This past November (2017), the FDA released its much-anticipated framework for regulating regenerative medicine delivery. Critics of regenerative medicine were noticeably underwhelmed by the framework, while those who favor of things like stem cell and platelet-rich plasma (PRP) therapies over more invasive procedures were pleased.
As an operator of a direct-to-consumer (DTC) clinic, you might be wondering how the new framework affects your practice. The answer depends on whether your clinic is legitimate. A legitimate clinic does not claim that regenerative medicine is a miracle cure for everything from cancer to heart disease. It is a clinic that offers treatments based on proven medical science.
As for the framework itself, the FDA is somewhat limited in what it can do with DTC clinics based on its current definitions of two terms: ‘minimal manipulation’ and ‘homologous use’. According to a previous framework developed over a decade ago, DTC clinics whose stem cell procedures fall within FDA definitions do not need to apply for approval. The only way the FDA could change this is by reworking its definition through a process that would require a lot more time and bureaucratic red tape.
Selective Enforcement Now the Norm
FDA Commissioner Scott Gottlieb made it clear last summer that his agency’s desire to protect consumers against fraudulent and dangerous regenerative medicine procedures was the motivating factor behind creating a new framework. In order to get a new framework done in a relatively short amount of time, the FDA decided against redefining its terms. Rather, they created a set of guidelines for selective enforcement.
According to Apex Biologix, a Utah company that sells regenerative medicine equipment and supplies, DTC clinics should be using autologous stem cells (those donated by the patients being treated) that are minimally manipulated and injected only into the patient from which they come to maintain FDA compliance.
The FDA plans to go after DTC clinics operating outside those boundaries. For example, any clinic or physician who combines autologous stem cells with live virus material to allegedly boost immunological response would be an FDA target. That practice is clearly outside established boundaries.
The FDA has explained selective enforcement to the Regulatory Affairs Professionals Society this way:
“Specifically, under limited conditions, when a product requires an investigational new drug application (IND) or premarket approval (biologics license applications or BLAs), the agency intends to focus its enforcement actions on products that pose higher risks. For example, actions related to products administered by higher-risk routes of administration (e.g., those administered by intravenous injection or infusion, aerosol inhalation, intraocular injection, or injection or infusion into the central nervous system) will be prioritized over those associated with a lower risk (e.g., those administered by intradermal, subcutaneous, or intra-articular injection).”
Most Clinics Will Not Be Affected
The good news of the FDA framework is that most clinics offering legitimate treatments will not be affected by enforcement efforts. If your clinic is using minimally manipulated autologous stem cells to treat osteoarthritis, for example, you have nothing to worry about. What you are doing falls within FDA boundaries and is considered minimally risky.
If your clinic is extracting stem cells, manipulating them, and then injecting them into the eyeballs of patients suffering from macular degeneration, expect to be targeted. What you are doing is both risky and outside of established boundaries.
Love it or hate it, the new FDA framework for regulating DTC stem cell clinics is now in place. It is a framework intended to weed out fraudsters while allowing legitimate clinics to continue pursuing effective treatments that do not harm.