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ACCESS Through OTC Innovation Act
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.
Summary
This bill amends the Federal Food, Drug, and Cosmetic Act to streamline the process for evaluating over-the-counter monograph drugs. It requires the FDA to apply the least burdensome approach when determining whether an over-the-counter drug is generally recognized as safe and effective. If published reports are insufficient to support a drug request, the bill requires the FDA to meet with the applicant upon request to provide recommendations on what types of evidence are needed, including guidance on study design and size. The FDA must prepare meeting minutes and document its recommendations in the administrative record. The bill does not change the FDA's standards for determining whether a drug is safe and effective or whether a request is complete for review.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
- Rep. Landsman, Greg [D-OH-1] (D-OH)
Actions (2)
- Dec 18, 2025 Referred to the House Committee on Energy and Commerce. · house
- Dec 18, 2025 Introduced in House
Similar bills (6)
Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.
Full text
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>
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