DEA Eases Requirement for FDA-approved Clinical Trials on Cannabidiol
In letters to the relevant federal agencies, Sen. Chuck Grassley has pressed for the removal of unnecessary barriers to scientific research into the medical risks and benefits of cannabidiol (CBD), a non-psychoactive component of the marijuana plant that may help children with severe epileptic seizures and other conditions. In June, at the request of Grassley and Sen. Dianne Feinstein, the Department of Health and Human Services (HHS) agreed to eliminate an extra layer of review for non-government funded cannabidiol research that it previously required its Public Health Service to complete. Also at that time, at the senators’ request, the Justice Department and HHS agreed to evaluate cannabidiol to determine whether it can be classified on a lower schedule than the entire marijuana plant, which may make research on it proceed somewhat more easily.
Today, the Drug Enforcement Administration (DEA) announced that it has agreed to a third request of the senators – to ease some of the regulatory requirements for those who are conducting Food and Drug Administration (FDA)-approved clinical trials on cannabidiol by permitting waivers that will let research proceed seamlessly if the researcher requires more CBD than was initially approved by the DEA. According to the DEA, “These modifications will streamline the research process regarding CBD’s possible medicinal value and help foster ongoing scientific studies.”
Grassley is Chairman of the Judiciary Committee and the Caucus on International Narcotics Control. Grassley made the following comment on the DEA’s announcement.
“This is good news toward the progress on scientific research on cannabidiol. Removing more barriers will help allow scientists to determine its potential medicinal value. Right now, parents who are desperate to help their children live in uncertainty over cannabidiol. Federal agencies should do whatever they responsibly can to help research proceed so these families can get answers.”