Case 4 “Efficacy”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

lachydrinThe fourth case is in the area of efficacy, specifically dermatological efficacy. I think this has always been fascinating to me. That’s why I wanted to share a range of over-the-counter brands like Keri Lotion and PreSun, a high SPF sunscreen product, as well as prescription brands, particularly Lac-Hydrin and Botox, a well-known injectable product.

Now the key claim for these products range from simply treating dry skin to aging skin. There was actually a big difference between showing the signs and symptoms of dry skin to PreSun, which was, because of the sunscreen component, could actually claim to prevent aging skin. From a prescription standpoint, Lac-Hydrin was able to show that it actually changed the profile of the skin, preventing a more medical form of dry skin called xerosis, but it was never able to claim that it could reduce the wrinkles caused by dry skin. Of course, Botox is well known for its claims to reduce wrinkles and a lot of medical indications as well, but the difference is Botox actually changes the structure of the skin and reduces the visible signs and the physical signs of facial wrinkles.

The regulatory lesson here, especially in dermatological efficacy, was the important differences in the over-the-counter monograph or direction for promotional claims of OTC products and then the OPDP review of prescription products, which had to be individually based on the product’s labeling.


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