The Pain Project: Alternatives to Opioids
April 16, 2024: This episode of NCL’s “We Can Do This!” health podcast is focused on alternatives to opioids for pain control.
April 16, 2024: This episode of NCL’s “We Can Do This!” health podcast is focused on alternatives to opioids for pain control.
March 27, 2024
Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831
Washington, DC – Today, the National Consumers League sent a letter to the Federal Trade Commission urging oversight of vehicle manufacturers’ collection of consumer data. Modern cars can collect a range of information on drivers, including the locations they visit, their exact weight, and their texts and call records. Consumers are often unaware of this data collection and are even more surprised when insurance companies utilize this surveillance to increase drivers’ premiums. As digitally connected vehicles become more commonplace, the risks they pose to consumer privacy will only become greater—absent mandatory safeguards.
The full letter can be found here.
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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 nclnet.org.
March 27, 2024
Media contact: National Consumers League – Reid Maki, reidm@nclnet.org, (202) 207-2820
Washington, DC – The Child Labor Coalition (CLC), representing 37 groups engaged in the fight against domestic and global child labor, expresses support for the innovative enforcement strategies in this week’s enforcement action by the Wage and Hour Division of the U.S. Department of Labor (DOL). The action, announced March 25th, involved fines of $296,951 for a Tennessee parts manufacturer, Tuff Torq, and required the company to set aside $1.5 million as “disgorgement” of 30 days’ profit related to the company’s use of child labor. Disgorgement is a legal term for remedy requiring a party that profits from illegal activity to give up any profits that result from that activity.
Tuff Torq, which makes components for outdoor, power-equipment brands such as John Deere, Toro, and Yamaha, illegally employed 10 children, including a 14-year-old, for work that was hazardous—an identified task involved permitting a child to operate a power-driven-hoisting apparatus, which is a prohibited occupational task.
The Department employed several new or recent strategies in the case, including employing the Fair Labor Standards Act’s “hot goods” provision, which was used to stop the shipment of goods made with oppressive child labor.
“The use of the ‘hot goods’ enforcement tool is also an important new strategy, which Wage and Hour announced it would use last year,” said Reid Maki, director of Child Labor Advocacy for the National Consumers League (NCL) and the CLC. “It’s another critical tool in DOL’s arsenal. Once companies realize that the shipment of goods has been stopped, they feel an immediate impact of the violation.”
“This is the first use of victim’s fund that we have noticed in a child labor enforcement action,” added Maki. “Teens employed in factory settings are often unaccompanied minors and typically very impoverished. When enforcement agents find teens working illegally, they are dismissed with no resources to survive, move forward, and reassemble their lives. A victim’s fund is something the CLC and the Campaign to End US Child Labor – the CLC is a founding member – has touted as desperately needed.”
A third innovation involves how DOL calculates child labor fines. DOL recently announced it planned to change formulas for calculating fines, which previously had been capped at $15,000 per child involved in violations at a specific work site. The new strategy involves applying the maximum fines for each violation, not limited to the number of children involved.
“It’s clear they have used the new formula in the Tuff Torq fines,” said Maki. “Fines levels came in at an average of $30,000 per child—almost double what we would have seen under the old formula. With Congress unable, at this point, to pass into law any of several bills that would increase fines by a factor of ten, DOL’s creativity here is most welcome. Fines must be raised to inflict some real pain on corporate perpetrators. We’re not where we want to be yet, but it’s good to inch closer.”
“Wage and Hour also deserves praise for directing its enforcement action at Tuff Torq,” noted Maki. “In the past, corporations that benefited from child labor have often not been held accountable, as they blamed staffing agencies for illegal hires. Holding beneficiaries accountable is something DOL said it would do when it announced its meatpacking investigation results in February 2023—it’s great to see it happening.”
The Wage and Hour Division faces a big challenge in that its inspectorate, estimated at below 750 inspectors, is too small for a country the size of the U.S. The CLC has called for a doubling of the inspectorate over the next five years and is working to help increase congressional appropriations for that purpose.
Wage and Hour has noted a sharp increase in child labor in recent years, having found 5,792 minors working in violation of child labor laws. The Economic Policy Institute indicates the increase in violations is 300 percent since 2015.
