Washington, DC: The US Department of Health and Human Services announced this week that it has removed a requirement mandating that all investigative protocols seeking cannabis for clinical study must undergo a Public Health Service review. The review process, which was enacted in 1999 and applied only to clinical studies involving cannabis, was long criticized by advocates as unnecessarily burdensome and time-consuming.
Commenting on the change, a Health and Human Services spokeswoman said, "The department expects the action announced today will help facilitate further research to advance our understanding about the health risks and any potential benefits of medications using marijuana or its components or derivatives."
Under the new policy, investigators seeking to conduct clinical trials with cannabis or organic cannabinoids (like CBD) will still be required to gain approval from the US Food and Drug Administration, the US Drug Enforcement Administration, and the US National Institute on Drug Abuse. Further, approved protocols may only provide marijuana supplied by the University of Mississippi, the sole provider of cannabis for federally approved research.
NORML Deputy Director Paul Armentano welcomed the change, but acknowledged that additional, more systemic changes in the process are necessary, "Since the agencies in place to oversee and preserve cannabis prohibition are the very same agencies that control the approval process for clinical marijuana research, it remains unlikely that this change will lead to the sort of systemic changes necessary to permit the type of rational, objective review cannabis so deserves."
He added, "But even despite existing barriers to research, ample studies already exist to contradict cannabis’ federal, schedule I status as a substance without medical utility, lacking acceptable safety, and possessing a high potential of abuse. More clinical research is welcome, but unfortunately science has never driven marijuana policy. If it did, the United States would already have a very different policy in place."
For more information, please contact Allen St. Pierre, NORML Executive Director, at (202) 483-5500 or Paul Armentano, NORML Deputy Director, at: email@example.com.