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U.S. Senators Press Federal Agencies on Medical Marijuana Research
By Tom Angell on December 22, 2015
A group of eight U.S. senators, led by Elizabeth Warren of Massachusetts, is demanding answers from key federal agencies about why the government hasnt yet enacted policies to better facilitate scientific research into the medical benefits of marijuana.
There are currently numerous federal and state regulatory barriers to researching marijuana, the lawmakers wrote in a letter on Monday. This regulatory scheme which limits medical marijuana research is outdated and in desperate need of serious and immediate review. These problems are only exacerbated by a lack of coordination between the agencies and states.
The letter, addressed to the heads of the U.S. Department of Health and Human Services (HHS), the Office of National Drug Control Policy (ONDCP) and the Drug Enforcement Administration (DEA), reveals that those agencies provided a staff briefing for the Capitol Hill offices last month, but that it failed to answer key substantive questions.
The senators are concerned about a number of issues in particular:
The monopoly on cultivating cannabis for research currently maintained by the University of Mississippi, which, they write, limits access to adequate supply and appropriate varieties of marijuana and presents significant barriers to research.
The lawmakers want a detailed breakdown of how much of each strain of marijuana is grown at the university and how much of each strain is being requested by researchers.
They also want to know if there is a plan to add permits for additional growers, something that the head of the National Institute on Drug Abuse (NIDA) recently testified before a Senate panel would be beneficial.
They point out that countries like the United Kingdom, Canada, Israel, the Netherlands, Czech Republic, Portugal and Uruguay all allow more than a single source to grow cannabis for research while still complying with United Nations drug control conventions, refuting a DEA argument that the U.S.s current supply monopoly stems from treaty obligations.
Revising marijuanas current classification under the Controlled Substances Act in Schedule I, a category thats supposed to be reserved for drugs with no medical value.
The senators cite evidence that the Food and Drug Administration (FDA) has already made a recommendation about rescheduling but that DEA has not yet acted on that recommendation. The letter gives no indication about what FDAs recommendation is, but presses DEA to provide a timeline for acting on the evaluation.
The letter also asks whether DEA has separately asked FDA to analyze possible reasons for rescheduling cannabidiol (CBD), a component of cannabis that has shown promise in treating severe seizure disorders in children.
Interagency coordination to better facilitate marijuana research. The letter reveals that ONDCP is holding regular meetings on the topic with various federal agencies, but says, We continue to hear from the research community that the research application approval process is long, cumbersome and difficult to navigate.
The lawmakers want a detailed overview of all steps in the application process for researchers who want to study marijuana, including all steps at the DEA, FDA and local Institutional Review Boards, from initial application to receipt of marijuana from NIDA, including data on how long the entire process has taken for previously approved applications.
Surveillance and epidemiological studies on the use of medical marijuana in the U.S. This should also include investigations in diverse populations and with multiple modes of administration, the senators write.
They want to know if the Centers for Disease Control and Prevention (CDC) is working with NIDA or other agencies to collect data on the total number of medical cannabis users in the U.S. and which conditions they are treating with the drug. They also inquire if federal agencies are working with state health departments to coordinate research.
The senators reveal that NIDA is currently analyzing the feasibility of launching a national medical marijuana patient registry. A patient registry could significantly support the work of researchers and physicians, while also improving our understanding of the population of medical marijuana patients in the United States, they write, noting that Canada and California currently have such registries.
Coordination with states. Cooperation is vital to ensure that medical marijuana is being used effectively and appropriately by those who need it, the senators write.
They want to know if any federal agencies are providing guidance to states on testing standards for medical marijuana to ensure quality control, and if there is any regular and organized communication between federal agencies and states to coordinate efforts and long term plan development.
Besides Warren, also signing the letter are Sens. Barbara Mikulski (D-MD), Barbara Boxer (D-CA), Ron Wyden (D-OR), Jeff Merkley (D-OR), Kirsten Gillibrand (D-NY), Edward J. Markey (D-MA) and Cory Booker (D-NJ).
The senators had first written to the agencies in July, but were unimpressed with the initial response they received.
They call solving the ongoing barriers to research a time-sensitive matter that warrants immediate attention from federal agencies and are requesting a response from the federal agencies by no later than January 31, 2016.