“We are especially troubled by the prevalence of children in hazardous work,” said CLC Chair Sally Greenberg, who is also the CEO of the National Consumers League. “Far too many children are working illegally in meatpacking, auto supply factories, and other hazardous work sites. The U.S. can and must do more to protect these vulnerable children.”
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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 nclnet.org.
March 25, 2024
Media contact: National Consumers League – Reid Maki, reidm@nclnet.org, (202) 207-2820
Washington, DC – With the beginning of Farmworker Awareness Week today, the Child Labor Coalition (CLC), representing 37 groups engaged in the fight against domestic and global child labor, applauds Senator Ben Ray Luján (D-NM) and for introducing the Children’s Act for Responsible Employment and Farm Safety (CARE). The legislation, introduced on March 21, would close long-standing loopholes that permit children in agriculture to work for wages when they are only 12 and 13—younger than other teens can work. The bill would also ban jobs on farms labeled “hazardous” by the U.S. Department of Labor if workers are under the age of 18. Current U.S. law allows children to perform hazardous work at age 16.
“With their whole future ahead of them, our country must do better protecting children working in the agriculture industry,” said Senator Luján. “Across the country, thousands of children are working under hazardous conditions in the agriculture sector, risking their health and education. I’m introducing the CARE Act to raise the floor and bring our agricultural labor lines in with other industries to better protect children and improve the working conditions they operate in.”
“It’s amazing to us that discriminatory loopholes, which allow very young kids to work 70- and 80-hours a week, performing back-breaking labor on farms, have been allowed to exist since the 1930s,” said Reid Maki, Director of Child Labor Advocacy for the National Consumers League and the Child Labor Coalition. “The impact of the exemptions on farmworker children educationally is harmful and their health is at significant risk on farms.”
“We’re grateful for Senator Luján’s tremendous leadership on this issue.” said the CLC’s Chair Sally Greenberg, also the CEO of the National Consumers League. “It’s been 22 years since we’ve had a Senate bill that would fix our weak child labor laws that discriminate against farmworker children and leave them unprotected from farm dangers. This day was long overdue. We applaud Senator Lujan for taking action to protect child farmworkers.
“Growing up as a migrant farmworker child, I saw first-hand the detrimental consequences of our inequitable child labor laws,” says Norma Flores López, Chair of the Child Labor Coalition’s Domestic Issues Committee. “Working 70 hours a week, performing back-breaking work did not prepare me for a career in agriculture. Rather, it robbed me of my childhood and my health. Working children must be protected from dangerous work that is not age-appropriate, and the CARE Act provides this critical change in our labor laws.”
In the House, Rep. Raul Ruiz introduced a version of the CARE Act, H.R. 4046, earlier in the congressional session; it has 45 cosponsors.
The Senate bill, which does not have a number yet, has been endorsed by 46 organizations, including the AFL-CIO, the Economic Policy Institute, the UFW, Farmworker Justice, the National Education Association, the American Federation of Teachers, and the National Farm Medicine Center. The House version has been endorsed by 200 national, regional, and state-based organizations, noted Maki.
“The US will not fix the country’s child labor problem until Congress provides children working in agriculture with the same protections as all other working children. Congress should pass this bill without delay to protect children from dangerous work that harms their health and development,” said Jo Becker, children’s rights advocacy director, Human Rights Watch.
In addition to raising the minimum age at which children could work in agriculture, CARE would significantly increase minimum fines for employers who violate agricultural child labor laws; the bill would also establish minimum fines for the first time. The legislation would also codify a ban on children applying pesticides and increase data collection and analysis of child farmworker injuries.
The children of farm owners working on their parents’ farms would not be covered by the protections of the CARE Act—this aligns with the wishes of organized farmer groups.
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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 nclnet.org.
March 15, 2024
Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831
Washington, DC – The National Consumers League is condemning a vote by the Florida House of Representatives to approve legislation that will upend Miami-Dade’s proposed local workplace standards requiring drinking water, cooling measures, recovery periods, posting or distributing materials informing workers how to protect themselves, and requiring first aid or emergency responses. The Florida Senate approved the measure yesterday.
