The ad shown on the left is the subject of an FDA/OPDP “untitled letter” (definition), which took aim at a Sunovion professional print ad for seizure med Aptiom.
According to the FDA reviewer of the ad: “Although Aptiom may reduce seizure frequency, FDA is not aware of substantial evidence demonstrating any effectiveness of Aptiom on patients’ feelings of confinement associated with seizure.”
A typical letter for a typical drug ad seen in a physician-targeted publication/journal.
Imagine, if you will, a parallel world in which exists a trade publication for pharmaceutical legal/regulatory professionals. Let’s call the publication Modern Pharma Guidance™.
I envision this mag containing articles that review FDA guidance documents and the industry’s response to those guidances. You know, very similar to these Pharma Marketing News articles: PhRMA Tells FDA How It Wants to Correct “Misinformation” and FDA Tweet Blocks Pharma.
What would the ads look like in Modern Pharma Guidance, assuming the ads are designed by the same agencies that design drug ads in physician journals?
I imagine this ad goes on to promote the services of some consulting agency that overstates its ability to help pharmaceutical marketers create social media ads that comply with FDA guidelines. Unlike physicians, pharma marketers would have no governmental agency protecting them from such ads.
If you are employed by such an agency, talk to me. I can work with you on a version of this magazine powered by “content marketing.” You know what I mean, right? There are a lot of pharma marketers out there that need help overcoming the confinement of FDA regulations. We can make a lot of money!