Federal Bill Would Give FDA-Approved Botanical Drugs 12 Years of Market Exclusivity, With Potential Cannabis Implications
- The Advancing Botanical Drug Development Act of 2026 (H.R. 10150) proposes granting FDA-approved botanical drugs 12 years of market exclusivity to protect them from competing applications.
- The bill, introduced by Representatives Lauren Boebert and Derrick Van Orden, could impact cannabis-derived medicines as the FDA includes certain cannabis products under its botanical drug framework.
- The legislation aims to address development challenges unique to botanical drugs, such as plant variability, sourcing, and standardization, which often deter private investment.
- The FDA is currently focusing on advancing botanical drug development, having approved only four botanical products so far, and recently solicited public input on improving regulatory processes for these complex plant-based medicines.
A newly introduced federal bill would provide FDA-approved botanical drugs with 12 years of market exclusivity, a change that could have implications for the development of certain cannabis-derived medicines.
The Advancing Botanical Drug Development Act of 2026, H.R. 10150, was introduced by U.S. Representative Lauren Boebert (R-CO) alongside Rep. Derrick Van Orden (R-WI) and has been referred to the House Committee on Energy and Commerce.
Under the proposal, a botanical drug approved through a qualifying new drug application submitted after the legislation takes effect would receive a 12-year period during which competing applications that reference or rely on the approved product could not become effective.
The bill does not mention marijuana or cannabis specifically. However, the Food and Drug Administration (FDA) has explicitly identified cannabis-derived products as among those that can be developed under its botanical drug framework. FDA guidance directs developers of cannabis-derived drugs to its Botanical Drug Development guidance, and the agency maintains a Botanical Review Team that works with developers of cannabis-related drug products.
That means the proposed exclusivity period could potentially apply to qualifying cannabis-derived medicines, particularly complex plant-based formulations containing multiple constituents. It would not necessarily apply to every drug derived from cannabis. FDA generally excludes highly purified substances from its definition of botanical drug products.
The legislation says botanical medicines face development challenges not generally encountered with conventional synthetic drugs, including variations in plant material, sourcing requirements, batch consistency testing and the need to characterize and standardize multiple constituents. Lawmakers argue those added costs and uncertainties can discourage private investment in botanical drug development.
Boebert said the proposal is intended to create greater certainty for companies developing botanical medicines without weakening existing FDA requirements.
“Botanical drugs are FDA-approved medicines, not dietary supplements,” Boebert said when announcing the legislation, adding that the measure would retain clinical trial, safety and effectiveness requirements.
The proposal comes as the FDA itself is giving renewed attention to botanical medicines. Earlier this month, the agency opened a public request for information seeking feedback on ways to advance botanical drug development, citing regulatory and scientific challenges associated with complex plant-derived products.
FDA says just four botanical products have received approval through its new drug application or biologics pathways to date.