Measles, it ain’t over until it’s over
Dr. Linda Fu, general pediatrician at Children’s National Health System ….
Dr. Linda Fu, general pediatrician at Children’s National Health System ….
December 20, 2019
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832
Washington, DC –The National Consumers League (NCL), the nation’s pioneering worker and consumer advocacy organization responded to the Department of Justice’s settlement with LiveNation/Ticketmaster for engaging in anti-competitive practices in violation of their 2010 consent decree.
The following statement is attributable to Sally Greenberg, executive director of the National Consumers League:
Yesterday’s action by the Department of Justice to extend the 2010 Live Nation/TicketMaster consent decree by five and a half years was welcome news as it will prevent the ticketing giant from engaging in even more blatantly anti-competitive conduct. However, the DOJ’s action lacks the major fines, and additional structural and behavioral adjustments needed to bring transparency and competition to the opaque live event ticketing industry. Absent of these changes, Congressional action is sorely needed to fix the broken live event ticketing marketplace.
Fortunately, the Better Oversight of Secondary Sales and Accountability in Concert Ticketing Act of 2019 (“BOSS ACT”), (H.R. 3248/S. 1850) which is currently pending in the House and Senate, will provide a comprehensive fix to the ticketing mess. The Boss Act will end deceptive holdbacks and egregious undisclosed ticket fees. It will also require transparency on whether ticket sellers are affiliated with a venue and ensure that ticket holders can sell or give their ticket away as they see fit without extra fees. The time for Congressional action is long overdue. The system is rigged against consumers and that must change.
While we remain hopeful that yesterday’s actions by the DOJ are just a first step, we will continue to urge members of Congress to fix once and for all the broken live event ticketing system.
###
About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
December 20, 2019
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832
Washington, DC – The National Consumers League (NCL)urges caution in light of this week’s announcement on drug importation from the Department of Health and Human Services. Our primary concerns are that this proposed new rule will put the public at greater risk of counterfeit drugs while not clearly passing on any cost savings on to consumer.
NCL recently launched the Fake Rx Action Center in conjunction with our site Fraud.org, which aims to educate consumers on the risks posed by counterfeit medicines, and how to spot, avoid, and report them should consumers come across any fakes. Counterfeit medicines have already claimed lives across the country, and this proposal further endangers consumer health by undermining the security of the American pharmaceutical supply chain.
Opening the door for states, pharmacies, and distributors to obtain medications beyond U.S. borders means that consumers could more easily fall prey to bad actors from around the globe when being provided medications that have originated outside of the U.S. regulated manufacturing and distribution supply chain. As the World Health Organization has noted regarding the broader counterfeit issue, patients may end up with medications that have the wrong active ingredient, the wrong amount of active ingredient, no active ingredient, or dangerous added ingredients. While we will continue to advocate for access to affordable drugs, it is not clear from the regulations that any potential cost savings from obtaining medications outside the U.S. borders will be passed on to individual consumers. The goal of lowering prices for consumers without a clear assurance of out of pocket cost savings in these regulations is not worth increasing the risk of harm to consumers by exposing them to medications that may not meet the clear standards of U.S. law.
Our organization has put consumers first for more than 100 years. It is our belief that there are safer and more effective ways to provide access to necessary prescription medications than to expose Americans to potentially deadly counterfeits originating outside the United States.
###
About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
Kailash Satyarthi—Nobel Peace Prize Laurate and founder of multiple social activist….
December 19, 2019
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832
Washington, DC–The National Consumers League, the nation’s pioneering consumer and worker advocacy organization today applauds Senators Markey (D-MA) and Thune (R-SD) and Representative Pallone (D-NJ) for the passage of the TRACED Act, and Senator Markey (D-MA) and Representative Eshoo (D-CA) for the passage of the TRUE Fees Act. The Traced Act will provide regulators with the tools they need to crack down on illegal robocalls and the TRUE Fees Act will require cable and satellite TV providers to disclose an “all-in” price for their services.
The following statement is attributable to NCL Executive Director Sally Greenberg:
“The Passage of the Traced Act and the TRUE Fees act is a win for consumers. Because of these bills, the days of cable companies slamming consumers with hidden fees are numbered, and relief from illegal robocall scams is on the way. NCL applauds the passage of these bills and urges President Trump to quickly sign them into law.”
###
About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
Marcia Greenberger, the founder and co-president of the National Women’s….
