FDA AdComm Calendar for 2011 – Where is the Action?

At nearly the end of 2010, the FDA published the tentative calendar for advisory committee meetings for 2011.  Naturally, the agency cannot precisely detail the calendar at this stage, but it does provide a bit of a signal regardomg the number of new drugs that the agency anticipates considering over the course of the year.

According to a report in the Wall Street Journal, during 2010, the FDA approved 21 new drugs.  That doesn’t sound like a lot, but it is more than during 2007 when there were only 18 approved.  According to the article, in 2007 it was 18 approvals, in 2008 it was 24, there were 25 in 2009 and 2010 saw a drop to 21.

What, if anything, does the calendar – and more specifically, the number of meetings that have been scheduled – tell us about drug considerations for 2011?  The number of meetings is an indication – but that needs to be tempered with a few other factors.  First, meetings are often scheduled for purposes other than new drug applications – such as addressing ongoing safety issues or to provide insight into a policy issue such as the appropriate endpoint in a clinical study for a particular condition.  Second, some of the planned for meetings will be cancelled.

That said, let’s just have a look at the level of activity among two of the FDA’s centers – the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).

Looking below, one can see that the bulk of the action is slated to be in the field of drugs over biologics with CBER scheduling a total of 18 days compared to a total of 39 for CDER. And of all the committees, by far the most action is going to be in oncology with a whopping 12 days’ worth of meetings scheduled or the Oncologic Drugs Advisory Committee followed by 8 for Cardiovascular and Renal.  On the other hand, new activity in the Endocrinologic Drugs Advisory Committee appears low with only 1 meeting scheduled, signalling low anticipation of consideration for diabetic, weight loss or osteoporosis drug treatments. The Antiviral Drugs Advisory Committee has 3 days scheduled, but they are consecutive, which could imply a meeting that is centered on a policy issues rather than drug consideration.

There are not a lot of tea leaves here to read in that the schedule is subject to change, but as of right now for 2011, there are at least a few indications that it will be an active news year in cancer treatment and cardiovascular treatments.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
This entry was posted in Advisory Committee Prepapartion, Uncategorized. Bookmark the permalink.