This bill amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to apply the least burdensome appropriate means for supporting requests for certain administrative orders related to OTC monograph drugs. Specifically, it inserts a new subsection into Section 505G to guide how evidence is gathered and evaluated when an order under subsection (b)(5) is sought.
When published reports are insufficient to support the requested findings, the Secretary must meet with the requestor to discuss evidence needs, including potential study designs and sizes. Minutes of the meeting must be prepared and added to the administrative record along with a summary of the discussion and any recommendations.
The bill also preserves existing criteria for determining whether a drug is generally recognized as safe and effective and does not alter those standards.
At a Glance
What It Does
Adds new subsection (q) to Section 505G to require the Secretary to use the least burdensome means for supporting 505G(b)(5) orders for OTC monograph drugs. It sets out a meeting process, requires minutes, and mandates inclusion of meeting-recommendation parameters in the administrative record.
Who It Affects
Applicants seeking 505G(b)(5) orders for OTC monograph drugs, and the agency staff conducting reviews and maintaining records.
Why It Matters
Creates a more transparent, collaborative, and auditable pathway for evidence development, potentially reducing unnecessary burdens while preserving regulatory rigor.
More articles like this one.
A weekly email with all the latest developments on this topic.
What This Bill Actually Does
The ACCESS Through OTC Innovation Act introduces a new approach to how the FDA and the Department of Health and Human Services handle evidence for administrative orders tied to OTC monographs. At its core, the bill requires the agency to apply the least burdensome means when supporting such orders, especially when the existing published evidence is not enough to make a determination.
A key feature is the option for a pre-submission meeting: if an applicant requests it and the published data are insufficient, the agency will meet to discuss what kinds of evidence are needed and how large or designed those studies should be. The minutes of that meeting must be produced and placed in the administrative record along with a summary of the discussion and any recommendations about study parameters.
The mechanism is designed to increase clarity and collaboration without changing the fundamental criteria for deciding whether a drug is generally recognized as safe and effective, or the basic completeness standards for a request.
The Five Things You Need to Know
The bill creates new subsection (q) in Section 505G to govern how OTC monograph orders are supported.
If published reports are insufficient, the Secretary must meet with the requestor to discuss evidence design and study size.
Meeting minutes must be produced and provided to the requestor.
The meeting and its recommendations are added to the administrative record as a summary of the discussion.
The bill preserves existing criteria for GRAS/E determinations and does not alter completeness standards.
Section-by-Section Breakdown
Every bill we cover gets an analysis of its key sections.
Short Title
This Act may be cited as the ACCESS Through OTC Innovation Act, or the ACCESS Through OTC Innovation Act.
Least burdensome means for supporting admin orders for OTC monographs
Section 505G is amended by redesignating subsection (q) as (r) and inserting new subsection (q) after (p). Subsection (q) requires the Secretary to apply the least burdensome appropriate means for supporting requests under subsection (b)(5) to determine whether a drug is generally recognized as safe and effective. It also sets out a process for meetings with requestors when published reports are insufficient, requires that meeting minutes be prepared and shared, and obligates the Secretary to include recommendations and a summary in the administrative record. A rule of construction clarifies that these provisions do not alter the criteria for completeness or the GRAS/E determination.
This bill is one of many.
Codify tracks hundreds of bills on Healthcare across all five countries.
Explore Healthcare in Codify Search →Who Benefits and Who Bears the Cost
Every bill creates winners and losers. Here's who stands to gain and who bears the cost.
Who Benefits
- OTC monograph drug sponsors or applicants seeking a 505G(b)(5) order gain a clearer, least-burdensome evidentiary pathway and access to potential pre-submission meetings.
- Contract research organizations (CROs) and study designers benefit from explicit guidance on acceptable study designs, sizes, and parameters discussed in the meetings.
- Regulatory affairs teams at OTC drug manufacturers gain a more predictable process and auditable records to align internal approvals with agency expectations.
- Public health advocates and consumer groups benefit from increased transparency via meeting minutes and the administrative record.
- Independent researchers and public health bodies contributing evidence gain clearer pathways for collaboration and documentation.
Who Bears the Cost
- FDA/HHS staff will undertake meetings, prepare minutes, and compile administrative records, representing an incremental administrative burden.
- Applicants seeking 505G(b)(5) orders may incur costs to design, produce, or assemble the evidence and to participate in required meetings.
- CROs and private sector researchers may incur additional costs to tailor studies to meet agency recommendations.
- Small manufacturers with OTC products may face new or shifted costs to generate evidence that meets the
Key Issues
The Core Tension
Balancing the desire for faster, more transparent regulatory guidance with the need to safeguard thorough evidence review and uniform application across diverse OTC monograph cases.
The bill introduces a more collaborative, transparent process for OTC monograph determinations by mandating meetings and an auditable record when evidence is insufficient. While this can improve guidance and reduce back-and-forth, it also imposes additional administrative tasks on the agency and on applicants who must prepare and respond to agency recommendations.
The practical impact hinges on how consistently the least-burdensome standard is applied and whether the meeting process accelerates or delays final determinations in particular cases.
Try it yourself.
Ask a question in plain English, or pick a topic below. Results in seconds.