Debra Borchardt
Opinions expressed by Forbes Contributors are their own.
Christmas came early for cannabis research scientists. The U.S. Drug Enforcement Agency (DEA) decided to ease
some of the regulatory requirements that had been imposed on those who
were conducting FDA-approved clinical trials on cannabidiol (CBD).
Since marijuana or cannabis is a schedule 1 controlled substance, researchers are subjected to very restrictive procedures in order to study the drug. Many states, patients, doctor’s groups and drug companies all desire more information regarding the effects of cannabis on various illnesses, but with difficult conditions placed on those trying to do the studies the results lag the demand.
The changes are meant to streamline the research process and help the existing scientific studies. The DEA has sent letters to those scientists affected by the decision that is in effect immediately.
Before the change, if a scientist realized they needed more CBD to complete their study, they had to request in writing a change to their DEA research registration. The process delayed the study as the paperwork wound its way through the bureaucratic approval process that included not only the DEA, but also the Food and Drug Administration.
With this new change, the researcher can request a waiver and upon approval, easily modify their study protocol. The waiver takes the place of the approval step.
The FDA and the DEA work together on cannabis. The FDA oversees drugs for medical use, but since cannabis is considered a controlled substance, the DEA has to step in with its oversight as well.
“This is certainly a step in the right direction towards the
development and proof of CBD as an empirically efficacious compound.
These modifications will streamline the research process regarding CBD’s
possible medicinal value and help to bolster existing scientific
research and studies,” said Seth Yakatan, CEO of Kalytera. Kalytera is
one of the leading research companies that is developing synthetic CBD
(Cannabidiol) compounds for various ailments including Osteporosis,
Prader-Willi Syndrome, and Obesity.

ARLINGTON, VA – MAY 23: Medical marijuana
user Angel Raich (2nd L) of Oakland, California, speaks as (L-R)
clinical neurologist Denis Petro, Rick Doblin, President of the
Multidisciplinary Association for Psychedelic Studies, and Lyle Craker,
professor of plant and soil science of University of Massachusetts, look
on during a news conference in front of the headquarters of U.S. Drug
Enforcement Administration to call on the administration to accept the
recommendation from a DEA administrative law judge to end the federal
monopoly on the supply of marijuana that can be used in FDA-approved
research May 23, 2007 in Arlington, Virginia. Angel Raich, 41 suffers
from an inoperable brain tumor as well as several other complex medical
conditions and began using medical marijuana to ease pain and gain
appetite after her doctor suggested it in 1997. Coming from a
conservative upbringing, Angel didn’t feel comfortable using an illegal
substance, especially in front of her children. Raich sued U.S. Attorney
General John Ashcroft and Drug Enforcement Administration director Asa
Hutchinson to block them from interfering with her medical marijuana use
and to avoid drug charges and arrest. Angel lost her case and appeal.
She is now preparing to undergo treatment for her brain tumor. (Photo by
Alex Wong/Getty Images)
Since marijuana or cannabis is a schedule 1 controlled substance, researchers are subjected to very restrictive procedures in order to study the drug. Many states, patients, doctor’s groups and drug companies all desire more information regarding the effects of cannabis on various illnesses, but with difficult conditions placed on those trying to do the studies the results lag the demand.
The changes are meant to streamline the research process and help the existing scientific studies. The DEA has sent letters to those scientists affected by the decision that is in effect immediately.
Before the change, if a scientist realized they needed more CBD to complete their study, they had to request in writing a change to their DEA research registration. The process delayed the study as the paperwork wound its way through the bureaucratic approval process that included not only the DEA, but also the Food and Drug Administration.
With this new change, the researcher can request a waiver and upon approval, easily modify their study protocol. The waiver takes the place of the approval step.
The FDA and the DEA work together on cannabis. The FDA oversees drugs for medical use, but since cannabis is considered a controlled substance, the DEA has to step in with its oversight as well.
No comments:
Post a Comment