FDA Research Protocols On DTC Brief Summary Info To Be Finalized In Fall

FDA expects to finalize internal protocols this fall for agency-conducted studies on the brief summary information in direct-to-consumer ads.

The Center for Drug Evaluation & Research's ad division plans to conduct three studies to assist its development of a final guidance on brief summary content and format.

The agency issued a draft guidance in February that proposed alternative formats to the brief summary of risk information. The draft recommended that ad sponsors avoid using technical and medical language and proposed eliminating infrequent, less severe risks from the brief summary (¹ (Also see "Risk Information “Window” Proposed By FDA For DTC Print Ads" - Pink Sheet, 9 Feb, 2004.), p. 4).

The Division of Drug Marketing, Advertising & Communications presented an update on its brief summary research activities during a Food & Drug Law Institute meeting Sept. 13.

FDA's initial study is expected to encompass 600 individuals at eight shopping malls. The agency will survey consumer responses to a mock weight-loss drug ad to analyze the effectiveness of language and risk information in the brief summary.

FDA said the high incidence of obesity was one reason for choosing a mock weight-loss drug.

"We wanted it to be a realistic category," DDMAC Social Science Analyst Amie Braman, PhD, said. "And, of course, it would be a bonus if it was a timely issue and if it was a public health concern, since we are a public health agency."

FDA noted that the DTC campaigns for weight-loss drugs have not been widespread, which would mean that patients would not have significant prior experience with brief summaries for real products.

Roche attempted a product-and-use campaign for its weight loss therapy Xenical (orlistat), but shifted to unbranded and reminder ads to avoid addressing GI side-effects. An unbranded TV ad drew an FDA letter for referencing the "XeniCare" patient support program (² (Also see "Roche Xenical Ad "XeniCare" Reference Removed After Drawing FDA Letter" - Pink Sheet, 21 May, 2001.), p. 14).

FDA's "first study is a two-by-two design," Braman said. "The first factor that we're going to be looking at is language, consumer-friendly language versus medical language."

"This has not been studied in the DTC application at this point. We want to really get some cold, hard data on the issue of consumer-friendly language versus medical language in a brief summary format," she said.

"The second factor that we plan to look at in this first study is risk severity," Braman said.

"There are large differences, as you know, among drug classes," she said. "We plan to look at this issue within the same drug class so that we can really look at whether it is risk severity that might play a role in how people process information in a brief summary."

The goal of the first study is to determine why and how consumers use the brief summary information. The ad division will then conduct two more studies before issuing the final guidance.

FDA expects to begin collecting data by spring 2005. While the data collection is not expected to take long, the agency conceded that the final guidance is unlikely to be issued soon.

"This research on brief summary is going to be very important to us," DTC Review Group Leader Melissa Moncavage said. "I think that before issuing a final guidance, we'd like to see the results of this" and "other research right now being conducted."

"We'd also be interested in getting the final results of that research being conducted by outside organizations. So, it's going to be awhile," she added.

At a Drug Information Association meeting in June, a University of Georgia professor presented research indicating consumers prefer that the brief summary appear in a question-and-answer format compared to other layouts (³ (Also see "DTC Brief Summary: Consumers Prefer Q&A Format Over Others" - Pink Sheet, 21 Jun, 2004.), p. 10).

Pending release of a final guidance, FDA wants companies "to try out these suggested alternative methods" outlined in the draft, Moncavage said.

"We'd still like to see companies look at the guidance and try to apply it. That will help us also as we are thinking about what the final guidance should look like."