Recently, the FDA announced the first FDA-approved medicine that contains purified natural compounds derived from cannabis. This drug, Epidiolex, is proven to reduce seizures for small children over the age of two with rare forms of epilepsy. At the center of this announcement lies a contradiction between federal categorization of cannabis as a Schedule I Drug with no medicinal value and a federal agency approving a medicine derived from compounds in the plant. Until the cannabis compound used in Epidiolex, cannabidiol (CBD), is rescheduled by the Drug Enforcement Agency, it will be unavailable to patients. Lack of federal rescheduling hinders scientific research of the cannabis plant and stops beneficial medicines from being available to patients with pain in states where marijuana is illegal.
Julie Raque, Director of Marketing for Cannabistry Labs, a professional cannabis research, development, and branding company, has a background in both the pharmaceutical and biotech industries. Her ten years of marketing experience in big pharma gives her a unique perspective on the challenges in bringing new drugs to market. She spoke to CannEpoch about the difference between bringing cannabis products to market versus traditional pharmaceuticals, the recent FDA announcement and what that means for the cannabis industry as a whole as well as what it means for the future of the traditional pharmaceutical space.
CannEpoch: What does the FDA-approval of Epidiolex mean for the future of cannabis-derived products?
Julie: Recently, the FDA approved the first medicine that contains purified natural compounds derived from cannabis. This drug, Epidiolex, is proven to reduce seizures for children over the age of two with rare forms of epilepsy. At the center of this announcement lies a contradiction between the federal categorization of cannabis as a Schedule I Drug with no medicinal value, and a federal agency approving a medicine derived from compounds in the plant. FDA Commissioner Scott Gottlieb, M.D., cautioned that Epidiolex’s green light is not an approval for marijuana but an approval for “one specific CBD medication for a specific use.” Until the cannabis compound used in Epidiolex, cannabidiol (CBD), is rescheduled by the Drug Enforcement Agency, it will be unavailable to patients in the United States. There are several ways the approval of Epidiolex could affect the future of both the pharmaceutical industry and the average American cannabis consumer.
CannEpoch: Discuss the possible rescheduling of CBD’s Means Research and Innovation.
Julie: The key learning from the FDA’s decision is GW Pharma’s approach to harnessing CBD’s potential and packaging it into a medicine that conveys the safety, consistency and clarity that FDA approval affords. Because GW Pharma’s CBD trials passed the rigorous testing standards, trials and regulations of the FDA, the federal government is now taking steps to reschedule the CBD compound. This is a step forward for everyone in the cannabis industry, as the government begins to finally acknowledge the powerful potential of cannabis. Cannabis is such a unique plant with a myriad of abilities – we are just scratching the surface of research and development. With Epidiolex approved, the FDA pathway for creation and testing of novel CBD formulations may occur. This means that both research institutions such as universities and large pharmaceutical companies will be able to test and discover new applications for CBD. These institutions and companies have immense resources; which, when put to work on the cannabis plant could mean providing innovative therapies that make a difference in people’s lives. At the same time, isolating CBD research to only the pharmaceutical industry would result in a limitation of the types of products available and result in the high cost of prescription drugs with limited access.
CannEpoch: Will big pharma drive the price of CBD-based therapies Up?
Julie: While GW Pharma has been a pioneer in conducting the scientific research to prove CBD has some effect in well-controlled clinical studies, this may not bode well for the average consumer. Pharmaceutical companies will no doubt be able to capitalize and highlight the amazing properties of CBD, but this research will come at a premium and access will inevitably be determined by managed care plans. Even those who receive insurance coverage, depending on the nature of their insurance, may find the cost of Epidiolex or any other CBD based therapy too high.
Many cannabis industry advocates argue that consumers should have access to CBD products outside of the prescription-drug realm due to high prices and monopoly of the market. Coincidently, because of adult-use cannabis being legal in various U.S. states, many people have already started experimenting with CBD and other cannabis-derived medicines. This is called consumer-driven crowdsource pharmacology. Instead of lab tested medicines hitting the shelf, average consumers have a say in what kind of product is produced. They can easily reach out to their dispensary and give feedback about an oil, or maybe their neighbor who makes chocolate edibles can experiment with the amount of THC oil in the chocolate. In this way, there are loads of potential therapies created. Unlike Advil, CBD and THC medicines are extremely specific to each ailment. All the products out there are special. One tincture might work for one person, and another for someone else.
When it comes to cannabis products, we currently live in a golden age of consumer-driven crowdsource pharmacology versus a golden age of research in institutions. If we can marry these two phenomena, the cannabis industry will be made all the better. It is important to have both big pharma and institutional research centers involved, so long as CBD and cannabis products are not isolated to solely their jurisdiction. The more research about the effects of cannabis means potential solutions for healthcare, and the more products available means more people will be able to access the right medicine for their ailment.
The FDA approval of GW Pharma’s Epidiolex is one step in the journey between the U.S. and systematic assessments of cannabis plants. While this approval could lead to the rescheduling of the CBD compound, THC remains a Schedule I compound. Until the federal government and state governments are on the same page in regard to the cannabis plant, innovation in the space will be stunted. However, Epidiolex’s approval has shed light on the federal government’s willingness to legalize parts of the plant- a big moment in recognizing the medicinal benefits of cannabis.