This measure rushed through the state legislature ahead of adjournment on Friday, March 8th and will prevent local governments throughout Florida from requiring water, shade breaks or training so workers can protect themselves from heat illness, injury, and fatality.
Reid Maki, director of child labor advocacy for the Child Labor Coalition under the National Consumers League, made this statement:
“Not only is the Florida legislature usurping the duty of local government to protect workers from heat stress in one of the hottest states in America, but by denying workers access to water and protection this Dickensian measure ignores the reality of heat and heatstroke among Florida’s workers. Indeed, hundreds of workers die across the U.S. from heat exposure each year. The legislation also forbids the posting of educational materials to help workers protect themselves from the heat.
NCL has throughout its history worked to eradicate child labor and abusive labor practices, including protecting children in America working in the fields from exposure to heat, dangerous chemicals, and long hours. U.S. law allows children to work at younger ages in the agricultural sector despite its significantly increased danger. It also allows teens to do work known to be dangerous at younger ages—16 versus 18. NCL works to close both of those loopholes and protect children from agricultural dangers and exploitation. These vulnerable teen workers in agriculture are at great risk from heat exposure.
NCL is urging Governor Ron DeSantis to veto this legislation. NCL also urges the United States Congress to enact the Asuncíon Valdivia Heat Illness, Injury and Fatality Prevention Act, which would direct the Occupational Safety and Health Administration to adopt interim heat standards, while the agency continues its years-long slog of adopting a final heat protection rule. NCL is a member of the national Heat Stress Network, which works to protect outdoor works from heat dangers.
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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 nclnet.org.
March 13, 2024
Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831
Washington, DC – Today, the National Consumers League sent a letter to the United States Senate urging action on the Shrinkflation Prevention Act. As American consumers struggled with spiking inflation, companies posted steep profits. One analysis found that corporate greed drove over 50% of consumer price increases in the years following the pandemic. One of the methods businesses have used to extract greater profits has been shrinkflation—selling less product at the same price. The Shrinkflation Prevention Act would officially designate this as an unfair or deceptive practice.
“Multiple surveys have found that consumers are unhappy with this practice,” said NCL CEO Sally Greenberg. “Almost four out of five Americans say they feel cheated by shrinkflation. Despite this sentiment, sellers continue to take advantage of the public and participate in this trend.”
The full letter can be found here.
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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 nclnet.org.
By Nancy Glick, Director of Food and Nutrition Policy
Every year, the calendar is full of national health observances – special months, weeks and days that raise awareness of serious diseases and health issues. While all are valuable to advance the health of the Americans, Obesity Care Week taking place March 4-8 is especially significant.
Why? Because even though the adult obesity rate now exceeds 42 percent – the highest level ever recorded – obesity is still viewed as a problem of lack of willpower, too many health professionals act in discriminatory ways based on people’s size, and those seeking obesity care often face exclusions in insurance plans or restrictive practices that delay or deny treatment.
The consequence is that that only 10 percent of people with obesity get help from medical professionals, meaning the disease remains largely undiagnosed and undertreated.
It doesn’t have to be this way. There are a variety of safe and effective treatment options. And medical societies, including the American Medical Association (AMA), agree that obesity is a complex disease requiring ongoing quality care. The key is for society – including health professionals, insurers and policymakers – to care about obesity and agree that treatment matters. Here are the reasons why.
It is long past time for health professionals, employers, insurers, policymakers and the American public to care about obesity and work collectively to break down the barriers that prevent people from accessing proper care and treatment. This is the purpose of Obesity Care Week – to shine a light on a disease that no one has wanted to talk or think about and shift the way society views obesity and treats the disease.
Obesity Care Week is also an opportunity to call attention to the first Obesity Bill of Rights for the nation, developed by NCL and the National Council on Aging in consultation with leading obesity specialists and issued in January 2024. Starting with the recognition that obesity is a treatable disease, the Obesity Bill of Rights establishes eight essential rights so adults will receive the same level of attention and care as those with other chronic conditions and have access to all treatments deemed appropriate by their health providers. Now is the time to advance changes in federal, state, and employer policies that will ensure these rights are incorporated into medical practice.
More information about the Obesity Bill of Rights is available at: www.right2obesitycare.org.
