What do FDA press releases for the year say about the rate of new approvals for 2016?
Periodically I take a look at what FDA has said – and a little bit conversely at what it hasn’t. In April, I provided an overview of the first quarter look at the press releases sent out by FDA. What we saw then was announcements of approvals – both for devices and drugs – were down from the previous year. As we cross the mid-year mark, it is time to update and see where we are in terms of FDA pronouncements.
It is important to note here that official announcements of FDA approval actions are just that – not every approval gets a press release. By my observation, they are generally focused primarily on matters that are noteworthy because they are just that – and this year have included a number of compounds that have had one or more of the following – breakthrough therapy designation, priority review status, accelerated approval and/or orphan drug status. You don’t usually see releases for drugs that are fifth in class, unless they bring something new to the table.
Here is an overview of letters comparing the first six months of approvals for the years 2013-2016.
The purple line at the top shows us the total number of press releases for the first half-year period of each year from 2013-2016. One can see that while there were more in 2013, the past few years appear relatively even, though slightly under the past few years.
However, when looking at the green line which denotes combined approval announcements (drugs, devices, and other -which includes tobacco, apps, food-related approvals), at 32 total approvals (drug, device and one in food) the number for the first half of this year was down quite a bit from last year, when FDA had a banner year of approvals of new molecular entities.
Both drugs (signified by the red line) and devices (signified by the blue line) are down, however, the drug approvals experienced a greater drop than did devices. By mid-year last year there were 28 new drug approvals compared to 19 so far in 2016. That said, when you look back to last year’s banner year of approvals, the bulk of the new drug approval announcements occurred in the second half of the year (47).
The other categories tracked – legal actions such as consent decrees, recalls and public health alerts and general announcements were all at similar levels to years gone by , though the issuance of new policy through rules is higher, with 14 issued so far this year, compared to only 7 at this time last year.
Again, approval announcements are not the same as approvals – many approvals have no FDA announcement. But using the press releases as an indicator of the current approval rate of new molecular entities, unless the second half of this year follows the same pattern as last year, there may be indications that 2016 is not the banner year in approvals that marked 2015.