her communications role at NCL, Carol works closely with development and senior staff on fundraising strategy and proposal writing.

Carol was promoted to director of communications and later Vice President of communications in 2003 and 2004. Prior to her work at NCL, she worked as a reporter in newsrooms in California and Montana. Carol earned bachelor’s degrees in History and Political Science and a minor in English literature at the University of California, Los Angeles.

Katie Brown - Communications Manager

Katie Brown joined NCL as the Communications Manager in January 2022. Katie has been working in the Communications field for 12 years with a focus in entertainment public relations and directly with non-profits since 2016, previously working at Community Advocates for Family and Youth before coming to NCL. Katie is a native of Washington, DC; she holds a Bachelor of Arts from Pace University in New York. When Katie is not working, she enjoys giving back by volunteering with Court Appointed Special Advocates and Service Angels.

Development

Karen Silberstein - Senior Director of Development

Karen Silberstein joined the staff of NCL in July 2018. She has a background in fundraising and development, as well as program implementation in Workforce Development/Career and Technical Education. As Senior Director of Development, Karen is delighted to be working with the development team to support NCL’s mission. She brings strategic relationship building skills with extensive experience managing projects, and designing and developing collateral materials. Her most recent position involved outreach and events for University of the District of Columbia Community College, Workforce Development and Lifelong Learning.

Previously she worked in program development, researching funding opportunities and best practices in program implementation for Home Builders Institute, a training provider focused on the building trades. She holds B.A. in English from Oberlin College and a Ph.D. in French Literature and Culture from Columbia University. Recently, Karen has pursued graduate coursework in Public Administration at the University of the District of Columbia.

Elena Robertson - Development Manager, LifeSmarts

Elena Robertson is the Development Manager for LifeSmarts, NCL’s consumer education program that teaches real-world skills to more than 125,000 teens each year. Elena joined the National Consumers League in April 2020 as the Development Associate for LifeSmarts. Since joining NCL, Elena has increased LifeSmarts’ engagement with corporate partners and built upon the LifeSmarts Alumni Program. In early 2021, Elena created the LifeSmarts Alumni Advisory Board, a group of young professionals and LifeSmarts Alumni who help shape the programming and engagement of the LifeSmarts Alumni Association.

Elena has been working in non-profit fundraising and development since 2015, previously working at the Tragedy Assistance Program for Survivors before coming to NCL. Elena is from Fairfax, VA; she holds a Bachelors of Arts from Christopher Newport University and a Master of Arts from the University of London. When not focusing on LifeSmarts, Elena enjoys volunteering for causes that she cares about and is an avid marathon runner.

Toby Mulford - Development Manager

Toby Mulford joined the National Consumers League in June 2021 as the Development Manager. He has an extensive background in nonprofit theater and education, with 13 years as the Associate Artistic Director for Traveling Players Ensemble, a company that teaches theater and outdoor skills to teens and preteens. He also served as Managing Director for DC’s award-winning Faction of Fools Theatre Company. He holds a Bachelors of Science from the University of Delaware and a Masters of Fine Arts from the Dell’Arte International School of Physical Theater.

LifeSmarts

Lisa Hertzberg - LifeSmarts Program Director

Since July 2000, Lisa Hertzberg has directed the national LifeSmarts program, NCL’s fast, fun consumer education competition for teens and tweens. Lisa’s primary responsibilities include operating the national LifeSmarts program, strategizing growth, implementing new partnerships and program components, assisting state coordinators, developing educational materials, managing the online competition, and conducting the online and national competitions. Under Lisa’s direction, the program, formerly only available to high school students, has expanded into middle school classrooms across the country, serving a wider audience of student participants and coaches.

Before joining the National Consumers League, Lisa worked for 13 years for the Minnesota Attorney General’s Office, where she created and conducted consumer education programs and outreach efforts. In 1995 she launched the Minnesota state LifeSmarts program. Within several years the Minnesota program was the largest in the country involving students at more than 120 schools in 1999-2000.

Lisa is a graduate of Gustavus Adolphus College in St. Peter, Minnesota, where she studied communications and political science.

Cheryl Varnadoe - LifeSmarts Program Outreach Coordinator

Cheryl’s main responsibilities are planning and conducting LifeSmarts outreach across the country, presenting LifeSmarts at national conference/meetings, planning workshops and training webinars, marketing LifeSmarts on the state/national level and preparing competition collateral. She also manages the LifeSmarts Alumni Association.

Before joining the National Consumers League, Cheryl worked for 34 years as a 4-H County Extension Agent and Georgia 4-H Specialist where she led Georgia 4-H family and consumer science programs statewide. Her main focus was youth-centered consumer education programs. as well as starting the successful Georgia LifeSmarts program which grew rapidly in the past seven years.

