- The Food and Drug Administration has submitted a proposal for a set of studies that would assess how consumers read and absorb risk information in direct-to-consumer print advertisements.
- Often, print ads for pharmaceutical DTC campaigns have a main page that gives quick hits of the drug's efficacy and safety, and then a separate page that offers a brief summary of those benefits and risks. However, 2002 survey data cited by the FDA found about 27% of responders said they read half or more of the brief summary page, versus 78% who reported reading "all" or "almost all" of the main page info.
- In that light, the FDA's proposal would use eye-tracking technology to better understand where and for what length of time consumers look while viewing a printed DTC ad. It includes two studies, each enrolling 200 participants and aiming to see how their attention to drug risks changes when the quick hits are long or short and the brief summary is there or not.
DTC campaigns for pharmaceuticals are quite controversial. While the industry argues DTC is a great way to connect with consumers and educate them about a disease or potential therapy, critics counter that the ads are just as — if not more — likely to misinform.
The concern is especially high for complex and life-threatening diseases, such as cancer.
"Indeed, there have been great successes with these drugs in a modest number of patients, but it's very important for people to understand that there's an equal number who have just side effects, or minimal benefit and the side effects," Lowell Schnipper, a professor of medicine at Harvard University, said of immuno-oncology drugs and their commercialization in a May interview with BioPharma Dive.
Several studies have looked into how DTC advertisements affect consumer understanding of marketed drugs. But conclusions have varied, fueling the continued back-and-forth between DTC advocates and naysayers.
Meanwhile, the FDA has taken a relatively hands-off approach to DTC. When looking at the warning letters the agency has made publicly available this year, just three came from the Office of Prescription Drug Promotion while 43 came from the Office of Manufacturing Quality.
The agency has been trying to better understand the risks and benefits of this marketing, however. It issued guidance in 2012 about DTC television advertisements, detailing — among other things — what a company should include when submitting a pre-dissemination package for such ads and the potential penalties for releasing a commercial that violates the Federal Food, Drug, and Cosmetic Act. Still, companies can launch DTC campaigns without having the agency review them first.
Print ads are gaining more attention from regulators too. The FDA gave notice last June that it was seeking public comment about the planned 200-person print DTC studies, as well as a smaller pilot study. Ultimately five public comments were submitted.
The next step is for the Office of Management and Budget to review and approve the studies.