Marketing of Unproven and Unapproved Regenerative Medicine Therapies

Abstract

You may have received the same blast email that I have received a number of times from a company in Scottsdale, Arizona, that opens with "End of Year Blowout Sale: 3 for 1 on Exosomes or Whartons Jelly." The email further states that these products are "manufactured in an FDAregistered, cGMP compliant, ISO Certified lab," despite the fact that such birth products can be used only in a registered FDA clinical trial, since a directive from the United States (US) Food and Drug Administration (FDA) on May 31, 2021. This is a good example of the aggressive, direct-to-consumer marketing of unapproved and unproven cell therapies.As I am writing this editorial, I see this headline from MedPage Today, January 22, 2024: "FDA Warns Exosome Maker for Marketing Outside Its IND". According to this article, the manufacturer received an Investigational New Drug (IND) for a phase I/IIa clinical trial evaluating a single intravenous dose of a drug to treat COVID-19. However, the company apparently advertised their product for numerous other conditions outside of this specific IND. Furthermore, the FDA cited the company for "significant deviations" from current good manufacturing practice requirements as well as issues with sterility testing of their product.The 2 instances documented above point out some of the challenges in the rapidly growing regenerative medicine arena. The allure of regenerative medicine has led to a global industry of direct-to-consumer offerings of biologic products that, despite their promising potential, often have very little clinical data to support their use. This has been a pervasive problem in the area of regenerative medicine and is only growing. Regenerative medicine and orthobiologics can be lucrative, leading to aggressive marketing of products that have not been tested adequately for safety and/or efficacy. In this editorial I will explain some of the tactics used in these persuasive and aggressive marketing schemes. I will then briefly describe the criteria that should be considered before a product might be considered "proven", and finally I will list some mechanisms that can be used to report deceptive advertising claims and inappropriate marketing of unproven therapies.