Thursday, October 08, 2009

DDMAC’s Internet Stance Could Increase Consumer Risk: CEI

Written By Arnold I. Friede
October 7, 2009

A new Competitive Enterprise Institute (CEI) analysis cautions that FDA’s current policy restricting use of Internet sponsored links could have the unintended effect of making regulated information less available to consumers and making less reliable and unsubstantiated information more availabble. The report, issued just weeks before FDA holds a public meeting on drug advertising and promotion using the Internet and other new media, says that the agency’s crackdown on sponsored links and other Internet advertising by regulated companies “could elevate the prominence of search results that link to Web sites containing utterly unsubstantiated claims by fly-by-night operators for products that are largely beyond the agency’s enforcement reach. Indeed, if sponsored links for highly regulated drugs and devices become more rare, then an information seeker will be relegated to wading through a list of Web sites that contain all manner of information of dubious validity.”

The paper reviews objections that have been raised to FDA’s position that full risk information must be included on a Web page, banner ad, or sponsored link, rather than allowing use of Internet technology to place the risk information on a hyperlinked page. Defenders of this “one-click” approach say that the initial Internet ad is not the end but rather the starting point for an Internet user’s search for information.

Authors Arnold Friede (Arnold Friede & Associates) and CEI senior fellow Gregory Conko fault FDA for a 5/09 draft guidance on drug and device promotion generally that barely acknowledges the Internet’s existence other than in a footnote listing product Web sites among communication vehicles subject to regulation for advertising and promotion.

“The agency appears unwilling to recognize that hyperlinks are an integral part of the Internet with which virtually every Internet user is familiar,” they write. “Indeed, the very purpose of a key word search is to generate sponsored links to those sites where the searcher may find the relevant information he or she needs. This is precisely why a searcher initiates a key word search in the first place. To assert that the sponsored link’s landing page — on which the risk information is accessible — is irrelevant in determining the adequacy of the risk disclosure is to disregard the realities of the medium and to elevate form over substance.”

Friede and Conko also argue that FDA’s categorical rejection of the landing page as an integral component of the sponsored link could be seen as violating one of its own advertising interpretation principles — that seemingly separate statements should be aggregated and considered together in determining whether the ensuing ad complies with the risk disclosure requirements. Thus, FDA says that if reminder and help-seeking ads appear in close proximity, such as in the same magazine, they could be considered jointly as a promotional ad that requires full risk information disclosure. “It is not apparent why this same logic is inapplicable to hyperlinked risk disclosures in sponsored links where the information is accessible only one click away,” they say. “If the principle [is] that A accompanies B even if the two are not physically attached, then that same principle ought to apply in determining what constitutes a discrete component of an advertisement in the first place.”



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