An ad hoc coalition, spearheaded by industry veteran Arnold Friede, is formulating a proposal to challenge recent DDMAC actions it considers misguided.
The coalition will hold a conference call on June 3, at 10 a.m., and has invited all interested parties to participate. The call will discuss current FDA advertising policies, and what pathways can be used to rectify them. According to Friede, industry people as well as internet media companies have expressed "an enormous amount of interest" in the coalition, though funding has not yet enabled the group to become a formal organization.
In a podcast yesterday, Friede, formerly a longtime member of Pfizer's law counsel and an associate chief counsel at FDA, described recent DDMAC actions as a “blitzkrieg” that “bombarded the online advertising industry.” Specifically, Friede was referring to the 14 letters DDMAC sent to companies in April, which effectively upended the practice of “one-click” advertising online. The informal one-click rule refers to sponsored links that don't contain lengthy fair balance content within the link, but provide that information on the link's landing page. Until April, pharma marketers had considered this an acceptable practice. “Risk information available via the landing page should be considered an element of, and not distinct from, the statements in the search results that contain the sponsored link,” said Friede in an outline
defining coalition goals.
In the outline, Friede also suggested that members develop “a comprehensive written submission…setting forth why the interpretation of DDMAC in the [14 notices of violation] is wrong as a matter of current law and misguided as a matter of FDA (and public health) information policy.” Additionally, Friede said the group should develop “an alternative paradigm” for sponsored links, banner ads, emails and other communication online, as well as file a citizen petition with FDA advocating for the adoption of a coalition-developed approach to online advertising. Friede said in a phone call that FTC's Bureau of Consumer Protection has been much more appreciative of search advertising in terms of the public interest, and cited the Commission's disclosure guidance
for dot coms in 2000.
“The time is now to advocate for a more rational policy,” said Friede in the podcast. Friede currently serves as counsel to the law firm of McDermott Will & Emery, in Washington DC.
FDA released a draft guidance yesterday, asking reviewers to follow a “reasonable consumer standard” when evaluating promotions, although the guidance didn't address online advertising specifically. The guidance document is currently open for public comment. The Coalition for Healthcare Communication, led by executive director John Kamp, issued a statment yesterday asking would-be commentators to join its LinkedIn Group
to help devise formal comments.