Lawmakers need to be aware of the threats to public health posed by the proliferation of unregulated, untested CBD products currently widely available in the marketplace. There is a great deal of work to be done in Washington to better understand the healing potential of CBD, while also protecting consumers from the dangers of what is currently an anything-goes market environment.
That was the compelling message participants took from a congressional staff briefing last week on “The Future of Cannabis as a Drug.” Expert speakers, including National Consumers League Executive Director Sally Greenberg, issued a two-pronged call for action: to intensify clinical research into new medical treatments containing CBD, while encouraging the Food and Drug Administration (FDA) to proactively regulate non-medical, over-the-counter CBD products that are frequently mislabeled and contain potentially harmful ingredients.
The briefing featured opening remarks by U.S. Representatives Scott Peters (D-CA) and Cathy McMorris Rodgers (R-WA) and was moderated by Ron Manderscheid, Executive Director of the National Association of County Behavioral Health and Developmental Disability Directors and the National Association for Rural Mental Health. “We would like to have more understanding and more confidence in CBD products,” Rep. Peters explained. “You should know what you’re getting”.
Attendees received eye-opening data about the ways in which readily-available CBD products—sold in the form of oils, lotions, food additives, and more—have the potential to make consumers ill. Few realize, for example, that an independent study found 70 percent of the top-selling CBD products contain substances such as pesticides, arsenic, and toxic mold.
NCL’s Greenberg previewed upcoming academic research that will place a spotlight on the questionable science being utilized by CBD and cannabis companies, often in partnership with academia, to lend legitimacy to these products and short-cut the regulatory approval process. “Not only are these products untested, but they are inaccurately labeled,” said Greenberg. “We want FDA to do what it’s supposed to do, and what we as consumers expect it to do.”
NCL launched Consumers for Safe CBD to warn the public of the potential health and safety risks associated with unregulated and unlawfully marketed CBD products.
Susan Audino, a board member of the Center for Research on Environmental Medicine in Maryland, shared her findings on the lack of quality controls currently in the CBD marketplace and how product marketing is accelerating faster than the science used to substantiate claims of enhanced health and well-being. “We even trust McDonald’s to inform us of the number of calories in a Big Mac,” said Audino. “When it comes to cannabis, we are not afforded that same safety and assurance.”
James Werline, a pharmacist and the father of a daughter with a severe form of epilepsy, spoke to the promise and importance of CBD-related research. The only CBD medication currently approved by the FDA is used to prevent seizures caused by rare forms of childhood epilepsy. Angelique Lee-Rowley, Vice President, Global Chief Ethics and Compliance Officer at Greenwich Biosciences, discussed the importance of clinical research into new CBD treatments and shed light on the restrictions pharmaceutical companies have in educating consumers on product efficacy versus the retail and online marketers who have few boundaries in the claims they can make.
“We are on the verge of a major breakthrough,” said Rep. McMorris Rogers. “We want to be encouraging those breakthroughs. I am committed to helping with those developments.”
The briefing served to alert congressional staff to the seriousness of this issue. By 2022, the CBD marketplace is expected to reach $1.8 billion in sales, more than triple what it was just four years earlier. As the commerce expands, so do—without adequate consumer protections—the threats to health and safety.
December 17, 2019
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832
Washington, DC–The National Consumers League applauds the passage by the House of Representatives of three bills to protect consumers, all of which came from the Energy and Commerce Committee.
“We are grateful for the leadership of Chairman Pallone and Subcommittee Chair Schakowsky in getting these bills through the Committee and to the House floor for passage,” said NCL Executive Director Sally Greenberg. “The House is taking an important in protecting Americans—especially our children—from dangerous products and protecting consumers from overseas scams. Children are the most vulnerable consumers, and they need our advocacy. Products that prove dangerous to their health and wellbeing – like inclined sleepers and crib bumpers – should no longer be on the market, and we hope the Senate takes up these bills immediately. Thanks once again to the bipartisan efforts through the Commerce Committee and full House leadership for these important consumer protection measures.”
The House passed the following bills:
H.R. 4779, a bill to extend the Undertaking Spam, Spyware, And Fraud Enforcement With Enforcers Beyond Borders Act of 2006, reauthorizes the U.S. SAFE WEB Act, which improved the Federal Trade Commission’s (FTC) ability to combat unfair or deceptive acts or practices that are international in scope, through Fiscal Year 2027 and requires the FTC to issue a report to Congress describing the Commission’s use of and experience with the authority granted by the Act.
H.R. 2647, the “Safer Occupancy Furniture Flammability Act” or “SOFFA,” adopts the California upholstered furniture flammability standard as a national flammability standard for upholstered furniture to limit exposure to toxic flame retardant chemicals.
