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[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>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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