When I was at the FDA and we announced a new draft guidance on DTC print advertising, Dr. McClellan commented that when it came to the brief summary “less may indeed be more.”
Today the agency is calling for more research into this issue — but solid metrics already exist. Right now, as we speak, the FDA possesses a broad body of high quality research that has been conducted on the brief summary — with protocols reviewed and commented on by the folks at DDMAC.
The news item below is all well and good — but calling for more research is a poor excuse for lack of action on this important public health issue.
(FYI — Inside the agency the brief summary is often derided as being like the Holy Roman Empire — it is neither brief nor a summary).
FDA Will Survey Consumers on Brief Summary
The FDA plans to survey consumers on the content and format of the brief summary in direct-to-consumer ads, according to an advance Federal Register notice released April 24. “In recent years, FDA has become concerned about the adequacy of the brief summary in DTC print advertisements” because the detailed, technical prescription drug information geared toward physicians increasingly was used in ads for the public as a way for advertisers to fulfill the vague brief summary requirements, the notice states.
The FDA plans to investigate the role of context in providing useful information to consumers, such as comparing consumer perceptions after viewing mock ads with risk information in chart or paragraph form. The agency also will study whether listing side effects and placebo rates of occurrence influences perception. Additionally, the FDA will survey the effectiveness of brief summary information provided in question-and-answer, highlights and drug facts formats. The agency will accept comments for 60 days after publication in the Federal Register under docket number 2006N-0133.