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 unnecessary in light of existing data.”
PhRMA also takes exception to FDA research on “obscure topics,” such as “Spousal Influence on Consumer Understanding of and Response to Direct-to-Consumer Prescription Drug Advertisements” (read “Does Your Spouse Influence Your DTC Viewing Experience?”) to “Animation in Direct-to-Consumer Advertising.” (read “FDA Will Apply the ‘Uncanny Valley’ Hypothesis to Test the “Eeriness” of Animated Characters in Drug Ads”). See my SlideShare presentation (“Gallery of FDA Studies of DTC Advertising”) embedded at the end of this post.
But PhRMA may be “shooting itself in the foot” by criticizing FDA.
John Driscoll, a regulatory affairs consultant specializing in requirements for prescription drug promotion, said “One important point, however, is that these studies may not necessarily lead to more restrictive advertising policy. In fact, FDA just published findings of some of their research that indicated that *less* risk information in DTC ads may improve recall of the risks. Although this is not (yet?) reflected in any FDA policy, it is probably only by conducting studies like these that FDA would be willing to take a less restrictive approach in certain areas.”