What They Said in 2016 – FDA Releases

FDA ended the year quietly and began the new year in similar fashion. The holidays are of course a factor, but in all of October and November of 2016, there were only 3 releases issued for each month. Even in January, press releases were slow to start in the new year. In fact, from late 2016 until mid-January 2017, there were no press releases from the agency for a period lasting nearly one month – certainly the longest stretch in my time of observation. Despite the quiet, there has been lots happening – the subject of postings yet to come.

So the last quarter for the agency was not a highly audible one. That said, what did the agency have to talk about and how does it compare to other years? Time to take our annual look. First, here is an overview of how 2016 stacks up against 2015.

Perhaps first and foremost one can see that there were far fewer press releases in all during the year, but also that there were far fewer issued about approvals, particularly those for drugs or biologics – something noted in a posting in December. In fact, the drop-off in approval announcements is directly attributable to the significant drop in the number of press releases from 2015 to 2016.

Of the 32 drug/vaccine approval announcements, 22 involved new molecular entities according to FDA’s 2016 Novel Drugs Summary. The number of approvals for 2017 appears poised to pick up given that the report also states that there were 41 filings of BLAs and NDAs during 2016, leaving a fair amount for consideration in the coming year.

The other noticeable difference between the press announcements for this year and last is related to the issuance of rules. There has been recent observations made in the trade media that the number of guidance documents issued by FDA increased, perhaps a reflection of the agency wanting to get the guidance out prior to a new Administration. Not every guidance document is announced with a press release and in fact, some of the long-awaited guidance documents released in recent days (one on biosimilars, one on off-label) did not have accompanying announcements. In looking at the pattern over the year, press releases announcing a new rule or guidance occurred primarily in the first half of the year and was actually lowest for the final quarter.

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