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. 2021 Jul;34(7):1182-1186.
doi: 10.1111/tri.13930. Epub 2021 Jun 11.

US food and drug administration (FDA) panel endorses islet cell treatment for type 1 diabetes: A pyrrhic victory?

Lorenzo Piemonti  1 , Axel Andres  2 , John Casey  3 , Eelco de Koning  4 , Marten Engelse  4 , Robert Hilbrands  5 , Paul Johnson  6 , Bart Keymeulen  5 , Julie Kerr-Conte  7 , Olle Korsgren  8 , Roger Lehmann  9 , Torbjörn Lundgren  10 , Paola Maffi  1 , Francois Pattou  7 , Frantisek Saudek  11 , James Shaw  12 , Hanne Scholz  13 , Steve White  14 , Thierry Berney  2
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Free article

US food and drug administration (FDA) panel endorses islet cell treatment for type 1 diabetes: A pyrrhic victory?

Lorenzo Piemonti et al. Transpl Int. 2021 Jul.
Free article

Abstract

Allogeneic islet transplantation is a standard of care treatment for patients with labile type 1 diabetes in many countries around the world, including Japan, the United Kingdom, Australia, much of continental Europe, and parts of Canada. The United States is now endorsing islet cell treatment for type 1 diabetes, but the FDA has chosen to consider islets as a biologic that requires licensure, making the universal implementation of the procedure in the clinic very challenging and opening the manufacture of islet grafts to private companies. The commercialization of human tissues raises significant legal and ethical issues and ironically leads to a situation where treatments developed as a result of the scientific and economic efforts of academia over several decades become exploited exclusively by for-profit entities.

Keywords: European medicines agency; food and drug administration; pancreatic islet transplantation; regulatory authorities.

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