FDA's 45-day TV ad review

TV ads for most prescription drugs must be submitted to FDA for pre-review 45 days before the manufacturer intends to air them, according to an FDA draft guidance in tomorrow's Federal Register. The guidance isn't a bolt from the blue but rather a case of the agency catching up on old business – in this case, a clause in the 2007 FDA Amendments Act (FDAAA) authorizing the agency to “require the submission of any television advertisement for a drug … not later than 45 days before dissemination of the television advertisement.”