Immediate Guidance Slips Again
May 9, 2011 – A recent notice in the Federal Register calling for comments on a series of Food and Drug Administration (FDA) studies to determine the most effective way of presenting risk information online indicates that the FDA is still a long way from developing significant new social media guidance. This status leaves industry in an unsurprising state of limbo after the Division of Drug Marketing, Advertising, and Communications (DDMAC) missed at least two self-imposed deadlines for issuing draft guidance and did not set a new target date for the much-anticipated document.
“The FDA’s choice to start new studies rather than issue guidance is unfortunate,” said John Kamp, executive director of the Coalition for Healthcare Communication. “Healthcare providers, patients and care givers are on the Internet, searching and finding health information. Companies, knowing that much Internet health information is uninformed and biased, must participate even without FDA guidance,” Kamp asserted.
The agency states in an April 28 Federal Register notice that it plans to research the new venues available online for displaying risk and benefit information for prescription drug ads in a fair and balanced way.
According to the FDA, “The interactive nature of the Internet allows for features not possible with traditional media … such as scrolling information, pop up windows, linking to more information, and embedded videos.” The agency is planning a series of studies that test the different methods of risk and benefit information on branded drug sites, the results of which will “inform the development of future guidance.”
Study 1 will examine the visibility of risk information (scrolling versus no scrolling), Study 2 will look at whether special features (e.g., testimonial videos, interactive videos) influence the perception of risks and benefits, and Study 3 will investigate whether links to and citations from external organizations referenced on the home page affect consumer perception and understanding of risks and benefits.
“It was anticipated that the FDA’s draft Internet guidance … would address the key question about the possible use of hyperlinks to provide risk information in a variety of online and social media formats,” according to Arnold I. Friede, Arnold I Friede & Associates. “In its 14 [notices of violation] on the use of hyperlinks in sponsored research results, FDA categorically rejected the possibility that providing information via such links could possibly constitute ‘fair balance.’”
Friede also commented 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.”
Without any guidance in “the near term,” Friede continued, industry has two choices: (1) “refrain from engaging in any behavior that is the subject of the proposed studies,” or (2) “make rational decisions about what is and is not justified, or at least what should be justified, from a legal, policy, and communications standpoint.”
If a company takes the latter approach, it should be “prepared to defend those decisions if questioned by the FDA,” Friede