In the last 24 hours Reuters have reported the following
GW cannabis-derived epilepsy drug gets positive FDA staff review
LONDON (Reuters) – GW Pharmaceuticals’ cannabis-derived medicine for severe childhood epilepsy won a favorable review from U.S. Food and Drug Administration (FDA) staff on Tuesday, boosting hopes for its approval in the world’s biggest drugs market. Shares in the company, which has operations in Britain and the United States, were 11 percent higher in early Nasdaq trade on the news. GW’s medicine Epidiolex, which is given as a syrup, is a purified form of cannabidiol, one of the active ingredients found in marijuana. It contains less than 0.1 percent of tetrahydrocannabinol, the substance that makes people high.
The FDA briefing document, posted on the agency’s website was prepared ahead of an advisory committee meeting on April 19.
GW are moving quickly in Colorado and they have the following introductory bill going to the floor tonight.
Second Regular Session” “Seventy-first General Assembly
House Bill 18-1187
“A BILL FOR AN ACT”
101 “CONCERNING THE LAWFUL USE OF A PRESCRIPTION DRUG THAT”
102 “CONTAINS CANNABIDIOL THAT IS APPROVED BY THE UNITED”
103 “STATES FOOD AND DRUG ADMINISTRATION.”
The bill is being sponsored by the following representatives and the lobbyists, whoever they may be, have, been hard at work.
They have managed to get bi-partisan support in each chamber as well heavy hitter Senator John Cooke (Majority Whip) (R) on board to sponsor the bill.
What will this mean for local producers of CBD medical products, as yet, we just don’t know.
It may be that GW are unable to prove that their product, made with a CBD isolate molecule, is actually superior to products already being manufactured by local Colorado companies like Folium Biosciences (https://foliumbiosciences.com) who claim they are already making similar products composed of more than 100 cannabinoid molecules.
The speed at which this bill is being pushed to the floor has already raised a number of issues including the activity of lobbyists. We’re expecting a statement from a Colorado entity in the next 24-48 hours who may have been falsely linked to GW activities and the possibility that some lobbyists licenses are now expired.
We would also suggest that this activity is not just happening Colorado. CLR intends to keep an eye on this legislature but other states. We will be looking to see if similar bills suddenly appear in OR and WA houses. We’ve already heard hints of activity in states as far flung as Arkansas and Florida.
Th flip side of the coin as reported by MG Retailer.com concerns a catch 22 in current Colorado law and is as follows….
In an upside down case of regulatory disconnect, the first FDA-approved drug derived from cannabis may not be available to patients in Colorado, if approved by the Federal Drug Administration in June. In Colorado, pharmacies cannot sell cannabis medications, and cannabis dispensaries cannot sell FDA-approved drugs because they are not licensed pharmacies.
So, without a change in state regulatory law, the first FDA-approved drug derived from cannabis would be unable to be distributed for sale in Colorado.
Epidiolex could be prescribed through a conventional pharmacy–if Colorado lawmakers change current laws.
Representatives Lois Landgraf (R-Colorado Springs) and Janet Buckner (D-Aurora) have introduced a bill that would allow Colorado pharmacies to sell Epidiolex, while other non-FDA approved cannabis medicines would still be distributed through dispensaries. Currently, patients in Colorado, including children (through certified caretakers), access CBD oil and other medicinal products at cannabis dispensaries and patient facilities.
“Parents can still go to those dispensaries and get the product for their child. The other option [pending FDA approval] is that they [will be able to] get a prescription from their doctor that a pharmacist can legally fill and this would be a regulated product,” Landgraf told local Denver news affiliate CBS4.
HB 18-1187 Sponsors
House of Reps
Janet Buckner (D)
Lois Landgraf (R)
Senator John Cooke ( Majority Whip) (R)
Senator Dominick Moreno (D)
Here is the full text of the bill2018a_1187_01