Arguments against the Requirement of a Biological License Application for Human Pancreatic Islets: The Position Statement of the Islets for US Collaborative Presented during the FDA Advisory Committee Meeting
| Autor: | Kenneth A. Andreoni, Beth Schrope, Robert C. Harland, R. Paul Robertson, John B. Buse, Ling-Jia Wang, Jordan Pyda, Oyedolamu K. Olaitan, Yolanda T. Becker, Mark A. Hardy, Roi Anteby, Gregory L. Szot, Piotr Witkowski, Piotr J. Bachul, Chirag S. Desai, Jon S. Odorico, Silke V. Niederhaus, Martin Wijkstrom, Fouad Kandeel, Raja Kandaswamy, Michelle A. Josephson, Tomasz Kozlowski, Peter L. Abrams, Jason L. Gaglia, Joseph R. Leventhal, Wanxing Cui, Shakir Hussein, Camillo Ricordi, Andrew M. Posselt, Robert J. Stratta |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
endocrine system Advisory committee medicine.medical_treatment Clinical Sciences 030204 cardiovascular system & hematology Autoimmune Disease Organ transplantation 03 medical and health sciences Patient safety 0302 clinical medicine 0502 economics and business medicine pancreas Intensive care medicine License geography Transplantation geography.geographical_feature_category business.industry Pancreatic islets 05 social sciences Diabetes Food and Drug Administration General Medicine allogenic islet cell transplantation Islet medicine.anatomical_structure Commentary Medicine 050211 marketing business Allotransplantation |
| Zdroj: | Journal of clinical medicine, vol 10, iss 13 Journal of Clinical Medicine Journal of Clinical Medicine, Vol 10, Iss 2878, p 2878 (2021) |
| Popis: | The Food and Drug Administration (FDA) has been regulating human islets for allotransplantation as a biologic drug in the US. Consequently, the requirement of a biological license application (BLA) approval before clinical use of islet transplantation as a standard of care procedure has stalled the development of the field for the last 20 years. Herein, we provide our commentary to the multiple FDA’s position papers and guidance for industry arguing that BLA requirement has been inappropriately applied to allogeneic islets, which was delivered to the FDA Cellular, Tissue and Gene Therapies Advisory Committee on 15 April 2021. We provided evidence that BLA requirement and drug related regulations are inadequate in reassuring islet product quality and potency as well as patient safety and clinical outcomes. As leaders in the field of transplantation and endocrinology under the “Islets for US Collaborative” designation, we examined the current regulatory status of islet transplantation in the US and identified several anticipated negative consequences of the BLA approval. In our commentary we also offer an alternative pathway for islet transplantation under the regulatory framework for organ transplantation, which would address deficiencies of in current system. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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