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The Medical Marijuana Research Expansion Act, which was reintroduced in February 2021 and passed last April by the House of Representatives, seeks to facilitate cannabis-specific scientific research and potential drug development. Also, the legislation would substantially expand scientific research on marijuana, allowing scientists to study products from dispensaries.

Last Thursday, a revised version of the bill was introduced in Congress.

Background

In March 2022, the Senate gave a green light to a bipartisan marijuana bill meant to promote marijuana research. The legislation, sponsored by Sens. Dianne Feinstein (D-CA), Brian Schatz (D-HI), and Chuck Grassley (R-IA), is titled Cannabidiol and Marihuana Research Expansion Act.

The bill, filed by Rep. Earl Blumenauer [D-OR] and Rep. Andy Harris [R-MD], will ease the process by which researchers apply for approval to study cannabis and will place deadlines on federal agencies to consider the applications in a timely manner.

What’s Next?

A revised version of the bill was introduced in Congress last week. The proposal includes provisions that would ease the process by which researchers apply for approval to study cannabis.
Now, members of Congress are fast-tracking legislation, which is scheduled for floor action this week. The bill contains language that is similar to Senate Bill 253, which Senate members unanimously passed last April.

The Act provides a 60-day timeline to the office of the US Attorney General (AG) to either approve or deny the applications from scientists wishing to engage in clinical trials involving the use of cannabis by human subjects.

However, some agencies in charge to review and approve the scientists’ protocols, do not have an explicit timeline to complete their reviews. This is the case of the Secretary of the US Department of Health and Human Services and by the National Institutes of Health prior to the AG’s authorization.
“Currently, the limited variety of cannabis cultivars accessible to federally licensed researchers does not represent the type or quality of cannabis products currently available in legal, statewide markets,” said NORML’s Deputy Director Paul Armentano. “The fact that nearly one-half of US adults have legal access to these multitudes of cannabis products, but our nation’s top scientists do not, is the height of absurdity and it is an indictment of the current system. This proposal misses the opportunity to change that reality.”

The Act also requires the US Attorney General to solicit applications from those seeking to cultivate cannabis for research or potential drug development purposes and provides a timeline for the AG to approve those applicants,” reads a statement.

What Is The Role Of Federal Agencies In Facilitate Cannabis Research?

US Drug Enforcement Administration, under current regulations, has the competence of reviewing and licensing marijuana cultivators, as well as issuing Schedule I licenses to scientists who wish to study cannabis in clinical settings.
“In 2016, the agency announced that it would expand the pool of federally licensed cultivators beyond the University of Mississippi,” reads a statement. “In May 2021, the agency announced that it had reached agreements with a handful of third-party applicants to allow them to grow cannabis for use in federally approved clinical trials.”

However, the US National Institute On Drug Abuse has not yet officially partnered with these entities, nor is there an explicit timeline for when they would do so.

Scientists seeking to analyze and work with cannabis have expressed that “it takes years for the DEA to approve their research protocols and that the quality of cannabis provided by the University of Mississippi cultivation program is substandard, inferior, and not representative of available products in state-legal markets.”
According to the above, Medical Marijuana Research Act, “allows licensed scientists access to cannabis flowers and other products manufactured in accordance with state-approved marijuana programs.” However, those explicit provisions were not included in the new bill that both chambers are fast-tracking.

Finally, the legislation requires federal agencies, including the U.S. Department of Health & Human Services (HHS), to provide a report on the “potential therapeutic effects of cannabidiol or marijuana in serious medical conditions.” Similar reports have been compiled by the US National Academies of Sciences, Engineering, and Medicine for Congress in recent years, but these reports have not received much attention.
Photo: Courtesy Of National Cancer Institute On Unsplash

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