As we noted earlier this month, the Food and Drug Administration (FDA) published a Notice for Comment regarding the Examination of Online Direct-to-Consumer Prescription (DTC) Drug Promotion. The Notice, which solicits comments on three proposed consumer studies testing different ways of presenting benefit and risk information in on-line DTC prescription drug websites, reveals how far away FDA is from issuing guidance on key issues of concern to industry, including social media.
In response to this notice, The Advertising Coalition submitted comments, which focused on assuring that FDA’s regulation of DTC advertising, including online promotion, continues to protect the public health while at the same time retaining the ongoing viability of these communications.
The Coalition is comprised of national trade association whose members are engaged in the development and dissemination of DTC advertising. Members include advertisers, advertising agencies, broadcast companies, cable operators and program networks, and newspaper and magazine publishers with substantial interest in online and new media.
Coalition Comments
One of the problems the Coalition identified with the proposed studies is that by the time the proposed surveys are finally designed, approved by the Office of Management and Budget, fielded, analyzed, the results made publically available, and then acted upon by FDA, it is virtually certain that the media being studied will have changed in ways not envisioned in the research. Essentially, the Coalition pointed out that FDA’s research now may no longer be particularly relevant when it is completed. A summary of the studies are noted below.
First, the Coalition argued that FDA should not delay issuing draft internet guidance, including the social media, pending the availability of the additional evience that the proposed studies are intended to yield.
The Coalition pointed out that FDA has collected “ample information in the course of its November 2009 two-day public hearing on promotion of FDA-regulated products using the Internet and social media, and in the ensuing written comment period, to develop much-needed guidance on key issues of concern.”
Moreover, FDA is already behind on issuing this guidance, which the agency promised by the end of 2010, and then later to the end of the first quarter of 2011. Eventually, this could mean that FDA could delay issuance of any draft guidance on DTC Internet promotion, including the use of social media, for a protracted and indeterminate length of time.
As a result, the Coalition noted that industry is now left with ad hoc agency enforcement actions with respect to DTC Internet promotion, including fourteen notices of violation (NOVs) that the Division of Drug Marketing, Advertising, and Communications (DDMAC) sent on April 2, 2009 to the pharmaceutical industry. However, the Coalition asserted that these types of enforcements, including warning letters, have a “serious chilling effect on protected speech, such as DTC communications, which the FDA has acknowledged may be of high public health value.
Accordingly, the Coalition encouraged FDA to proceed with the issuance of draft guidance even as the proposed consumer surveys are undertaken, and should the results alter FDA’s thinking, there is no legal impediment to the agency’s medication of the draft guidance at a later date.
Second, the Coalition asserted that the FDA should adopt a context-based approach to fair balance that does not categorically prohibit use of conspicuous hyperlinks to provide risk information.
Specifically, the Coalition asserted that FDA must take immediate action with respect to the use of hyperlinks to provide risk information. The Coalition noted that, “guidance by the FDA on this point alone would remove a substantial and needless barrier to the use of new media that is often constrained by space limitations on the maximum content that can be displayed at any single moment in time in a given promotional execution.”
Additionally, the Coalition argued that FDA should not categorically preclude the use of conspicuous hyperlinks to provide risk information in prescription drug promotion. Instead, they argued that FDA should import the concept of context into its evaluation of whether hyperlinked risk information is functionally and practically available and thus is part and parcel of the integrated advertising execution and hence satisfies regulatory fair balance requirements.
The Coalition also recognized that adopting a contextually-based regulatory approach would be in full accord with applicable legal and regulatory requirements, and consistent with an appropriate and enlightened policy on the subject, analogous to the approach to information disclosure via hyperlinks taken by a sister agency, the Federal Trade Commission. The Coalition also pointed out that contextual evaluation of risk disclosure via conspicuous hyperlink is explicitly supported by the U.S. Supreme Court’s discussion in Kordel v. United States.
The Court reasoned that, “one article or thing is accompanied by another when it supplements or explains it, in the manner that a committee report of the Congress accompanies a bill. No physical attachment of one to the other is necessary. It is the textual relationship that is significant.”
Based on this reasoning, the Coalition argued that FDA has no justification to ignore context entirely and to categorically preclude the provision of information in prescription drug promotion through the use of conspicuous hyperlinks.
Finally, the Coalition asserted that the proposed studies do not take account for multiple executional elements simultaneously at play in internet drug promotion nor the broader online informational milieu.
The Coalition noted that FDA’s proposed research techniques are uncertain and inadequate because the online environment is multi-dimensional, and the proposed studies appear to be better suited for static environments where cause and effect can be determined by isolating a single variable. In addition, the Coalition argued that the proposed studies fail to address and consider how individual online promotional executions are affected by the broader health information environment in which they appear.
Specifically, the Coalition recognized that online prescription drug advertising must be assessed in the context of the online health information-seeking behavior that is by now a familiar part of our everyday lives. Consequently, they asserted that any fair evaluation of the adequacy of “fair balance” must somehow assess this broader multi-factorial environment.
Check back with more information about the FDA’s proposed studies, comments, and changes to the proposed studies.
FDA DTC Proposed Studies
The purpose of study 1 is to investigate whether the presentation of risk information on branded drug Web sites influences consumers’ perceptions and understanding of the risks and benefits of the product. FDA will examine the format (e.g., whether the risk information is presented in a paragraph or as a bulleted list) and visibility (i.e., the risk information can be seen without scrolling down versus the risk information cannot be seen without scrolling down) of risk information on the homepage of a prescription drug Web site.
The purpose of study 2 is to investigate how special features such as personal testimonial videos and interactive visuals on branded drug Web sites influence perceptions and understanding of the risks and benefits of the product. FDA will examine these special features in the context of the prominence of the presentation of risk information in two levels, more prominent and less prominent. An example of a more prominent display of risk information might involve including the risks as part of the spoken testimonial, whereas a less prominent display may involve a scrolling text of the risks after the animated video.
The purpose of study 3 is to investigate whether links to and citations from external organizations referenced on the homepage of branded drug Web sites influence consumer perceptions and understanding of the risks and benefits of the product. FDA will examine two types of information: Hyperlinks to the external organization’s Web site (e.g., a link to a National Medical Association) and citations from an external organization (e.g., a citation to a National Medical Association’s guidelines). FDA will also examine the type of organization (e.g., nonprofit or online health community).
In these three studies, participants will be randomly assigned to view one version of a (fictitious) prescription drug Web site. After viewing the Web site, participants will answer a series of questions about the drug. FDA will test:
- How the manipulations affect outcomes such as perceived efficacy,
- Perceived risk
- Behavioral intention, and
- Accurate understanding of the benefit and risk information.
In each study, the fictitious prescription drug will be for the treatment of a high prevalence medical condition and modeled on an actual drug used to treat that condition. Participants will be consumers who have been diagnosed with the medical condition of interest.