[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 10150 Introduced in House (IH)]

<DOC>






119th CONGRESS
  2d Session
                               H. R. 10150

 To amend the Federal Food, Drug, and Cosmetic Act to provide a period 
   of market exclusivity for botanical drugs, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            August 27, 2026

 Ms. Boebert (for herself and Mr. Van Orden) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to provide a period 
   of market exclusivity for botanical drugs, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Advancing Botanical Drug Development 
Act of 2026''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Chronic and age-related diseases are among the leading 
        causes of disability, impaired quality of life, and health care 
        spending in the United States.
            (2) Many chronic and age-related diseases involve multiple 
        biological pathways and complex pathophysiology, yet most 
        currently approved therapies are designed to target a single 
        molecular pathway.
            (3) Botanical drugs regulated by the Food and Drug 
        Administration (in this section referred to as the ``FDA'') 
        under section 505 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355) may contain multiple naturally occurring active 
        constituents capable of acting on multiple biological pathways 
        simultaneously and safely.
            (4) Since the FDA established a regulatory pathway for 
        botanical drugs in 2004, only a limited number of botanical 
        drugs have received approval, despite significant scientific 
        and therapeutic potential and the growing interest of patients 
        in evidence-based, FDA-approved treatment options derived from 
        natural products.
            (5) In addition to the costs associated with the clinical 
        development of conventional synthetic drugs, botanical drugs 
        present unique scientific and manufacturing challenges arising 
        from the natural variability of plant-derived raw materials, 
        including the need for extensive sourcing controls, batch 
        consistency testing, constituent characterization, and 
        standardization processes to ensure safety, quality, and 
        effectiveness. These additional development burdens may 
        increase costs and commercial uncertainty for sponsors seeking 
        to bring innovative botanical therapies to market.
            (6) As a result of these unique scientific, manufacturing, 
        and regulatory challenges, existing intellectual property and 
        regulatory exclusivity frameworks may not provide sufficient 
        incentives to support private investment in the research and 
        development of innovative botanical drugs.
            (7) Congress has previously recognized that certain 
        categories of complex medical products require tailored periods 
        of regulatory exclusivity to encourage innovation and 
        facilitate long-term investment in research and development.
            (8) Expanding incentives for the development of safe and 
        effective botanical drugs may increase multi-target treatment 
        options for patients suffering from multi-pathway, chronic and 
        age-related diseases while promoting biomedical innovation and 
        economic growth in the United States.
            (9) Advances in computational biology, artificial 
        intelligence, and systems pharmacology have created new 
        opportunities to identify and develop innovative botanical drug 
        combinations capable of addressing complex diseases through 
        multi-pathway mechanisms of action.
            (10) It is in the public interest to encourage the 
        development and approval of multi-target, evidence-based, FDA-
        regulated botanical drugs subject to the same standards of 
        safety and effectiveness applicable to other drugs regulated by 
        the FDA.

SEC. 3. PERIOD OF MARKET EXCLUSIVITY FOR BOTANICAL DRUGS.

    Section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(c)(3)(E)) is amended by adding at the end the following:
    ``(vi)(I) A botanical drug approved under subsection (b)(1) 
pursuant to an application submitted after the date of enactment of 
this clause shall be entitled to a 12-year period during which no 
application submitted under subsection (b)(2) or (j) that references or 
relies upon such drug may become effective.
    ``(II) In this clause, the term `botanical drug' means a botanical 
drug subject to subsection (a), as determined by the Secretary by 
regulation.''.
                                 <all>