CBD oil could gain prescription-level approval in Colorado
Author: Marianne Goodland - April 5, 2018 - Updated: April 12, 2018
DENVER — On one side: segments of Colorado’s hemp and marijuana industry, claiming a bill that won final approval in the Colorado House of Representatives Thursday will benefit just one company and could carry a rash of unintended consequences.
On the other: other segments of the hemp and marijuana industry, joined by parents and doctors who want the drug, known as Epidiolex, to be approved by the federal government and allowed as a prescription medication for seizure disorders in children.
The two sides are sparring over House Bill 1187, which would ensure that when the Food and Drug Administration approves Epidiolex, Colorado law will allow it to be prescribed by doctors and dispensed by pharmacies.
Epidiolex is an oral drug manufactured by GW Pharmaceuticals of England. Its primary ingredient is cannabidiol or CBD oil, and it’s used to treat rare seizure disorders in children like Lennox-Gastaut and Dravet syndromes. The pending FDA approval would only allow patients with aforementioned syndromes to be treated with the drug. CBD oil is currently categorized as a dietary supplement and, hence, is not regulated by the FDA.
The bill has split the cannabis industry in Colorado, with some fearing that the patents held or pending from GW for Epidiolex will prohibit other companies from getting into the pharmaceutical side of the industry. The measure’s supporters, however, claim the change in law will actually broaden the opportunities for the industry.
CBD oil has been used to treat seizure for years, but not as a prescribed drug. Its use as a seizure treatment got started with Charlotte’s Web, a CBD product developed by seven brothers in Colorado now under the name of CW Hemp.
The oil is considered industrial hemp under Colorado and federal law.
Last year GW applied to the FDA for expedited approval of Epidiolex, for which they are seeking a patent, and that approval is anticipated sometime this year. Once the FDA has approved the drug, the Drug Enforcement Agency (DEA) will have 90 days to remove CBD from its list of Schedule 1 banned drugs. The agency maintains that it believes CBD is still an illegal Schedule 1 controlled substance, in part because CBD lacks FDA approval.
As introduced, House Bill 1187 had sought to add a new section into Colorado’s criminal code dealing with FDA approval and a list of conditions under which CBD would be legal, such as how it’s dispensed, dosage and requiring a legitimate medical purpose. But that didn’t fly with the marijuana and hemp industries.
Republican Rep. Marc Catlin of Montrose spoke against House Bill 1187 prior to its final vote Thursday. Colorado is the number one producer of hemp, he said, but this bill, although well-intentioned, is rushed, he explained.
“I don’t want to take the risk that the hemp industry” won’t grow into the industry it can be, he said.
“Hemp is the medicine of the future and I want to give it every chance it can get,” Catlin said. This bill worries the hemp industry, which fears this drug could supplant the efforts of Colorado’s hemp industry, he said.
That was countered by the bill’s House sponsors, Republican Rep. Lois Landgraf of Fountain and Democrat Janet Buckner of Aurora, both of whom said the industry would benefit from the bill, as would children suffering from seizures for which other treatments have not been as effective.
Veronica Carpio of Grow Hemp Colorado told Colorado Politics this week the original bill raised concerns about unintended consequences.
One of those issues, she said, is about dosage. She likened the possible rules around dosage to the difference between over-the-counter Tylenol and prescription-strength Tylenol. A bottle of CBD oil as it exists today may contain as much as 1,500 mg of CBD, although the dosage itself might be recommended at only 5 mg. That’s something you can buy at any dispensary, medical or otherwise. But she said the bottle itself — at 1,500 mg — might be considered a prescription-level drug that requires a doctor’s order and purchase at a pharmacy. That will hurt the hemp market, she said.
She also pointed out that GW has been seeking similar legislative changes in states all over the country for its product, which is produced in England. Colorado won’t get any of the tax revenue it currently enjoys from home-grown products, she said.
The majority of the hemp industry would like to see this bill put on hold until after the FDA approval, Carpio said. “We aren’t in a rush,” but GW is, she added.
That’s not where the bill is now, according to Christian Sederberg, a Denver attorney who has worked on Colorado’s marijuana laws from its earliest beginnings. House Bill 1187 was amended by the Public Health Care and Human Services Committee to simplify the whole issue, and that’s the version that was approved by the House Thursday on a 59-3 vote.
The bill is now pretty straightforward, Sederberg explained. It would remove FDA-approved drugs sold by a pharmacy and prescribed by a health care provider from the definition of marijuana as it applies in the criminal code. The same section provides an exemption for recreational and medical marijuana and industrial hemp, which is where CBD oil comes from.
The changes were sufficient to gain the buy-in of the Realm of Caring Foundation, which was set up by the creators of Charlotte’s Web and is run by Heather Jackson. She had initial concerns about the bill and points out she believed it was written solely for the benefit of GW Pharmaceuticals and Epidiolex.
Jackson believes the changes make the bill acceptable and won’t impact her foundation’s ability to use Charlotte’s Web with their clients. Giving families more options is a good thing, she told Colorado Politics. Some families won’t try CBD oil because it’s cannabis but would be willing to try it if it’s prescribed by a doctor and their health insurance will cover the costs, Jackson said.
“We can’t limit their options no matter how we feel” about big pharmaceutical companies, Jackson said, adding she’s in favor of getting Epidiolex into the available options for families. Jackson also believes the bill, if passed, will open up opportunities for other pharmaceutical-based CBD products. “GW is just the first,” she added.
Steve Schultz, vice president of investor relations for GW, told Colorado Politics that the company is anticipating FDA approval around the end of June. FDA approval would automatically change the definition of CBD from a Schedule 1 drug, which has no medical utility and a high potential for abuse, to a drug with a medical use.
The purpose of seeking a change in Colorado law is because the state doesn’t automatically follow DEA changes. That has to be done legislatively, he said.
“Our medicine will be distributed like most traditional medicines, through a pharmacy,” Schultz said. “We’re not trying to get in the way of artisanal products” such as CBD that is still classified as a dietary supplement. “This will lead to more options for patients, not less.”
The Colorado CBD market could certainly benefit from FDA approval, according to Steven Goldman, lab director for Evio Labs. He views the bill as a positive for the hemp industry and for small businesses, such as his, that support the industry.
Producers of Colorado-based CBD oil seeking FDA approval will have to go through rigorous FDA testing, Goldman said. Currently, CBD products aren’t tested because they’re considered a dietary supplement. But with the change in law, Goldman said the hemp industry “will have to up their game” in order to compete on a higher level, even for the products that aren’t pharmaceutical-grade. That means tests for potency (the label’s accuracy), as well as contaminants, whether microbial, solvents, heavy metals or pesticides.
He pointed out that Epidiolex had to be tested by the FDA. He said the testing process is very safe and accurate, with clinical trial data to back it up.
“The rest of the market will rise to meet that standard,” Goldman said.