Political Advocacy Program Proposal

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Dec 6, 2023

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1 POLITICAL ADVOCACY: THE RARE ACT Political Advocacy Program Proposal Steven Kristofer Hoskins Herzing University HA610-8: Health Policy and Management G. Stan Reeley, Ph. D. October 22, 2023
2 POLITICAL ADVOCACY: THE RARE ACT Rare diseases, while individually uncommon, collectively affect millions of people worldwide. These conditions often result in significant suffering, but due to their rarity, they receive limited attention and research funding. The Recognizing and Advancing Rare Diseases Excellence (RARE) Act is a piece of legislation sponsored by Senator Tammy Baldwin with the aim of addressing the unique challenges faced by individuals living with rare diseases. Rare diseases, often characterized by their low prevalence in the population, pose significant hurdles in terms of diagnosis, treatment, and research ( Boycott, K. M., Lau, L. P., Cutillo, C. M., & Austin, C. P., 2019) . This summary will examine the key provisions of the RARE Act, discuss the potential benefits it offers to patients, and advocate for its widespread support and passage. The RARE Act, introduced by Senator Tammy Baldwin in 2019 and reintroduced in 2021, is primarily designed to establish a Rare Disease Center of Excellence within the National Institutes of Health (NIH). This center would serve as a hub for coordination and research on rare diseases, fostering collaboration between researchers, healthcare providers, and patient advocacy groups. It aims to expedite the development of diagnostics and therapies for these conditions, address the shortage of medical professionals with expertise in rare diseases, and promote greater awareness and understanding of rare diseases within the health care system (Congress.gov, 2023). This act has the goal of allocating additional funding for research into rare diseases. It promotes reforms to streamline the drug approval process for rare disease treatments, making it more efficient while maintaining rigorous safety standards. This change could potentially expedite the availability of life saving therapies. The RARE Act recognizes the importance of patient advocacy and support by providing resources to establish patient registries and strengthen patient engagement in research and clinical trials. The legislation includes provisions for
3 POLITICAL ADVOCACY: THE RARE ACT educating healthcare providers about the complexities of diagnosing and treating rare diseases, which will lead to quicker diagnosis and improved outcomes. The RARE Act also promotes public awareness campaigns to help people understand the unique challenges faced by this population and the importance of rare disease research ( Seoane-Vazquez, E., Rodriguez- Monguio, R., Szeinbach, S. L., & Visaria, J., 2018). One of the key features of the RARE Act is the creation of a comprehensive, publicly accessible, and up-to-date Rare Disease Database. This database would contain information about the prevalence, natural history, and available therapies for rare diseases affecting Americans. It is intended to be a valuable resource for patients, caregivers, and health care professionals, aiding in early diagnosis and informed decision making. The Act also seeks to establish a network of rare disease research consortia, bringing together experts in the field to share knowledge and collaborate on clinical trials ( Fermaglich, L. J., & Miller, K. L., 2023) . My position on the RARE Act is one of wholehearted support. Rare diseases affect approximately 30 million Americans, many of whom face significant delays and diagnosis, limited treatment options, and a lack of medical expertise. The rare act addresses these issues comprehensively by promoting research, raising awareness, and fostering collaboration. This legislation recognizes the fundamental right of individuals living with rare diseases to access accurate information, quality care, and effective treatments. Furthermore, it acknowledges the potential for scientific breakthroughs in rare disease research to benefit not only those with rare conditions but also individuals with more common diseases, as discoveries in rare disease pathways often have broader applications ( Adachi, T., El-Hattab, A. W., Jain, R., Nogales Crespo, K. A., Quirland Lazo, C. I., Scarpa, M., Summar, M., & Wattanasirichaigoon, D., 2023) .
