Adverse Event Reporting A Missed Opportunity

AER BoogeymanWhen asked what the # 1 concern pharmaceutical marketers have regarding using social media, the adverse event reporting (AER) boogey man is cited most often.

Many marketers hope the FDA will issue guidance to help them neutralize the boogey man, but that is not likely to happen any time soon. In fact, I’ve heard that DDMAC won’t be issuing those guidelines (see, for example,, but has handed the job over to another division of the agency. In my mind that does not bode well — at least DDMAC is the devil we know!

Meanwhile, a recent Supreme Court ruling may have greater repercussions for adverse event reporting by the drug industry than any guidelines the FDA may issue. The urge to avoid this boogey man at all costs may have more to do with CEO compensation that with fears of rank-an-file marketers.

Read this entire OpEd piece by John Mack here: