For the second time this week, FDA has announced that the Office of Management and Budget (OMB), the government's regulatory oversight body and clearinghouse, has signed off on a study it intends to conduct regarding correct advertising aimed directly at consumers, otherwise known as corrective DTC advertising.
The study was first announced in draft form in February 2012, when FDA issued a notice in the Federal Register saying it intended to research "how corrective advertising may impact consumer misperceptions about prescription drug product safety and efficacy."
While not as common as regular direct-to-consumer (DTC) advertising, corrective DTC advertising is nevertheless important because it is intended to make up for deficiencies identified in earlier advertising. For example, if a pharmaceutical company runs a two-page advertisement in a popular magazine misstating the risks of a product, FDA might require it to run a corrective advertisement soon thereafter to alert the same readers to the accurate risks of that product, as well as an accompanying notice explaining why the advertisement is running again.
FDA's Office of Prescription Drug Promotion (OPDP) cites the 2009 example of an advertisement run by Bayer Healthcare on its website, saying that the company "produced and aired corrective advertising for Yaz, a birth control pill, following a warning from FDA regarding misleading claims."
But even though FDA requires corrective advertising in such cases, it concedes a surprising point: It isn't sure if they actually work as intended.
"Researchers and policymakers currently lack empirical literature regarding the various influences of DTC corrective ads on prescription drug consumers," FDA explains. And that's where its now-cleared research study on corrective DTC advertising comes into use.
A Study of Three Variables
FDA explained in its original Federal Register notice that it wanted to look at three independent variables: Message exposure, similarity of the original and corrective ads, and the length of time between exposure to the original advertisement and the subsequent corrective advertisement.
Those variables would be assessed through a two-phase study. Phase 1 would seek to determine how people react to corrective DTC advertising when they have already seen the original advertisement, and gauge their assessment of the product's risks, benefits and correct use of the drug. A group of people who have only seen the original, incorrect advertisement would be used as a control group.
Phase 2 of the study would look at the remaining two variables, those being the time between exposure and the similarity of elements studied. The phase is intended to study whether either variable affects a viewer's assessment of the corrective advertising.
At the time of the initial Federal Register notice, FDA said it anticipated the study would take about 3,092 hours to complete-a relatively large undertaking by FDA standards. However, new estimates approved by OMB seem to have increased that time burden substantially, and FDA now estimates the study will take 5,496 hours and three years to complete. Approximately 6,650 people will actually be eligible to participate in the study, FDA noted.
FDA noted that the large number of respondents is necessary to account for drop-out over the course of the longitudinal study. Similar studies are known to lose between 15-25% of respondents after the first year.
Obese Study Participants and Gamification
Study participants will be individuals with a body mass index (BMI) greater than 25-in other words, overweight or obese-who will be asked to see an as-yet-undefined advertisement. FDA hypothesizes that the corrective advertisement is effective, and that the effect will be pronounced when the ad is similar in style to the original and seen soon after the original ad.
Another interesting point from FDA's explanation to OMB: It plans to use a sort of "gamification approach to ensure survey participants remain engaged in the survey. Phase 1 respondents will receive up to 20,000 "points" with a real-life value of about $20, while Phase 2 respondents are eligible for up to 40,000 points. Those points are then redeemable for gifts and vouchers at a "partner network" involved with FDA, or for cash, raffle entries or sweepstakes.
The total cost of the study will be $103,874, or approximately one third of what it plans to spend on a similar study of the effects of DTC marketing on so-called "physician extenders" like nurses and physician assistants. The total cost to the government, however, including the creation of the study, analyzing the results, and programming the study, will be $1,158,859 over the three years.
Pretesting of the study is set to begin between April and June 2013, with data to be collected between September 2013 and June 2014, and final results available in February 2015.
FDA: Announcement of Office of Management and Budget Approval; Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising
FDA Docket on the Study
OMB's Summary Data About the Study
OMB Documents on the Study