FDA Press Release 2015 – What They Said

Last year and the year before, Eye on FDA provided an overview of press releases from the agency for the year that had just passed. The information comes from a database of press releases that I started back in 2013 tracking information on what was said in various categories and the purposes for which releases were posted. It is time to look back at what FDA had to say in 2015 and get a little insight into how it might differ from previous years.

A few observations of note:

  • With 173 releases this year, the total number of press releases increased this year slightly and was more than either 2013 (165) or 2014 (161);
  • You may have read that FDA approved a record number of drugs this year logging in at 45 new approvals. Counting all approval announcements – which includes drugs, devices and apps, as well as approvals for new indications – there were more approval-related announcements in 2015 (104) than there were in either of the previous two years (90 in 2014 and 81 in 2013);
  • Of the 104 approval-related announcements in 2015, 76 involved drugs, 27 involved devices and 1 was an app approval – the only category to show an increase was among drug approvals;
  • Of the 76 drug approval related announcements in 2015, one-third of them (25) involved oncology which is both a numeric and proportional increase over either 2013 or 2014.

One can see in a year by year comparison that the number of approvals is a greater percentage of the announcements. Legal actions also increased slightly in proportion during 2015 while public health alerts decreased somewhat as did rule making oriented announcements. In short, FDA attention this year appeared to be on approvals.

That’s the picture for 2015. It will be interesting of course to see what the new year brings, particularly with a new FDA Commissioner coming to the job.

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