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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. 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. 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.

PBPA Commends HHS Funding to Support Maternal and Infant Health. The funding announcement follows the release of a report by the U. 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. This disparity was further exacerbated for Black women in the U. While the COVID 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. 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. Diana Degette D-CO-1 and Fred Upton D-MI 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.

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.

Unfortunately there is conflicting evidence from two different clinical trials, one representative of a diverse U. population and another studied in a largely white population in Europe.

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. 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.

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. In , 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.

most vulnerable to preterm birth and one not. 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. Formed in 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. For the fifth year in a row, the U. Young woman with credit card shopping online on digital tablet while lying at home.

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