Regenerative Medicine and FDA: Echo Chamber or Calm before the Storm?  
​​[Posted on: Thursday, December 7, 2017]

Since its announcement of four new guidance documents regarding regenerative medicine about a month ago, there has been a lot of confusion in the regenerative medicine industry. Some of FDA’s actions appear as if the Agency has decided to ignore most public comments it received in the recent years on the topic, indicating that FDA was sitting in an echo chamber where it heard only its internal people but not the public. At the same time, it has been very quiet about the big elephant in the room, namely, hundreds of illegal stem cell clinics in the country, openly conducting business with impunity. FDA did announce that most such clinics need to become compliant within 36 months, while at the same time promising enforcement actions. These dual meaning statements could mean that FDA may be getting ready for major enforcement actions in the near future, the proverbial calm before the storm. The FDA announcements, were much hyped by the FDA and its media sources but there was little new in the content. FDA restated its previous statements with additional examples. The pseudo-new policy announced also amounted to primarily confirming what was either previously announced with less fan fare or acknowledgment of what was already the existing situation in the regenerative medicine industry. Most of the post-announcement talk from FDA has been regarding the RMAT designation which mostly applies to conventional stem cell developers. Most of the adult stem cell clinics will not be eligible for the RMAT designation due to lack of robust data needed to support such designation. Plus there is little incentive for such clinics to pursue formal approval if they can stay in lucrative business as is. There is no doubt that FDA wants to get in front of the discussion on regenerative medicine, primarily the stem cell therapies. And there is also no doubt that there clearly two kinds of stem cell industries; one section is actively developing conventional stem cell therapies via the IND/BLA route, while the second section is that of hundreds of so-called  “stem cell clinics” offering treatments to hundreds of thousands of patients each year for practically all kinds of diseases. So far, all of FDA’s announcements have pretended as if the regenerative medicine industry is a monolithic entity of the first kind that needs one set of rules, but that’s not the case. FDA need to announce measures that could distinguish and respect the second kind of stem cell companies defining distinct, relevant, logical, and practical measures to regulate the adult stem cell industry to risk alienating patients who depend on these therapies.