There has been great concern raised about a Statement the FDA Commissioner issued on November 16, 2017, due to the forceful comments he made about non-compliant physicians and clinics offering a variety of “unproven” therapies for use in treating a large number of pathologies. But what motivated the Commissioner to issue the letter last November?
Consider these three points:
1) Cares Act 2016 gave the FDA new responsibilities and accountability to expedite the processing of various therapies. And the FDA released two draft guidances on aspects of the Cares Act 2016 on November 16, 2017.
2) There was a paper that was published in March 2017 that detailed the tragic loss of sight by three patients who had received stromal vascular fraction (SVF) therapy obtained from the patients’ fat tissue for treating macular degeneration. The blindings occurred at the US Stem Cell Clinic, whose CSO is Ms. Kristin Comella. Subsequently, the FDA conducted an audit of USSCC, which was found wanting and issued a Warning Letter in August 2017.
3) The FDA had the US Marshals raid StemImmune, Inc. (San Diego, CA) to confiscate vials of Smallpox virus vaccine (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573427.htm ). The vaccine was being used in combination with autologous SVF preparations to treat cancer patients at the California Stem Cell Centers (Rancho Mirage and Beverly Hills, CA). It would appear that one or both of these treatment clinics are affiliated with the Cell Surgical Network (CSN), which was founded by Drs. Berman and Lander.
So, with all of these events going on last year, the Commissioner probably thought there was a need to take a strong position and he did that in his Statement. Here are a couple of comments the Commissioner made in his remarks:
“…the rapid growth and promise of this field has increasingly sowed the ground for the entry of some unscrupulous actors…”
“By exploiting the lack of consumer understanding of this area, as well as the fear and uncertainties posed by the diseases these bad actors claim to treat, they’re jeopardizing the legitimacy and advancement of the entire field.”
It seems pretty obvious that the Commissioner doesn’t take kindly to “bad actors” who are wreaking chaos in the regenerative medicine world, warning as he did that the FDA will be working to “ensur(e) that those who skirt these regulations are held accountable.” The regulations the Commissioner refers to are found in 21 CFR 1271, for which two Guidances were issued on the same day as his statement.
Since my association with autologous regenerative therapies is of the FDA-compliant kind (autologous-type PRP and BMC), I wasn’t worried about his comments, unlike the hawkers of cord blood, amniotic fluid with live (sometimes?) cells and micronized tissues. In fact, I took solace in the following comment in the Commissioner’s Statement:
“To be clear, we remain committed to ensuring that patients have access to safe and effective regenerative medicine products as efficiently as possible. We are also committed to making sure we take action against products being unlawfully marketed that pose a potential significant risk to their safety.”
So, taking the Commissioner’s comments at face value, it would seem the FDA definitely will be going after the manufacturers of non-compliant donor-derived therapies, and the clinics/physicians who apparently don’t have an ethical bone in their bodies when using these readily available products to treat any and all pathologies. In fact, the FDA has been busy issuing Untitled and Warning Letters since the Commissioner’s Statement last November.
For example, Mr. Douglas Ginter, President and CEO of Physicians Products, Inc., received an Untitled Letter on January 26, 2018 in which he was called to task for failing to get clearance or pre-market approval of a PRP kit his company sells. He was cited by the FDA as claiming on his company’s website that the kit was “FDA approved”. Seriously! The government may be trillions of dollars in debt, but to think the FDA wouldn’t be able to pay the electricity bill in order to remain connected to the Internet just is pressing your luck.
Another regulatory action of note in January was the issuing of a Warning Letter to American CryoStem Corporation on January 3, 2018. I will go through this company’s sins in more detail in the next post.