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In the past few weeks, the United States House of Representatives followed the lead of the bipartisan effort in the Senate to reschedule marijuana as a Schedule II drug instead of its current status as Schedule I.
As with most things in Congress, the intent was good but the execution leaves much to be desired. On the upside, if this passes, Marijuana businesses would finally have unfettered access to banking…and that’s where the positives end. All the sudden, marijuana will be in the same group as vicodin, adderall, hydrocodone, and percocet. And every new marijuana drug (for example, ALL OF THEM) will have to be developed with chemically identical doses designed to diagnose, cure, mitigate, treat or prevent a specific disease.
Essentially it means that no one could legally sell any marijuana or marijuana-derived product until they complete the FDA’s Drug Review Process (DRP). I’ll give you the easy, simplified version in 12 easy steps.
- Preclinical (animal) testing.
- An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.
- Phase 1 studies (typically involve 20 to 80 people).
- Phase 2 studies (typically involve a few dozen to about 300 people).
- Phase 3 studies (typically involve several hundred to about 3,000 people).
- The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
- Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
- After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
- If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor’s research on the drug’s safety and effectiveness.
- The FDA reviews information that goes on a drug’s professional labeling (information on how to use the drug).
- The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
- FDA reviewers will approve the application or issue a complete response letter.
The Marijuana Industry is unable to afford a Drug Review Process, and Big Pharma would be unwilling to fund a DRP on a chemically inconsistent product (should we do a DRP for every strain to treat different conditions?) with poorly understood physiological effects and marketability.
Besides testing requirements, there are other problems with rescheduling Marijuana. Dispensaries would be illegal because you’d have get your marijuana from a pharmacy with a doctor’s 90-day prescription. Another problem is that the FDA would require the United States Pharmacopeia and National Formulary to list marijuana to even CALL it a “drug”. (unlikely) And WHAT ABOUT HEMP?
In short, if we want the Marijuana industry to survive. Hemp should be regulated like Corn and Marijuana should DE-scheduled and regulated like a herbal product, dietary supplement or vitamin. So my dear congress, Marijuana doesn’t fit in with the other Schedule II drugs and trying to make it fit would be a colossal mistake.