Promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience reads the DDMAC letter to Eisai Medical Research. The ads mentioned show patients seemingly confused and then, after a talk with the doctor, better able to interact with family members. To DDMAC this is misleading; to consumers and caregivers of people with Alzheimer’s it communicates that maybe there are some medications out there that can help patients who have been effected by this terrible disease.
As I watched TV yesterday I saw several DTC drug ads whose creative could be interrupted as a claim of efficacy. Smile on the face of a Cialis couple ? Can’t have that because the data shows that not everyone who takes Cialis is going to have a satisfactory sexual experience.
A lot of people are wondering what the FDA & DDMAC are going to do when it comes to social media and DTC ads. In fact a lot of drug companies are taking a very conservative approach when it comes to new media like Twitter or Facebook. Letters like these are going to cause a lot of legal and regulatory to put their pens away as they try and determine if the creative is an overstatement of efficacy. It just became a lot harder for DTC marketers.
Tags: creative, data, DDMAC, drug-companies, DTC, eisai-medical, fda letters, more-effective, reads-the-ddmac, Social Media, terrible


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