Epidiolex, a CBD-based medicine created by the British GW Pharmaceuticals, has become the first cannabis-based medicine to be approved by the United States Food and Drug Administration (FDA). This decision also happens to make Epidiolex the first approved medication for an intractable form of epilepsy called Dravet syndrome, though it is also approved for Lennox-Gastaut syndrome, another severe form of epilepsy.
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D.
This is a huge and significant step forward in the United States, where on a federal level, cannabis is considered to have no medicinal value and be extremely addictive and dangerous. For decades patients have medicated illegally and the plant has been demonized under prohibition, with so many legal barriers that studying it is nearly impossible. This has caused thousands of patients to go without a much needed medicine, and caused many to be unaware of the plant’s medicinal value to them because we simply didn’t know enough about it.
Now, however, over half of the country allows medical marijuana and a growing number of states have legalized adult use – but the federal government still, until now, has never budged. GW Pharmaceuticals was able to do clinical trials in the UK and brought their new medicine to the FDA for approval – and now that they have received the approval, patients who previously had little or no options for treatment will find relief through CBD.
“We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products.”
While the FDA has approved Epidiolex, the federal laws have not changed – so now, the laws conflict. Epidiolex, made of CBD (which is a cannabis derivative), is legal for doctors to prescribe to patients – but CBD is a part of the cannabis plant, which is illegal and a Schedule I drug according to the Controlled Substances Act. According to the definition of a Schedule I drug, one of the main qualifiers is that the substance has no medicinal value, and now the government is fully acknowledging that at least one part of the plant does, in fact, have medicinal value.
Logically, the laws need to be amended to accommodate the newly approved CBD medicine – a rescheduling to Schedule 2 if nothing else. Whether the Drug Enforcement Administration will do this any time soon seems unclear, and possibly unlikely, as they have denied petitions to reschedule cannabis multiple times in recent years.
Rescheduling wouldn’t immediately change much about the legal status of cannabis, but it would open the doors for companies in the U.S. to complete clinical trials like the ones Epidiolex was subject to – likely allowing many more cannabis-based medications to receive FDA approval in the coming years. For now, Epidiolex is making history as the first cannabis-based medicine to be legal in the United States in nearly a hundred years.