More or Less – FDA Press Releases 1st Quarter 2016

There are going to be times when FDA has less to say than at other times. In fact, there have actually been times where the agency has gone weeks without issuing a press release about anything. This quarter was not one of those times, but the volume of material slowed this year compared to the same period in 2015.

Keeping track of what the agency says and when it says it is just one means of monitoring activity. I track the releases and categorize them and have 520 of them going back through 2013. I just went through a lengthy process of updating and correcting entries going back through last year and thought it would be a good idea to provide you with a comparison of last year at this time with the beginning of this year. There were a few things of note:

  • Looking back to the first quarter of 2015, the agency issued 46 press releases, compared with the same quarter a year later when 32 were issued.
  • Perhaps most noteworthy were the announcements involving approvals. In the first quarter of 2015 when it was a record year for approvals, FDA announced 31 during the first quarter – 11 were devices 19 were drugs and 1 was an app. In 2016 during the same period, the agency announced only 13 approvals – 4 were devices and 9 were drugs.
  • Otherwise, the announcements were very much on par with last year. In 2015, there were 6 general type announcements, 7 related to legal issues (seizures, consent decrees, e.g.) and 2 rule/guidance related releases. In 2016 there were 9 general announcements, 6 legal and 3 policy or rule announcements.

Does the drop off in approval announcements for the first quarter of this year signify that this year will not see as many approvals as were seen during the banner year that was last year?  A single quarter is only a short measure in time and lots can change over 3 quarters, but it is an early indicator that we should continue to look at – and will.

(So far in April, there has been another approval announcement.)

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