Sloppy End of Year FDA Filings Have Lower Approval Odds

In the fourth quarter, the FDA receives more new drug applications — and approves less of them — than at any other time of year.

According to a Dow Jones report, roughly 44 percent of all FDA approval applications are filed in the fourth quarter. Yet those applications have just a 38 percent chance of gaining a first-cycle approval, while those filed in the third quarter have a 70 percent chance.

The reason, according to FDA and industry sources in the article, may have something to do with the fact that drug makers often promise their investors they’ll file for approval by the end of the year, then find themselves rushing to meet that goal:

“I personally believe people are pushing to submit things by the end of the year for business reasons as opposed to ‘It’s ready,’” said Robert Yetter, microbiologist with the FDA’s Center for Biologics Evaluation and Research.

Biotechs are notorious for over-promising and under-delivering on deadlines; there’s even an industry joke that to figure out how long it will actually take to do something, you take the length of time the company says it will take, increase it by one order of magnitude, and add one. So three days becomes four weeks, seven weeks becomes eight months, etc.

But it looks like this might be the one case where it’s actually good to default on your promise — or at least, it’s better than rushing. Filing in January or February will still lead to an approval decision by the next December, but rushing an end of year filing could mean a complete response letter the next September followed by weeks or even months of fixing sloppy data and anywhere from two to 10 more months for another review cycle.