ACCESS Through OTC Innovation Act

[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 mea