January 20, 2021

The Niche

Trusted stem cell blog & resources

Historic Boston Globe editorial on FDA, stem cells & patients argues safety first

For the first time I have ever seen in at least half a dozen years, a major newspaper in the form of The Boston Globe has published an editorial on FDA regulation of stem cells.

Boston Globe

The editorial, entitled “It should be safety-first on stem cell therapies”, argues that while we should take patient concerns into consideration, it must be safety first on experimental stem cell therapies.  I commend them for this editorial and their common sense approach to this hot topic.Stem Cell Medicine

It’s great that the Globe places this opinion in the context of the upcoming FDA public hearing on regulations related to stem cells. The Globe’s opinion carries great weight and appears supportive of the FDA.

The Globe piece closes this way:

“The FDA has scheduled a public hearing on April 13 to solicit comments on draft guidelines it released last fall to clarify the use of stem cells. Under those guidelines, most cells would have to meet the same regulatory standards that apply to drugs. That concerns some patient advocacy groups, including the Alliance for the Advancement of Cellular Therapies and Patients for Stem Cells. They worry about approval procedures that could drag on for years, and they say denying patients control over the use of their own cells amounts to a civil-liberties violation. Those concerns deserve consideration, but patients also need to trust that any treatment they seek from a licensed physician or medical center has passed muster with the FDA. When stem cells are used as medicine, they should be regulated as medicine.”


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