H.R. 3172, the “Safe Sleep for Babies Act of 2019,” designates inclined sleepers for infants as banned hazardous products under the Consumer Product Safety Act. The bill was amended to include the text of H.R. 3170, the “Safe Cribs Act of 2019,” which also designates crib bumpers as banned hazardous products.
###
About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
December 16, 2019
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832
Washington, DC–The National Consumers League (NCL), America’s pioneering consumer and worker advocacy organization welcomed the news that the United State Department of Justice (DOJ) is reportedly preparing legal action against Live Nation Entertainment Inc. to crack down on anticompetitive conduct in the live event marketplace. In 2009, NCL led a coalition of consumer groups, independent promoters, and venue owners in opposition to the Ticketmaster-Live Nation merger. Since the merger was approved in 2010, NCL has continued to advocate for fairness and transparency in the live event ticketing marketplace.
The following statement is attributable to NCL Vice President of Public Policy, Telecommunications and Fraud John Breyault:
“The DOJ’s interest in reining in Live Nation’s abuses is a welcome development, and long overdue. While robust enforcement of the consent decree may help, it won’t solve the entrenched ticketing industry practices that cause untold frustration for consumers. This is just the latest sign that the DOJ’s approval of the original Ticketmaster-Live Nation merger was the wrong decision. Anyone who has tried to buy tickets knows that the live event marketplace, dominated by Live Nation, is rigged against fans. Congressional action to rein in abuses by Live Nation and others in the live event marketplace is necessary to restore sanity and fairness to the ticket-buying experience.”
###
About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
December 10, 2019
Dear Member of Congress,
For more than 120 years, the National Consumers League has pursued the values of access to quality products, honest labeling, and safe, effective medicines for America’s consumers. We write to you today about a growing public health concern affecting millions of Americans in every state and congressional district across the country. Unregulated, untested cannabidiol (CBD), an extract of the hemp plant, has infiltrated the market in a dizzying range of products. These products pose a significant threat to consumers.
The CBD market is one of the fastest growing retail segments in the nation. By 2022, Americans are expected to purchase approximately $1.8 billion worth of these products, triple the amount since last year. CBD, however, continues to raise questions and concerns for consumers.
CBD products are not currently tested or evaluated for safety and efficacy, nor required to meet similar safety standards as the tube of toothpaste we buy at the grocery store. CBD products are too often deceptively labeled and may contain contaminants that can harm consumers. Independent testing of the 240 top-selling CBD products found that 70 percent were contaminated with substances including lead, arsenic, herbicides, pesticides, and toxic mold.
New public opinion research conducted by Greenberg Quinlan Rosner finds that voters overwhelmingly – an 83 percent majority – support allowing the Food and Drug Administration (FDA) to evaluate and regulate CBD products. The research found that ensuring the safety and effectiveness of CBD grows even stronger among those who have used CBD products or describe themselves as very familiar with them. When asked about illness resulting from vaping CBD, 83 percent of respondent expressed concern, with nearly half, 48 percent, being very concerned.
This is why NCL created Consumers for Safe CBD in partnership with Consumer Federation of America (CFA) and Community Anti-Drug Coalitions of America (CADCA) to encourage the FDA to take strong, effective, and prompt action to protect the public from the potential harms posed by unregulated, untested CBD.
As Executive Director of NCL, I hope you will lend your voice in calling for the FDA to take immediate action to protect consumers from potentially harmful CBD products and pursue four common-sense objectives:
1. WARN THE PUBLIC OF THE DANGERS OF THE CBD MARKET
The public should be warned regarding the dangers of unapproved, untested CBD products. Clearly, as verified by the explosive growth in sales, the public is not appropriately informed about the potential dangers of unapproved, untested CBD products that contain harmful contaminants and may not have the ingredients listed on product labels. Resources should be devoted to a national informational campaign that warns consumers of these dangers. There is a growing interest in CBD products, but the marketplace is largely an unregulated “wild west,” and consumers literally often have no way of knowing what is contained in the products they are purchasing.
2. ENFORCE EXISTING REGULATIONS REGARDING LABELING (INGREDIENTS, RISKS, ETC.)
The FDA should curtail the proliferation of potentially dangerous, unapproved CBD products by using its existing legal authority. The FDA should use its authority to penalize manufacturers, marketers, and distributors of CBD products that: 1) make medical claims that cannot be scientifically verified, 2) market products to minors, 3) sell products that contain higher or lower-than-advertised levels of CBD and/or THC, or harmful ingredients and 4) sell products that have inaccurate labels. Swift and strong enforcement can serve as an effective deterrent effect against the future marketing of unapproved, potentially harmful CBD products.
