改革食品、药品和营养保健品监管制度以改善公众健康并降低医疗成本。

Reforming Food, Drug, and Nutraceutical Regulations to Improve Public Health and Reduce Healthcare Costs.

作者信息

Wimalawansa Sunil J

机构信息

CardioMetabolic & Endocrine Institute, North Brunswick, NJ 08902, USA.

出版信息

Foods. 2025 Jun 30;14(13):2328. doi: 10.3390/foods14132328.

Abstract

Neglecting preventive healthcare policies has contributed to the global surge in chronic diseases, increased hospitalizations, declining quality of care, and escalating costs. Non-communicable diseases (NCDs)-notably cardiovascular conditions, diabetes, and cancer-consume over 80% of healthcare expenditure and account for more than 60% of global deaths, which are projected to exceed 75% by 2030. Poor diets, sedentary lifestyles, regulatory loopholes, and underfunded public health initiatives are driving this crisis. Compounding the issue are flawed policies, congressional lobbying, and conflicts of interest that prioritize costly, hospital-based, symptom-driven care over identifying and treating to eliminate root causes and disease prevention. Regulatory agencies are failing to deliver their intended functions. For instance, the U.S. Food and Drug Administration's (FDA) broad oversight across drugs, devices, food, and supplements has resulted in inefficiencies, reduced transparency, and public safety risks. This broad mandate has allowed the release of unsafe drugs, food additives, and supplements, contributing to the rising childhood diseases, the burden of chronic illness, and over-medicalization. The author proposes separating oversight responsibilities: transferring authority over food, supplements, and OTC products to a new Food and Nutraceutical Agency (FNA), allowing the FDA to be restructured as the Drug and Device Agency (DDA), to refocus on pharmaceuticals and medical devices. While complete reform requires Congressional action, interim policy shifts are urgently needed to improve public health. Broader structural changes-including overhauling the Affordable Care Act, eliminating waste and fraud, redesigning regulatory and insurance systems, and eliminating intermediaries are essential to reducing costs, improving care, and transforming national and global health outcomes. The information provided herein can serve as a White Paper to help reform health agencies and healthcare systems for greater efficiency and lower costs in the USA and globally.

摘要

忽视预防性医疗保健政策导致了全球慢性病的激增、住院人数增加、医疗质量下降以及成本不断攀升。非传染性疾病(NCDs)——尤其是心血管疾病、糖尿病和癌症——消耗了超过80%的医疗支出,占全球死亡人数的60%以上,预计到2030年这一比例将超过75%。不良饮食、久坐不动的生活方式、监管漏洞以及公共卫生倡议资金不足正在推动这场危机。使问题更加复杂的是有缺陷的政策、国会游说以及利益冲突,这些使得以医院为基础的、针对症状的高成本治疗优先于识别和治疗以消除根本原因及疾病预防。监管机构未能履行其预期职能。例如,美国食品药品监督管理局(FDA)对药品、器械、食品和补充剂的广泛监管导致了效率低下、透明度降低以及公共安全风险。这种广泛的授权使得不安全的药物、食品添加剂和补充剂得以放行,导致儿童疾病增加、慢性病负担加重以及过度医疗化。作者提议划分监管职责:将对食品、补充剂和非处方药产品的监管权移交给一个新的食品和营养保健品管理局(FNA),使FDA改组为药品和器械管理局(DDA),以便重新专注于药品和医疗器械。虽然全面改革需要国会采取行动,但迫切需要进行临时政策调整以改善公众健康。更广泛的结构性变革——包括全面改革《平价医疗法案》、消除浪费和欺诈行为、重新设计监管和保险系统以及消除中间商——对于降低成本、改善医疗服务以及转变国家和全球健康状况至关重要。本文提供的信息可作为一份白皮书,以帮助改革美国及全球的卫生机构和医疗系统,提高效率并降低成本。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f98f/12248432/3c6d75eb42ae/foods-14-02328-g001.jpg

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