Direct-to-consumer marketing is a topic of regular interest to regulators with the US Food and Drug Administration. At various times during the past several years, it has announced studies involving the use of composite scores in DTC advertising, the affect of DTC advertising on healthcare professionals, and corrective advertising resulting from improper DTC marketing.

Now it's making some substantial changes to a DTC study first approved in 2011, according to documents published on the Office of Management and Budget's (OMB) website.

The study, entitled "Experimental Study of Comparative Direct-to-Consumer (DTC) Advertising," was first approved in 2011 as a new collection of information. Under federal law, all such studies involving the public and a federal agency must first be approved by OMB's Office of Information and Regulatory Affairs (OIRA) and be subjected to a period of public comment.

In the past, companies have used that opportunity to comment to propose changes to the studies, including the addition of new questions, edits to existing questions, and the deletion of others that were deemed to be inappropriate.

Correlating Data

But industry isn't the only one interested in getting more information out of the study, as OMB's documents show.

In a new information collection request submitted to OIRA on 23 July 2013, FDA-which did not submit a Federal Register notice regarding the request-explained that it's looking to "correlate four questions" from an existing health survey conducted by GfK with several of its own questions from the Comparative DTC survey.

FDA takes pains to note that it is "not requesting additional data" to be collected. Rather, it's looking to take information from the GfK survey and compare it against its own data "to explore some additional relationships"-information that should be of interest to almost anyone who works in the highly-regulated pharmaceutical marketing sector.

One of the questions pertains to how difficult a patient finds it to pay for his or her prescription medication, with answers ranging from "not at all difficult" all the way up to "extremely difficult."

Focus on Internet and Social Media

Another question looks to see how consumers are actually looking for information, be it from in-person sources or online. Possible choices include doctors, healthcare professionals, family, friends, disease associations, pharmaceutical companies, newspapers, the Internet (specifically including social media), television, or not at all.

A third and related question polled participants on what resources they use to find health and wellness information on the Internet, including health-related websites like WebMD, social media, search engines, blogs, pharmaceutical company websites, hospital websites, government websites, and news websites.

Given the pressure from industry for FDA to release a guidance document on social media use by industry, this could be seen as yet another instance of the agency trying to determine how consumers use social media to find healthcare information.

A fourth and final question relates to consumer behavior on the internet, and asks if consumers have participated in any of the following activities:

• signed up for an Internet-based newsletter
• communicated with a doctor or other healthcare provider via email
• read and/or posted a comment on a health-related blog
• participated in a live chat room
• read and/or posted a comment in an online forum or message board
• looked for quality ratings for physicians, hospitals, or clinics published by news journals
• looked for cost information for specific prescription drug treatments
• looked for cost information for specific doctors, hospitals, or clinics
• posted ratings or comments about a physician, hospital, or clinic on a health plan or other type of website

The point of the entire exercise is to allow FDA to "look at the relationships between these variables and perceived risk, perceived benefit, behavioral intention, and source credibility from our existing questionnaire," it explained. "We expect that cost issues and information seeking tendencies will have direct effects on each of the dependent variables and that the relationship between these two independent variables and behavioral intention will be moderated by perceived benefit and risk."

OMB Notice