It’s a given in the industry that new cannabis processing and product manufacturing facilities should be built FDA-compliant.
What that means is following a laundry list of rules, including having easily cleanable floors and walls, systems for monitoring environmental conditions and many others.
Responsible cannabis business operators are well versed in what their production facilities need to do to be FDA compliant. Facilities such as the under-construction MedPharm in Aurora, Colorado; WannaBrands in Boulder; and L’Eagle in Denver all strictly adhere to these FDA guidelines, which are, after all, the best manufacturing practices for food and drugs.
The thinking behind this pro-active construction is that the FDA will be checking out how compliant they are soon with a list of federally-mandated rules on cannabis-related production.
But the other given is that this is still a Schedule 1 substance, and the FDA does not have to get more involved in the cannabis business at this time. But it seems like they are getting ready to make some moves quickly if and when needed.
The FDA is modifying the way it works, and that’s good news for the industry. A statement released by FDA Commissioner Scott Gottlieb in October announced the creation of the first advisory committee comprised solely of patients, care-partners and others who represent the needs of patients. It’s an effort to “broaden the engagement with patients”, and to “deepen the involvement of patients in the regulatory activities,” according to the statement.
What the formation of this Patient Engagement Advisory Committee (PEAC) means is that the FDA is stepping back from just saying here’s our objective science data, take it or leave it – and is addressing exactly how a drug affects a patient and why they need it. They want to involve the end-user more to identify health priorities and outcomes. They want to know more about patient culture and processes to help in product development.
While this new group was developed specifically for medical devices, it’s easy to see that the FDA is going further with its drug investigative work. They have seen how important data-analyics is to their regulatory process, and that it’s the patients themselves who are providing that dynamic shift. You can see what the FDA is thinking in their broader statements from this release: “Patients are increasingly collecting much of this real world data. They are spearheading the creation of novel registry platforms that collect heatlh data to track their progress.. and we’re fostering interactions with these patient-led registries to help them become vehicles for regulatory change.”
The goal here, beyond medical devices, is to facilitate cross-center policy making when it comes to how the FDA develops more consistent and cutting edge approaches to engaging patient perspective in their scientific process. “We need to elevate the science of these endeavors, and develop some basic, common practices and principles,” the commissioner wrote. “As the science of measuring patient preferences continues to evolve, our policies must also adapt.”
The recent announcement comes after the FDA took steps recently to streamline its operations, which is designed to give the agency a methology for quicker response to regulatory action about a food or drug and could be a major benefit for their future work in cannabis.
According to a report in CBE, cannabis researchers hoping to work with the FDA are encouraged by this alignment action, noting that, when the agency considers any regulatory work on cannabis, it would have to investigate, test and approve the cannabis plant compound by compound – 400 by some estimates – in a long process that could take up to ten years. Anything that can speed up the process is an undeniable benefit toward regulation and the eventual advancement of the industry.
The alignment came about because of a real concern that the agency couldn’t keep up with its mission of inspecting, testing and regulating on a timely basis.
Better engagement with patients. Faster alignment for regulatory development. It’s beginning to sound like the FDA and the cannabis industry are getting close to being on the same page.
Source: Cannabis Business Executive