02 Sep Update on the FDA
Nearly every time we sit down to send out an update about the legal issues with the FDA something new happens that seems to change our perspectives.
First, we are not worried, upset or afraid that the FDA will prevail and end our ability to provide point of care treatments for our patients. Indeed, this fight is for our patients. Most of us have very good jobs and little to nothing to lose but our patients are at real risk.
After refusing to sign a Consent Decree offered by the FDA that would acknowledge that SVF from your own body is a “drug” allow us to continue providing SVF point of care under specific conditions, we were served with a civil lawsuit to seek a permanent injunction against us providing point of care SVF. To be clear, this means they are attempting to use the courts to shut down SVF point of care production. Unless and until they prevail, we can all continue our current operations since only a permanent rather than temporary injunction was sought. We have no plans of losing this battle and are willing to take it to the Supreme Court if necessary.
This also included an injunction against delivering Vaccinia virus (ACAM2000) for cancer therapy and expanded cells (ATCell) from American CryoStem. Of course, these last two issues were never significant other than we were trying to complete some IRB approved safety studies for an IND filing with the FDA. The FDA inspectors knew that and we had already agreed not to continue the safety studies if the FDA preferred we obtain the IND first. We’ve been informed that the FDA rarely has someone refuse to sign a Consent Decree. We refused to sign because this would give the FDA complete power over us forcing us to hire FDA experts and then have the FDA inspect us periodically to ensure that SVF was studied, manufactured, licensed, and labelled as a drug identical to mass produced pharmaceuticals. We would never be able to make an autologous biologic such as SVF like a pharmaceutical product and the FDA would likely never approve us to resume caring for our patients.
As you all should know, the FDA has written guidance documents that even they admit are not legally binding but are recommendations. They have used their guidance documents to suggest that SVF meets the criteria of as a drug. Their logic follows that if SVF is a drug it must therefore be made according to the same standards as any mass-produced pharmaceutical. Upon their audit inspection in July/August 2017, they noted three glaring points. First, that SVF was not uniform in dose, strength and purity. Second, on occasion, our SVF processing exposed the tip of our syringes to air. Third, we did not validate the sterility or concentration of the crystalloids (e.g. D5LR, Saline) we used in the processing of SVF. Of course, we’re not making huge quantities of a mass-produced pharmaceutical in batches that would be difficult to validate for sterility if those conditions were not met. Mass produced drugs need to be uniform in dose, strength and purity as it’s a specific product for sale. The crystalloids need to be validated because you are making huge vast quantities and don’t want anything to adulterate your product. The same goes for doing everything in a very clean (dust free) environment. Additionally, you could never make an FDA approved drug product from a human as we are not sterile animals and even though we may have no major or obvious diseases, we may carry unknown viruses or prions. How and why the FDA plans to allow allogeneic products makes little sense considering the long-term ramifications that may exist.
Additionally, and very significantly, drug companies both own and manufacture the products they produce. SVF is neither owned by us nor manufactured by us. It is a natural product (i.e. the patient’s own cells) that they solely own. Thus, we argue for very obvious reasons, Personal Cell Therapy (PCT) with autologous SVF could never be considered analogous with a pharmaceutical product and thus we should not be considered to be producing a drug that needs to go through the same route as such mass-produced pharmaceuticals. Whether the FDA has the authority to call our own cells used for our own personal use drugs or not is significant as to whether they can invade our right to privacy or control to our own possessions without due process.
We’ve long argued that if the FDA wants to be involved with PCT, then a registry would be the best way to police the arena. This, however, can be done the way we’re currently doing it through a privately (or publicly) run database. Data moves surgery forward. And, the ability to repeat successful results ultimately validates the process.
With the advent of the Consent Decree we hired the Venable LLP law firm. They have huge offices in Washington DC and in California. Todd Halpern is the principal lead however he is well flanked by a number of outstanding legal personnel. Having known of other FDA legal specialists, we find Venable better than the others. Still, attorneys need to be coached. We (Elliot, Sean and Mark) flew to DC in July and met face to face with the entire Venable team working with us. We gave a thorough power point presentation and spent several hours going over all of the issues and complaints that had been filed. We firmly believe the FDA should be on trial, responsible to explain the arbitrary and capricious manner in which they conceived these unscientific regulations.
At the same time we were served, Kristin Comella, PhD (U.S. Stem Cells), was served with a similar complaint. We currently share the same law firm – Venable. Needless, to say, the legal battle is expensive and we appreciate that our CSN affiliate members are helping to defray some of the expense with the current surcharge on kits. We’re all in this together – we can’t let the FDA win this fight otherwise we’re all going to be looking for a different way of helping out patients or building our own GMP approved facilities and going through a prohibitively costly and time consuming licensing process.
Meanwhile, we are not solely focused on winning in court but also have been looking at a variety of ways to win on the political playground and gain political support. We may have a few avenues of influence to get to remain hopeful that President Trump will become aware of this unconstitutional breach of patient rights and intervene to stop this regulatory overreach. If you have relationships with influencers, congressmen, or senators, please help us reach out to them and make them aware of the situation. We have a position letter ready to give them if they show interest. Dr. Comella recently had a meeting with the White House Health Advisor that seemed to have gone very well. It appears that the White House is sympathetic to our position. We have a couple other avenues to the White House we are also entertaining as we believe it would be much more compelling to shut this complaint down on notice from the Executive division as opposed to going to court.
Should we go to court, we have been assigned to Judge Jesus Bernal in Riverside County for the Federal Court for the Central District of California. We are confident that we will prevail should we go to court in a fair trial. While the FDA has largely prevailed for this particular issue, we don’t believe they have been properly challenged. They have mostly had suits challenging their authority over the practice of medicine. We’re not challenging that as we are challenging their lack of authority over the practice of surgery along with their arbitrary rules that were not based upon the guidance documents that they claimed to be based upon and also that this surgical procedure is not analogous compatible with pharmaceutical manufacturing principals. Further, we have published evidence of exceptional safety – beyond that of any FDA approved pharmaceutical.
As far as our voice is concerned, we have told our attorneys that we will not remain silent as was originally recommended, but that we were compelled to make sure we answered back to the press. Our initial press went unanswered and made us appear guilty. Subsequently, we have been aggressive and spoke to several members of the media. We’ve met in person with writers from the New York Times and we have several other media programs in the works. To all our affiliates – keep it honest. Remember, we have data that we can share, but we are still doing investigational work with SVF.
Ultimately, obstacles are important to build the strength of an organization. We’re convinced this will make us stronger, better, and better able to move Personal Cell Therapy into the next phase of acceptance. Ultimately, we must think of our patients and whether this is their best interests or is it better if the FDA prevails and shuts us down. Clearly, our mission has always been to advance personal cell therapy for the well-being of our patients. With your help, we will work tirelessly towards that goal. Shutting it down would be seriously detrimental to our patient’s well-being.
We have told our attorneys that we will not remain silent as was originally recommended, but that we were compelled to make sure we answered back to the press. Our initial press went unanswered and made us appear guilty. Subsequently, we have been aggressive and spoke to several members of the media. We’ve met in person with writers from the New York Times and we have several other media programs in the works. To all our affiliates – keep it honest. Remember, we have data that we can share, but we are still doing investigational work with SVF.