If marijuana is moved from Schedule 1 to Schedule 3 of the Controlled Substances Act, that would expand both access and product selection for medical marijuana patients.
But rescheduling likely wouldn’t impact how state-regulated MMJ dispensaries operate.
“Schedule 3 allows essentially a new pathway for cannabis to be in the marketplace, which is through an FDA-approved drug channel,” said Amy Rubenstein, a partner with the international law firm Dentons.
Pharma pipeline
Rubenstein explained that moving marijuana to Schedule 3 would make it easier for companies to develop cannabis-based drugs and get U.S. Food and Drug Administration approval for them.
Once drugs have FDA approval, they can be purchased with a physician’s prescription at federally licensed pharmacies.
She added that developing drugs, going through the requisite studies and getting approval takes years, so it would be a long time before consumers are able to shop at pharmacies for federally approved, marijuana-based drugs.
Medical marijuana patients, however, could continue to buy regulated cannabis products from state-licensed dispensaries.
And state-regulated recreational marijuana retail owners would be able to operate without fear that federal authorities would crack down on their operations, observers said.
“The state-legal markets are not going to disappear,” Rubenstein said.
‘Significant undertaking’
Justin Brandt, partner with Scottsdale, Arizona-based law firm Bianchi & Brandt, agreed.
“I think at some point it’s possible that we’ll see (medical marijuana products) in pharmacies,” he said.
“But even when cannabis is at Schedule 3, companies or whoever wants to sell under the purview of the FDA/federal law, they’re going to have to go through clinical trials and will have to do the same steps that Big Pharma goes through in getting an FDA-approved drug to market.
“That is a significant undertaking. It costs a lot of money. It takes a significant amount of time. We’re talking years. So, we’re quite a few years away from something like that.”
Flower stays put
While the FDA could eventually approve medical marijuana, don’t expect the agency to approve flower or other combustible products, experts warned.
“I can see it being sold in pharmacies, but I think it would have to be in a different form factor,” said Vince Ning, CEO of California marijuana distributor Nabis.
“I just don’t see a pharmacy or a Kaiser Permanente selling cannabis flower. It’ll probably be in a pressed-pill form or something that’s a medical-grade, concentrated product.”
Ning added: “I think dispensaries will still exist. I hope that direct-to-consumer channels also start to open up. I think that there needs to be more access to channels, because that’s what will help eradicate the illicit market.” (Full Story)