Senators reiterated concerns about monopoly held by National Institute on Drug Abuse on the bulk manufacture of marijuana for research.
By
Washington, DC -United States Senators Elizabeth Warren
(D-Mass.), Barbara Mikulski (D-Md.), Barbara Boxer (D-Calif.), Ron Wyden
(D-Ore.), Jeff Merkley (D-Ore.), Kirsten Gillibrand (D-N.Y.), Edward J.
Markey (D-Mass.), and Cory Booker (D-N.J.) sent a follow-up letter to
the U.S. Department of Health and Human Services (HHS), the Office of
National Drug Control Policy (ONDCP), and the Drug Enforcement
Administration (DEA) seeking additional information about the agencies’
efforts to facilitate and coordinate scientific research on medical
marijuana.
The letter comes after the agencies’ response to the senators’ July letter and a subsequent staff briefing failed to answer key substantive questions.
The senators reiterated the important role the federal agencies have to collaborate with each other and with states to conduct research on the risks and benefits of medical marijuana use.
Instead, they wrote, “there are currently numerous federal and state regulatory barriers to researching marijuana. This regulatory scheme which limits medical marijuana research is outdated and in desperate need of serious and immediate review, and these problems are exacerbated by a lack of coordination between the agencies and states.”
The Senators seek additional information from the agencies in several areas:
(1) The supply of marijuana for research purposes. The senators reiterated concerns about the monopoly held by the National Institute on Drug Abuse (NIDA) on the bulk manufacture of marijuana for research purposes, which “limits access to adequate supply and appropriate varieties of marijuana and presents significant barriers to research.” While the DEA said in the staff briefing that it does not view supply limits as a barrier, the senators note this explanation “only applied to one strain of marijuana and does not reflect feedback we have heard from researchers in our states.” The letter asks for additional details about the agencies’ efforts to meet the needs of researchers.
(2) Assessment of marijuana rescheduling. In July, the senators asked about the timeline for the FDA to complete its analysis of the rescheduling of marijuana and to make a recommendation to the DEA, and the DEA’s expected timeline upon receipt of this recommendation. The agencies failed to provide this information in their response and during their staff briefing; however, subsequent public statements from the Department of Justice (DOJ) indicate HHS has already made its recommendation. The letter asks the agencies to confirm this and to clarify the process for a re-scheduling determination for marijuana and cannabidiol (CBD).
(3) Interagency coordination and research applications. ONDCP
is coordinating regular meetings with relevant federal agencies about
encouraging research, and noted at the staff briefing that this led to
the elimination of the duplicative HHS Public Health Service Review
Board. The senators said that while this is a “positive step,” they
“continue to hear from the research community that the research
application approval process is long, cumbersome, and difficult to
navigate.” The letter requests further details about the application
process for qualified researchers.
(4) Surveillance and epidemiological studies. “Federal agencies should work to facilitate surveillance and epidemiological studies to assess how medical marijuana is being used,” wrote the senators. “We asked about this in our initial letter and our briefing, and we are concerned that there was no mention of efforts to collect these data.”
(5) Coordination with states and inter-agency cooperation. The senators explained that the agencies “informed us that federal agencies have been in communication and are coordinating on this issue, but failed to describe in detail the nature and type of these communications.” The letter seeks specific details about the agencies’ coordination efforts.
“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,” wrote the senators.
The letter comes after the agencies’ response to the senators’ July letter and a subsequent staff briefing failed to answer key substantive questions.
The senators reiterated the important role the federal agencies have to collaborate with each other and with states to conduct research on the risks and benefits of medical marijuana use.
Instead, they wrote, “there are currently numerous federal and state regulatory barriers to researching marijuana. This regulatory scheme which limits medical marijuana research is outdated and in desperate need of serious and immediate review, and these problems are exacerbated by a lack of coordination between the agencies and states.”
The Senators seek additional information from the agencies in several areas:
(1) The supply of marijuana for research purposes. The senators reiterated concerns about the monopoly held by the National Institute on Drug Abuse (NIDA) on the bulk manufacture of marijuana for research purposes, which “limits access to adequate supply and appropriate varieties of marijuana and presents significant barriers to research.” While the DEA said in the staff briefing that it does not view supply limits as a barrier, the senators note this explanation “only applied to one strain of marijuana and does not reflect feedback we have heard from researchers in our states.” The letter asks for additional details about the agencies’ efforts to meet the needs of researchers.
(2) Assessment of marijuana rescheduling. In July, the senators asked about the timeline for the FDA to complete its analysis of the rescheduling of marijuana and to make a recommendation to the DEA, and the DEA’s expected timeline upon receipt of this recommendation. The agencies failed to provide this information in their response and during their staff briefing; however, subsequent public statements from the Department of Justice (DOJ) indicate HHS has already made its recommendation. The letter asks the agencies to confirm this and to clarify the process for a re-scheduling determination for marijuana and cannabidiol (CBD).
(4) Surveillance and epidemiological studies. “Federal agencies should work to facilitate surveillance and epidemiological studies to assess how medical marijuana is being used,” wrote the senators. “We asked about this in our initial letter and our briefing, and we are concerned that there was no mention of efforts to collect these data.”
(5) Coordination with states and inter-agency cooperation. The senators explained that the agencies “informed us that federal agencies have been in communication and are coordinating on this issue, but failed to describe in detail the nature and type of these communications.” The letter seeks specific details about the agencies’ coordination efforts.
“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,” wrote the senators.
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