H.R. 6868 — ACCESS Through OTC Innovation Act

This section requires the Secretary of Health and Human Services, when evaluating requests for administrative orders on over-the-counter (OTC) monograph drugs under section 505G(b)(5) of the Federal Food, Drug, and Cosmetic Act, to apply the least burdensome appropriate means for determining whether a drug is generally recognized as safe and effective (GRASE). Specifically, the section (1) mandates such meetings with requestors if published reports are insufficient and the requestor makes a reasonable written request, to provide recommendations on necessary evidence (including potential study designs and sizes), with preparation and availability of meeting minutes and inclusion in the administrative record of study recommendations and a discussion summary; and (2) specifies that these requirements do not alter criteria for deeming a request sufficiently complete for review or for GRASE determinations. (The redesignation of existing subsection (q) as (r) is administrative.)