FDA Press Releases – 1st Quarter 2015

Last year I began a new database that tracks the press releases of FDA as a way to see what news the agency is talking about and provided a year end look at 2014. Looking back at the quantity and subject matter can lend some perspective into trends that may be developing. Unlike OPDP Warning/Untitled letters, with press releases there is some volume.

And what we can plainly see is that this quarter, FDA has had much more to say this quarter than the same quarter a year ago with 45 releases so far in 2015 compared to 34 in 2014. What is all the news about? Approvals, approvals, approvals.

Here is at what FDA had to say during the first quarter of 2015, with a comparison to the year before:

Among the nearly twice as many approvals announced in the first quarter of 2015, there were 11 devices, 18 drug and 1 app, which compares to 5 device and 11 drug during the same period last year. In his maiden speech given before the Food and Drug Law Institute, acting FDA Commissioner Stephen Ostroff noted that last year, the agency approved 51 new molecular entities. If they keep pace with this quarter, 2015 would certainly likely surpass that number.

We’ll have to see what happens in the second quarter and we’ll look again.