Interesting take on things.
I don’t think pharma is interested in spending billions of dollars to get the FDA to approve cannabis. Maybe, but I doubt it, not when the patent is already held by the government (no really!) and there’s so much other stuff that patenting it (which is what gives them market exclusivity) isn’t really going to work.
So basically generic manufacturers - of course, they are big as well.
But that supposes that rescheduling actually happens. And that with rescheduling there is a negative change in enforcement patterns.
Pharma could ALREADY be doing these things (they are not). And Pharma isn’t actually pay to play - anyone can do it (fuck small companies, big companies, international companies, family companies, are already involved in FDA approved supply chains…)
Why do you think this would impact your HEMP company? Hemp derived stuff is already illegal under the FDA (they have been VERY specific) and rescheduling d9THC doesn’t change that hemp derived stuff is already descheduled (since 2018). So unless you think that rescheduling d9THC will somehow impact the enforcement patterns of the FDA (since they are very limited enforcement of the existing rules right now…) to your already descheduled Hemp products…
And also - if you already have rigorous testing and high quality stuff, what makes you think you don’t already meet the GMPs? Under the FDA there is no “certification” or other bullshit. Its establishment license - which is just $5,672 per year. Much less than most cannabis license costs, potentially more than your hemp license. And then an inspection - basic GMP requirements for training, cleaning, documentation, and testing. And when I say basic, what I mean is, normal business practices for most people, so if your company is a cut above you will probably be fine.
But even then - the FDA has already said NO to hemp derived food, drugs, and cosmetics. So I wouldn’t expect you to actually go and get that. So unless rescheduling weed leads to a change in enforcement against state licensed groups and hemp operators (seems pretty wild to me, but one never knows!) I don’t know why we would expect anything to change.
What would really change things - would be if the FDA says that hemp derived stuff is allowed in food and dietary supplements and cosmetics (you can put it into drugs, but you have to do your clinical trials and your NDA first, which costs $$$$$). Then you might see bigger players come into the space. But that’s not what rescheduling is about. -shrug-
Here are the things I think will be positive about rescheduling.
- Just generally historical to remove something from Schedule 1, that I have advocated for since 1997
- Immediately removes the 280E taxation burden for all licensed state operators, and potentially unlicensed ones too.
- Pushes the ball back into the FDA’s court for everything else I mentioned above. Right now they are saying no to hemp derived stuff because Scheduling, unsafe, not GRAS, etc. With rescheduling research becomes much simpler, which means you can potentially get to a “cannabis is food not drugs” place. Although I personally think it needs its own category of botanical drug. -shrug-
- Removes the stigma for cannabis being enemy #1 on the CSA
- Potentially allows Harm Reduction programs and opiate recovery programs to start using cannabis to treat opiate addiction and recovery (currently not allowed for federally funded programs)
- Unleashes researchers across the country (since they no longer have to be CSA Schedule 1 licensed facilities) to do all the work that other countries have been doing
- Allows other government agencies (like USDA, SBA, NIST, NIH, etc.) to start actively funding and participating in companies and research groups working with this drug (currently not allowed due to schedule 1 status)
I could probably add more to the list. Any one of those would probably have been enough to tip the scales in my opinion - but there are really so many more positives!