Cheryl earned her Master’s of Education degree from the University of Georgia in Athens, GA. Her course focus was Family & Consumer Science Education. She is a lifelong 4-H’er and continues her involvement as a 4-H volunteer leader.

Ryan Barhoush - LifeSmarts/Food Safety & Nutrition Program Associate

Ryan Barhoush joined the National Consumers League in January 2022 as a Program Associate supporting both the LifeSmarts Program and NCL’s Food Safety & Nutrition public policy area. Prior to joining NCL, Ryan interned at Gulf International Forum as a research analyst studying OPEC. Besides being a consumer advocate, Ryan is passionate about foreign policy, corruption and transparency issues, and anti-trust monopolies in the marketplace. Ryan received his BA in Political Science from the University of Central Florida.

Operations and Finance

Arlene Johnson - Managing Director

Arlene Johnson joined the National Consumers League in January 2018.  She is responsible for the financial management and daily operational efficiency at NCL. She works closely with the executive director in overseeing the resources and needs of the organization.

Arlene has developed a passion for working for non-profit organizations that are committed to making a difference in society. She is committed to educating individuals in matters that promote the greater good.

Before joining NCL, Arlene spent 10 years as director of finance and administration at Brookings Executive Education, where she supported the education of executives in leadership and policy issues. Arlene’s prior experience includes financial management at George Washington University, MCI Telecommunications, and PepsiCo Inc. She has also served as the Chief Operating Officer of an interior design firm.

Arlene is a graduate of Howard University, where she earned a B.B.A degree with a concentration in Finance.

Andrea Smith - Associate Director, Operations and Finance

Andrea Smith joined the National Consumers League as operations manager in January 2019. She assists the managing director with improving operational systems, processes, and policies towards supporting NCL’s mission. She also collaborates in the development of short- and long-term strategic goals for the operations department.

Prior to joining NCL, Andrea worked for 12 years as the director of finance and administration for the non-profit education association American Association of Colleges for Teacher Education (AACTE), where she was responsible for daily operations, human resources, and financial management.

Andrea has also worked for the Friends of the National Zoo (FONZ), Red Coats Janitorial Services, and Potomac Services in finance and administration management.

Andrea is currently a member of the Society for Human Resource Management (SHRM). She earned a Bachelor of Science degree in business administration from Paine College.

Adrienne Archer - Office Manager / Executive Assistant

Adrienne Archer was recently promoted to the Office Manager position at NCL. In this new role, she continues to support the Operations and Finance Department, NCL’s Board of Directors and now provides support to the LifeSmarts Program. She joined the National Consumers League (NCL) in March 2020 as NCL’s Executive Assistant and provided support to the Operations team. Prior to joining NCL, she worked for 23 years at the Transportation Research Board (TRB) of the National Academies of Sciences, Engineering and Medicine (NASEM), in successive administrative support roles.  While at TRB, she participated in the NASEM Mentorship Program, where she mentored numerous administrative staff. She also completed the NASEM Emerging Leaders Workshop and Conflict Resolution for Responsible Staff Officers training programs.  Adrienne has a B.A. in Psychology from George Washington University and a B.A. in Sociology from George Mason University.

Public Policy: Child Labor & Workers’ Rights

Reid Maki - Director of Child Labor Issues and Coordinator of Child Labor Coalition

Reid Maki joined the National Consumers League in March 2008. In his work at NCL, Reid coordinates the activities of the Child Labor Coalition, striving to minimize abusive child labor and to protect the health, safety, and well-being of child workers in the United States and abroad. Reid is a proponent of corporate social responsibility, including fair labor standards for American workers.

Prior to joining NCL, Reid worked for 12 years at the Association of Farmworker Opportunity Programs (AFOP) where he directed the Children in the Fields campaign, a joint effort launched by AFOP, NCL, and the International Initiative to End Child Labor. Their goal was to end the legal loopholes in child labor law that permit child agricultural wage laborers to work longer hours and to work at younger ages than children working in other industries. Reid was an active member of the Child Labor Coalition between 1994 and 2006.

Reid worked for both daily and weekly newspapers as a reporter earlier in his career. He earned bachelor’s and master’s degrees in American History at the University of Massachusetts at Amherst and Stanford University, respectively.

Public Policy: Food Safety & Nutrition

Nancy Glick - Director of Food and Nutrition Policy

Nancy GlickNancy Glick joined the staff of the National Consumers League as Director of Food and Nutrition Policy in September 2020 after a long career in health and nutrition communications, advocacy, and public policy.

At NCL, Nancy works closely with the executive director and stakeholder organizations to develop policy positions and mount education and advocacy campaigns on key issues of concern to consumers, including food insecurity, food safety, eliminating food waste, food fraud, obesity and diet-related diseases, and improving food and beverage labeling.

