When Dry Eye Foundation first contacted the FDA about biologic eye drops in April 2022, they urged us to share several articles with our community. Below are links to those articles.
1. The regenerative medicine industry was given a 3.5-year grace period to comply with FDA regulations.
The grace period expired in May, 2021.
Innovative Regenerative Medicine Therapies – Patient Safety Comes First
In 2017, the FDA issued guidance on the regulatory framework for regenerative medicine therapies.
This policy gave manufacturers three-and-a-half-years to determine the appropriate regulatory pathway for their products, and if an application is needed, ample time to prepare and submit the appropriate application to the FDA.
[The FDA is] once again reminding manufacturers, clinics, and health care practitioners and providers that the compliance and enforcement discretion policy for certain human cells, tissues, and cellular and tissue-based products (HCT/Ps), including regenerative medicine therapies, ended on May 31, 2021.
2. Regenerative medicine therapies have real risks.
Important Patient and Consumer Information About Regenerative Medicine Therapies
FDA has received reports of blindness, tumor formation, infections, and more, detailed below, due to the use of these unapproved products….
Potential Risks of Treatment with Unapproved Regenerative Medicine Products
It is of utmost concern that unapproved regenerative medicine products that have no proven clinical benefit and that may cause serious harm are marketed to patients.
Because these products are not FDA-approved, it’s very likely that adverse events are underreported by health care providers who treat patients with these products, and by patients who may have been harmed.
Public Safety Notification on Exosome Products
They may claim that they these products do not fall under the regulatory provisions for drugs and biological products – that is simply untrue.
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.
3. Myths and deception abound.
DEF comment: Do you really want to trust a company that goes to such lengths to lie to you?
Important Patient and Consumer Information About Regenerative Medicine Therapies
The US Food and Drug Administration (FDA) regulates regenerative medicine products….These products require FDA licensure/approval to be marketed to consumers. Before approval, these products require FDA oversight in a clinical trial….
FDA is aware that patients and consumers are… told that a product is registered with FDA, as a way to suggest that the products being offered are in compliance with FDA laws and regulations. This is often false. The… fact that a firm has registered with FDA and listed its product does not mean the product is legally marketed.
Please know that if you are being charged for these products or offered these products outside of a clinical trial, you are likely being deceived and offered a product illegally.
If you are being offered any of these products outside of a clinical trial for which FDA has oversight, please contact FDA at ocod@fda.hhs.gov
Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes