This week a large number of people and entities released their presentations that will be given at the FDA Part 15 Meeting on Social Media and Medical Product Promotion to be held Thursday and Friday, November 12 and 13th at the National Transportation Safety Board in Washington, D.C. Many of those involved have released copies of their presentations, so this seems like a good idea to offer a brief overview of a few of the most important presentations tomorrow (aside from Google’s and Yahoo’s):
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PhRMA – First, let’s look to industry as represented by the Pharmaceutical Research and Manufacturers Association (PhRMA). Here is what they are saying in both their written testimony and their slide presentation. The one new thing in PhRMA’s presentation is the notion of the inclusion of an FDA-logo that would serve as a sort of approval stamp on Internet content that would indicate that the risk information has been FDA-reviewed. They address the paid search issue and suggest balance though two links, one to product information and one to risk information. Without talking about Sidewiki in particular, the presentation does state that industry should only be responsible for content that it has provided and over which it has control. That sort of, but not completely, addresses not only Sidewiki but in a round about, indirect way, correcting content on Medpedia and Wikipedia, though those specific examples, like Sidewiki, are not mentioned. They close by overviewing adverse event criteria, but don’t talk about adverse event specific situations in need of resolution. The notion is an interesting contribution to a part of the discussion.
Arnold I. Friede and Associates – Next is Arnie Friede who provides an insightful and well-thought out analysis of the issues. Arnie Friede is a lawyer with a food and drug law practice and was an Associate Chief Counsel at FDA’s Office of Chief Counsel. Arnie has identified the FDA’s approach to 3 various issues that serve as barriers to more effective use of social media by medical product manufacturers, which seems to be the construct to which most are leaning. They are (i) the approach to risk information; (ii) whether and when statements of off-label use are attributable to a manufacturer; and (iii) adverse event reporting. During the first day, Arnie will address the first two and the adverse event reporting issue on Day 2 of the meeting. With respect to risk disclosure, stresses the “notion that context is relevant in determining where and how risk information may appropriately be disclosed” and states that this position is in alignment with current FTC thinking. He seeks to borrow from risk disclosure standards of DTC advertising where there are “adequate provision” requirements which acknowledge the fact that there is not sufficient time nor space in a television ad for the comprehensive encyclopedic disclosures required in print and states that there needs to be similar consideration for Internet representations, presumably whether in the context of a paid search ad or a twitter feed. He doesn’t think that the FDA needs to embrace the now-defunct, and never factually based “one-click” rule, but rather the agency should commit to the development of an “adequate provision” for risk information in the context of social media. Regarding off-label promotion, he cites the examples of Sidewiki, and by reference I think, Medpedia and Wikipedia, as venues that are ripe for off-label writing by non-pharmaceutical sources, without pharmaceutical involvement, but which may keep regulated medical product companies from correcting misinformation that might be contained in such entries (which, in my opinion, creates a public health concern that is not resolved by the status quo of the FDA’s posture – at least as perceived by medical products companies). He cites current FDA practices with respect to other instances where industry might not have direct control over the statement of off-label uses that currently exist. While not offering a direct solution, he does speak to the need for the FDA to articulate guidelines that clarify the now muddy situation. Certainly, this area is one of paramount concern, he says, given the extreme consequences and current level of activity aimed at off-label promotion. (As to Adverse Events, that will be reported tomorrow and delivered on Friday).
Download FDA Internet Public Hearings Remarks First Day
WOMMA – Finally, the Word of Mouth Marketing Association will be presenting remarks specifically directed at the concerns revolving around the use of the Internet in general, and social media in particular, around adverse event reporting. Their presentation provides insight into their efforts to assess the real threat of adverse events in these venues. Their methodology was to examine 500 randomly selected online healthcare messages and matched them up against the four criteria for assessing whether or not an adverse event is reportable. Of the 500 messages, only 1 was found to meet all four criteria to be reportable. They state that there are outstanding questions that need to be considered – (i) what is a company’s responsibility to monitor online discussions or adverse events?; (ii) does a company’s greater presence online change that responsibility? (iii) in the event of a high profile event, is there a duty to reach out to do monitoring?
All of these are great presentations and provide astute insights and present many questions. But keep in mind, the questions raised are in response to questions being asked by FDA. At some point, there need to be some answers as well, such as offered by PhRMA’s logo notion. But there are a whole host of questions unanswered out there and at the end of the day, let’s hope we accumulate answers over the two days, as well as raising the importance of the questions.
