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# Stem Cell Anecdotal Claims ‘Worrisome’: Califf
- URL: https://www.fdaweb.com/stem-cell-anecdotal-claims-worrisome-califf/
- Published: 2016-12-01T12:00:00.000Z
- Updated: 2026-09-14T21:51:58.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5137470

FDA commissioner **Robert Califf** and two agency colleagues say that while the agency is committed to facilitating development and ultimate licensure of safe, effective stem-cell therapies, the lack of scientific evidence in some claims is “worrisome.” Writing in the *New England Journal of Medicine*, Califf *et al* [say](http://www.nejm.org/doi/full/10.1056/NEJMp1613723?query=TOC&ref=fdaweb.com) that the medical literature “is replete with instances of therapeutic interventions pursued on the basis of expert opinion and patient acceptance that ultimately proved ineffective or harmful when studied in well-controlled trials comparing them with the standard of care.”

The article reviews the potential benefits and risks of stem-cell therapy and says that without a commitment to the principles of adequate evidence generation, “we may never see stem-cell therapy reach its full potential.”

The authors say the agency can best do its job by engaging frequently with developers to optimize the efficiency of their programs, ensure that developers make full use of programs designed to expedite advancement and approval of new products, and establish innovative approaches to evidence generation that allow smaller sponsors or researchers to develop needed data collaboratively.