Document Type

Notes

Publication Date

2-8-2023

Keywords

Controlled Substances Act, Cannabis, Drug Development

Subject Category

Constitutional Law | Law

Abstract

Cannabis is a federally illegal drug in the United States, yet thirty-seven states and four territories have now enacted laws allowing the production, distribution, and consumption of cannabis for medical use. An estimated 5.5 million individuals in medical-use states are qualified to purchase cannabis to treat and mitigate symptoms for conditions ranging from cancer to post-traumatic stress disorder to chronic pain. But, only three cannabis drugs have been approved by the Food and Drug Administration (FDA).

The current state of federal illegality creates a problem of supply and demand—consumer demand for cannabis is high, but the number of approved drug products and indications for use remains extremely low. Federal agencies maintain that they support cannabis drug development, but current regulations add hefty requirements to the already complex and costly drug approval process.

This Note provides an overview of the current regulatory approval process for cannabis drugs and identifies specific barriers to research and development, specifically restrictions on the supply of cannabis for research and the current demand for cannabis drugs. As the FDA has a responsibility to protect the public health by ensuring drug safety and efficacy, it should prioritize its study of cannabis products, given that the plant and many of its chemical compounds likely have significant therapeutic potential.

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