On Tuesday the FDA published the Guidance Agenda for the agency for 2011 in the Federal Register. It is important to note that the agenda is more of a Guide to Guides and is not a hard and fast schedule.
Evidentiary on that point – one thing of curious note is that the Guidance on the Internet and Social Media is listed here, as it was in the 2010 Guidance Agenda. That could mean one of two things. First, the draft guidance that the Division for Drug, Marketing and Advertising (DDMAC) said it was trying to release by year end may not be released. There was always a caveat attached to that goal that some elements of the release were beyond DDMAC control.
But the other thing it could mean is that there will be more than one draft guidance. It has been widely expected for some time by many that the draft guidance would not address the entire spectrum of subject matter covered in the November 2009 two-day public meeting on the topic and that there would likely be multiple guidances divided among different subject matter jurisdiction. So the fact that it was slated for 2010 and is listed for 2011 could simply mean that there is a subsequent draft guidance coming out after the first.
In any case, the long-awaited draft on the Internet and Social Media was not the only one of note. Under the categorical heading of advertising, in addition to the guidance on Promotion of Prescription Drug Products Using Social Media Tools, there were slated a “Comparative Claims in Drug Promotion,” and “DTC Television Advertisements – DTC Pre-Review Program”.
In the way of clinical trial designs, there were topics slated for “Non-inferiority Trials” and “Adaptive Trial Designs”.
And, of course, there was a lot of activity scheduled for tobacco given FDA’s new authorities in this area.
The one thing that struck me, however, was that I didn’t see any hint of the development of some sort of guidance regarding the creation of a regulatory pathway for biosimilars. Thoughts in that regard or information to share would be most welcomed.
In any case, there are a lot of guidance topics listed here which gives us a lot to watch for and talk about in the coming year.
Mark – regarding the biosimilar guidance and/or regulatory pathway: in reading the tea leaves (always a risky proposition) and comparing the past 5 years of trend timelines, I told my newsletter readers last month not to expect anything until 2012. Frankly, I also have a sense that political calculations play into this as the agency will likely take a wait-and-see approach with the new Congress.
– john