Anyone who reads this blog knows that apparently I like to count things. Why? Well it provides the basis to confirm or refute general observations, and also can provide perspective that makes you stop and think and wonder. But if you didn’t stop and take note of what’s changed and what hasn’t, you might not stop and think at all. For some time now, I have followed FDA’s pronouncements to the public in the form of press releases and put them into a database. Here is the story they tell to date for 2017.
First of all, FDA is saying less. And less. Comparing the first quarter of 2017 with the same time period from 2016, the agency sent out 23 press releases during the first three months, compared to 32 last year. However, if you look at the first three months of 2015, FDA sent out 46 releases during the first quarter, twice the number for this year. So the trend is very much down.
When they did talk, what did they have to say? It would appear that when it comes to approvals, the agency is on par so far with last year at this time, but down quite a bit from 2015 which was a banner year for approvals. So the early returns – which are early – would indicate that 2017 is looking a lot more like 2016 than 2015 for approvals.
Looking only at one quarter gives us the beginning of some insight and perhaps serves to raise some questions for what we might look for in the coming year. For example, if the number of approval announcements stay at this rate next quarter, this year will look a lot more like last year. Looking at the rule-related announcements – last year there were 6 and this year 2 – makes one wonder whether the Administration’s 2 for 1 standard for issuing new regulations (add one, subtract two) – about which we’ve heard very little of late – has had an impact. And is the drop in legal actions (consent decrees, etc) reflective of a slow down in enforcement or is it just a blip? And finally, is FDA just getting more quiet over the years? We’ll have to tune in next July to see how we are doing on these questions, and perhaps more to come.