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Internet Ad Regulation: Industry Seeks To Develop Alternate Framework

Executive Summary

Some members of the pharmaceutical industry are developing an alternate framework for regulation of the Internet to propose to FDA after the agency's citation of sponsored search results

Some members of the pharmaceutical industry are developing an alternate framework for regulation of the Internet to propose to FDA after the agency's citation of sponsored search results.

The ad hoc group continues to coalesce, but tentatively includes manufacturers as well as media companies. The goal is to develop an alternative oversight strategy that FDA could employ and then convince the agency to adopt it.

The stakes are high. Following FDA's letters to 14 firms stating that the links which appeared in search returns needed more risk information, companies scrambled to revise their use of sponsored links (1 (Also see "Internet Promotions Must Be Redesigned After FDA Cites Sponsored Web Links" - Pink Sheet, 13 Apr, 2009.), p. 32). Many in industry are concerned that without clear guidance from FDA, companies will shy away from promoting on the Internet, leaving patients to get information from completely unregulated sources.

A memo from McDermott Will & Emery attorney Arnold Friede outlines the group's expected strategy. "In addition to arguing why FDA is incorrect as a matter of current law (e.g. 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), the group would develop an alternative framework for consideration."

"This alternative framework would also address other near-term communications issues, such as e-mail to physicians and how disclosures of risk information, if any, in the 'subject' line should be addressed," Friede notes. "Longer term, the group should take into consideration the development and implementation by FDA of a rational legal, regulatory, and policy approach to social media more generally."

As people spend more time online and expect more interaction from the Web sites they visit, drug firms feel a need to have presence in the new social media, but are unsure how to handle user-generated content (2 (Also see "Social Media: Ignorance Not Bliss For Pharma, DIA Panelists Say" - Pink Sheet, 2 Mar, 2009.), p. 32).

The coalition hopes to present its alternate paradigm to FDA, as well as making its case outside the agency, including other parts of the administration and FTC's Bureau of Consumer Protection. A final option includes a formal citizen petition to FDA.

- M. Nielsen Hobbs ([email protected])

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