FDA issues warnings and reminder to stem cells developers

Posted By American Med Spa Association, Thursday, December 27, 2018

In a recently issued press release the FDA announced that they had sent a warning letter to Genetech Inc. and Liveyon LLC both firms working with stem cell derived products.  Genetech develops and processes the stem cells into products which are then distributed by Liveyon. This warning was in response to a FDA inspection of the Genetech processing facility and multiple reports of E. coli infections following use of Genetech products distributed by Liveyon.  Genetech were developing several products for treating various orthopedic conditions.  These products were derived from human umbilical cord blood and would be administered to the patient by injection into the joint or vein or applied directly to the tissue.  Genetech however had not submitted an Investigational New Drug Application that would have permitted them to use these drugs on humans in while the drugs are in the development stage. Nor had they received a biologics license needed to market these type of products.  The biologics license is needed when the product is derived from human tissue but not intended for use in the donor or a genetically similar relative. 
The FDA also took this opportunity to mail letters to other companies working in the stem cell and regenerative medicine field to remind them of the FDA’s Regenerative Medicine Policy Framework.  Under the framework the FDA will exercise discretion on enforcing investigational new drug application and premarket approval requirements rules against certain products.  This period of discretion will end in November of 2020 and during that time the FDA will refrain from enforcement actions on certain products as long as the product doesn’t pose significant safety concerns.  The Agency encourages manufactures to engage with them to determine what rules and processes apply in advance of the sunset of this discretionary period.  You can read the regenerative medicine policy framework documents here for additional details into the FDAs rules.
Because stem cell based procedures are at the forefront of innovation you can expect much greater scrutiny by regulatory bodies.  We’ve previously discussed some of these areas of concern in relation to medical advertising here and here.  However it is not limited only to those issues as attorney Jay Reyero with ByrdAdatto warns: “While the use of stem cells is a growing trend, the legal implications can be tricky as you have to traverse both Federal law as well as state law, not to mention state licensing boards.  Any clinic or provider interested in offering a form of stem cell therapy, or a product utilizing stem cells, needs to find experts who can help them navigate these issues.”  With the FDA discretionary period lasting 2 more years and countless products in development this will be an active and evolving for the foreseeable future.