What They Said – 2nd Quarter 2017

During a somewhat slow week given the holiday that coincides with the end of the second quarter, this is a good time to look back at press releases for the quarter and the year so far.

A single press release tells us what is happening today for the agency. The aggregation of press releases tells us about trends with respect to events or emphasis by FDA. To that end, once a quarter I consult my database of FDA press releases to provide a look-back at what has been issued during the quarter and so far this year.

First looking to volume on a year-by-year basis, the overall trend is down. In 2015, the agency issued 161 releases and in 2016 that fell to 122. So far for this year the agency has issued a total of 53, which if you annualized it would project only 106 for the year unless the pace picks up.

Next just the quarterly numbers. Last we checked, during the first quarter of 2017  FDA sent out 23 releases – fewer than it had for the first quarters of either 2015 or 2016. For this second quarter of 2017, the pace has picked up a bit with 29 press releases issued by the agency. That said, the number for this quarter is fewer than were released during the same quarter last year (40), and even with that of 2015 for the same quarter (29). In short, this year FDA has said less than it has in either of the previous two for both the first and second quarters.

Of note this quarter, the number of General Announcements picked up, a reflection of new leadership announcing agency policy and direction with respect to orphan drugs, competition and opioids.

Content-wise the main focus is on the number of approval announcements by FDA. Overall approval announcements this quarter picked up with 16 announced, up over 14 from last quarter but of the 16, 11 were drug approval announcements (same as last quarter), though 3 of them this quarter involved label expansions and not new drugs.  Of the 16 approval announcements this quarter, there 5 were in the device category, an increase of 2 from the first quarter.

Overall, it would appear that approvals are not running high. Press releases about approvals tend to be, but are not exclusively, reflective of the approval of new molecular entities (NME). (Remember, 2015 was a banner year for approvals.) For 2017, while the number of approvals announced during the first quarter was slightly ahead of last year, the announcements fall short of those announced in 2015 during the same time period.

Here is a comparison of the releases during the first six months of the year for 2015-2017:

However, when compare where we are with respect to NME approvals looking at 2017 to 2016 and 2015 and  you will see that in fact FDA has already surpassed all of 2016 and is well ahead of where we were mid-year for 2015. By mid-year there were 23 NME approvals by FDA, compared to 22 for all of 2016. The banner year of 2015, which saw 45 new NME approvals had only 14 by mid-year. While there have been 22 press releases issued this year regarding drug approvals, several have involved label expansions. This year, the NME approvals are occurring but the press releases are not.

We’ll check in again at the end of the third quarter.

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