H.R. 6868

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

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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).''.
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