Tetra is leading the way along the pharmaceutical pathway
The United States Food and Drug Administration removed any doubt about plans for maintaining its strict oversight of cannabis and cannabinoid-derived compounds with changes to the Agriculture Improvement Act which it announced yesterday. https://www.newcannabisventures.com/fda-asserts-regulatory-authority-over-cannabis-derived-products/
The new law made modifications related to the production and marketing of hemp with low concentrations of THC (the psychoactive compound in cannabis). As a result, hemp will fall outside the Controlled Substances Act, and won’t be considered an illegal substance under federal law. What the law did not change, however will be the regulators’ authority over products that contain cannabinoids. In a nutshell, cannabis and cannabinoid-derived products are drugs and they will be treated as such, with approvals and access taking the same route as for any other drug available for human use.
If all of this sounds familiar, it should be. It is precisely the same approach that Tetra Bio-Pharma has been taking to discover, develop and then commercialize cannabinoid-derived compounds. Tetra’s regulatory experience and expertise has been moving the process along further and faster and just yesterday we announced positive results of a Phase 1 trial in healthy human subjects for PPP001 with plans underway for a Phase 2 to investigate the product in fibromyalgia. Our more advanced Phase 3 trial with PPP001 for advanced cancer pain is also well underway.
To quote the FDA news release “we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of the source of the substance, including whether the substance is derived from a plant that is classified as hemp under the Agriculture Improvement Act.”
With the goal of public health and safety in mind, it appears that the FDA is going to keep a very close watch on drug claims for products containing CBD or other cannabinoid-derived products and will hold these to the same high standard as prescription pharmaceuticals, whether they are for humans or our family pets.
It has been several years now that Tetra Bio-Pharma went down a different path to aggressively pursue a path to commercialization of cannabinoid-derived products that is built on the foundation of scientific evidence. Being different sometimes means, being misunderstood. The fact that what we do is aligned with the FDA, and other health regulators, speaks volumes about our instincts and our actions.
By the sound of the news announcement those looking to circumvent the process should fear the wrath of the FDA and the enforcement of the rules. And while this sounds onerous for those looking to make a fast buck, it seems that the greatest opportunity lies in following the established pathways for drug approvals, which is Tetra Bio-Pharma’s core competence. Being ahead of the curve on the regulatory requirements means that we are already well placed to produce the clinical data that the FDA is expecting.