*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings
March 5, 2024
Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831
Washington, DC – Today, the White House Competition Council announced new actions to lower costs for consumers and promote market health. The Consumer Financial Protection Bureau (CFPB) finalized a rule to save consumers $10 billion a year by capping credit card late fees to an average of $8. The Federal Communications Commission (FCC) is initiating a ban on bulk billing, a practice where landlords or service providers charge all tenants in a building for a particular service—even for residents who do not choose that service. Lastly, the Department of Agriculture (USDA) is implementing protections for farmers and ranchers from retaliatory practices used by the industry’s dominant firms.
The following statement is attributable to NCL Chief Executive Officer Sally Greenberg:
“Under President Biden’s leadership, consumer protection agencies are doing critical work to guard the marketplace against industry misconduct. As more industry sectors have become increasingly consolidated, today’s actions are necessary to ensure that consumers aren’t ripped off and to protect producers from illegal retaliation and discrimination. When businesses concentrate market power and employ unfair practices to maintain that dominance, new legal safeguards and structural reform become necessary to protect the public from further harm. Today’s announcements are an important piece of this effort to maintain healthy marketplaces that benefit consumers and workers.”
The National Consumers League has worked to protect both consumers and workers from consolidated corporate power since 1899. From advocating against banking fees that disproportionately affect marginalized communities to fighting for transparency in telecom billing, NCL continues to provide a voice for the public interest.
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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 nclnet.org.
February 28, 2024
Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831
Washington, DC – NCL celebrates the 30th anniversary of its LifeSmarts program at the National Press Club in Downtown Washington, DC, on Wednesday, February 28. LifeSmarts is the organization’s national consumer literacy program that gives young people in middle and high school the necessary skills to become successful adults, preparing them to be informed consumers and workers.
“We want this evening to celebrate 30 years of this incredible program and honor our partnership with four wonderful organizations that have made LifeSmarts the extraordinary program that it is today,” said NCL CEO Sally Greenberg.
Receiving NCL’s LifeSmarts Lifetime Partnership Award were Steven Mitchell, Executive Director and CEO of Business Professionals of America (BPA); Alex Graham, President and CEO of Future Business Leaders of America (FBLA); Sandy Spavone, Executive Director of Family, Career and Community Leaders of America (FCCLA); and Chelle Travis, Executive Director of SkillsUSA.
The program also included LifeSmarts Advisory Board member Molly Alawode of Kenvue, a longtime partner of LifeSmarts, and Andrew Harris, Director of Public Policy at Amazon, which has also been a major supporter of LifeSmarts.
“I want to congratulate all our LifeSmarts Lifetime Partnership Award honorees,” said Lisa Hertzberg, LifeSmarts program director. “We are honored to work with each of them and we appreciate the opportunities to have partnered with them and make a difference in the lives of so many youths.”
For more information on this year’s event, visit the 2024 Spring Soiree.
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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 nclnet.org.
February 27, 2024
Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831
Washington, DC – A coalition of consumer and health groups is urging Treasury Secretary Janet Yellen to ensure that the agency responsible for regulating most alcoholic beverages in the U.S. – the Alcohol and Tobacco Tax and Trade Bureau (TTB) – keeps its commitment to require standardized alcohol labeling on all beer, wine, and distilled spirits products by initiating three promised rulemakings on nutrition, ingredients, and allergen labeling on an accelerated basis.
The appeal comes in the form of a February 27 letter from five leading public interest groups as TTB begins a series of “listening sessions” on labeling and advertising of alcoholic beverages on February 28. Raising concerns that the listening sessions are no more than a delay tactic to maintain the status quo and “slow walk deliberations for months,” the organizations – the Asthma and Allergy Foundation of America (AAFA), Center for Science in the Public Interest (CSPI), Consumer Federation of America (CFA), Food Allergy Research and Education (FARE), and National Consumers League (NCL) – called for TTB to publish the rulemakings by June 2024.
The Treasury Department promised that TTB would issue mandatory alcohol labeling rules in a November 17, 2022 letter in response to a lawsuit filed by CSPI, NCL, and CFA. The Department stated its intention to publish the three rulemakings before the end of 2023.
