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DEA Eases Requirements for FDA-Approved Clinical Trials on Cannabidiol

Grassley applauds decision

December 24, 2015
FROM DEA Public Affairs and Office of U.S. Senator Chuck Grassley (R-Iowa) , Toledo Chronicle, Tama News-Herald

DEC 23 (WASHINGTON) - The United States Drug Enforcement Administration (DEA) recently eased some of the regulatory requirements imposed by the Controlled Substances Act (CSA) for those who are conducting FDA-approved clinical trials on cannabidiol (CBD), an extract of the marijuana plant. These modifications will streamline the research process regarding CBD's possible medicinal value and help foster ongoing scientific studies. The DEA notified affected researchers by letter of the changes, which take effect immediately.

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."

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Senator Chuck Grassley
R-Iowa

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."

Federal Regulation (21 CFR 1301.18) requires researchers conducting CBD-based clinical trials under an FDA Investigational New Drug Application to have a DEA research registration. This registration permits the possession of an approved amount of CBD for a specific research protocol. Prior to now, researchers who expanded the scope of their studies and needed more CBD than initially approved for had to request, in writing, a modification to their DEA research registrations potentially delaying that research while the modification underwent an approval process that includes both the DEA and the Food and Drug Administration (FDA). Under these changes, a previously registered CBD clinical researcher who is granted a waiver can readily modify their protocol and continue their research seamlessly. This waiver effectively removes a step from the approval process.

Marijuana is a Schedule I controlled substance because of the presence of tetrahydrocannabinol (THC), marijuana's psychoactive ingredient. Because CBD contains less than 1 percent THC and has shown some potential medicinal value, there is great interest in studying it for medical applications. Currently, CBD is a Schedule I controlled substance as defined under the CSA. hough the FDA approves drugs for medical use in the United States, the DEA regulates the handling of all controlled substances, including those being used by researchers to conduct studies.

 
 
 

 

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