FDA Approves Almost Everything

FDAWe just got treated to a whole lot of drama this week as to whether Addyi, a drug to boost women?s libidos, would be approved. But based on the data, that approval was probably a foregone conclusion.

As recently as 2008, companies filing applications to sell never-before-marketed drugs, which are referred to by the FDA as ?new molecular entities,? faced rejection 66% of the time. Yet so far this year the FDA has rejected only three uses for new chemical entities, and approved 25, an approval rate of 89%.

Those numbers come from a new analysis commissioned by Forbes from BioMedTracker, a division of publishing giant Informa that helps investors track events in the pharmaceutical industry. And if you dig into them, the drop is even sharper.

The way BioMedTracker follows new molecular entities is slightly different from the way the FDA does. BioMedTracker users want to know about every use of a new medicine. That means that the 2015 rejection count includes rejections of Avycaz, a new antibiotic from Allergan AGN -3.02%, for hospital-acquired pneumonia, and selling Jardiance, a diabetes drug from Eli Lilly and Boehringer Ingelheim , in combination of metformin. But Avycaz was approved for two other uses and Jardiance is on the market by itself.

So in reality, the FDA approval rate is more like 96%. Eliminating BioMedTrackers counting of multiple uses for the same drug means FDA approved 23 drugs and rejected 1, Merck ?s anesthesia antidote, Bridion. Again, that means 19 of 20 new drug applications were approved.

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