FDA Encourages Use of Drug Master Files to Support Cannabis Research

The U.S. Food and Drug Administration (FDA) is alerting those involved in research on drugs containing cannabis and cannabis-derived compounds of the potential benefits of using Drug Master Files (DMFs).

The FDA has heard concerns from some stakeholders about their ability to protect proprietary information while participating in drug development. FDA has given these concerns much thought and is suggesting that stakeholders involved in research and development of drugs that contain cannabis and cannabis-derived compounds who have these concerns consider the Drug Master File (DMF) pathway.

DMFs are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They allow parties to reference material (e.g., Chemistry, Manufacturing and Controls (CMC) of a component of a drug product or drug product information) without disclosing DMF contents to those parties and these files have no cost associated with their submission to the FDA in support of INDs or NDAs. In accordance with the Generic Drug User Fee Amendments (GDUFA), there is a provision for DMF fees if submitted in support of ANDAs. The draft Drug Master Files Guidance for Industry provides more detailed information on DMFs and their use at FDA.

In addition to maintaining confidentiality of proprietary information for the DMF holder, the DMF process permits review of the information in a DMF by FDA to support applications submitted by one or more applicants. A DMF holder must provide a Letter of Authorization (LOA) to their DMF for FDA to conduct a technical DMF review in support of a clinical trial or drug application. The DMF holder and their customers can reach their own agreements about information sharing, but FDA will not reveal any DMF contents to the applicant. The DMF will be reviewed only when it is referenced in an application or another DMF to determine whether it is adequate to support the particular submission that references it. A single DMF may be used to support multiple applications at one time, as long as each applicant has provided FDA with a LOA from the DMF holder.

“The FDA continues to believe the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. In fact in July 2020, FDA published a draft guidance (“Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry”) to provide FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds,” according to a statement from the FDA.