File this under ‘let’s see if anyone at the FDA is paying attention.’ Before distributing or airing various promotional materials, drugmakers are required to submit these items to the FDA for review. Why? The agency wants to make sure the materials include all the necessary safety and efficacy information. Every drugmakers knows this – and certainly, the largest drugmakers have regulatory and marketing personnel to plan for these submissions accordingly. izer, nonetheless, managed to run afoul of the FDA with a promotional brochure for its Zithromax antibiotic. And Pfizer ran afoul in a big way. Its brochure was deemed false or misleading because it omitted and minimized important risk information, made unsubstantiated superiority claims, omitted material facts, broadened the indication for the drug product, made misleading efficacy claims and made unsubstantiated claims, according to a June 19 untitled letter. Another way of looking at this is what did Pfizer not do incorrectly?
