As each quarter ends, it has been an Eye on FDA practice to look back and compare different types of activities to assess any changes or trends from FDA over the course of time. Today we’re going to look at the press releases for the first half of the year and at each quarter specifically, compared to the same time periods from last year.
If your own intuition has led you to think that the public is hearing more from FDA than they used to, then rest assured that you’d be right. The level of communication emanating from FDA is up dramatically over last year and over the first quarter. And the Commissioner is leading the way.
First of all, let’s look at the first half of the year. During the first six months of 2017, FDA issued 52 press releases, but for the same period this year, it more than doubled to 126 releases.
During the first quarter of 2017, FDA issued 23 releases and then saw a slight increase in the second quarter to 29. But in 2018, the number of releases issued the first quarter was 56 (more than double the same quarter the year before) and in the second quarter, that number increased to 70. That means that so far this year, not only has the overall number of releases increased, but so has the velocity.
What are they talking about – what leads to the increase? In the update on the first quarter of 2018, it was noted that the increase in the number of “Statements from the Commissioner” was the reason behind the spike. Such statements prior to the Gottlieb area were rare as hen’s teeth. Today they are exceedingly common and they are generally, though not always, employed to provide a depth beyond the issuance of a press release – to provide history and context around policy and to demonstrate progress – and to provide a personal stamp on agency developments by the Commissioner.
Here is a close up look comparing the first quarter of this year to last, and a comparison of the first 6 months of 2018 to the same period for 2017.
- Approvals – You will note that while the total number approvals are slightly up for 2018 (32) over 2017 (30), drug approvals were actually down slightly (22 in first half of 2017 versus 19 in first half of 2018), while device approvals have gone up.
- Legal Actions – Another big difference between last year and this was the increase in the number of announcements related to a legal action – a warning or consent decree – related in large part to actions the agency has been taking vis a vis kratom, e-cigarettes and opioid-related products.
- Scott Speaks – Finally, the biggest change of all – Commissioner Statements. In the first half of 2017 there were 7 releases in the catch-all category of “General Announcements”, 4 of which were Commissioner Statements. In the first half of 2018, there were a whopping 72 General Announcements, 53 of which were Commissioner Statements, which is something like a 1200 percent increase. What does he talk about? Everything. He provides deeper background than exists in a press release about things the agency is doing – from the legal warnings on e-cigarettes to the reasoning behind new guidance documents and the policy implications of FDA actions, which may be announced in press releases, to provide context.
As noted in the report from last quarter, communications at FDA has definitely changed – there is more of it, and it is more in-depth. And the Commissioner is front and center as a driver.