Rx-to-OTC Switch & ACNU Innovation Strategy

The Work

An Rx-to-OTC switch is one of the highest-stakes regulatory and commercial decisions a consumer health or pharma organization makes. The investment in label comprehension, self-selection, and actual-use studies is substantial. The FDA bar is high. And the program can fail not on safety or efficacy, but on whether consumers can correctly self-select the product, understand the label, and use it appropriately without a clinician. The FDA's ACNU framework (Additional Condition for Nonprescription Use) opens a new path: nonprescription approval supported by an additional condition that helps ensure appropriate self-selection or use, such as a digital tool, test, or self-check. That changes what's feasible. It does not lower the bar.

RGM provides senior judgment at the points in a switch or ACNU program where the wrong assumption is most expensive to fix later — before the consumer-behavior studies are designed, before the FDA briefing strategy is committed, and before the program is locked into one pathway when another is the better fit. The work is grounded in decades of leading switch and consumer healthcare programs inside global organizations.

What's typically included

Switch feasibility assessment — senior read on whether a switch (traditional or ACNU-enabled) is realistic for the product, the indication, and the consumer use case, before significant investment.
Evidence & consumer-behavior requirements — framing what the program will need across label comprehension, self-selection, and actual-use studies, and where the current plan is under- or over-engineered.
ACNU pathway evaluation — structured assessment of whether an additional condition (digital tool, self-test, or other) could enable a switch that would not otherwise be feasible, and what that implies for the development plan.
FDA engagement strategy — meeting type selection, briefing strategy, and question framing specific to switch and ACNU programs.
Innovation roadmap — positioning a switch or ACNU program inside a broader consumer health innovation portfolio, including sequencing and commercial intent.

When this is the right conversation

Companies typically engage RGM here when a switch candidate is being evaluated and leadership needs a senior read before committing to consumer-behavior study investment; when an existing switch program is mid-flight and needs an outside view on what FDA feedback actually requires; when ACNU is being considered as the path that makes a previously infeasible switch viable; or when a consumer health portfolio is being shaped and switch/ACNU programs need to be sized against other innovation bets.

Output you can use

A feasibility read on the switch or ACNU candidate with the reasoning behind it. A sequenced view of the consumer-behavior and clinical evidence the program will actually need, separated from what it would be nice to have. An FDA engagement strategy tied to the program's open questions. Recommendations written for a development committee, a board, or an investor without further translation.

Rx-to-OTC Switch & ACNU Innovation Strategy

What's typically included

When this is the right conversation

Output you can use

Evaluating a switch or ACNU program?

Related Services

Regulatory Strategy & FDA Engagement

Innovation & Product Development Advisory

Women's Health Regulatory & Innovation Advisory