It has been about a year since the FDA announced a crackdown on regenerative medicine procedures offered by doctors and clinics not necessarily willing to play by the rules. In the months since, the FDA has sent countless warning letters while reviewing current regulations pertaining to stem cell and PRP procedures. The agency recently took the next step in proving it means business by suing the South Florida clinic responsible for motivating the FDA to get involved.
The U.S. Stem Cell, a Sunrise, Florida clinic, made national headlines last year when three patients were severely harmed by treatments intended to address macular degeneration. The patients experienced complications ranging from loss of vision to blindness. Their plight motivated the FDA to begin taking action against clinics whose procedures could be harmful to patients.
U.S. Stem Cell received warning letters from the FDA ordering them to stop marketing their procedures for lack of approval. News reports say the clinic has ignored the warnings, prompting the recent lawsuit. The suit asks for an injunction forcing the South Florida clinic to stop treating patients until their procedures get the proper FDA scrutiny.
Stem Cell Procedures and FDA Guidelines
It is truly unfortunate that patients of U.S. Stem Cell have been harmed by their doctors. It is also unacceptable that the clinic has failed to respond to FDA warning letters. But at this point, it’s important for the rest of us to step back and realize that the goings-on in South Florida are not indicative of the entire regenerative medicine industry.
What U.S. Stem Cell is accused of doing goes above and beyond what most legitimate clinics offer. They are taking stem cell material and manipulating it in such a way as to exceed already existing FDA guidelines, according to the lawsuit. As such, their procedures require FDA approval.
On the other hand, a clinic that extracts fat tissue and then processes it in a centrifuge in order to isolate stem cells is not exceeding FDA guidelines. Because the material is minimally processed prior to injection, the risk of complications is extremely low. The procedures are already considered safe by the FDA and the medical community at-large.
A proper understanding of what clinics are doing is critical to making sound judgments about regenerative medicine. As in any industry, there are those clinics and doctors choosing to operate outside of established guidelines in order to sell their services. It is only right to take action against them. But such clinics and doctors are the exception rather than the rule.
The Danger of Over-Regulation
Most of us would agree that it is the FDA’s responsibility to crack down on clinics like U.S. Stem Cell. Unfortunately, however, actions taken by the clinic and its doctors have now put the entire regenerative medicine industry at risk of over-regulation. Because they decided not to follow rules, the FDA is seriously considering overhauling regulations to require approval for every stem cell procedure regardless of how safe it is.
Apex Biologix, a company that supplies regenerative medicine clinics with stem cell kits and processing equipment, points out that most stem cell clinics in the U.S. are doing things the right way. They are extracting and processing stem cell material well within FDA guidelines and, as such, not offering treatments that could harm patients.
Let us hope the FDA lawsuit against U.S. Stem Cell does not pave the way for over-regulation. The FDA is right to make it clear they mean business, but they shouldn’t use the suit to seize total control over the regenerative medicine industry.