Guidance Breakdown: Formal Dispute Resolution and Administrative Hearings Under Section 505G
What OTC monograph manufacturers and requestors need to know when challenging a Final Administrative Order.
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Back in December, the FDA issued a procedural guidance that closes a gap in the OTC monograph modernization framework: how companies can formally challenge a Final Administrative Order issued under section 505G of the FD&C Act.
The guidance—Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G—explains how the CDER expects scientific and medical disputes over OTC monograph decisions to be handled once the FDA has issued a Final Order.
The guidance applies to OTC monograph drugs governed by section 505G, Final Administrative Orders issued under section 505G(b)(2) or expedited orders under 505G(b)(4), and Scientific and/or medical disputes arising from those Final Orders.
Eligible parties include requestors (any person or entity marketing, manufacturing, processing, or developing an OTC monograph drug) and sponsors (entities marketing, manufacturing, or processing a drug listed under section 510(j)). So, if you are not directly subject to the Final Order (or did not participate in required earlier steps), you may not be eligible to challenge it through these pathways.
If you manufacture, market, develop, or process OTC monograph drugs (or submit OMORs), this document effectively defines the only structured pathway to challenge the FDA’s final scientific determinations without going straight to court.
To be clear, these procedures directly affect:
Whether an OTC product can legally remain on the market.
Whether a condition is deemed GRASE or not.
Whether labeling, formulation, dosage, or route of administration must change.
Whetherthe FDA’s scientific judgment becomes final and unreviewable.
We’ve briefly broken down what the FDA is doing here, who can use these pathways, how they work in practice, and where companies commonly misunderstand their options. Industry to communicate and respond at each phase of the inspection lifecycle.
Why the FDA issued this guidance
The short answer: Congress required it!
Section 505G was added to the FD&C Act by the CARES Act in 2020, replacing decades of informal OTC rulemaking with an administrative order system. Under this system, the FDA issues proposed orders and Final Orders determining whether OTC drugs are GRASE.
But Congress also required the FDA to provide formal mechanisms to challenge those Final Orders, including:
Formal Dispute Resolution (FDR) up to the Director of CDER.
Administrative hearings after FDR is exhausted.
Consolidated proceedings when multiple parties are affected.
Section 505G explicitly directs the FDA to describe these processes publicly. This guidance fulfills that mandate and replaces piecemeal references scattered across prior FDR guidance and internal practices.
What this guidance does—and doesn’t—do
The FDA is very explicit about the scope here. What it does:
Defines who may request FDR or a hearing.
Defines what types of disputes are eligible.
Establishes strict timelines and procedural requirements.
Explains howthe FDA reviews, accepts, denies, or consolidates requests.
Clarifies confidentiality and public disclosure expectations.
What it does not do:
Create any new legal rights.
Expand the FDA’s authority.
Apply to NDAs, ANDAs, or biologics.
Cover judicial review or litigation strategy.
Allow new data or new analyses to be introduced.
Formal Dispute Resolution (FDR): what it is and when it applies
The FDA is clear that FDR is only for scientific and/or medical disputes. Under this guidance, it’s appropriate when an eligible requester or sponsor disputes the FDA’s determination in a Final Order regarding:
Whether a drug is subject to prescription-only requirements.
Whether a drug, class, or combination is GRASE under section 201(p)(1).
The scientific basis for the FDA’s final monograph conditions.
This mirrors the FDA’s longstanding view that FDR is not a policy debate. It’s a mechanism for reviewing scientific disagreements.
The guidance draws bright lines here! You cannot request an FDR for proposed orders, interim Final Orders, meeting minutes, Advice letters or informal correspondence, or issues being pursued simultaneously through other FDA channels.
The FDA explicitly discourages parallel regulatory or legal actions while an FDR is pending, so don’t be surprised if duplicative escalation may weigh against acceptance.
Timing matters more than most teams realize
One of the most operationally important aspects of this guidance is how unforgiving the timelines are. Key deadlines include:
45 calendar days to request FDR after issuance of a Final Order.
30 calendar days for each subsequent level of appeal.
No acceptance of late requests.
No appeal to the next management level until the prior level is complete.
For expedited orders, the FDA may shorten timelines to ensure hearings conclude within the statutorily required 12-month window. From a risk standpoint, this means companies must prepare a dispute strategy immediately upon issuance of a Final Order, not weeks later.
No new data means no second chances
One provision that might get misunderstood in this guidance is the FDA’s position on new information. FDA states plainly: No new data may be submitted. No new analyses of previously reviewed data may be submitted. Even re-analysis of existing data is considered “new information.”
The deciding official’s review is strictly limited to what was already in the administrative record at the time the Final Order was issued. Practically speaking, this means your public comments during the proposed order stage matter enormously. Weak or incomplete submissions cannot be “fixed” during FDR, and FDR is not a “do-over.” It’s a structured appeal of the FDA’s interpretation of the existing record.
Expect public visibility!
Unlike many FDA dispute processes, OTC monograph proceedings are generally public. The FDA explains that FDR submissions may be made publicly available upon submission, and hearings are generally public. Only limited categories of information remain confidential (e.g., certain pharmaceutical quality information and raw datasets).
Importantly, FDR meetings themselves are not open to the public, but the materials submitted often are. From a communications standpoint, this means companies should assume:
Arguments may be read by competitors.
Positions may become part of the public monograph record.
Internal alignment and messaging discipline are critical.
How the FDA actually processes an FDR request
Once submitted through the CDER NextGen Portal, the process unfolds like this:
Preliminary review. FDA evaluates eligibility, timeliness, and whether consolidation is appropriate.
Acceptance or rejection letter. Within 30 calendar days of the request window closing, the FDA issues an acceptance or rejection.
