The House has passed a revised version of the Medical Marijuana and Cannabidiol Research Expansion Act, HR 8454, sending it back to the Senate for action. With previous bipartisan approval, the legislation is expected to soon head to the President’s desk.  The bill is a critical step forward in federal legalization and regulatory science of medical marijuana and cannabidiol (CBD), aiming to ease restrictions on the research and commercialization of medical marijuana and CBD products. 

According to the National Conference of State Legislatures, medical marijuana is currently permitted in 37 states, three territories and the District of Columbia.  The issue of gaps in marijuana research came to the nation’s attention in 2020, when the House Committee on Energy and Commerce hosted several hearings focused on the availability of such research. Public health experts, government agencies, and others testified, urging Congress to act to address legal and regulatory barriers that present challenges to advancing marijuana research.

Several other countries are ahead of the curve in encouraging marijuana research, as well as contributing to the scientific knowledge base for the potential of these products.  Israel, for example, became the first country to allow medical research and marijuana cultivation in 2007 and currently hosts the world’s largest number of medical marijuana clinical trials.  Over the past 15 years, Israel has reformed its approach to medical grade marijuana (to improve ease of access) and has authorized exports of medical marijuana.  Other countries with active marijuana research sectors include Uruguay, Canada, the Netherlands, and the Czech Republic.

In an effort to meet US demand, Congress has fast-tracked the bill, which would:

  • Through a registration program with the US Department of Justice (DOJ), create a pathway for marijuana research without violating the Controlled Substances Act.  Marijuana, and its derivatives, is a Schedule I drug under the Controlled Substances Act (CSA) and is illegal to possess or distribute under US federal law.  See 21 U.S.C. § 802(16).  This classification extends essentially to “all parts of the plant Cannabis sativa L,” as well as synthetic equivalents and extracts.  The bill would amend the CSA to require DOJ to receive applications to conduct marijuana and CBD research as well as applications to manufacture marijuana for research.  DOJ must approve or deny such appplications within 30 days of receipt.
  • Require DOJ to assess and address any shortages of supply of marijuana for research purposes.  DOJ, along with the Department of Health and Human Services (HHS), would be required to make this determination on an annual basis and, if there is a shortage, outline the specific steps to “restore an adequate an uninterrupted supply of marijuana, including of specific strains, for research purposes.”
  • Encourage communication between patients and physicians about the potential harms and benefits of cannabis.  The bill explicitly provides that a state-licensed physician does not violate the CSA by discussing currently known potential harms and benefits of marijuana and marijuana derivatives (including CBD) with patients (or the parents of minor patients).
  • Clarify that companies can manufacture FDA-approved drug products.  The bill would explicitly permit manufacturers to apply to commercially manufacture an approved drug containing or derived from marijuana, as well as to import marijuana products for both research and as an ingredient in FDA-approved drug products.
  • Require HHS and the National Institutes of Health (NIH) to report cannabis medical research.  The Bill would require analysis and submission of information on “the potential therapeutic effects of cannabidiol or marijuana,” the potential effects on the human body, and the barriers associated with marijuana research in states that have legalized marijuana use.

Outside of the proliferation of marijuana products in the US because of non-federal legalization, the potential that marijuana may one day be de-scheduled raises the inevitable question of how those products would be regulated.  Regulatory science is a key component of the answer.  NIH has previously identified priority areas of interest to include “evaluating the endocannabinoid system as a new target for pain and addiction therapies,” “disentangling the distinct therapeutic benefits and potential health risks of different component compounds within cannabis as they relate to pain,” and “evaluating the effects of cannabis and exposures to other substances during vulnerable periods of development.” 

Should the bill become law, the American public may be one step closer to understanding the benefits and risks of medical marijuana and CBD.