- The MEDS Act proposes to reduce regulatory hurdles for obtaining approval from the DEA to conduct research on the use of marijuana
- Instructs DEA to establish manufacturer licenses for the commercial production of FDA-approved medical marijuana products
Last week, bipartisan legislation was introduced in the US Senate and the House of Representatives to amend the Controlled Substances Act and ease federal obstacles for medical researchers to conduct clinical studies on the medical benefits of marijuana.
The Marijuana Effective Drug Studies (MEDS) Act of 2016 was introduced by Senators Hatch (R-UT), Schatz (D-HI), Tillis (R-NC), and Coons (D-DE) in the Senate. Similar legislation was introduced by Representatives Harris (R-MD), Blumenauer (D-OR), Griffin (R-VA), and Farr (D-CA) in the House. The bill does not take a position on legalization of marijuana.
The MEDS Act creates a faster process for obtaining approval from the US Drug Enforcement Administration to conduct research on the use of marijuana, addressing major barriers faced by researchers who wish to study the potential medical uses of the drug. The legislation would create a new registration process specifically for marijuana, reducing the approval wait time and additional layers of protocol that is currently experienced by researchers seeking approval from the DEA. The legislation also would make it easier for researchers who obtain approval to conduct studies to acquire the drug by directing DEA to license additional marijuana manufacturers for the purpose of scientific research and drug development. (Note that for the purposes of the CSA, the "manufacture” includes activities related to production, preparation, and processing of a substance.)
In addition, it would instruct the agency to establish manufacturer licenses for the commercial production of the FDA-approved medical marijuana products. Currently, the only government approved producer of marijuana for research is the University of Mississippi which has led to complaints that it often takes years to acquire research-grade drugs that meet researcher’s specifications, if the drug is produced at all. Finally, the bill would eliminate the frequently imposed DEA requirement that marijuana be kept in bolted safes and codifies current DEA policy related to the storage of the drug.
The MEDS Act responds to increasing concerns that current federal policies governing medical research on the efficacy and safety of marijuana are so cumbersome that they create obstacles for the scientific community to conduct clinical research that is critical to informing medical practice. It also comes at a time when other efforts have been advanced in Congress to move marijuana from Schedule I to Schedule II. Bipartisan legislation, the Compassionate Access, Research Expansion, and Respect States Act of 2015, was introduced last year in the U.S. Senate and House of Representatives. To date, no action has been taken on the bill in Congress.
Separately, as we noted here, in response to pressure from Senator Elizabeth Warren (D-MA) and seven other Senate Democrats who urged the federal government to take steps to facilitate “sensible research” into marijuana’s medical benefits, the DEA announced this spring that it is evaluating whether to downgrade the classification of marijuana under the CSA, which could allow more research into its potential medicinal benefits. Just last week, those same Senators issued another letter, asking the DEA for an update on the status of its re-scheduling determination and again urging the DEA to reassess the regulatory hurdles imposed by the DEA and the Food and Drug Administration to receive approval and access to marijuana, which, according to the Senators, present “a significant barrier for legitimate researchers.”
In light of increasing Congressional pressure and legislative activity at both state and federal levels, DEA’s historical reluctance to relax its regulation of marijuana may no longer be a tenable position. Even if DEA opts not to move marijuana from Schedule I (with a decision expected later this summer), it seems likely that changes, at the policy or legislative level, will be made in the near future to lessen the burden that currently exists for medical marijuana researchers.