Editor's Note
An act of Congress may be required to compel the DEA to issue marijuana manufacturer registrations for research, according to FDA Law Blog. This article summarizes Rep. Matt Gaetz's (R.-FL) Medical Cannabis Research Act of 2019 ( H.R. 601 ), which would require the Attorney General through DEA to issue registrations to at least three applicants to manufacture cannabis for legitimate research purposes within a year, and to register at least four applicants in subsequent years. Registered manufacturers would be limited to supplying cannabis to DEA-registered Schedule I researchers for “use in preclinical research or in a clinical investigation pursuant to an investigational new drug exemption” under the Food, Drug and Cosmetic Act. 
The Medical Cannabis Research Act of 2019 if enacted as written will not change the legal status of marijuana nor affect CSA provisions regulating cannabis manufacturers for other than research purposes, including commercial drug product development by the private sector.

Requiring DEA to grant a certain number of registrations is problematic in that it appears contrary to the CSA wherein DEA is only required to grant a registration if the applicant is qualified. While we would assume that a number of the current applicants should be able to meet the CSA requirements, this is not a given. In lieu of requiring DEA to issue a certain number of marijuana manufacturer registrations each year, the bill would require DEA to grant or deny the registrations, or request additional information, within one year of receiving an application.

Congressman Gaetz stated: “[c]urrently, all federally-approved studies of medical cannabis get their product from one source, and it is extremely subpar . . . [it] is weak and often moldy . . . federally grown cannabis is scarce; there is not enough product.”

It is time that DEA and DOJ make good on their announcement to issue additional registrations for marijuana manufacturers. Manufacturer compliance with CSA recordkeeping and security requirements minimize risk of diversion. It is unfortunate that it may require an act of Congress to facilitate legitimate medical research with cannabis, but American patients and the public are worthy.