3. DETERMINE SAFE LEVELS OF THC/CBD TO BE ALLOWED IN CBD PRODUCTS
Clear differentiation between medicines and consumer products should be established, including firm parameters as to CBD levels that can be safely included in a particular product. The FDA should establish a firm, enforceable ceiling on the potency of CBD that can be contained in an individual product and require safe packaging practices, similar to the child-proof cap closures on prescription medicines. All products should include a 1-800 phone number to allow concerned consumers to call the manufacturer to make specific inquiries about the product.
4. ENCOURAGE ROBUST CLINICAL RESEARCH INTO THE POTENTIAL OF CBD TO IMPROVE HEALTH AND LIVES
The FDA should incentivize CBD research, clinical trials, and the creation of new CBD treatments that are thoroughly vetted through the proven FDA process. CBD has the potential to improve lives, but with little research and clinical data, the risk is currently greater than the reward. We should encourage research to ensure that CBD reaches its full potential.
Your constituents should be protected from the potential dangers related to CBD products. This does not require the creation of new laws or regulations, but rather that the FDA simply use its existing authority to protect public safety. The agency has already sent more than 50 warning letters to CBD product manufacturers making egregious health claims about their products’ ability to treat cancer and other serious illnesses. It recently advised women who are pregnant or breastfeeding to avoid using any CBD products, citing a number of health and safety risks. But these efforts need to be stepped up. We hope you will join us in asking the FDA to erect stronger safeguards, including safe concentration limits, around a rapidly growing, but unregulated, industry that is already causing harm to consumers.
If you or your staff has any questions, please reach out to our Director of Health Policy Patricia Kelmar at patriciak@nclnet.org or 202-207-2824.
Thank you for your consideration.
Sally Greenberg
Executive Director
National Consumers League
###
About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
The work of the National Consumers League is making a difference in people’s lives across the country. Meet some of the consumers touched by our programs.
Read about NCL’s impact
Paige, 55, a Nashville wife and mother of two, answered an employment ad for secret shoppers. Before sending payment to the scammers, she reached out to NCL.
Read about NCL’s impact
A grease fire flared up in Decklan’s kitchen. As his family scrambled and panicked, fearing that the whole house might erupt in flames, Decklan remained calm. He hurried over to the pantry, grabbed some baking soda, and dumped it on the fire quickly extinguishing the blaze.
Read about NCL’s impact
Cincinnati resident Charles, 45, lost his computer business — and health insurance— during a time of economic downturn. A diabetic, Charles was now unable to afford his medication. He stopped taking it which made him seriously ill and put his life at risk.
Read about NCL’s impact
Jeremy is a fast-food worker who has been employed at a number of Chipotle restaurants in New York City. When he was just 20 years old, he took part in an NCL research project that revealed that management practices within the fast food chain were putting workers—and food safety for customers—at risk.
Read about NCL’s impact
[gravityform id=”11″ title=”true” description=”false”]
[gravityform id=”9″ title=”true” description=”false” ajax=”true”]
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.”
/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
<embed src=”https://art19.com/shows/ce489618-5918-423a-9b5f-35ce4c28ca09/episodes/2f8fa6fc-6aad-4f1f-bf13-3bdb0aa41732/embed?theme=light-custom&primary_color=%231850a3″ width=”100%” height=”300″></embed>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/c7b22520-c0aa-4718-9b59-4ee67e494547/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/ab80228e-48d9-4a45-a894-a1bfc4e41c64/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/ea08cbc0-f9f2-4082-9222-4e33f68b6826/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/5039453f-6008-413a-9f6b-c9be649fd26e/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/fafb46f8-6d90-4cd8-91be-616366d1b8ca/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/25f0485d-bbce-46c8-bb90-139dcf1a2e7b/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/ffbcae35-84c5-4c8b-9686-6e2c79679dd0/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/520bdd73-d142-4508-9706-d81b5c042dff/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/12354e8b-bf15-4eba-b34f-20e435df3bb7/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>
<iframe src=”https://art19.com/shows/we-can-do-this/episodes/e2091efc-d66d-49f4-aa8e-8e6249858310/embed?theme=light-custom” style=”width: 100%; height: 200px; border: 0 none;” scrolling=”no”></iframe>