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561 - I realize that ads with only name, price, and/or quantity are considered exempt. If I was to compare the price of Drug X to Drug Y, and have a statement that said "Drug X offers a __% savings vs Drug Y", would this be considered promotional and render it non-exempt?
FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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PAAB code section 1.5 addresses what is considered exempt. It states that “company price lists containing no therapeutic claims, price comparisons or claims of company or product merit, status or issues” are exempt. As a claim of “offers savings vs a competitor” would be viewed as a price comparison, this message would not be exempt.
