The pharmaceutical industry lobbying group 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, Pharmaceutical Research and Manufacturers of America (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. FDA officials at that meeting, however, questioned industry's arguments and motives for loosening regulations on off-label promotions.
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."
In addition, the group notes that FDA has proposed research on obscure topics, ranging from "Spousal Influence on Consumer Understanding of and Response to Direct-to-Consumer Prescription Drug Advertisements" to "Animation in Direct-to-Consumer Advertising."
"We suggest that the Agency publish a comprehensive list of its prescription drug advertising and promotion studies from the past five years and articulate a clear vision for its research priorities for the near future," the comment said. A separate PhRMA comment published Wednesday also included the same criticisms.
Prescription drug advertising in the US (which is the only country in the world other than New Zealand to allow direct-to-consumer (DTC) advertising) has been increasing in recent years, with reports saying the total spend topped $5 billion in 2015. However, some groups, like the American Medical Association, have called to ban DTC advertising in the US. For its part, FDA began conducting its first public survey since 2002 on DTC ads in February 2016.
And some experts do not think that FDA's research into drug advertising and promotion may necessarily lead to more restrictive regulations.
John Driscoll, a regulatory affairs consultant specializing in requirements for prescription drug promotion, told Focus: "Ever since the 2009 risk guidance FDA has been referencing published literature in support of its policy/guidance positions. As there is limited available literature on many of these topics, I think FDA believes it has to conduct these studies itself to get good answers to their outstanding policy questions.
"One important point, however, is that these studies may not necessarily lead to more restrictive advertising policy," Driscoll added. "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."