Senator Elizabeth Warren (D-MA) urges efforts to better facilitate “large scale clinical trials.”
In the past year, we have witnessed a major shift in the political landscape when it comes to medical marijuana and the public’s understanding of cannabidiol. Most recently, leaders in the Senate on both sides of the political aisle are demanding the federal government take steps to further advance clinical cannabis research.
On July 9, Senator Elizabeth Warren (D-MA), along with Senators Cory Booker (D-NJ), Barbara Boxer (D-CA), Kirsten Gillibrand (D-NY), Edward Markey (D-MA), Jeff Merkley (D-OR), Barbara Mikulski (D-MD), and Ron Wyden (D-OR), sent a formal letter to representatives of the US Department of Health and Human Services (HHS), the Office of National Drug Control Policy (ONDCP), and the Drug Enforcement Administration (DEA) urging them to take efforts to better facilitate “large scale clinical trials” in regard to the use of medical marijuana in states that have legalized it.
The letters states: “HHS has tools to collect data, conduct surveillance, and perform large scale clinical trials while states continue to focus on implementation. HHS has the capacity to facilitate interstate communication in order to derive a more accurate picture of medical marijuana use and treatments across the country. It is time for the federal government to pick up these tools and use them.”
The Democratic Senators also called on the federal government to diversify its sources of research-grade cannabis and demanded that they eliminate “extraneous regulatory barriers for researchers who wish to perform scientific studies on the use of marijuana for various diseases.”
Their sentiments were echoed in a Time Magazine op-ed penned by Democrat Sen. Diane Feinstein (CA) and Republican Sen. Charles Grassley (IA), who similarly demanded the Feds “cut red tape and streamline the licensing and regulatory processes so [that medical marijuana] research can move ahead.”
The two Senators further asked the administration to “definitively determine if CBD (cannabidiol) has scientific and medical benefits,” and to “look at expanding compassionate access programs where possible, to benefit as many children as possible.”
Both Senators had previously been outspoken critics of proposed changes in state laws permitting qualified patients to use cannabis therapeutically.
Federal regulations currently demand that investigators seeking to conduct clinical trials with cannabis or organic cannabinoids (such as cannabidiol) are required to gain approval from the US Food and Drug Administration, the US Drug Enforcement Administration, and the US National Institute on Drug Abuse. (An additional regulatory requirement mandating that the US Public Health Service review all clinical protocols was abolished last month.) Further, approved protocols may only utilize marijuana supplied by the University of Mississippi, the sole provider of cannabis for federally approved research. Testifying before Congress in June, NIDA Director Nora Volkow said that the agency’s monopoly on the federally licensed production of marijuana for clinical research is problematic and ought to be amended to include additional producers.
Senator Warren and her co-signers have requested that their letter be answered by no later than August 31, 2015.