To amend the Federal Food, Drug, and Cosmetic Act to provide for expedited approval of priority nonprescription drugs, and for other purposes.

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9774 Introduced in House (IH)]

<DOC>

119th CONGRESS
  2d Session
                                H. R. 9774

   To amend the Federal Food, Drug, and Cosmetic Act to provide for
  expedited approval of priority nonprescription drugs, and for other
                               purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             July 20, 2026

Mr. Latta (for himself and Mr. Landsman) 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 for
  expedited approval of priority nonprescription 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. PRIORITY NONPRESCRIPTION DRUGS.

    (a) In General.--The Federal Food, Drug, and Cosmetic Act is
amended by inserting after section 506L (21 U.S.C. 356l) the following:

``SEC. 506M. PRIORITY NONPRESCRIPTION DRUGS.

    ``(a) In General.--
            ``(1) Designation.--The Secretary may, at the request of
        the sponsor of a nonprescription drug, designate as a priority
        nonprescription drug under this section a drug intended for
        nonprescription use that is subject to an application submitted
        (or to be submitted) under section 505(b), if the Secretary
        determines that the drug meets the criteria specified in
        subsection (d).
            ``(2) Nonprescription defined.--In this section, the term
        `nonprescription' means, with respect to a drug, that such drug
        is not subject to section 503(b)(1).
    ``(b) Request for Designation.--The sponsor of a drug subject to a
pending application under section 505(b) for nonprescription use may
request that the Secretary designate the drug as a priority
nonprescription drug.
    ``(c) Designation.--Not later than 60 calendar days after the
receipt of a request under subsection (b), the Secretary shall
determine whether a drug meets the criteria for designation as a
priority nonprescription drug under this section, and if so, make such
designation.
    ``(d) Criteria.--
            ``(1) Eligibility.--Except as provided in paragraph (2), a
        drug described in subsection (a) is eligible for designation as
        a priority nonprescription drug if--
                    ``(A) the drug is intended for a novel
                nonprescription indication that could provide a
                meaningful public health benefit;
                    ``(B) the drug is a new molecular entity; or
                    ``(C) the drug contains an active ingredient that
                has never been available in a nonprescription drug.
            ``(2) Exclusion.--A drug is not eligible for designation as
        a priority nonprescription drug if the drug is subject to a
        risk evaluation and mitigation strategy under section 505-1 or
        if the drug is a controlled substance (as defined in section
        102 of the Controlled Substances Act).
    ``(e) Actions.--If the Secretary designates a drug as a priority
nonprescription drug, the Secretary shall take such actions as are
appropriate to facilitate the development of, and expedite the review
of, an application or supplement to an application for such drug, which
may include--
            ``(1) holding meetings with the sponsor and the review team
        throughout the development of the drug;
            ``(2) providing timely advice to, and interactive
        communication with, the sponsor regarding the development of
        the drug to ensure that the development program to gather the
        nonclinical and clinical data necessary to demonstrate the
        inapplicability of the criteria described in section 503(b)(1)
        is as efficient as practicable;
            ``(3) involving senior managers and experienced review
        staff, as appropriate, in a collaborative, cross-disciplinary
        review;
            ``(4) assigning a cross-disciplinary project lead for the
        Food and Drug Administration team to facilitate an efficient
        review of the development program and to serve as a scientific
        liaison between the review team and the sponsor; and
            ``(5) taking steps to ensure that the design of any
        necessary nonclinical or clinical trials is as efficient as
        practicable, when scientifically appropriate, including
        reliance on real world evidence.
    ``(f) List of Conditions.--
            ``(1) Establishment.--Not later than 18 months after the
        date of enactment of this section, the Secretary shall publish
        in the Federal Register a list of conditions for which a
        nonprescription drug, if developed for the condition, could
        provide meaningful public health benefit.
            ``(2) Public comment.--The Secretary shall provide a period
        of not less than 30 days for public comment on--
                    ``(A) the list under paragraph (1); and
                    ``(B) any updates to such list.''.
    (b) Rule of Construction.--The amendment made by subsection (a)
shall not be construed to alter the evidentiary standards or the
information required for approval of a nonprescription drug under
section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355).
    (c) Report to Congress.--Not later than 4 years after the date of
enactment of this Act, the Secretary of Health and Human Services shall
submit to Congress a report containing--
            (1) the number of nonprescription drugs for which a sponsor
        requested that the Secretary designate such a drug as a
        priority nonprescription drug under section 506M of the Federal
        Food, Drug, and Cosmetic Act, as added by subsection (a);
            (2) the number of nonprescription drugs for which the
        Secretary approved such request;
            (3) the number of priority nonprescription drugs (as
        designated under such section) for which the Secretary approved
        an application under section 505 of the Federal Food, Drug, and
        Cosmetic Act (21 U.S.C. 355);
            (4) an overview of the resources used to implement such
        section; and
            (5) any recommendation on further improvement on increasing
        over-the-counter drug approvals using a framework similar to
        the designation framework established in such section.
    (d) Sunset Date.--The authority provided to the Secretary of Health
and Human Services under section 506M of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), shall cease to be effective
September 30, 2032.
                                 <all>