Washington D.C. – The Drug Enforcement Administration (DEA) is making policy changes that could make it easier for patients to access Epidiolex.
Epidiolex, produced by GW Pharmaceuticals, is currently the only cannabis-based medicine approved by the Food and Drug Administration. The medication is derived from CBD and is used to treat rare forms of childhood epilepsy.
The DEA has decided it no longer views Epidiolex as a product that falls under the Controlled Substances Act. Now, Epidiolex can be prescribed by physicians who are not specifically part of the DEA’s drug monitoring program.
“This decision is a lightening bolt of sanity,” Martin A. Lee, director at Project CBD, a nonprofit devoted to promoting research into the medicinal uses of cannabinoids, told The Philadelphia Inquirer. “De-scheduling the drug will allow it to be prescribed off label.”
Although federal agencies are starting to come around on hemp and CBD, there still are strict regulations that must be followed—something CBD producers can attest to.
“If you put CBD in a product that has not been vetted by the FDA, that product still may not be legal,” Lee said.
Of course, as with any new cannabis, hemp, or CBD legal change, it will take time to ascertain the full effect the DEA’s decision will have on the industry.
“I think it’s a positive move for what it portends for CBD products in general but it’s not clear what the political implications are,” Lee said. “You’d think it would liberate CBD from the confines of a pharmaceutical framework because there isn’t a major difference pharmacologically between Epidiolex and the other products circulating in the unregulated market.”
As big as the news is, Epidiolex is currently administered to a small number of patients. To access the drug, patients must meet a very strict set of criteria. Also, for any patients without access to health insurance, Epidiolex is almost certainly out of reach. Without assistance from an insurance policy, a full regimen of the drug can cost upwards of $32,500.