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4 POLITICAL ADVOCACY: THE RARE ACT The RARE Act is not only a matter of compassionate care but also a strategic investment in the future of healthcare. It encourages innovation, reduces the burden on the health care system by preventing misdiagnoses and unnecessary tests, and supports the development of precision medicine. Its emphasis on interdisciplinary collaboration ensures that the knowledge and expertise of different stakeholders in rare disease management are leveraged to their full potential. As a result, this legislation is not only a moral imperative but also a wise and forward- thinking policy. To underline the importance of the RARE Act, it is worth considering the perspectives of industry leaders and experts in the field. Dr. Stephen Groft, the former Director of the National Center for Advancing Translational Sciences (NCATS) at the NIH, has stated that the RARE Act “will advance the progress in rare diseases by creating a home for collaboration among the many agencies and programs.” Such endorsement from a prominent figure in the rare disease research community underscores the potential impact of this legislation on the field ( Boycott, K. M., Lau, L. P., Cutillo, C. M., & Austin, C. P., 2019) . Additionally, a study published in the Orphanet Journal of Rare Diseases titled “The Impact of Rare Diseases: A Systematic Review” highlights the substantial socioeconomic burden of rare diseases. The study found that individuals with rare diseases often face delayed diagnosis, misdiagnoses, and a lack of effective treatments, leading to increased healthcare costs and reduced quality of life. The RARE Act directly addresses these challenges by focusing on improving diagnosis, treatment, and research, thus offering a pathway to alleviate the economic burden on both patients and the healthcare system ( Adachi, T., El-Hattab, A. W., Jain, R., Nogales Crespo, K. A., Quirland Lazo, C. I., Scarpa, M., Summar, M., & Wattanasirichaigoon, D., 2023) .
5 POLITICAL ADVOCACY: THE RARE ACT To take action, you should contact your representatives. Write to or call your senators and representatives to express support for the RARE Act. Encourage them to prioritize this important legislation. Spread awareness by using social media, community events, and other platforms to raise awareness about this act and the challenges faced by those with rare diseases. Join or support patient advocacy groups working to advance the cause of rare diseases. These groups often have valuable insights and can amplify our collective voice. Keep informed about the progress of the RARE Act and other legislative efforts related to rare diseases. In conclusion, the RARE Act is a crucial piece of legislation aimed at addressing the challenges faced by individuals living with rare diseases. It provides a comprehensive approach to research, diagnosis, and treatment, and its potential benefits extend beyond the rare disease community to the broader healthcare system. My position on this legislation is one of enthusiastic support, and I urge fellow citizens, healthcare professionals, and lawmakers to join in advocating for the passage of the rare act. By doing so, we can make significant strides toward improving the lives of those with rare diseases comma advancing medical knowledge comma and building a more equitable and efficient healthcare system. Rare diseases should no longer be ignored. They deserve the recognition and excellence the RARE Act promises to provide.
6 POLITICAL ADVOCACY: THE RARE ACT References Adachi, T., El-Hattab, A. W., Jain, R., Nogales Crespo, K. A., Quirland Lazo, C. I., Scarpa, M., Summar, M., & Wattanasirichaigoon, D. (2023). Enhancing Equitable Access to Rare Disease Diagnosis and Treatment around the World: A Review of Evidence, Policies, and Challenges. International journal of environmental research and public health , 20 (6), 4732. https://doi.org/10.3390/ijerph20064732 Boycott, K. M., Lau, L. P., Cutillo, C. M., & Austin, C. P. (2019). International collaborative actions and transparency to understand, diagnose, and develop therapies for rare diseases. EMBO molecular medicine , 11 (5), e10486. https://doi.org/10.15252/emmm.201910486 Fermaglich, L. J., & Miller, K. L. (2023). A comprehensive study of the rare diseases and conditions targeted by orphan drug designations and approvals over the forty years of the Orphan Drug Act. Orphanet journal of rare diseases , 18 (1), 163. https://doi.org/10.1186/s13023-023- 02790-7 Seoane-Vazquez, E., Rodriguez-Monguio, R., Szeinbach, S. L., & Visaria, J. (2018). Incentives for orphan drug research and development in the United States. Orphanet journal of rare diseases , 3 , 33. https://doi.org/10.1186/1750-1172-3-33
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