Biden Administration Streamlines Registration Processes for Research on Schedule I Substances

September 13, 2021 11:38:19

Last week, the White House Office of National Drug Control Policy recommended that a modification be made to the federal drug scheduling system in an effort to simplify the process of conducting studies on schedule I substances, which include cannabis and psychedelics like psilocybin.

In a letter to Congressional leaders, the ONDCP stated that it wanted to encourage research on the substances by streamlining the registration process for researchers to access Schedule I drugs. This move is part of an extensive initiative to develop a strategy to decrease the supply of illicit fentanyl while diminishing barriers to scientific research on schedule I drugs and protecting civil rights.

Experts have in the past criticized the scheduling system, stating that it hindered scientific research from progression. The National Institute of Drug Abuse Director Volkow has previously described the existing process as cumbersome and lengthy.

The ONDCP stated that its objective was to align registration for research on every schedule I drug with the process for registering to conduct research on schedule II drugs.

It asserted that the Biden Administration was in favor of conducting more research on fentanyl-related substances and other schedule I drugs, as it would facilitate the advancement of evidence-based public policy.

Under the existing process, the registration applications for Schedule I and II drugs must include qualifications and experience to carry out the studies, information on security and storage and a general research proposal.

However, there’s an added burden for applicants who plan to carry out research on schedule I substances, as the secretary of health and human services has to determine the merits of their research protocol as well as the competency and qualifications of every practitioner that requests registration. Officials, scientists and advocates state that this makes the process to receive approval to conduct research on schedule I substances burdensome.

Other agencies are trying to follow suit, with the DEA recently proposing a huge increase in the production of psilocybin and cannabis for research purposes.

In a Federal Register filing, the DEA stated that it supported regulated research on substances classified under schedule I, noting that the increase in the aggregate production quota reflected the need to meet the requirements for the production of new medications.

The DEA also ended the monopoly on federally authorized marijuana manufacturing, which would make it easier to meet the new cannabis production goal. The agency noted that the increase would also allow researchers to study the effects of cannabis.

When the federal government removes many of the barriers that have been making it cumbersome for studies to be conducted on controlled substances, there is likely to be a more conducive environment for entities like Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) to conduct studies aimed at finding new remedies, especially for mental health illnesses.

NOTE TO INVESTORS: The latest news and updates relating to Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) available in the company’s newsroom at

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