A Penny for Your Clots? Examining Tax Incentives for Whole Blood Donation under FDA Guidelines
Kees D. Thompson
ABSTRACT
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.
Food and Drug Law Journal
Volume 75, Number 1