With just eleven of the twenty-two working days left in July for the OGD to report approval actions, the number of full approval actions stands at twenty-nine and tentative approval actions sit at eight, for a total of thirty-seven so far this month. These numbers are derived from the FDA’s All Approvals page here.
Compared with last month’s total of all approval actions of sixty-two, if things progress at the same rate for the rest of the month of July, the OGD will hit seventy-four total approval actions (fifty-eight approvals and sixteen tentative approvals). We all know that the numbers game is just that, a game, but it is the game that that industry chases. So, we are also guilty as charged! But approvals are and have always been the primary marker of success as judged by the generics industry for as long as I can remember (and trust me, I remember back from Day 1 of the Hatch-Waxman Act). That’s right sports fans, it does not seem like any other metric is even remotely in the same ballpark of importance as approval actions.
Even though we all know that the OGD does a lot more than push out approvals, and certainly we do not want to imply that the OGD is not working hard or is not performing, but approvals are the holy grail that all else is benchmarked against. It is the win/loss record as industry views the game. So, grab a hot dog and a beer (or soda) and settle back in your chair and watch to see how the approval actions pile up in the bottom half of the July inning! Don’t worry, we will be here to report on the end of this inning when the third out of July is called.