Our Important FDA Struggle-Or Are the Stem Cells in Your Body Drugs?
“Courage is what it takes to stand up and speak: courage is also what it takes to sit down and listen.”-Sir Winston Churchill
Our current situation with the FDA has been one of those moments in a professional career when you have to decide if you will follow or lead. Sometimes leadership means standing up for what’s right, other times it’s more appropriate to “sit down and listen”. Once in a lifetime you’re given an opportunity to change the status quo. This is one of those moments.
First, it’s important to note that our current disagreement with FDA will not in any way impact Regenexx-SD (the same surgical procedure stem cell therapy we have always performed for certain conditions). Nor will it impact our other innovative regenerative medicine procedures. The only thing impacted for now is cultured stem cells, which the FDA believes is a drug. We believe our practice is the most advanced cell therapy practice in the US with a state of the art cell biology lab and the innovative therapies for orthopedic medicine-this will continue. We will also continue to innovate.
Our dispute with the agency is a landmark fork in the road for 21st century medicine. Are your stem cells your body parts to be used by you and your doctor to help heal your injuries and diseases, or are they drugs to be packaged, regulated by FDA, and sold back to you in a vial by big pharma? As professionals, when we first recieved an untitled letter from the agency in 2008, we decided the agency first had no authority over a physician practicing medicine in any state and second their assertion that our patient’s cultured stem cells were a drug made no common sense. At that point we could have decided that since they were the FDA they must by default be right, but that didn’t make sense either. We then sent the agency a letter stating why they didn’t have authoity over the matter and why they were not correct in their assumptions. Much to our surprise, the agency refused to meet on numerous occasions and discuss the matter, i.e.talk out why they felt they were right and why we felt we were right. When they first showed up on our doorstep in early 2009 to see what we were doing, we knew we had to act, so we took the unprecidiented step of suing the agency. We did that 3 more times, with the agency stating in numerous court documents that it hadn’t yet decided what to do about us and that it didn’t know what it’s “final agency action” was going to be. Our goal with our suits was to force the agency to explain why it had authority over a medical practice, why it’s rules concerning our patients stem cells were lawfully adopted, and where congress had every granted it the authority to regulate our patients cells as drugs. In the end, we got what we wanted, which is the agency in court, who now must answer these questions.
In the end, it’s also all about patients. What we have developed is a ground breaking non-invasive treatment that clearly helps many patients avoid more invasive and more risky surgeries. The cultured cell procedure we perform is clearly much safer (based on the data we have published and collected) than these surgeries. We will win this one for our patients.
Below are a list of links that go into more depth on this issue:
-Fierce Pharma Manufacturing-http://www.fiercepharmamanufacturing.com/story/injunction-will-test-fda-rule-over-stem-cell-remedy/2010-08-11
-Stem Cell Pioneers – http://www.stemcellpioneers.com/showthread.php?p=11052
World News Daily-http://www.wnd.com/?pageId=191177