PhRMA May Be Shooting Itself in the Foot by Criticizing FDA DTC Studies

As reported by RAPS (here), the Pharmaceutical Research and Manufacturers of America (PhRMA) is"harshly criticizing the US Food and Drug Administration's (FDA) research focused on prescription drug advertising and promotion and calling for a clearer vision on how this research protects public health.""FDA has proposed to undertake projects in a variety of disparate topics without articulating a clear, overarching research agenda or adequate rationales on how the proposed research related to the goal of further protecting public health. Within the last year, the Agency has increased such efforts at an exponential pace," Kelly Goldberg, PhRMA vice president and senior counsel for biopharmaceutical regulation, and Ryan Kaat, senior director of law, wrote in comments published 11 August on an FDA notice."PhRMA has long sought to ease FDA's rules on advertising and promotion particularly as FDA last November held a meeting to consider the off-label promotion of drugs with some regulations," noted RAPS. Some FDA officials at that meeting, however, questioned industry's arguments and motives for loosening regulations on off-label promotions (read “Ex-FDA Commish Califf Says #Pharma Needs a Code of Ethics to Prevent ‘Misleading’ Off-Label Marketing”).But now, PhRMA is taking FDA to task for proposing new studies"seemingly without fully appreciating its own previous research" and some proposed studies"are often unnecessa...
Source: Pharma Marketing Blog - Category: Pharmaceuticals Tags: DTC Advertising FDA PhRMA Study Source Type: blogs