Yesterday we learned that the FDA issued a warning letter to the cord stem cell firm, Cord for Life. In this warning, the FDA indicated that the firm’s product is actually a drug product and lacks necessary pre-market approvals. In addition, the agency highlighted apparent deviations from CGMP practices.
The most important part of the warning letter is the clarity it brings that, yes, allogeneic umbilical cord stem cell and other perinatal stem cell products generally are drugs requiring a cleared IND and a BLA. In other words, you can’t just market such perinatal stem cell products including amniotic and placental materials without working with the FDA.
A striking press release (PR) accompanied the warning to Cord for Life with broader implications. In it the agency reaffirmed its stepped-up actions against non-compliant stem cell clinic and supplier firms more generally. Under the leadership of Commissioner Dr. Scott Gottlieb and CBER Director Dr. Peter Marks, this co-released warning letter and PR continues a trend of much greater transparency and stronger language by the agency in regard to stem cell clinic-related firms.
The PR also indicates a continued trend of the agency issuing dozens of what I’m calling “mini-warning” letters to firms it sees as high-risk, non-compliant businesses marketing unapproved stem cell drug products. It seems these mini-warning letters are meant to indicate to these firms that their time is running out to become compliant. Note that the term “mini-warning letter” is not something the FDA uses or even necessarily approves of others using, but it seems apt to me.
The PR nicely sums up recent FDA actions including the mini-warning letters in this passage:
“Over the past year, we have sent 45 manufacturers and health care providers regulatory correspondence, including warning letters, and we have two court cases pending. We’re committed to taking appropriate steps to address those that jeopardize the health of the people we are sworn to protect.
“Today, we’re continuing these efforts. The agency issued a warning letter to Cord for Life, Inc., located in Altamonte Springs, Florida, for manufacturing unapproved umbilical cord blood products in violation of current good manufacturing practice (CGMP) requirements, including failing to validate processes to prevent bacterial contamination, raising potential significant safety concerns that put patients at risk. In addition, we issued 20 letters today to separate manufacturers and health care providers across the country who may be offering unapproved stem cell products, reiterating the FDA’s compliance and enforcement policy.”
Overall, I’d say Gottlieb and Marks are doing a great job addressing the unproven stem cell clinic problem. Although Dr. Gottlieb is moving on from the FDA very soon (tomorrow, I think), I expect the stepped up action on clinic-related firms to continue accelerating under the leadership of Acting Commissioner Dr. Norman E. (Ned) Sharpless working with Dr. Marks.