Anyone who's kept an eye on the drugmakers this year won't be surprised by this statistic: The Food and Drug Administration approved fewer drugs this year than it has since 2007. According to the Wall Street Journal, which took the time to add them all up, the FDA only approved 21 drugs this year, compared with 25 in 2009 and 24 in 2008.
Dwelling on the past isn't usually all that useful for investors; the markets are forward-looking after all. But a little review of recent drug approvals and rejections is useful to see what the future holds for drugmakers in 2011 and beyond.
Drugs do get approved
It's easy to get wrapped up in the FDA's seemingly schizophrenic rejections, but the simple fact of the matter is the agency does approve drugs.
The easiest way to get a drug approved is to treat an unmet need and pass clinical trials that prove the drug works. Witness Dendreon
If a drug fails to meet both criteria, the chances for regulatory success fall substantially.
On the flip side, obesity drugs from VIVUS
Expect the unexpected
That's pretty much the mantra coming out of the FDA lately, which makes it more difficult for investors to handicap the likelihood of an FDA approval.
The biggest surprise of the year was the announcement that Amylin Pharmaceuticals and Eli Lilly would have to prove that their diabetes drug, Bydureon, didn't cause heart problems before the FDA would approve it. The FDA already had already turned the drug down once for relatively minor issues, so it was surprising that the agency would come back with such a large request.
Should have been on this year's list
The number of approved drugs could have had two more additions had it not been for the FDA bumping those decisions into next year.
Human Genome Sciences
This week, MannKind
Upcoming in 2011
I have no idea whether we'll see more drug approval in 2011 than we saw this year. Keep in mind that the overall level isn't determined by just the FDA; the number of applications will have some bearing, which is predicated on the number of positive clinical trials.
There are a few drugmakers that we know will be getting decisions in 2011.
Orexigen Therapeutics is due to round out the trio of obesity drugs with a decision on Contrave due at the end of January. Contrave is the only one of the three to get a positive recommendation from its FDA advisory panel, so it has a better chance at an FDA approval than the "somewhere between unlikely and nonexistent" I gave lorcaserin and Qnexa. But an approval is far from guaranteed. The FDA rejected Esbriet after a positive panel, for instance.
At the other extreme, Vertex Pharmaceuticals'
Keeping in mind that you still have to expect the unexpected, of course.