Stepping up its campaign against non-compliant human cell tissue products (HCT/Ps), the Food and Drug Administration (FDA) on April 3 cautioned 20 companies—which it refused to name when we asked—that their products are non-compliant and may be violating FDA regulations.
In the same announcement, FDA Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter W. Marks, M.D., said they had just sent a formal warning letter to a Florida company which has claimed that its HCT/P products treat orthopedic conditions. They also mentioned two lawsuits the FDA has filed, against another Florida company and a California company which have defied FDA orders to stop selling human cell tissue-based products (HCT/Ps) without biologics licenses.
Possibly the most significant aspect of the lengthy statement, however, was that their language has become much more intense, and their aim at the HCT/P industry broader, since a similar statement and set of letters in December (“CDC: Patients Contaminated by Allograft Umbilical Cord Products,” Orthopedics This Week, January 24, 2019).
MiMedx OrthoFlo disappears from website
On Sunday, March 31, the MiMedx web site included a tissue-based orthopedic product called OrthoFlo as one of its products and had two web pages devoted to it. One of those MiMedx pages described OrthoFlo as being minimally manipulated and for homologous use—two regulatory terms which are at the core of the FDA’s actions.
However, by Friday, April 5, OrthoFlo was no longer listed as a product, and the URLs of the two OrthoFlo pages bounced back to the home page.
Google still listed the no-longer-available OrthoFlo web page as valid in a search on April 9, which probably confirms that its removal was quite recent. Once Google re-indexes, the search we used should follow a “301″ redirect, which would cause Google to show the URL of the new web page. Also, OrthoFlo was still listed as of this writing as a MiMedx product on what seems* to be another MiMedx website, getbacktogo.com, at this page: https://getbacktogo.com/products#quicktabs-product_tabs=3
*The ownership of getbacktogo.com is secret. Its registrar, Tucows, lists it as a private registration fronted by a Toronto, Canada private registration service. It uses the MiMedx logo and links back to the main MiMedx website, but strangely, it still shows the former management team headed by Parker “Pete” Petit as being in charge.
The main MiMedx website still lists another HCT/P product, AmnioFix, which it describes as an allograft which can “reduce scar tissue formation, modulate inflammation, enhance surgical wound healing, and act as a barrier membrane.”
The FDA questioned MiMedx about AmnioFix back in 2013, saying that it was micronized (ground into powder) and therefore not “minimally manipulated,” which meant that a biologics license was required. AmnioFix today is described as dried but not crushed into powder.
FDA language on HCT/P enforcement is becoming more forceful
The FDA’s April 3 statement reaffirmed FDA’s mechanism for allowing the commercialization of human tissue products derived from bone marrow and peripheral blood have been in place for decades and allow these HCT/P products to be treat “certain cancers, like leukemia, and certain other serious diseases and conditions, such as aplastic anemia.”
“But most forms of regenerative medicine,” Gottlieb and Marks said, “are still in early stages of development and adult stem cells and stem cells from birthing tissues have not yet been shown to be safe and effective for use in the treatment of any other diseases or conditions.”
“There’s a false premise being asserted by some in the field that a product derived from a person’s own body and then manipulated and reinserted for another use different from the one it played in its original location is not subject to FDA regulation just because it originated from the person it was given back to.”
“We’ve seen too many cases of sponsors claiming that cells aren’t subject to FDA regulation just because the cells originated from the same patient to whom the eventual manufactured product is being given. And we’ve seen too many cases of companies making unsubstantiated claims that these treatments prevent, treat, cure or mitigate disease where the products have sometimes led to serious patient harm.”
“In addition to the products re-injected into the cell donor, many other HCT/P products on the market, usually derived from placental or umbilical cord tissue or blood, are being injected into third parties who are neither the donor patient nor a close relative. Their vendors claim that they are “homologous”—that is, that they’re being used for the same purpose as they came from when they’re injected into a sufferer’s joints, for example.”
Did manufacturers interpret “enforcement discretion” as “OK to ignore FDA?”
The FDA’s California court case is against California Stem Cell Treatment Center Inc., with locations in Rancho Mirage and Beverly Hills, California; Cell Surgical Network Corporation of Rancho Mirage, California; and Elliot B. Lander, M.D. and Mark Berman, M.D., who, according to the FDA, control operations in about 100 treatment clinics.
Dr. Berman has a web page at which says, “We’re actually performing a surgical procedure and the FDA does not approve surgery.”
A joint website of the clinics says they’re investigating treatments for “neck arthritis and spine disease, back arthritis and spine disease, knee problems, hip problems, elbow and hand problems and shoulder problems,” among other conditions.
The Florida court case against US Stem Cell Clinic LLC involves eye treatments, not orthopedic. It is trying the same legal argument as the California clinics. FDA seeks permanent injunctions to stop both groups from selling.
The new FDA Warning Letter went to Cord for Life, Inc., of Altamonte Springs, Florida, which claims that its umbilical cord-blood-based products are “regenerative” medicines for orthopedic use.
Are some of these more marginal HCT/P companies operating under the mistaken notion that, in effect, the FDA’s 36-month window of “enforcement discretion” ending in November 2020 is tacit permission to keep selling until then? MiMedx, we note, seemed to express this view in statements the Wall Street Journal and on Marketwatch published last August.
Both sets of justifications, no doubt, are fueling, in part, the FDA’s more aggressive regulatory stance.
The bottom line: the FDA is working hard to separate the marginal allograft “stem cell” players from the more mainstream allograft processors and suppliers—who, we note, tend to support their HCT/P products with extensive processing information, detailed IFUs and clinical information from top clinics and hospitals.
Bill,
Can you provide the names of the 20 companies which the FDA has cited? It will be of immense help to understand what type of companies (high risk claims) that the FDA is going after.
Dear Bob,
We did ask for those names and the FDA did not release them to us.
Robin Young