Recently, the Food and Drug Administration (FDA) published a Notice for Comment regarding the Examination of Online Direct-to-Consumer Prescription Drug Promotion. The Notice, which solicits comments on several 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.
Background
FDA’s current regulation of advertising and promotion for prescription drugs derives largely from its immediate post-1962 regulation of doctor-directed print communications. While the agency adopted a policy in 1999 that recognizes to a limited extent the difference between advertising on television and in print, the paradigm of encyclopedic and contemporaneous risk disclosure that emerged in the context of physician-directed communications remains largely intact as applied to all communications, regardless of the medium or the target audience.
The article notes that FDA’s basic authority and paradigmatic approach remains largely unaffected even by the recent Food and Drug Administration Act Amendments of 2007 (FDAAA) that added a number of specific provisions on direct-to-consumer (DTC) advertising. In fact, the agency’s regulations continue to make the longstanding distinction between, on the one hand, promotional communications that are subject to an array of mandatory disclosures from “reminder advertisements” that are not, without acknowledging any differences that might be occasioned by the use of different media.
Today however, pharmaceutical products are launched and marketed in a number of new modalities and venues that did not exist a short time ago. Increasingly, prescription products are promoted to consumers online in such formats as banner ads, Web sites, and videos. The interactive nature of the Internet allows for features not possible with traditional media (i.e., print, radio, and television), such as scrolling information, pop up windows, linking to more information, and embedding videos.
FDA regulations require that prescription drug advertisements include a ‘‘fair balance’’ of information about the benefits and risks of advertised products, both in terms of the content and presentation of the information. All prescription drug ads that make claims about a product must, therefore, also include risk information in a ‘‘balanced’’ manner. Currently, there are a number of questions surrounding how to achieve ‘‘fair balance’’ in online DTC promotion.
After citing a few studies conducted on the effect of online DTC promotion, the FDA noted how the original regulations that presently determine FDA’s position on DTC promotion were written at a time when the available media for DTC promotion were print and broadcast, and the primary audience was health care professionals. This dynamic is shifting, and as a result, evidence is needed to support guidance development. Accordingly, the notice then goes on to describe a series of 3 studies the FDA will conduct to examine the issue of online DTC promotion, and a fourth that is qualitative.
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 the American Heart Association) and citations from an external organization (e.g., a citation to American Heart Association 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.
FDA and the Internet
In light of FDA’s recent notice, an article written by Arnie Friede, former FDA Associate Chief Counsel, and former Senior Corporate Counsel for Pfizer, Inc., and Robert B. Nicholas, Chair of McDermott Will & Emery’s FDA practice group, explained why it’s time for FDA to write an Internet policy.
The article discussed how the FDA’s Draft Risk Disclosure Guidance does not address the unique features of such common communication techniques as sponsored links, banner advertisements, e-mail to physicians and patients, social media such as blogs or Twitter, or any other form of Internet communication more generally. As a result, the authors noted that FDA applies the same principles about risk disclosure by manufacturers in prescription drug advertising “… to all promotional pieces, regardless of the medium used.”
Accordingly, the article gives an example of FDA’s approach to regulation of the Internet as simply a different form of print communication. Specifically, they noted that FDA’s recent enforcement actions have significant and adverse implications for use of key word search engines, such as Google, which is perhaps the most powerful tool on the Internet for quickly locating and accessing relevant information on health and well-being.
On April 2, 2009, the Division of Drug Marketing, Advertising, and Communications (DDMAC) in FDA’s Center for Drug Evaluation and Research (CDER) sent a “broadside” to the pharmaceutical industry, and by implication, the internet advertising community, when it simultaneously issued 14 Notices of Violation (NOVs). The NOVs categorically reject the use by manufacturers of hyperlinks to web sites that are identified in the URL in the sposnroed link by specific brand name.
Each of the NOVs makes accusations that information in a sponsored link that includes a website address consisting of the trade name for a specific product, and that appears on the results page of an internet search enginge when a key word search is conducted, is not a reminder advertisement but instead is “labeling” and “advertising” that is categorically misleading and hence “misbrands” the drug within the meaning of the Act.
In particular, if there is any affirmative statement about the product or the disease it treats on the face of the sponsored link, then, according to DDMAC, all of the mandatory risk information otherwise required by FDA’s advertising and promotion regulations must likewise appear on the face of the sponsored link and will not be considered in the disclosure analysis eve if fully and completely available one click away, via the hyperlink.
The authors asserts that this approach “effectively precludes the use of sponsored links that disclose the product name and provide a modicum of benefit information to alert searchers to what they will encounter when they click on the hyperlink.”
