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HR10150119th CongressWALLET

Advancing Botanical Drug Development Act of 2026

Sponsored By: Representative Boebert, Lauren [R-CO-4]

Introduced

Summary

market exclusivity for botanical drugs

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This bill would create a dedicated pathway to encourage investment in plant-based therapies by granting protected market time for qualifying botanical drugs. It would also require the Secretary to write rules that define which products count as "botanical drugs."

  • Drug developers: A qualifying botanical drug approved from an application submitted after enactment would get a 12-year period during which no 505(b)(2) or 505(j) application that references it could become effective.
  • Competitors and follow-on manufacturers: Would be prevented from relying on the approved botanical drug to bring competing products to market for 12 years, delaying lower-cost alternatives.
  • Patients and clinicians: Aims to spur multi-target, evidence-based botanical therapies by addressing unique manufacturing and development challenges and creating stronger incentives to invest in those products.

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Bill Overview

Analyzed Economic Effects

1 provisions identified: 1 benefits, 0 costs, 0 mixed.

12-Year Market Protection for Botanical Drugs

If enacted, the bill would give certain FDA-approved botanical drugs a 12-year period of market protection. This protection would apply only to botanical drugs approved from applications submitted after the date the law takes effect. During those 12 years, other FDA applications that reference or rely on the approved botanical drug (including abbreviated reliance pathways) could not become effective. The Secretary of Health and Human Services would write rules to say which products count as "botanical drugs." The change would not alter other exclusivity or patent rules beyond this 12-year protection.

Sponsors & CoSponsors

Sponsor

Boebert, Lauren [R-CO-4]

CO • R

Cosponsors

  • Rep. Van Orden, Derrick [R-WI-3]

    WI • R

    Sponsored 8/27/2026

Roll Call Votes

No roll call votes available for this bill.

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