[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6868 Introduced in House (IH)]

<DOC>






119th CONGRESS
  1st Session
                                H. R. 6868

    To amend the Federal Food, Drug, and Cosmetic Act to direct the 
 Secretary of Health and Human Services to apply the least burdensome 
appropriate means for supporting certain administrative order requests 
    with respect to over-the-counter monograph drugs, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           December 18, 2025

 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 direct the 
 Secretary of Health and Human Services to apply the least burdensome 
appropriate means for supporting certain administrative order requests 
    with respect to over-the-counter monograph 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 Consumer Choice, Equity, 
Safety, and Self-Care Through OTC Innovation Act'' or the ``ACCESS 
Through OTC Innovation Act''.

SEC. 2. LEAST BURDENSOME MEANS FOR SUPPORTING CERTAIN ADMINISTRATIVE 
              ORDER REQUESTS WITH RESPECT TO OVER-THE-COUNTER MONOGRAPH 
              DRUGS.

    Section 505G of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355h) is amended--
            (1) by redesignating subsection (q) as subsection (r); and
            (2) by inserting after subsection (p) the following:
    ``(q) Least Burdensome Means for Supporting Requests for Certain 
Administrative Orders.--
            ``(1) In general.--For purposes of determining whether a 
        drug is generally recognized as safe and effective under 
        section 201(p)(1) when evaluating a request submitted under 
        subsection (b)(5), the Secretary shall apply the least 
        burdensome appropriate means for supporting such a request and 
        satisfying the requirements of this section.
            ``(2) Meeting requests.--
                    ``(A) In general.--In the case of an order 
                requested under subsection (b)(5), and if published 
                reports are insufficient to support the requested 
                findings, the Secretary shall meet with the requestor, 
                if the requestor makes a reasonable written request for 
                the meeting, for the purpose of providing 
                recommendations on the types of evidence necessary, 
                including, if appropriate, the potential design and 
                size of any studies to support a demonstration that the 
                drug is generally recognized as safe and effective.
                    ``(B) Preparation and availability of meeting 
                minutes.--The Secretary shall prepare, and make 
                available to the requestor, the minutes of any such 
                meeting.
                    ``(C) Administrative record.--In the case of any 
                such meeting, the Secretary shall reduce to writing and 
                make a part of the administrative record--
                            ``(i) any recommendations regarding the 
                        parameters of studies under this paragraph that 
                        the Secretary provides to the requestor; and
                            ``(ii) a summary of the meeting discussion.
            ``(3) Rule of construction.--Nothing in this subsection 
        shall be construed to alter, supersede, or limit the criteria--
                    ``(A) for determining under subsection (b)(5)(A) 
                whether a request is sufficiently complete and 
                formatted to permit a substantive review; or
                    ``(B) for determining whether a drug is generally 
                recognized as safe and effective under section 
                201(p)(1).''.
                                 <all>