“We write … to express our dismay and serious concern that TTB has backtracked from its written undertaking of the November 17, 2022 agreement,” the groups wrote to Secretary Yellen. “TTB has, in effect, enabled recalcitrant companies by delaying indefinitely rulemakings on mandatory alcohol labeling while opting for a voluntary rule under which labeling “Serving Facts” or “Alcohol Facts” and ingredients are optional.”
Focusing on the health consequences of delaying action on alcohol labeling, the letter from advocates to Secretary Yellen describes how better alcohol labeling will benefit the 84 percent of U.S. adults who drink alcoholic beverages – 216 million people – and who currently do not have the facts about the alcohol they are consuming to protect their health and safety. Overconsumption of alcohol is a costly public health problem that has become much worse in recent years, as alcohol-related deaths have risen substantially. Among the key concerns, alcohol is involved in about 30 percent of all traffic crash fatalities in the U.S, is a source of empty calories that contributes to obesity, can impact blood sugar control in people with diabetes, and labeling can be a life-or-death matter for people with food allergies. Additionally, excessive drinking increases the risk of liver disease, hypertension, cardiovascular disease, alcohol use disorders, certain cancers and severe injuries.
“The consensus among public health and nutrition experts and consumers themselves, in favor of mandatory and complete alcohol labeling is overwhelming,” said Thomas Gremillion, Director of Food Policy at the Consumer Federation of America. “By reneging on its promise to initiate rulemakings, TTB continues to deny Americans the same helpful and easily accessible labeling information now required for conventional foods, dietary supplements, and nonprescription drugs.”
The letter to Secretary Yellen also stresses that alcohol manufacturers have the capability to put standardized Serving Facts labels on their products, when required. This is the case for products such as some hard ciders, hard seltzers, and wine coolers that are regulated by the Food and Drug Administration, which requires such products to have the same Nutrition Facts panel and ingredients statements on nonalcoholic beverages, from soft drinks to juices.
“To date, TTB has taken the position that requiring standardized nutrient content labeling on alcoholic beverages is too costly and burdensome for beverage alcohol manufacturers,” said Sally Greenberg, CEO of the National Consumers League. “However, the inconvenient truth for the industry is that some of the very same companies whose products do not include a Serving Facts statement if they are regulated by TTB already put complete alcohol labeling on their hard ciders, hard seltzers, wine coolers, and other FDA regulated wines and beers.”
Highlighting that the time has come for mandatory alcohol labeling, the letter makes clear that the agency’s current voluntary labeling rules are not working. Although the rule gives companies the option of putting “Serving Facts” or “Alcohol Facts” and ingredients information on their products, new research from the Center for Science in the Public Interest finds that most manufacturers have opted out of TTB’s voluntary program. Using TTB’s COLA database to examine the labels for 132 of the nation’s top beer and wine brands, CSPI’s study found that only 11 labels of the 65 beer brands examined (17%) and none of the 67 wine brands included ingredients lists while 18 beers (28%) and no wines used the voluntary “Serving Facts” label, and one additional beer brand carried the voluntary “Alcohol Facts” label. CSPI’s review also showed that even when serving information is included on beer and wine labels, there is no standard format for where and how the disclosures appear, making it hard for consumers to find information easily and compare different brands.
“We have the data that demonstrate that Treasury’s voluntary rule has failed to adequately improve transparency in alcohol labeling,” said Dr. Peter G. Lurie, President of the Center for Science in the Public Interest. “Ensuring that the agency ends this ineffective voluntary regime by issuing mandatory labeling rules necessitates national leadership. This is why we are appealing directly to Secretary Yellen to intercede personally to require the agency to commit to publish all three proposed rules by June 2024.”
The 2022 letter whereby TTB undertook to publish standardized alcohol content, calorie, and allergen labeling by the end of 2023 resulted from a lawsuit filed by Center for Science in the Public Interest, Consumer Federation of America, and the National Consumers League on October 3, 2022. The suit charged TTB with failing to act on a citizen petition, submitted to the Treasury Department in 2003 to mandate alcohol labeling. CSPI, CFA, and NCL filed the petition along with a coalition of 66 other organizations and eight individuals, including four deans of schools of public health.
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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 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.
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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.
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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.
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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.
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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.”
/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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