Indianapolis, In. — Attorney General Curtis Hill today praised the process by which the U.S. Food and Drug Administration for the first time has approved a cannabis-based drug – Epidiolex. The drug, which contains purified cannabidiol (CBD), will be used to treat two rare forms of childhood epilepsy.
“Regarding the development of medicine, we should follow the standard scientific protocols developed in the United States for approving products as effective and safe,” Attorney General Hill said. “I said the same thing during discussions last year about CBD oil, and this is what I continue to believe. We should respect the guidance of the FDA.”
Any further forays into the use of marijuana as medicine should go through the same process that produced FDA approval for Epiodiolex, he said.
“We all long for breakthroughs in scientific research that help treat disease, illness and injury,” Attorney General Hill said. “The appropriate path to these breakthroughs in the United States involves the FDA — which approves a substance to be a medicine, outlines its legitimate prescribed use and provides guidance on proper dosage. Such a process is different from simply labeling something as ‘medicinal.’ ”
Earlier today, FDA Commissioner Scott Gottlieb made similar observations in a prepared statement.
“This is an important medical advance,” Gottlieb said. “But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced.”
