The U.S. Food and Drug Administration has sent an untitled letter to R3 Stem Cell, LLC of Scottsdale, Arizona, and its chief executive officer, David Greene, M.D. The company, through its affiliated centers or clinics throughout the U.S., offers unapproved stem cell products to treat a variety of diseases and conditions, such as Lyme disease, diabetes, Parkinson’s disease, stroke, kidney failure and amyotrophic lateral sclerosis (ALS). The products offered by R3 Stem Cell, LLC are not approved by the FDA.
The FDA has notified each of R3 Stem Cell, LLC’s more than 50 affiliate centers or clinics of this action.
“We continue to see companies and individuals use questionable marketing campaigns to take advantage of vulnerable patients and their families with unproven claims about their unapproved stem cell products. The reality is that at this time, there isn’t enough evidence to support the use of stem cells for purposes other than reconstitution of blood formation and the immune system,” said FDA Acting Commissioner Ned Sharpless, M.D. “We’ve made it clear to the industry and the public that while we are taking a risk-based approach to regulatory actions, the FDA will continue to protect patients from the most egregious actors in this field. We will prioritize appropriate regulatory actions against those who place people’s health at risk by promoting unapproved products.”
In the FDA’s review of the R3 Stem Cell, LLC website, the agency found that the company promotes stem cell therapies for numerous diseases or conditions, such as dementia and Parkinson’s disease, and directs patients with ALS, diabetes, kidney failure, Lyme disease, Parkinson’s disease and stroke to certain “R3 Stem Cell Centers of Excellence” for stem cell treatment. The untitled letter notes that the company advertises that a variety of other conditions can be treated at R3 Stem Cell Clinics, including rheumatoid arthritis, spinal stenosis, and trigeminal neuralgia (nerve pain).
It appears that the products offered by the company would be regulated as drugs and biological products under the Federal Food Drug and Cosmetic Act and the Public Health Service Act. Prior to marketing, such products require a demonstration that the products are safe and effective for their intended uses. Manufacturers who fail to comply with FDA requirements may be subject to enforcement action, such as seizure, injunction, or prosecution.
“We encourage firms to engage with the FDA about regulatory oversight of this field and work with the agency for appropriate development, including designing clinical trials, to explore the safety and potential benefits of these products. We intend to step up our oversight of those sponsors who have not engaged the regulatory process in the proper development of their stem cell products that are regulated as drugs, devices, and/or biological products under the statutes and existing regulations, and whose products create more significant potential risks because of the way that they’re manipulated or delivered,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Over the past year, the FDA has sent 46 manufacturers and health care professionals regulatory correspondence, including today’s untitled letter. We have also sent warning letters, and we have two court cases pending. We’re committed to taking appropriate steps to address those that jeopardize public health.”
As highlighted in 2017 with the release of the FDA’s comprehensive regenerative medicine policy framework, the FDA is applying a risk-based regulatory approach to the oversight of regenerative medicine products, taking into account how products are being administered as well as the diseases and conditions for which they are intended. The agency noted that it intends to exercise enforcement discretion for certain products until November 2020 with respect to the FDA’s investigational new drug application and premarket approval requirements when the use of the product does not raise reported safety concerns or potential significant safety concerns.
The FDA offers opportunities for engagement between potential manufacturers and the agency, such as through the INTERACT program, to facilitate product development. It also encourages the use of its expedited programs whenever applicable, in addition to the collaborative development of products as discussed in a New England Journal of MedicineExternal Link Disclaimer perspective authored by the FDA.
Health care professionals and consumers should report any adverse events related to treatments with R3 Stem Cell, LLC products and/or other stem cell treatments to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.