The FDA Role in Cannabis Research is the same as it is with any other product used as a medication or therapeutic agent, including any products from plants including cannabis research. Researchers need to collaborate with the FDA and submit an IND application to the Center for Drug Evaluation and also Research (CDER).
The standard drug development process, according to the FDA is:
“Drugs undergo laboratory and animal testing to answer basic questions about safety. Drugs are tested on people to make sure they are safe and effective. FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it.”
The IND application procedure offers scientists a path to follow that consists of regular communications with the FDA to support effective medication advancement while safeguarding the clients who are enlisted in the trials.
The FDA Drug Development Process and Cannabis-Derived Products
The FDA understands that there is increasing interest in the potential utility of cannabis for a variety of medical conditions, as well as research on the potential adverse health effects from use of cannabis.
Performing medical research study using cannabis-related substances that are arranged by the DEA frequently involves communications with several federal agencies. This includes: a registration administered by the DEA; acquiring the marijuana for research study from NIDA, within the National Institutes of Health, or an additional DEA-registered source; as well as evaluation by the FDA of the IND or INAD application as well as study method.
For a Schedule I regulated compound under the CSA, DEA required added security and protocols including Schedule I-level security requirements at the site marijuana will be examined. Clean and pure supplies of cannabis to test with are critical and therefore the FDA has partnered with the University of Mississippi to cultivate marijuana for study at a safe and secure center. In time the FDA may expand it’s program to include additional growers and distributors for clinical studies and research purposes.
Growing Interest in Cannabis Research
With the exponential interest and demand for cannabis related product and the legal advancements by states in approving medical use for marijuana, expanding the conditions allowed, the FDA has recently clarified their approach and policies as they relate to cannabis research and approval.
The FDA currently has several programs designed to improve the process for drug approval based on it’s performance in studies and outcomes, and these include:
- Fast Track
- Breakthrough Therapy
- Accelerated Approval
- Priority Review
While these are standard programs for all products in the FDA regulatory and development process, the agency also has stood up a Botanical Review Team that addresses specifically issues relating to drugs that are plant based, including cannabis-derived products.
The FDA Stance on Scientific Studies of Cannabis
Does the FDA object to the scientific investigation of medical marijuana use? No. The FDA believes that medically valid study performed under an IND application is the very best method to determine what people could benefit from the use of medications derived from cannabis.
The FDA supports the ongoing research by:
- Providing information on the process needed to carry out medical research study using marijuana.
- Supplying information on the details requirements needed to develop a drug that is stemmed from a plant such as cannabis. In December 2016, the FDA upgraded its Guidance for Industry: Botanical Drug Development, which supplies sponsors with advice on sending IND applications for herb medicine items.
- Offering specific support for investigators curious about conducting scientific research utilizing cannabis as well as its constituents as a part of the IND process through conferences and also regular communications throughout the medicine growth process.
- Providing general support to private investigators to help them recognize and also follow the procedures to carry out professional study with the FDA Center for Drug Evaluation and also Research’s Small Business and also Industry Assistance team.
Additional Concerns about CBD Products
FDA is actively working to learn more about the safety of CBD and CBD products, including the risks identified above and other topics, such as:
- Cumulative Exposure: The cumulative exposure to CBD if people access it across a broad range of consumer products. For example, what happens if you eat food with CBD in it, use CBD-infused skin cream and take other CBD-based products on the same day? How much CBD is absorbed from your skin cream? What if you use these products daily for a week or a month?
- Special Populations: The effects of CBD on other special populations (e.g., the elderly, children, adolescents, pregnant and lactating women).
- CBD and Animals: The safety of CBD use in pets and other animals, including considerations of species, breed, or class and the safety of the resulting human food products (e.g., meat milk, or eggs) from food-producing species.