July 3, 2024: The Child Labor Coalition strongly supports the Biden Administration’s proposed rule to protect indoor and outdoor workers from extreme heat.
July 2, 2024: For two years now reproductive justice – as a term, a framework, and an ideal – has been thrust into the mainstream.
June 26, 2024: On June 20, the first day of Summer 2024, 1,086 baby onesies were placed in a display across from the U.S. Department of Transportation headquarters in Washington, DC, representing the number of young lives lost to hot cars since 1990 in the United States.
June 25, 2024: The National Consumers League joined the Consumer Protection Brownbag event, moderated by Adam Teitelbaum, the Director of the Office of Consumer Protection at the DC Attorney General’s Office.
June 25, 2024: Last week, NCL submitted comments to the Centers of Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) in response to their request for public comments in advance of the ACIP meeting.
June 21, 2024: As the 2024 political campaigns intensify, we’re going to be hearing a lot from candidates about what they’re going to do to make healthcare more affordable.
May 30, 2024: The National Consumers League welcomes the introduction of the 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act), which makes needed reforms to protect the 340B program from misuse while lowering drug costs for low-income patients.
May 29, 2024: On this health series episode of NCL’s “We Can Do this” podcast, Director of Health Policy, Robin Strongin, sits with Sarah Ikenberry, Senior Communication Advisor for the Office of Therapeutic Biologics and Biosimilars at US Food and Drug Administration, and Julie Reed, Executive Director of the Biosimilars Forum.
May 28, 2024: With the summer travel season under way, consumer and passenger rights advocates today called on the Biden Administration to act expeditiously on consumer protection rulemakings and other actions mandated by the recently enacted Federal Aviation Administration reauthorization language.
May 23, 2024: NCL and its partners announced the winners of the thirteenth annual Script Your Future Medication Adherence Team Challenge, a competition designed to engage pharmacy students and faculty across the nation by encouraging teams to develop creative initiatives to raise public awareness about the importance of medication adherence, vaccine confidence, and safe drug disposal, among other topics.
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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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.
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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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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.
