I 
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 sup-
porting certain administrative order requests with respect 
to over-the-counter monograph drugs, and for other pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives 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 Inno-
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vation Act’’ or the ‘‘ACCESS Through OTC Innovation 
Act’’. 
SEC. 2. LEAST BURDENSOME MEANS FOR SUPPORTING 
CERTAIN 
ADMINISTRATIVE 
ORDER 
RE-
QUESTS 
WITH 
RESPECT 
TO 
OVER-THE- 
COUNTER MONOGRAPH DRUGS. 
Section 505G of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355h) is amended— 
(1) by redesignating subsection (q) as sub-
section (r); and 
(2) by inserting after subsection (p) the fol-
lowing: 
‘‘(q) LEAST BURDENSOME MEANS FOR SUPPORTING 
REQUESTS FOR CERTAIN ADMINISTRATIVE ORDERS.— 
‘‘(1) IN
GENERAL.—For purposes of deter-
mining 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 burden-
some appropriate means for supporting such a re-
quest 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 
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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 ap-
propriate, the potential design and size of any 
studies to support a demonstration that the 
drug is generally recognized as safe and effec-
tive. 
‘‘(B) PREPARATION AND AVAILABILITY OF 
MEETING MINUTES.—The Secretary shall pre-
pare, 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 ad-
ministrative record— 
‘‘(i) any recommendations regarding 
the parameters of studies under this para-
graph that the Secretary provides to the 
requestor; and 
‘‘(ii) a summary of the meeting dis-
cussion. 
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‘‘(3) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed to alter, super-
sede, or limit the criteria— 
‘‘(A) for determining under subsection 
(b)(5)(A) whether a request is sufficiently com-
plete and formatted to permit a substantive re-
view; or 
‘‘(B) for determining whether a drug is 
generally recognized as safe and effective under 
section 201(p)(1).’’. 
Æ 
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