June 27, 2011 — The Food and Drug Administration (FDA) should move forward with its social media/Internet guidance and not wait for the results of the three studies it recently announced it would conduct to test benefit and risk information presentations on direct-to-consumer (DTC) prescription drug Web sites, according to comments submitted to the FDA today by The Advertising Coalition in response to an April 28 Federal Register notice.
“Patients, health care providers and the industry need the FDA to provide Internet and social media guidance as soon as possible,” said John Kamp, executive director of the Coalition for Healthcare Communication (CHC). “Good research is always valuable, but guidance is what is needed right now.”
Accordingly, the comments state, “The [Advertising] Coalition encourages the FDA in the strongest possible terms to proceed with the issuance of draft guidance even as the proposed consumer surveys are undertaken.”
The comments also note that because online media are volatile, what the FDA learns about consumer preferences or comprehension today might no longer apply in the near future, that a lack of guidance may be stifling DTC outreach and that the FDA should address the permissibility of hyperlinks to provide risk information in the forthcoming draft guidance.
The Advertising Coalition represents U.S. advertisers, ad agencies, media and media-related companies engaged in the development and dissemination of DTC prescription drug advertising. The CHC participates in The Advertising Coalition through the American Association of Advertising Agencies (4As).
Industry Needs Guidance Now
The Advertising Coalition’s comments state that although the FDA may seek additional evidence to support its guidance, the agency already has enough information to develop new media guidance. Further, the Coalition asserts that the results of these FDA studies will represent only a snapshot of consumer input in an ever-changing online environment.
“Certainty is an elusive goal, particularly when it comes to studying the effects of particular executional techniques in dynamic new media that are evolving rapidly in real time,” according to The Advertising Coalition. If the agency issues guidance now, “there is surely no legal impediment to the agency’s modification of the draft guidance at a later date,” the comments state.
“The uptake of the new media by patients, caregivers and professionals is simply astounding,” added Kamp. “Industry must participate to ensure that quality information is available. FDA guidance would reduce regulatory risk and support wider industry participation,” he said.
In the wake of ongoing delays from the FDA regarding this guidance, DTC advertisers are left tracking ad hoc agency enforcement actions – Notices of Violation and Warning Letters – to determine what is and is not permissible DTC Internet promotion, a situation that can hinder the positive benefits of DTC promotion.
“While regulation through enforcement may have in terrorem effects that FDA perceives as beneficial, this approach has a correspondingly serious, chilling effect on protected speech, such as DTC communications, that FDA has acknowledged may be of high public health value,” the comments state.
Fair Balance Should Be Determined by ‘Net Impression’
The Advertising Coalition also objects to the FDA’s current enforcement position that hyperlinks are not an appropriate mechanism to provide risk information in online DTC marketing. Arnold I. Friede, Arnold I. Friede & Associates, who authored The Advertising Coalition’s comments, previously told CHC that the FDA’s “categorical rejection” of the use of hyperlinks to provide risk information is “inconsistent with the approach FDA has taken in other analogous contexts.”
Quoting a 2009 FDA guidance, the Coalition’s comments state that the FDA at that time acknowledged the need for contextualizing both risk and benefit information. “This proposition that risk communication be evaluated based on overall ‘net impression’ and what ‘the piece as a whole conveys’ is congruent with the notion that conspicuously hyperlinked risk information, depending on context, is as much part and parcel of an advertising execution as any information that appears on the face of the promotional piece itself,” according to the comments.
The comments also reference a U.S. Supreme Court case (Kordel v. United States) discussion which states that depending on context, one piece of information can accompany another and be deemed labeling without physical attachment between the two.
Additionally, The Advertising Coalition points out in its comments that the FDA should take into account the limitations of using traditional research techniques to better understand multi-faceted and fast-changing media. By the time the research results are available, the comments state, “it is virtually certain that the media being studied will have changed in ways not envisioned in the research.”