H.R. 10150

[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.''.
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