As the date nears, the buzz and excitement levels seem to be rising. All of the pharma-related conferences that are happening right now seem to be feeding that even more, which I think is good.
I received a little more news about the hearing this morning, and I've posted the email from the coordinator, Jean-Ah Kang, PharmD, below. So now all of you are just as informed as I am about where things stand.
I also wanted to make a few quick but important points about the upcoming hearing:
- Talk and share. I appreciated the opportunity at Digital Pharma to talk about the hearing with peers and chat with others that will be speaking/attending. What a smart bunch of people! I expect more of the same when I attend eyeforpharma's eComm next week. (Let me know if you'll be there; I'd love to meet you.) Also see Fabio Gratton's online meeting place of sorts for tweets, documents, people, and organizations involved in the hearing. It's actually pretty nice to see industry and agencies coming together on this topic.
- I'll be speaking. I'll be speaking at the hearing on behalf of Intouch Solutions, and am excited and privileged to do so. I'm curious about the various tweets that have said "such and such was invited to speak at FDA hearing ..." Did FDA indeed specifically invite people to speak, or did they, like me, request to speak and have their request granted? I don't know the day or time I'll speak; they haven't announced those yet. But I can't wait to see the agenda!
- Think bigger than social media. Although the focus of the buzz is around social media, remember the name of the hearing itself mentions use of "the Internet and Social Media Tools" and a review of the document reinforces that it goes beyond social media. We've certainly all been craving some social media guidelines and direction from FDA, but let's not forget they've barely given us guidelines on Internet promotion as a whole. I'd appreciate - and plan to discuss - the use of search engine advertising, banner advertising, and even Web sites within the broader "Internet" marketing context.
- Submit written comments too! Arnie Friede (principle with a law firm specializing in FDA-related legal/regulatory matters and speaker at Digital Pharma) and Paul Loeback (DDMAC) both made this point at conferences recently, and it's worth repeating: Even if you or your organization is not speaking at the hearing, be sure to submit comments! The deadline is Feb. 28, 2010. It seems a long way away, but these written comments are really where pharma marketers and other stakeholders will have the most space and time to make a logical case for what we need/want, and how that balances with what's best for consumers. See the official notice from FDA for details on how to submit. I plan to both speak AND submit comments.
(And see Arnie Friede's paper titled "Yes We Can" here on the topic - it's well-referenced, well-thought-out, and a great read.) - Not in DC? Watch the Webcast. FDA will be providing a free, live webcast of this public hearing; however, details are not yet available. According to FDA, you can use the below link to check back for information on the webcast and updates about the public hearing, which will be posted as soon as possible:
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm184250.htm - When to expect guidance. Paul Loebach, Project Manager, DDMAC was quoted at the e-Patient Connections conference that industry can expect guidance by the end of 2010 as a good estimate. Note: I was not there and did not hear it firsthand, but several reliable 'sources' quoted him via Twitter using hashtag #epatcon. Also see John Mack's blog post on the topic here; he WAS there, and is apparently the one that asked the question "when?" That timeline surprised me, but also makes me wonder if they already have a draft in the works.
- Stay informed. For the final word on D.C. Tweetups, realtime updates, comments, and news about the hearing, follow the hashtag #fdasm on Twitter and again, see http://www.fdasm.com/.
See you in D.C.!
____________________________________________________Dear Speakers,
First of all, thank you for your interest and support of our upcoming public hearing on November 12-13, 2009. We are excited about collaborating with each of you to further our mission of protecting the public health with regard to the promotion of FDA-regulated medical products using the Internet and social media tools.
Secondly, we know that many of you are anxious to receive your scheduled time slots and other logistics, and we apologize for not being able to follow-up sooner. We have had some last-minute requests and changes from speakers and continue to be flooded with registration inquiries, but overall we've had a very positive response from the public. As you may have heard, we received over 800 registration requests for the 350 available seats, which were allocated on a first-come, first-served basis as reflected in the Federal Register notice. We sincerely thank you in advance for your commitment and your patience as we move forward in the next couple weeks.
While you are not receiving your scheduled time slots or the final agenda in this e-mail, here is some preliminary information:
We accommodated all speakers who submitted registration requests before the deadline on October 9, 2009; as a result, we are planning for a total of 62 different individuals/organizations to speak during the two-day hearing.
As noted in your previous speaker confirmation e-mails, the morning session of Friday, November 13, will be devoted to the discussion of Internet adverse event reporting (i.e., Question 5 in the Federal Register notice).
If you specified a preference for a particular day or time to present, we tried to accommodate you as best we could; however, as you can imagine, it was impossible to do this for everyone. For example, if you were scheduled for two separate slots (i.e., one for Question 5 and one for Questions 1, 2, 3, or 4), we were not able to schedule both slots on Friday, November 13, for every individual/organization in this situation.
In the interest of achieving a public hearing that is informative and well-represented by our stakeholders, each individual/organization will likely be allotted ten or less minutes per presentation or oral testimony. We will strictly adhere to the final agenda, and you will not be permitted to exceed your allotted time to speak. If you have not done so already, please begin preparing your presentation or oral testimony accordingly.
While this anticipated length of time is significantly shorter than many of your requests, please understand that this opportunity allows you to provide a high-level executive summary or focus on the most important aspects of your data, research, and views. You have until February 28, 2010, to provide additional detailed information by submitting comments to this docket.
You will need to submit your final presentation (e.g., PowerPoint) or oral testimony (e.g., Word document, PDF file) to us so that we may provide copies to the 13 FDA panel members for reference during the two-day proceedings. Slides and other visuals will be loaded onto FDA's laptop prior to Thursday, November 12, and the deadline for submitting all final materials will be towards the middle to end of next week (we will specify the due date when you receive your scheduled time slots).
We hope that the above details give you a little more information on what to expect, and we will be following up with your scheduled time slots and the final agenda in the very near future.
On behalf of DDMAC and FDA, thanks again for your participation and support! Jean-Ah
Jean-Ah Kang, PharmD
Special Assistant to the Director Division of Drug Marketing, Advertising, and Communications Food and Drug Administration
0 comments:
Post a Comment