Cannabis for Medical Use: Clinical Pharmacology Perspectives on Scientific and Regulatory Challenges

Abstract

There has been growing interest in developing therapeutic agents and other consumer products derived from cannabis and its components. To date, the US Food and Drug Administration (FDA) has not approved cannabis as a safe and effective drug for any indication. With the progressive state legalization of cannabis for medical use, healthcare providers and consumers must understand what is known about the safety and efficacy linked to cannabis.

Figure 1

Legal and regulatory requirements for cannabis clinical studies. IND status is needed from the FDA, which requires a clinical study protocol and details about the cannabis product (e.g., certificates of analysis providing cannabinoid profile/purity and testing for contaminants; stability testing; and manufacturing procedures). The timeline for initial IND submission review is 30 days. However, for IND amendments, there is no specific timeline. Once the IND is granted (safe to proceed), the clinical protocol, along with the IND can be submitted to the IRB. During this time, acquisition of the cannabis product can begin, which requires a DEA schedule I license (if the product contains > 0.3% THC (https://www.deadiversion.usdoj.gov/fed_regs/rules/2020/fr0821.htm)), which can take up to a year to obtain. Once the clinical protocol is approved and the IND is granted, the DEA provides final approval. The entire approval process can take up to a year. DEA, Drug Enforcement Administration; FDA, US Food and Drug Administration.