Keeping our eye on FDA press releases as one measure of the way FDA talks to us is a regular feature here on Eye on FDA and there is no better time to look back than when we begin a new year, particularly as we do so with a new FDA Commissioner.
Overall, FDA has been pretty consistent over the years in the way that the agency communicates. When looking at 2017, however, there are some notable differences.
On the consistency side, with the exception of last year, FDA has issued about the same number of press releases from year to year. In 2017, there were 164 releases, which is on par with 2015, 2014 and 2013. Last year, the number was only 122, however, so we are back on track when it comes to volume.
When it comes to the way FDA is communicating, there are big differences in 2017. As noted in a posting in late November – A Manner of Speaking – Commissioner Scott Gottlieb has made liberal use in conveying information via the issuance of “Commissioner Statements”. In fact, in 2016, there was just a single such statement issued by then FDA Commissioner Robert Califf. In 2017 there were 36, one of which was by Dr. Califf and the balance by Dr. Gottlieb. As mentioned in the prior posting on the matter, it is a way for Dr. Gottlieb to mark progress on a number of fronts and signal for the attention of key stakeholders. It is also a means for putting his personal stamp or brand on what is happening at FDA.
One of the things that accounts for the substantial increase in releases in 2017 over the previous year was the increase in the number of approval announcements. In 2017, there were 77 approval-related announcements of either a new drug, device, biosimilar or other medical product compared to just 59 the year before.
The increase in General Announcements for this year – a category that is a catch-all for grant awards, program launches, study outcomes and the like – is due in large part to the fact that Commissioner Statements are usually included in this category unless making an announcement specific to one of the other categories.
Finally, the approvals profile for each year varied considerably with 49 of the 2017 announcements involving the approval of a drug, expansion of a drug label or approval of a biosimilar, compared to 32 such announcements in 2016. For devices there were 25 approval announcements this past year compared to 26 the year before. But the big standout in 2017 was the approval of the first 3 gene therapies.
Overall, with the exception of last year, the volume has remained fairly consistent, but this year certainly saw some changes in both substance and style.