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首页> 外文期刊>Food and Drug Law Journal >A Penny for Your Clots? Examining Tax Incentives for Whole Blood Donation under FDA Guidelines
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A Penny for Your Clots? Examining Tax Incentives for Whole Blood Donation under FDA Guidelines

机译:你的凝块一分钱? 在FDA指南下审查全献献血的税收优惠

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摘要

Blood is a valuable commodity, used for scientific research, drug development, and life-saving transfusions into ailing patients. It is also sacred: it cannot be created artificially, and it is considered by some to be a defining feature of one's humanity. But when contaminated, it can be deadly. Acknowledging these realities, the Food and Drug Administration (FDA) regulates blood donation in the United States in a highly nuanced fashion, permitting cash payments to donors of blood used for research while discouraging-to-the-point-of-prohibiting any direct monetary compensation to donors of blood destined for transfusion. FDA's policies, however, create significant ambiguity on what constitutes impermissible "monetary payment" under its guidelines. Facing frequent blood shortages, hospitals and blood banks have embraced this ambiguity, providing donors with an array of valuable incentives just short of cash payments to encourage donations. Sitting squarely in this zone of ambiguity are individual tax incentives-which on the one hand can be as literally valuable as cash to their recipients, but on the other are not immediately redeemable or transferable. Personal tax incentives tied to blood donations have never been used in the United States, but they have been proposed by state legislators, and they have been enacted overseas. This Article analyzes how personal tax incentives would fit into FDA's current regulatory scheme if they were enacted in the United States. Examining the history of blood transfusions, the specific concerns underlying opposition to paying donors, and FDA's regulations, this Article ultimately concludes that tax incentives should not be treated as direct monetary payments to donors and incur the associated labeling requirements. Whether or not their implementation would be a wise policy, tax incentives should be considered permissible non-monetary incentives under FDA guidelines.
机译:血是一种有价值的商品,用于科学研究,药物开发和节省生命的输血进入疾病患者。它也是神圣的:它不能是人为地创造的,有些人认为是一个人类的定义特征。但污染时,它可能是致命的。承认这些现实,食品和药物管理局(FDA)规范美国在美国的献血中以高度细致的方式,允许对用于研究的血液供捐赠者的现金支付,同时劝阻 - 禁止任何直接货币对注定输血的血液供体的补偿。但是,FDA的政策为其指导方针构成了不允许的“货币支付”而产生了重大歧义。面对频繁的血资短缺,医院和血库都接受了这种模糊性,为捐助者提供了一系列有价值的激励措施,只需短缺现金支付来鼓励捐款。在这个歧义的这个区域中,坐在这个歧义的区域中是个性税收激励 - 这一方面可以像现金到他们的收件人那样有价值,但另一方面没有立即可赎回或可转让的现金。与献血的个人税收激励措施从未在美国使用过,但他们已经被国家立法者提出,他们已经在海外制定了。本文分析了个人税收激励措施如何适应FDA在美国颁布的现行监管计划。检查血液输血的历史,对捐助者的反对派和FDA的法规潜在的具体问题最终得出结论,税收激励不应被视为向捐助者的直接货币支付,并产生相关的标签要求。如果其实施是明智的政策,应当在FDA指南下审议税收激励措施。

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