The article notes that manufacturers who wish to alert searchers to what information is available through a sponsored link must now use what may amount to “bait and switch” tactics by omitting from the URL the name of the very product whose FDA-regulated website the searcher will be redirected to when activating the hyperlink. This “anachronistic approach” threatens not only the ongoing utility of sponsored links but also suggests either a hostility to or perhaps a fundamental lack of appreciation for the importance of an array of other Internet communications tools that can be used to provide valuable health information to consumers in connection with FDA-regulated products.
Even though each of the search results includes a hyperlink to risk information that is accessible “one click away,” DDMAC nevertheless concluded that this is inadequate to communicate any risk information whatsoever because of the absence of the contemporaneous mandatory disclosures on the face of the sponsored link itself. However, limitations in the number of characters in this medium make it impossible to provide all the risk information on the face of a sponsored link, yet it is readily accessible by clicking on the hyperlink.
As such, the authors conclude that if these enforcement actions continue to represent FDA policy going forward, then as a practical matter, the NOVs effectively erode the value of sponsored links resulting from key word searches that identify a specific product by name in the URL or elsewhere on the face of the sponsored link. Moreover, these NOVs appear to be implicitly reaffirming FDA’s longstanding unwillingness to adopt a discrete regulatory policy on Internet communications that acknowledges the information value of new media and their technological differences from traditional communications channels.
Discussion
Consequently, the author’s note that based on the Obama Administration’s use of the Internet, especially for health information, the FDA must adopt a more considered approach for these new media than the approach represented by DDMAC’s enforcement “tsunami” of NOVs on sponsored links.
While they recognize that a comment period is an opportunity to begin this process, the authors assert that there is “ample room even under current law for FDA to apply a more nuanced approach to regulation of sponsored links, and to new media more generally, than the agency itself acknowledges in the NOVs.
For example, in concluding that the face of the sponsored link represents an independently discrete portion of the advertisement that requires that all mandatory disclosures be immediately and contemporaneously viewable when the link appears on the search results page, DDMAC appears unwilling to recognize that hyperlinks are a technologically intergral part of the Internet medium that virtually ever Internet user is familiar with. In fact, the very purpose of a key word search is to list those hyperlinks that the searcher should “click” to find the relevant information being sought.
Accordingly, to assert that “the landing page of the linked information, through which the risk information is accessible, is irrelevant in determining the adequacy of the disclosure is to disregard the realities of the medium and to elevate form over substance.”
The authors also acknowledge that FDA’s approach on hyperlinked disclosures is likewise inconsistent with prior FDA policies that accept the limitations of particular media and with the Federal Trade Commission’s (FTC’s) approach. For example, in its “major statement” guidance for risk disclosures in television advertising, FDA acknowledges the inability of TV to carry contemporaneous and instantaneous disclosure of risk information and the agency provides a mechanism, through its so-called “adequate provision principles.
The FTC takes a more “nuanced” and “tech savvy” approach to linked disclosures by examining the conspicuousness of the hyperlink, whether it signals the availability of risk information, and other contextual factors in determining the adequacy of the disclosure. In this respect, the FTC acknowledges that there are differences occasioned by differing media and that regulatory policy should be flexible enough to accommodate these.
Another argument the authors put forward is that in FDA’s Draft Guidance for Industry, Help Seeking and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms, the agency took a stance about separate statements that should be taken together as one advertisement. In other words, the closer the information is present physically or in time to one another, the more likely it is that the separate messages contained in the two pieces will be remembered together in memory as one entity. As a result, the authors ask why this same logic is inapplicable to hyperlinked risk disclosures in sponsored links where, after all, the information is accessible one click away.
In the end, the authors argue that a “reasonable person” who conducts a key word search using an internet search engine knows to click on the hyperlinked information should they wish to have more information because that is what the medium is all about and why the searcher uses it. Just like the newspaper reader knows to go beyond the front page to get the rest of the story, and just like the television viewer knows to watch later parts of a commercial where risk information generally appears, so too does the web searcher know what a hyperlink is and how to use it.
As a result, the authors conclude that FDA’s approach overlooks entirely the ability of the Internet to be the messenger, empowering those who wish to convey information and those who wish to obtain information and even more importantly, to link the two together, worldwide, in a virtual dialogue.
Comments
Electronic comments can be submitted through http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with Docket No. FDA–2011–N–0230.
For further information contact Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301–796–7726, e-mail: Ila.Mizrachi@fda.hhs.gov.
Comments must be submitted by June 27, 2011.