The FDA is currently in the process of finalizing a regulatory pathway for stem cell therapies. With less than one day before the FDA docket closes, we urge you to share your personal experience with stem cell therapy and submit comments on the FDA docket to support continued access of accessible, safe and effective stem cell regulation treatment options available in the United States through trusted Medical Professionals.
*FDA Docket closes at 11:59pm EST on Tuesday, September 27, 2016.
The current framework applicable to stem cell therapy and the use of a person’s own stem cells is based on the same regulatory pathway 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 regulatory pathway to market a new drug is a very long process, which under the best circumstances can take 10 to 15 years at a cost of tens of millions of dollars. 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. may be limited and possibly obsolete for those with unmet clinical needs.
Dr. Steven A. Brody, Chief Scientific Officer at StemGenex recently presented at the FDA Public Hearing on Draft Guidances Relating to the Regulation of HCT/Ps. The purpose of the hearing was to obtain comments on four draft guidances relating to the future regulation of adult stem cell therapies. The event was heavily attended by nearly 500 attendees and 90 speakers, whereas many of the speakers advocated for continued access to safe and effective adult stem cell therapies.
Amending the draft guidances would be a positive step towards providing medical professionals the ability to offer their patients stem cell therapy, a treatment option that has shown life-changing quality of life benefits for countless individuals.
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.