I attended a few more presentations this morning at CBI's 8th Annual Forum on eMarketing for the Pharmaceutical Industry in Princeton, NJ. I missed FDA's presentation on its use of Web 2.0 Communication Channels for Public Health, but I don't think I missed much if I expected to discover from the FDA what is permissible for drug companies to do within those channels.
Jonathan Richman -- an ePharma Pioneer Club member -- pointed out that the FDA can use social media, but pharma companies cannot (see "FDA Uses Social Media, But You Can’t"). Actually, not only can the FDA use social media, it can also do it in a way that violates its own regulations! For example, the FDA is free to post a video about a new drug that they approved WITHOUT including fair balance information! An example is shown below.
It used to be that every time a government official spoke at these conferences they would start off with a little joke: "We're from the government and we're here to help you." I don't think the FDA speaker mentioned that today.
Nevertheless, when the FDA is doing more than pharma companies with social media, "we need to figure out how to get in there," said Stacy Reese, Associate PRA Director at AstraZeneca. She spoke on "Managing the Risks Associated with Online Discussions." Although she did not actually tell the audience how to manage the risks, she did a great job pointing out what the risks are and presented some interesting scenarios to consider.
Specifically, Reese spoke about adverse event reporting (AER) and off-label promotion, the two scariest boogey men that pharma faces in its quest to engage in social media marketing.
[BTW, Reese included a disclaimer that her comments do not represent the views of AstraZeneca and she suggested that each company should determine the best approach to social media that meets its specific business needs.]
Regarding AER, Reese compared a real life sales rep/doctor conversation about an adverse event to a similar conversation held online via a discussion board. Obviously, the sales rep is obligated to report the conversation. While there is no recording or written record of the live conversation, in the case of the discussion board, the conversation is recorded and archived. But how much of it does the FDA require to be submitted on Form 2253?
Although I may not fully understand the distinction, it's questions like these that keep pharma regulatory people awake at night.
The main takeaways from Reese's presentation are (1) there are many social media marketing issues that need to be addressed, and (2) pharma companies must develop standards that tell them how to address these issues before they get too deeply involved. It appears that AZ has thought it all through and has its standards in place. If only they could share them with the rest of us.
What's needed is for a meeting of the minds to mull over all the scenarios mentioned by Reese and decide what the best practices should be. At the table should also be representatives from vendor companies that offer services to pharma as well as patient advocates.
It would also be nice if the FDA were also involved. Unfortunately, the FDA may attend such meetings as an observer, but it won't say whether or not any "best practices" developed will pass regulatory muster. As was pointed out at the conference by several attendees, the FDA can only tell you what you are doing wrong and unless it issues specific "guidance," the agency remains mum about what is the right thing to do when engaged in social media marketing.