Tuesday, March 09, 2010

Arnold Friede Responds to Comments Submitted by the Center of Digital Democracy to the FDA Regarding #FDASM

The following is a comment submitted to the Ignite Health Blog by Arnie Friede, of Arnold I. Friede & Associates, in response to the comments submitted to the FDA from the Center of Digital Democracy regarding the use of Internet & Social Media for the Promotion of FDA-regulated Medical Products.

One of the things I told clients after FDA’s Social Media Public Hearing last November is that the agency was largely hearing only one side of the story and that there was another side that was likely to emerge in the written comments. An important example of “the other side of the story” is the attached filing by the Center for Digital Democracy (CDD). CDD describes itself as “dedicated to ensuring that the public interest is a fundamental part of the new digital communications landscape; from open broadband networks, to free or low-cost universal Internet access, to diverse ownership of new media outlets, to privacy and other consumer safeguards, CDD works to promote an electronic media system that fosters democratic expression and human rights.”

CDD raises a variety of privacy and other concerns related to various digital marketing and social media techniques that it claims have unprecedented abilities to take advantage of consumers. It proceeds to identify a number of arguably problematic techniques currently being deployed by the pharma industry that evidence the abuse of this new technology. CDD encourages FDA, before providing any safe harbors for social media and opening up the proverbial floodgates, to work with the FTC and other agencies to address these issues. CDD’s comments merit careful study.

It is certainly the case that many if not most of the concerns voiced by CDD are beyond FDA’s specific statutory authority and hence outside what FDA should be looking at as a strictly legal matter. For example, and with certain limited exceptions, privacy issues are not normally with the agency’s statutory remit. By the same token, the concerns that CDD voices are inextricably tied to the new technology and it is hard, at first blush, to see how FDA can simply ignore them and say, in effect, “that’s not our job”. I guess the point is simply that FDA is now hearing from a broader array of interests than the predominantly industry-focused testimony that was provided at the November Public Hearing. This will complicate the process and add an inevitable degree of uncertainty and delay.
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