In July 2018 the FDA issued a Draft Guidance for Industry on Innovative Approaches for Nonprescription Drug Products. There are three key takeaways.
- First, with this Draft Guidance, the Agency gives Sponsors permission to consider innovative approaches beyond the Drug Facts Label (DFL), when the DFL alone is insufficient to assure safe use in a nonprescription setting. The draft also documents that the Agency believes it has the authority to approve ‘additional labeling’ beyond the DFL if that labeling can be shown to improve outcomes in over-the-counter (OTC) self-selection studies.
- Second, while the Draft Guidance discusses “two” innovative approaches, they are difficult to distinguish from each other. (Discussed further below.) In reality, there appears to be only one innovative change which is that the FDA will now consider approving something incremental to the DFL that a Sponsor proposes for testing in a self-selection study and for use in marketing.
- Third, the FDA’s over-riding message is that each Rx-to-OTC switch is unique and the merits of each proposal will depend on the appropriateness for each switch and the circumstances of the particular drug under consideration. Thus, the Draft Guidance invites a case-by-case discussion between the Sponsor and the Agency for using something incremental to the DFL.
Let’s look deeper. The Agency’s first innovative approach is titled “Labeling in Addition to the DFL for Nonprescription Drug Products”. Labeling examples provided by the Agency include:
- Leaflets inside the package (which have long been common in OTC switches)
- Video display messages
- Website information
- Statements or questions on a mobile app
This is where the Agency explicitly says that they “may” approve additional labeling, thus documenting their conclusion that they have the authority to do so.
The second innovative approach, titled: “Nonprescription Drug Products with Additional Conditions for Safe and Effective Use” poses more interesting possibilities. Examples include:
- A mobile app self-selection test conducted prior to purchase that affirms a consumer’s appropriateness to use the OTC product
- Consumer affirmation, again performed prior to purchase, that they have viewed a text or video that describes how to use the product appropriately
If a Sponsor chooses to use an ‘additional condition’, the Agency writes, the Sponsor should consider how to ensure proper implementation of it. However, the Draft Guidance does not explicitly say that a Sponsor must demonstrate that the consumer will actually use the ‘additional condition’ once it is available to the consumer. Nor does it say that the pre-purchase text or video viewing has to positively influence a consumer’s self-selection decision.
Perhaps these apparent loopholes are subject to the inherent linkage between the two innovations mentioned in the Draft Guidance. Clearly, any ‘additional condition’ would obviously require content in the form of text or images or both. Hence, it becomes ‘additional labeling’, which is covered in the first innovative approach. Further, any ‘additional labeling’, including the explicitly written mobile apps or videos, are subject to FDA approval. Such approvals are based on data, data that demonstrates the labeling leads to self-selection at performance thresholds established with the FDA. Hence, the two approaches are inextricably linked.
In short, the Draft Guidance can be simplified into three short sentences:
- If a Sponsor intends to use more than the DFL to achieve proper self-selection and use, the Agency will consider it as additional labeling subject to approval.
- In doing so, the Sponsor should demonstrate that the consumer will use/read the incremental labeling, and that it delivers the agreed performance thresholds.
- Sponsors must discuss such initiatives with the FDA because every switch is different.