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)