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.
Thanks for your post Mark. As you correctly point out, the pharma industry left more holes than they attempted to plug. However, the mere fact that they were able to corral a group of executives across five companies speaks volumes of how social media has been elevated within companies. I touched on my thoughts on this announcement last week (http://prforpharma.com/2010/02/01/analyzing-pharma-social-media-working-group%E2%80%99s-response/) so I will only summarize here. Basically, I think you’ve covered it. The social media working group took a step in the right direction by actually proposing solutions—a step few people have been willing to take. That being said, the suggestions on how to handle off-label usage and AEs are unlikely to stick. The off-label usage issue is particularly tricky. While the SMWG’s suggestion is rooted in the right place—transparency—it ignores the grassroots nature of social media. An off-label usage comment, even if it is only up for an hour, could potentially set off a firestorm of comments across the company-owned site and across other social networks. At that point, response would quickly become unmanageable. Pharma companies are better off holding all comments for moderation and if one is received that mentions off-label usage; it could be triaged and dealt with out of the public’s eye. This way, you are still engaging with that individual but mitigating the risks of off-label discussion.
Thanks Chris – well said.
“Of the questions posed by the FDA in the agency announcement of the meeting, the SMWG responded to Questions 2 and 5.”
Funny how a “response” doesn’t necessarily mean an “answer.” Great piece, especially when you indicated you think not many pharma companies will respond by the Feb. 28 cutoff — it DOES speak volumes, and makes no sense considering big pharma heads are so gung-ho about social media integration but slightly petrified to take action without all guidelines being provided…and they of course have every right to feel that way.
It’s difficult to harness the B2C-benefit of incorporating social media into the pharma realm when so many restrictions are already in place when looking to take advantage of a participatory platform that’s driven almost completely by public interest and interaction (a.k.a. non-pharma folk looking to get their point across without considering the restrictions by which companies NEED to abide). I’m looking forward to it all, and thanks for the post!