September 16, 2024

The FDA plays a pivotal role in the regulation and support of scientific research into cannabis and its medical applications. As interest in the medicinal uses of cannabis continues to grow, understanding the FDA's framework and guidelines is essential for researchers, healthcare providers, and patients alike.

FDA's Role in Cannabis Research

Guidance and Support

The FDA provides comprehensive guidance for conducting clinical research involving cannabis. This includes updated protocols for developing cannabis-derived drugs, as outlined in the Guidance for Industry: Botanical Drug Development. The agency also released Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, which serves as a resource for researchers.

Researchers can engage with the FDA through meetings and regular interactions, particularly with the Center for Drug Evaluation and Research (CDER), which assists in navigating the complexities of clinical trials involving cannabis.

IND Application Process

To initiate clinical research, researchers must submit an Investigational New Drug (IND) application to CDER. This application includes detailed study protocols, qualifications of investigators, and assurances regarding informed consent and subject protection. Regular communication with the FDA is crucial to ensure patient safety and trial efficacy.

Botanical Drug Development

For those focused on cannabis-derived drug development, the FDA encourages contacting relevant review divisions within CDER. The Botanical Review Team (BRT) offers expert guidance and resources tailored to botanical drug development, including pre-IND meetings to address specific queries.

Legal and Regulatory Considerations

The legal landscape surrounding cannabis research is shaped by several key factors:

  • Controlled Substances Act (CSA): Cannabis sativa L. has been classified as a Schedule I substance since 1970. However, the Agriculture Improvement Act of 2018 (Farm Bill) removed hemp (containing ≤0.3% THC) from CSA controls, simplifying research processes for hemp-derived products like CBD.
  • Regulatory Interactions: Research involving Schedule I substances necessitates site-specific registration with the DEA. The National Institute on Drug Abuse (NIDA) oversees the cultivation of research-grade marijuana, which researchers may need to obtain for their studies.
  • Animal Research: For studies involving animal drug products, researchers must establish an Investigational New Animal Drug (INAD) file with the Center for Veterinary Medicine (CVM).

The FDA’s Current Position on Cannabis

Despite significant interest in cannabis's medical potential, the FDA has not approved any marketing applications for cannabis itself as a treatment. However, it has approved specific cannabis-related products:

Cannabis-Derived Products

  • Epidiolex (Cannabidiol, CBD): The only FDA-approved cannabis-derived product for treating seizures associated with Lennox-Gas taut syndrome and Dravet syndrome in patients aged 2 years and older.

Synthetic Cannabis-Related Products

  • Marinol (Dronabinol): A synthetic THC used for nausea from chemotherapy.
  • Syndros (Dronabinol): Similar to Marinol but available in liquid form.
  • Cesamet (Nabilone): A synthetic cannabinoid used for chemotherapy-induced nausea.

These products are available only through prescriptions from licensed healthcare providers.

Understanding Cannabis Compounds

Cannabis sativa L. contains over 80 cannabinoids, with two prominent ones being:

  • Cannabidiol (CBD): Known for its therapeutic benefits without psychoactive effects.
  • Tetrahydrocannabinol (THC): The psychoactive component responsible for the "high."

Cannabis can be cultivated to produce varying concentrations of these cannabinoids, resulting in different cultivars.

Types of Compounds

  • Cannabis-Derived Compounds: Naturally occurring compounds extracted from the plant.
  • Cannabis-Related Compounds: Synthetic compounds created in laboratories that may or may not occur naturally in the plant.

The FDA’s Approach to Unapproved Cannabis Products

The FDA acknowledges that many unapproved cannabis products are used for various medical conditions but emphasizes that these products have not undergone rigorous clinical trials to demonstrate their safety and efficacy. The agency warns that unapproved products may pose unpredictable safety risks.

Facilitating Development of Cannabis-Based Therapies

To expedite the development of new therapies, the FDA offers several programs:

  • Fast Track: Accelerates development and review of drugs treating serious conditions.
  • Breakthrough Therapy: Provides intensive guidance for drugs showing substantial improvement over existing treatments.
  • Accelerated Approval: Allows earlier approval based on surrogate endpoints likely to predict clinical benefit.
  • Priority Review: Shortens review time for drugs that significantly improve treatment options.

Additionally, expanded access provisions enable patients with serious conditions to access investigational products when no satisfactory alternatives are available.

Conclusion

The FDA is committed to advancing scientific understanding and therapeutic applications of cannabis through a structured regulatory framework. By providing clear guidance and support to researchers, the agency ensures that any approved cannabis-related drug products are safe, effective, and high-quality. Understanding these regulations empowers patients and caregivers to make informed decisions regarding medical cannabis use while staying updated on advancements in cannabis-based therapies.