[Congressional Record Volume 163, Number 91 (Thursday, May 25, 2017)]
[Senate]
[Pages S3220-S3221]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. FEINSTEIN (for herself, Mr. Grassley, Mr. Durbin, Mr. 
        Tillis, and Mrs. Ernst):
  S. 1276. A bill to require the Attorney General to make a 
determination as to whether cannabidiol should be a controlled 
substance and listed in a schedule under the Controlled Substances Act 
and to expand research on the potential medical benefits of cannabidiol 
and other marihuana components; to the Committee on the Judiciary.
  Mrs. FEINSTEIN. Mr. President, I rise today to introduce the 
Cannabidiol Research Expansion Act with my colleagues, Senators 
Grassley, Durbin, Tillis, and Ernst.
  Cannabidiol, or CBD, is a nonpsychoactive component of marijuana. In 
many instances parents, after exhausting other treatment options, have 
turned to CBD to as a last resort to treat their children who have 
intractable epilepsy. Anecdotally, CBD has produced positive results.
  However, due to existing barriers and the fact that marijuana is a 
schedule I drug, rigorous research that is needed to better understand 
the long-term

[[Page S3221]]

safety and efficacy of CBD as a medicine, as well as the correct dosing 
and potential interaction with other medications, is lacking.
  The Cannabidiol Research Expansion Act seeks to both reduce these 
barriers and spur additional research to ensure that CBD and other 
marijuana-derived medications are based on the most up to date 
scientific evidence. It also provides a pathway for the manufacture and 
distribution of FDA-approved drugs that are based on this research.
  It does this while maintaining safeguards to protect against illegal 
diversion.
  First, the bill directs the Departments of Justice and Health and 
Human Services to complete a scientific and medical evaluation of CBD 
within 1 year. Based on this evaluation, the legislation directs the 
Department of Justice to make a scheduling recommendation for CBD that 
is independent of marijuana. This may include transferring the schedule 
of CBD to another schedule, or removing it from the list of controlled 
substances altogether. A scheduling recommendation for CBD that is 
independent of marijuana has never been done before.
  Second, without sacrificing appropriate oversight, it streamlines the 
regulatory process for marijuana research. In particular, it improves 
regulations dealing with changes to approved quantities of marijuana 
needed for research and approved research protocols. It also expedites 
the Drug Enforcement Administration registration process for 
researching CBD and marijuana.
  Third, this legislation seeks to increase medical research on CBD, 
while simultaneously reducing the stigma associated with conducting 
research on a schedule I drug. It does so by explicitly authorizing 
medical and osteopathic schools, research universities, practitioners 
and pharmaceutical companies to use a schedule II Drug Enforcement 
Administration registration to conduct authorized medical research on 
CBD.
  Fourth, the bill allows medical schools, research institutions, 
practitioners, and pharmaceutical companies to produce the marijuana 
they need for authorized medical research. This will ensure that 
researchers have access to the material they need to develop proven, 
effective medicines. Once the FDA approves these medications, the bill 
allows pharmaceutical companies to manufacture and distribute them.
  Fifth, the bill allows parents who have children with intractable 
epilepsy, as well as adults with intractable epilepsy, to possess and 
transport CBD or other nonpsychoactive components of marijuana used to 
treat this disease while research is ongoing. To do so, parents and 
adults must provide documentation that they or their child have been 
treated by a board-certified neurologist for at least 6 months. They 
must also have documentation that the neurologist has attested that 
other treatment options have been exhausted and that the potential 
benefits outweigh the harms of using these nonpsychoactive components 
of marijuana. The neurologist must also agree to monitor the patient 
for potential adverse reactions.
  Finally, because existing Federal research is severely lacking, the 
bill directs the Department of Health and Human Services to expand, 
intensify, and coordinate research to determine the potential medical 
benefits of CBD or other marijuana-derived medications on serious 
medical conditions.
  The 2016 National Academy of Sciences report, titled ``The Health 
Effects of Cannabis and Cannabinoids: The Current State of Evidence and 
Recommendations for Research'' underscored the need to reduce research 
barriers, increase the supply of CBD and marijuana for research 
purposes, and address existing research gaps.
  The Cannabidiol Research Expansion Act seeks to do just this.
  This bill is critical to helping families across the country as they 
seek safe, effective medicines for serious illnesses. I hope my 
colleagues will join me in supporting this important legislation.
                                 ______