The FDA has made clear its intention to regulate the stem cell industry. To that end, the federal agency has already instituted a small number of regulations intended to rein in doctors and clinics that insist on defying current regulatory standards.
In light of the current environment, it is difficult to argue against the fact that something needs to be done to prevent doctors from injuring their patients. But that doesn’t necessarily mean regenerative medicine needs to be so regulated that innovation and progress are stifled. And that is the worry, explains the Advanced Regenerative Medicine Institute (ARMI).
The ARMI trains doctors to use PRP and stem cell injections as a treatment for musculoskeletal injuries, degenerative joint disease, and more. They hear the concerns of doctors and clinics alike, concerns that all the advances made in regenerative medicine thus far could be curtailed by excessive federal regulation.
Regulation is not necessarily bad in and of itself. In fact, here are ways sensible regulations could actually help the stem cell industry:
1. Redefining Minimally Manipulated Material
Current FDA regulations allow doctors to use autologous stem cell material to treat patients – but only if the stem cell material remains minimally manipulated in the office. Unfortunately, minimal manipulation is not well defined by the FDA. There is enough room for interpretation to cause problems for both doctors and patients.
A new definition of minimally manipulated material would go a long way toward clearing up the ambiguities. This would make it easier for doctors to ensure compliance. It would also make it more difficult for careless doctors to harm their patients.
2. Fast Tracking New Procedures
One of the biggest stumbling blocks to FDA approval of stem cell procedures is the regulatory environment itself. It can take millions of dollars and many, many years to gain FDA approval for a new procedure or medical device. Why would stem cell clinics go through the hassle of gaining approval if they can legally perform stem cell injections utilizing minimally manipulated, autologous material?
If we truly want FDA approval and clinical studies showing efficacy of stem cell treatments, we have to make it as easy as possible to do both. A reworking of the regulations to allow fast tracking autologous stem cell procedures is the first step. It would help by getting new procedures to market faster. In turn, that will promote further research.
3. Make Insurance Coverage More Palatable
As far as anyone knows, not a single health insurance plan in the U.S. covers stem cell injections for musculoskeletal injuries and chronic joint disease. Thanks to federal regulations governing health insurance plans, it is just not feasible for insurance companies to cover what they consider experimental medicine.
New regulations aimed at taking some of the chains off insurance companies could open the door for future coverage. If insurance companies were allowed to tailor policies to individual customer preferences, they might be willing to cover stem cell injections for those patients willing to pay for such coverage. Likewise, those same patients would not have to pay for procedures they are never likely to utilize.
How would this sort of regulatory overall help stem cell industry? It would make stem cell injections more attractive to more patients. Those patients who could otherwise not afford to pay for treatments out-of-pocket would have access to them via their health insurance.
Regulation of the stem cell industry is coming. That could prove to be good or bad. It doesn’t have to be bad if the FDA is willing to embrace sensible regulations that actually help the industry.