As the Drug Enforcement Administration (DEA) moves marijuana from Schedule I to Schedule III, a new pathway for the development of marijuana-based prescription drugs opens. Schedule I drugs are deemed to have no medical use, which has hampered the development of marijuana drugs. Schedule III drugs do have a medical use and can be legally marketed and sold in compliance with federal law.
Marijuana is a unique substance and has been used by humans for thousands of years for medical and recreational purposes. According to the DEA, the ancient Chinese, Greeks, and Romans used cannabis, and its use spread through the Islamic Empire from the Middle East and North Africa.
The Food and Drug Administration (FDA) allows for the development of botanical drugs and provides some incentives specific to botanical drugs. As marijuana is a plant with well documented use, it's possible that botanical drugs containing marijuana will be developed in the coming years.
Neither the Food, Drug and Cosmetic Act (FDCA) or FDA regulation specifically defines botanical drugs. However, the FDA has issued guidance on botanical drugs and describes them as products derived from plant materials, algae, macroscopic fungi, or a combination thereof. According to the FDA, two botanical prescription drugs have been approved in the US: sinecatechins, Veregen® and crofelemer, Mystei". The definition of botanical drugs excludes highly purified substances, even if the substance is plant derived.
Botanical drugs have unique features compared to more traditional drugs. For example, unlike chemically synthesized and purified drugs, botanical drugs may have batch-to-batch variations. Additionally, the FDA considers the entire botanical mixture as the active ingredient in a drug as opposed to a specific constituent.
Developing drugs takes time and substantial cost. In order to develop a new drug, a party must submit a New Drug Application (NDA) and an Investigational New Drug Application (IND) in support of the NDA. The FDA has provided incentives to encourage clinical trials of botanical drugs by modifying the requirements for an IND and adopting a more flexible evidence standard. The FDA has reduced the amount of required chemistry, manufacturing, and control information and emphasized prior human experience as a substitute for animal toxicology studies. In addition, for early phase clinical trials, the FDA states that neither purification nor identification of the ingredient is required. Despite these incentives, the overall clinical efficacy and safety requirements must meet the same standards as other drugs. Drug development is highly regulated and complex, and although the FDA provides some incentives with regards to botanical drugs, the path to approval is still challenging.
Once marijuana is rescheduled, currently operating state-legal programs will remain unlawful under federal law. On the other hand, marijuana drugs developed in compliance with the FDCA and approved by the FDA would be completely legal under federal law. Developing a botanical drug may still be cost prohibitive for state-legal operators, but as the industry grows, that may change. It's also possible that larger pharmaceutical companies will explore the botanical drug pathway after rescheduling.
Reprinted with permission from the American Bar Association's Business Law Today May Month-In-Brief: Business & Regulated Industries.
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