Therapeutic Goods Administration (TGA) boss John Skerritt has called on the industry to prove CBD can work safely and effectively at higher doses and help rework the current rules “which are not written in stone”.
In December 2020, the TGA announced its decision to down-schedule CBD at a maximum dose of 150mg/day, already an increase on the 60mg/day it signalled in its interim decision in September last year.
Describing 150mg/day as ‘a compromise’, Skerritt told delegates at the MCIA’s virtual ACannabis EVOLVE conference today that the scheduling of cannabis products has been changed several times over recent years.
He said the maximum dosage for over-the-counter (OTC) CBD could go as high as 500mg/day if companies can prove safety and efficacy at that level.
“If a company did clinical trials and showed us that a product at 300mg or 400mg had an OTC-like side-effect profile, they could put in a rescheduling application at any time,” said Skerritt.
“In the future, 4-500mg of cannabidiol could be OTC, it’s just that there wasn’t the safety data to support that at this stage. But that doesn’t dissuade future research and future submissions.”
“I would encourage companies to do clinical trials at 150mg/day and maybe 300mg/day. Let’s say the 300mg works beautifully and 150mg’s not very good. The company could put in a rescheduling application for 300mg to become OTC, because presumably they have good safety data on that too.”
“Think a little outside the square because numbers specified in scheduling are not permanent.”
Skerritt flagged insomnia, mild anxiety and pain management as three indications which the TGA is in discussion with companies about, but added any indication will require evidence, “it can’t just be an opinion”.
“Think a little outside the square because numbers specified in scheduling are not permanent” – TGA boss John Skerritt
He said what is often missed in industry commentary is that the indication has to be suitable to be managed by a pharmacist, rather than a doctor.
“In a hypothetical scenario, you could find that 100mg of cannabidiol could be really fantastic for Tourette’s Syndrome, but the medication and management requires a doctor.
“Even if it was effective at that dose, certain conditions – like epilepsy as well – are not seen as those that a pharmacist should have overall management of. It’s usually a specialist physician.”
Skerritt refused to be drawn on when the first OTC CBD products are likely to be available in Australia, telling delegates that the TGA has yet to receive a formal application from any firm.
However, he added: “Some companies we talk to are quite confident they’ve already got good evidence for certain indications. Others have said ‘we’re just going to start our clinical trials’. I hope that we’ll receive an application during this calendar year and process it, but that’s in the hands of the companies.”
He urged firms to talk to the TGA about their submissions at an early stage.
“Don’t wait until you write your life’s thesis,” he added.
While Skerritt said the evidence and amount of documentation required to register an OTC medicine is not the same as for a prescription medicine, “you still have to show the thing works and is safe” and warned the industry could not expect any special treatment.
“Medicinal cannabis is not special or different as far as evidence requirements are concerned. We still apply the same OTC evidence standards as for panadol for pain relief.”
Speaking earlier, Cann Group COO Shane Duncan said the industry has a role to play in working with the regulator.
“One of the things the industry has been guilty of is saying ‘it’s been around for 100 years, what could go wrong?’” he said.
“The TGA and other regulators around the world have a framework to define the quality and safety standards of medicines.
“The industry needs to give away a bit of that ‘what could go wrong?’ philosophy and then the regulators will probably be a bit more open in terms of how we get through the registration process.”
Duncan added: “It’s always easy to pick on the regulator when typically these things are a partnership.”