R3 Stem Cell and CEO David Green received an untitled letter from the Food and Drug Administration (FDA) for unapproved stem cell products offered at its more than 50 centers around the U.S.
The unapproved products were marketed to treat diseases like Lyme disease, Parkinson’s disease, stroke, kidney failure and ALS.
“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. “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.”
The company has not demonstrated that their products are safe and effective, which is required by the FDA’s Federal Food, Drug and Cosmetic Act and the Public Health Service Act.
“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, 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.”