How Can FDA More Reasonably Regulate Autologous Stem Cell Procedures?

Dec 28, 2012   

In the December 26, 2012 edition of the Food & Drug Law Institutes (FDLI) Policy Forum, Andrew Ittleman of Fuerst Ittleman David & Joseph took on the question of how FDA may more reasonably regulate autologous stem cell procedures. In the article, Mr. Ittleman concludes that FDA, under certain circumstances described in the article, should exercise “enforcement discretion” with respect to autologous stem cell procedures. Mr. Ittleman also describes how FDA has interpreted the concepts of “minimal manipulation,” and “homologous use,” and discusses FDAs regulation of autologous stem cell procedures as being in direct conflict with traditional notions of the practice of medicine. A copy of the article is available here.