Looks like the FDA is getting down to some serious social science
According to the Pink Sheet, a study proposed by FDA to evaluate how benefit information is conveyed through direct to consumer advertisements could end up showing drug marketers how to describe "high" and "low" efficacy drugs.
The proposed study will evaluate how consumers' interpretations of a drug's efficacy after viewing DTC ads compare to the efficacy data in the product's label.
The study will be conducted in two concurrent parts - one looking at print ads and one at TV ads - and examine three factors: drug efficacy, visual format, and type of statistic.
The agency defines drug efficacy as a quantifiable, objective metric that can be conveyed in graphical representations of the drug versus placebo, with "high efficacy" meaning "noticeably better than placebo" and "low efficacy" meaning "minimally better than placebo."
The agency traditionally has discouraged companies from making such qualitative claims - or even making too much of quantitative numbers - in its advertising. But the proposed study endpoints suggest a growing FDA comfort with, and even an interest in, consumers receiving this kind of information.
Testing Pfizer-like pictographs
The study will examine graphs, pictographs and pie charts as ways to visually present that efficacy information, and whether statistical information is best conveyed as frequency, relative frequency, or percentage.
The test product will be for a cholesterol treatment and modeled on an actual drug, such as Pfizer's Lipitor (atorvastatin), with labeling used as the reference for defining efficacy levels and the objective metrics for clinical performances.
The study will include 4,500 participants, 2,250 in each group (television or print). The subjects will read or view one advertisement version, and then make a series of judgments about the drug in a 20-minute interview.
FDA first will test whether, within each format, the participants were able to distinguish between low- and high-efficacy drugs. Then, it will look at whether the participants' efficacy estimates differ across formats and how accurate the estimates are.
Comments on the proposed study, called "Experimental Study of Presentation of Quantitative Effectiveness Information to Consumers in Direct-to-Consumer Television and Print Advertisement for Prescription Drugs," are due by Aug. 21.
All to the good. And it sure beats the ignorant "drug facts box" – the a la nutrition facts panel idea,that’s being kept alive via legislation introduced by Senators Jack Reed (D, RI) and Barbara Mikulski, (D, MD) which, BTW, would also require comparative effectiveness information to be included in product labeling.
Vey