We must ensure that our public policy regarding medical marijuana is guided by the best science available, and in the absence of that science we must ensure that we are taking swift and deliberate steps to facilitate the research that provides for it, the senators write.
http://www.marijuana.com/blog/news/...deral-agencies-on-medical-marijuana-research/
U.S. Senators Press Federal Agencies on Medical Marijuana Research
By Tom Angell on December 22, 2015
A group of eight U.S. senators, led by Elizabeth Warren of Massachusetts, is demanding answers from key federal agencies about why the government hasnt yet enacted policies to better facilitate scientific research into the medical benefits of marijuana.
There are currently numerous federal and state regulatory barriers to researching marijuana, the lawmakers wrote in a letter on Monday. This regulatory scheme which limits medical marijuana research is outdated and in desperate need of serious and immediate review. These problems are only exacerbated by a lack of coordination between the agencies and states.
The letter, addressed to the heads of the U.S. Department of Health and Human Services (HHS), the Office of National Drug Control Policy (ONDCP) and the Drug Enforcement Administration (DEA), reveals that those agencies provided a staff briefing for the Capitol Hill offices last month, but that it failed to answer key substantive questions.
The senators are concerned about a number of issues in particular:
The monopoly on cultivating cannabis for research currently maintained by the University of Mississippi, which, they write, limits access to adequate supply and appropriate varieties of marijuana and presents significant barriers to research.
The lawmakers want a detailed breakdown of how much of each strain of marijuana is grown at the university and how much of each strain is being requested by researchers.
They also want to know if there is a plan to add permits for additional growers, something that the head of the National Institute on Drug Abuse (NIDA) recently testified before a Senate panel would be beneficial.
They point out that countries like the United Kingdom, Canada, Israel, the Netherlands, Czech Republic, Portugal and Uruguay all allow more than a single source to grow cannabis for research while still complying with United Nations drug control conventions, refuting a DEA argument that the U.S.s current supply monopoly stems from treaty obligations.
Revising marijuanas current classification under the Controlled Substances Act in Schedule I, a category thats supposed to be reserved for drugs with no medical value.
The senators cite evidence that the Food and Drug Administration (FDA) has already made a recommendation about rescheduling but that DEA has not yet acted on that recommendation. The letter gives no indication about what FDAs recommendation is, but presses DEA to provide a timeline for acting on the evaluation.
The letter also asks whether DEA has separately asked FDA to analyze possible reasons for rescheduling cannabidiol (CBD), a component of cannabis that has shown promise in treating severe seizure disorders in children.
Interagency coordination to better facilitate marijuana research. The letter reveals that ONDCP is holding regular meetings on the topic with various federal agencies, but says, We continue to hear from the research community that the research application approval process is long, cumbersome and difficult to navigate.
The lawmakers want a detailed overview of all steps in the application process for researchers who want to study marijuana, including all steps at the DEA, FDA and local Institutional Review Boards, from initial application to receipt of marijuana from NIDA, including data on how long the entire process has taken for previously approved applications.
Surveillance and epidemiological studies on the use of medical marijuana in the U.S. This should also include investigations in diverse populations and with multiple modes of administration, the senators write.
They want to know if the Centers for Disease Control and Prevention (CDC) is working with NIDA or other agencies to collect data on the total number of medical cannabis users in the U.S. and which conditions they are treating with the drug. They also inquire if federal agencies are working with state health departments to coordinate research.
The senators reveal that NIDA is currently analyzing the feasibility of launching a national medical marijuana patient registry. A patient registry could significantly support the work of researchers and physicians, while also improving our understanding of the population of medical marijuana patients in the United States, they write, noting that Canada and California currently have such registries.
Coordination with states. Cooperation is vital to ensure that medical marijuana is being used effectively and appropriately by those who need it, the senators write.
They want to know if any federal agencies are providing guidance to states on testing standards for medical marijuana to ensure quality control, and if there is any regular and organized communication between federal agencies and states to coordinate efforts and long term plan development.
Besides Warren, also signing the letter are Sens. Barbara Mikulski (D-MD), Barbara Boxer (D-CA), Ron Wyden (D-OR), Jeff Merkley (D-OR), Kirsten Gillibrand (D-NY), Edward J. Markey (D-MA) and Cory Booker (D-NJ).
The senators had first written to the agencies in July, but were unimpressed with the initial response they received.
They call solving the ongoing barriers to research a time-sensitive matter that warrants immediate attention from federal agencies and are requesting a response from the federal agencies by no later than January 31, 2016.
We must ensure that our public policy regarding medical marijuana is guided by the best science available, and in the absence of that science we must ensure that we are taking swift and deliberate steps to facilitate the research that provides for it, the senators write.
http://www.marijuana.com/blog/news/...deral-agencies-on-medical-marijuana-research/
