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.
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.
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.