A Few Pharma Companies Speak to FDA Social Media Docket
On January 29th new documents appeared in the FDA's docket that has been devised to collect commentary after the November 12-13 Part 15 meeting on social media and the Internet and medical product marketing. Up to this point, both in the actual meeting and in docket submission, medical product manufacturers have been largely non-participatory, with only a few participating in the meeting and until now, none submitting to the docket.
The submission was put into the docket by the "Social Media Working Group which the document states includes representatives from Amgen, AstraZeneca, Bristol Myers Squibb, Millenium Pharmaceuticals and sanofi-aventis U.S.
Of the questions posed by the FDA in the agency announcement of the meeting, the SMWG responded to Questions 2 and 5. It is perhaps emblematic of the complexity of the issues that the response document submitted by SMWG is sometimes unclear. As nearly as I can tell, here is some of what they had to say.
Question 2 asked how manufacturers can deliver fair balance when using tools that have space limitations and require real time communications. To this, with respect to company sites, microsites and communities, the companies promoted the use of links that would take an Internet user (a User) to full prescribing information. This is, in essence, the so-called "one-click" rule (that was never a rule at all) which was already rejected by the FDA in its April 2 Notice of Violation letters.
The companies divided their comments into a section on company sites and then a section on third party sites.
Respecting company sites, the SMWG said that companies should anticipate and monitor off-label comments on such sites and that FDA "could" require such monitoring and that companies clearly state "Terms of Use" associated with such sites and remove posts that violate said terms of use. For non-branded sites, Users would be notified that discussions are not meant to be product-specific and for branded sites, there would be a statement that postings must be FDA-consistgent, which assumes a User is going to know what is consistent and what is not.
Questions that are posed to companies respecting off-label use should be "labelled" themselves as involving off-label use and include links to prescribing information. The idea here is to keep the off-label comment there with the manufacturer notation that it is off-label as a means to mark it for others. Would FDA see that as educational or a closet way to spread word about off-label use?
On third party sites, when companies participate in "on-label" discussions, they should include a link to full prescribing information to maintain fair balance. With respect to off-label discussions the SMWG said companies "should refrain" from responding to off-label discussions, though how one does that is unclear. If a company is engaged in off-label discussions, then it should inform the community that a question pertains to off-label and thereby informs future Users of the fact. For real time responses, the companies suggested that static elements and materials that would be used in real time responses be submitted ahead of time on Form 2253.
It is hard to imagine the FDA being comfortable with company participation in off-label discussions, even if clearly marked as such.
Next the SMWG addressed Question 5 which focused on adverse event reporting. Here the SMWG cites the International Conference on Harmisation (ICH) which states that there is not an expectation that companies screen external websites for adverse events and outlines the four criteria by which AEs are reportable. They recommend that a site, presumably a company site, include a statement in the terms of use that conveys the fact that the site is not appropriate for reporting adverse events and instructs them how to report. That fails, however, to account for what happens when people ignore that term of use notation, don't see it, or use the site in spite of it. Nor does it even begin to address what happens if someone reports an adverse event on a Sidewiki, attached to the home page of a product site. Even though not technically a part of the site, should companies be under an obligation to monitor and correct?
The companies did not answer any of the other questions. More questions are left unanswered by pharma than answered. There are a wide array of questions left unanswered. Without input to stretch their vista on social media, the guidance that the agency eventually derives is likely to be much more limited and narrow than if there were more pharma, biotech and device involvement.
There is still time to respond by submission to the docket by February 28, but my gut tells me that not many pharmas are going to respond. What that communicates about the current system for the agency to gather input for its guidances and about the current regulatory environment speaks volumes. FDA should carefully consider what this silence means.
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All of Washington is braced for the onslaught of a snow storm that the weather service has termed "paralyzing" - obviously unaware of the fact that Congress is in a state of paralysis most of the time. Here is a little bit of what happened in the more active parts:
- Health Sensei Names Top 50 Health IT Blogs - A very nice listing with links to 50 Health IT blogs. Check it out.
- FDA MedWatch Updates Tysabri - Medwatch issued an update regarding risk of PML and Tysrabi to state that the risk increases with the number of infusions.
- Webinar on Social Media and Public Relations, Public Affairs - I will be giving a Webinar next week that advises on aproaches to using social media in the every day practice of communications - will be covering the basics and addressing some strategic frameworks. If you are interested you can sign up.
- FDA Budget Request - The agency submitted a request for a whopping $4 billion for FY 2011. The requests seeks increases for four initiatives - $318.3 million for food safety; $100.8 million for patient protection; $25.0 million for advancing regulatory science and $215 for tobacco regulation.
That's it for me this week. If you are someplace where it is not snowing in biblical proportions, stay there. If you are here, stay warm and good luck!