Prior to joining NCL, Nancy worked in the public relations field designing and implementing communications, social marketing, disease awareness, healthcare and nutrition advocacy, and public policy programs. From 2009 through mid-2020, Nancy was Director of Health Affairs and Advocacy at the global public relations firm MSL, working with a team of advocacy specialists to assist the firm’s clients in forming strategic alliances with health, medical, consumer, and patient groups in the United States and building coalitions to advance nutrition and health care issues.

Before joining MSL, Nancy served in a variety of executive positions at three other leading public relations agencies — Ruder Finn, Porter/Novelli, and Hill and Knowlton, Inc. Nancy was also a press officer at the Food and Drug Administration, where she handled food, cosmetic, drug, and consumer issues and agency announcements about product recalls.

Public Policy: Fraud and Telecom

John Breyault - Vice President of Public Policy, Telecommunications and Fraud

John Breyault joined the National Consumers League in September 2008. John’s focus at NCL is on advocating for stronger consumer protections before Congress and federal agencies on issues related to telecommunications, fraud, technology, and other consumer concerns. In addition, John manages NCL’s Fraud Center and coordinates the Alliance Against Fraud coalition. John is also Research Director for the Telecommunications Research and Action Center (TRAC), a project of NCL. In his role with TRAC, John advocates on behalf of residential consumers of wireline, wireless, VoIP, and other IP-enabled communications services.

Prior to coming to NCL, John spent five years as director of research at Amplify Public Affairs, where he helped launch the firm’s Web 2.0-based public affairs practice and focused on producing actionable public policy research. Earlier in his career, John worked at Sprint in its International Carrier Services Division and at the American Center for Polish Culture in Washington, DC.

John was a member of the FCC’s Consumer Advisory Committee from 2005 to 2007 and served on the Board of the Arlington-Alexandria Coalition for the Homeless. He is a graduate of George Mason University, where he received a bachelor’s degree in International Relations.

James Perry - Consumer Services Coordinator NCL’s Fraud Center

James Perry is a veteran staffer at NCL’s Fraud Center. Since January 2000, he’s been counseling consumers on a variety of scams ranging from telemarketing- to Internet-based issues. James began at the National Fraud Information Center/Internet Fraud Watch programs (now NCL’s Fraud Center) as a fraud counselor, speaking with thousands of consumers each year about cases of suspected and confirmed fraud. James was later promoted to supervise the staff of NCL’s Fraud Center, and he regularly speaks about his experiences counseling fraud victims to the media and nonprofit and law enforcement agencies.

As Consumer Services Coordinator, James monitors complaints submitted to NCL via the complaint form at www.fraud.org and serves as a representative on the Consumer Federation of America’s Fake Checks Working Group. At NCL, James works with law enforcement agencies to transmit consumer fraud complaints to more than 200 agencies in the United States and Canada.

Eden Iscil - Public Policy Associate

Eden Iscil joined the National Consumers League in October 2021 as a Public Policy Associate with the Fraud and Telecommunications team. Prior to joining NCL, Eden came from a background of legislative experience with three legislative sessions in the Virginia General Assembly, followed by an internship with Congresswoman Elaine Luria.

Besides being a public interest advocate, Eden is passionate about parliamentary procedure, Middle East policy, and music theory. Eden received their BA in Political Science and Music from Virginia Commonwealth University and an MA in Political Science from American University.

Public Policy: Health

Jeanette Contreras - Director of Health Policy

Jeanette Contreras portraitJeanette Contreras joined the National Consumers League in August 2020. Jeanette leads NCL’s health care policy program and serves as the key spokesperson and consumer advocate on safe medication use, drug affordability and accessibility, comprehensive health coverage for all, and the promotion of vaccines and other preventive health care services.

Prior to coming to NCL, Jeanette managed a national grassroots advocacy program at the American Academy of Family Physicians, and led consumer education and stakeholder engagement for the implementation of the Patient Protection and Affordable Care Act at the Centers for Medicare and Medicaid Services. She began her health policy career in the legislative office of the National Cancer Institute.

Jeanette served as President of the Hispanic Employee Organization for the U.S. Department of Health and Human Services from 2014-2016. She holds a bachelor’s degree in Political Science from the California State University, Los Angeles and a master’s degree in Public Policy from American University.

Milena Berhane - Health Policy Associate

Milena joined the National Consumers League as a Health Policy Associate in October 2021. Prior to working at NCL, Milena worked as a policy research assistant at George Washington University’s Sumner Redstone Center for Prevention and Wellness. Her work focused mainly on health equity policy both nationally and in the Washington, D.C. area, including chronic disease disparities in the nation’s capital, federal COVID-19 relief legislation, and access to health care in urban areas. Milena earned her Bachelor of Arts in Public Health Studies from Johns Hopkins University, and her Masters of Public Health in Health Policy from George Washington University.

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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.

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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.

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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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