We recently informed you that, due to an overwhelming public interest and response, the Food and Drug Administration (“FDA”) postponed the Public Hearing, “Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products,” which was initially scheduled for April, 2016. The hearing has been rescheduled for September 12 and 13, 2016, at the campus of National Institutes of Health (“NIH”) in Bethesda, Maryland, just northwest of Washington, D.C.
Currently, the FDA framework applicable to stem cell therapy and the use of a person’s own stem cells is based on the same regulatory process used for chemical drugs, vaccines and biologics. As a result, stem cells transplanted back into the same patient are included in the broader statutory definition of drugs. The FDA will consider information it obtains from the public hearing and postings on the online docket in finalizing draft guidance documents. If the FDA chooses to regulate a person’s own stem cells as a drug, future access to stem cell therapy in the U.S will be limited and possibly obsolete for those with unmet clinical needs.
We encourage you to share your personal experience with stem cell therapy and submit comments on the FDA stem cell docket that support continued access of accessible, safe and effective stem cell treatment options available in the U.S. through trusted Medical Professionals.
You can submit letters via mail or delivery to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
StemGenex looks forward to participating in the public hearing and will continue to advocate for stem cell therapy and the ability to access the healing benefits of our own stem cells.
Stem cell therapies hold incredible potential for the future of health care in the United States and around the world. We hope you will join us and participate in this critical journey and share your story and comments about stem cell therapy with the FDA.