FDA Warning Notification On Exosome Products

In a statement officials said, “We’ve seen too many cases of sponsors claiming that cells aren’t subject to FDA regulation just because the cells originated from the same patient to whom the eventual manufactured product is being given. And we’ve seen too many cases of companies making unsubstantiated claims that these treatments prevent, treat, cure or mitigate disease where the products have sometimes led to serious patient harm.”

“Patient safety is our first priority. These violative actions create a direct risk to patients. They also create indirect risks by potentially encouraging them to forgo otherwise effective, available treatments, and opt instead for purported treatments that create risks and offer no demonstrated benefits. These kinds of false claims and violative activities also do a tremendous disservice to innovators who are working to legitimately develop safe and effective stem cell therapies by casting doubt across the entire field.”

“Legitimate and well-intentioned investigators and firms are doing the essential groundwork to develop such products, fully in keeping with our statutes and regulations, examining their safety and potential benefits in a range of diseases and conditions, including cancers, heart failure, stroke and ALS (amyotrophic lateral sclerosis).”

Currently there are no FDA approved exosome products, certain clinics are offering exosome products to the patients. The FDA is suggesting that these clinics are deceiving patients with unsubstantiated claims for the potential of these products to prevent, treat, or cure various diseases or conditions, and claims of these products not falling under regulatory provisions for drugs and biological products are false. 

“The clinics currently offering these products outside of FDA’s review process are taking advantage of patients and flouting federal statutes and FDA regulations. This ultimately puts at risk the very patients that these clinics claim to want to help, by either delaying treatment with legitimate and scientifically sound treatment options, or worse, posing harm to patients, as evidenced by these recent reports of adverse events.”

The release recommends that anyone considering treatment with exosomes should:

• Ask if the FDA has reviewed the treatment. 
• Request facts and ask questions if you don’t understand something.
• Don’t participate in clinical trials that require an IND application.
• Learn about the regulations covering the product in the state/country you may be in.
• Be cautious.
• Report any adverse events related to the exosome products.

“We acknowledge the challenges that product development can present for smaller entities such as academic institutions and group practices. With the goal of helping to facilitate the development of stem cell products, and to help small groups of collaborating investigators, the FDA continues to encourage sponsors to discuss novel clinical development approaches with the agency, such as the collaborative development model highlighted in our guidance Expedited Programs for Regenerative Medicine Therapies for Serious Conditions. In addition, during the next year, the agency will explore whether there are additional ways that it can assist legitimate developers of stem cell products to come into compliance with its regulations.”

“FDA remains committed to protecting patients. Our work to ensure compliance with the law does not take away from our firm commitment to advance an efficient path for the safe and effective development of novel regenerative medicine therapies and to help foster beneficial new innovations. We’ll continue to work closely with investigators and firms legitimately working in this field and will do so in the most effective manner possible, while meeting the FDA’s standards for safety and efficacy. We look forward to working with those who share our goal of bringing safe and effective products to market to benefit individuals in need.”

“Stem cell therapies hold significant potential to improve human health. However, that potential will never be realized if careful scientific work and thoughtful clinical investigation supporting the safety and efficacy of these products for intended uses outside of hematologic and immunologic reconstitution are not conducted. The FDA is committed to helping advance the safe and effective development of novel stem cell therapies. We look forward to working with those who share our goal of bringing safe and effective products to market to benefit individuals in need.”