Advancing Botanical Drug Development Act of 2026
The source supplies the latest action, but no lifecycle stage.
Latest action (27 Aug 2026): Referred to the House Committee on Energy and Commerce.
What this bill does
H.R. 10150, the Advancing Botanical Drug Development Act of 2026, would amend the Federal Food, Drug, and Cosmetic Act to create a new period of market exclusivity for botanical drugs approved by the FDA. Specifically, a botanical drug approved through a new drug application submitted after the bill's enactment would receive 12 years during which the FDA could not allow a competing generic or abbreviated application referencing that drug to take effect. The bill directs the FDA to define "botanical drug" by regulation for this purpose.
The bill would primarily affect pharmaceutical companies developing plant-derived drugs regulated under the FDA's existing botanical drug pathway, established in 2004. By extending exclusivity, it aims to give these sponsors stronger financial incentives to invest in costly, complex development and manufacturing processes unique to botanical products, such as sourcing controls and batch testing. Patients with chronic or age-related diseases could eventually see more FDA-approved, multi-pathway botanical treatment options, though the bill itself does not guarantee new drugs will be developed—only that a longer exclusivity period will apply if they are approved.
The bill was introduced on August 27, 2026, by Rep. Lauren Boebert, with Rep. Van Orden as a cosponsor, and referred to the House Committee on Energy and Commerce. As of this summary, no further action has been taken; the bill would need committee consideration, a House vote, Senate passage, and the President's signature to become law.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
Timeline
27 Aug 2026
Referred to the House Committee on Energy and Commerce.
Common questions
- What does H.R. 10150 do?
- H.R. 10150, the Advancing Botanical Drug Development Act of 2026, would amend the Federal Food, Drug, and Cosmetic Act to create a new period of market exclusivity for botanical drugs approved by the FDA. Specifically, a botanical drug approved through a new drug application submitted after the bill's enactment would receive 12 years during which the FDA could not allow a competing generic or abbreviated application referencing that drug to take effect. The bill directs the FDA to define "botanical drug" by regulation for this purpose. The bill would primarily affect pharmaceutical companies developing plant-derived drugs regulated under the FDA's existing botanical drug pathway, established in 2004. By extending exclusivity, it aims to give these sponsors stronger financial incentives to invest in costly, complex development and manufacturing processes unique to botanical products, such as sourcing controls and batch testing. Patients with chronic or age-related diseases could eventually see more FDA-approved, multi-pathway botanical treatment options, though the bill itself does not guarantee new drugs will be developed—only that a longer exclusivity period will apply if they are approved. The bill was introduced on August 27, 2026, by Rep. Lauren Boebert, with Rep. Van Orden as a cosponsor, and referred to the House Committee on Energy and Commerce. As of this summary, no further action has been taken; the bill would need committee consideration, a House vote, Senate passage, and the President's signature to become law.
- Has H.R. 10150 become law?
- The source does not supply a confirmed lifecycle stage for H.R. 10150. Check the latest action and official source below.
- Who sponsored H.R. 10150?
- H.R. 10150 was sponsored by Rep. Boebert, Lauren [R-CO-4] (R-CO), with 1 cosponsor.
- What's the latest action on H.R. 10150?
- Referred to the House Committee on Energy and Commerce. (27 Aug 2026).
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