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Friday, May 9, 2014

Federal Government To Increase Its Supply Of Marijuana For Clinical Research

Federal Government To Increase Its Supply Of Marijuana For Clinical Research

Federal agencies are moving forward with plans to increase the US government’s production of research-grade cannabis.

Last week, the US Drug Enforcement Administration (DEA) publicly announced in the Federal Register that it is increasing its marijuana production quota from 21 kilograms to 650 kilograms (about 1,443 pounds) in order to meet increasing demand for the plant from clinical investigators.

Federal regulations permit a farm at the University of Mississippi to cultivate set quantities of cannabis for use in federally approved clinical trials. Regulators at the DEA, the US Food and Drug Administration, PHS (Public Health Service), and the US National Institute on Drug Abuse must approve any clinical protocol seeking to study the plant’s effects in human subjects.

On various occasions, marijuana reform advocates and researchers have publicly criticized NIDA for failing to approve proposed trials seeking to assess the therapeutic benefits of cannabis. However, in March, federal regulators finally signed off on a long-delayed clinical protocol from researchers at the University of Arizona College of Medicine to evaluate the use of cannabis its in war veterans suffering from post-traumatic stress. Also this spring, lawmakers in several states, including Alabama, Kentucky, and Wisconsin, passed legislation encouraging state-sponsored clinical trials to assess the therapeutic potential of cannabidiol – a nonpsychotropic organic component of cannabis – in the treatment of intractable epilepsy.

“The additional supply [of cannabis] to be manufactured in 2014 is designed to meet the current and anticipated research efforts involving marijuana,” A NIDA spokesperson told TheHill.com. “[T]his projection of increased demand is due in part to the recent increased interest in the possible therapeutic uses of marijuana.”

According to a keyword search using the terms ‘smoked marijuana’ on the clinicaltrials.gov website, eight trials are presently ongoing to evaluate the plant’s effects in humans. Two of these trials are assessing the plant’s potential therapeutic efficacy.