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Innovation In OTC Switches Takes Multimedia Approach In US FDA Draft Guidance

 
• By Malcolm Spicer

Sponsors can point consumers to video displays, website information and mobile apps to help them choose products that have been switched from Rx to OTC. Draft guidance on innovative switch applications to be followed by rule-making in near future.

Woman using touch screen mobile phone with blur shopping mall

FDA's new approach for making more Rx drugs available over-the-counter, particularly for chronic conditions, allows sponsors to tap into digital media and other tools to help demonstrate that consumers can assess whether an OTC drug is appropriate for them and they can use the product safely.

Sponsors proposing Rx-to-OTC switches must show that a consumer can select a product and use it safely without a physician's intervention. Existing regulations require that a consumer must be able to make this evaluation using only information in an OTC product's Drug Facts label (DFL)

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