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Just Easier This Way

In 2008, the US Food and Drug Administration rejected 66 percent of new drug applications, but so far this year, the agency has approved 89 percent of such applications, Forbes' Matthew Herper reports. His analysis draws on data commissioned by Forbes from BioMedTracker.

According to BioMedTracker, FDA approved 20 new molecular entity applications and rejected 20 in 2008, an approval rate of 50 percent. Herper notes that that rate fell the following year to 44 percent before rising in 2011 to 86 percent. The agency approval rate has since fallen and risen again, and reached 88 percent in 2014.

Looking at all new drug approvals, not just new molecules, a similar pattern emerges, he says.

"The evidence is that we're living in a golden age of drug approvals, at least from a drug company's perspective," Herper says, adding that this trend is likely to continue with the passage of the 21st Century Cures Act, which aims to further speed up the drug approval process.

According to FDA, approval rates are going up because it is doing what it is supposed to and because it is listening to patients who want drugs with even slight benefits to be approved, he says.

But this sped-up approval process, Herper adds, comes with risks. He notes that a previous wave of speedy approvals yielded Vioxx, which was withdrawn from the market, and Avandia, which has had its usage restricted.

"That's why we should tread carefully here. Already, the FDA is approving drugs almost all the time," he says. "It is doing so rapidly, with appropriately lower standards for rare diseases. How low do we want the bar to go?"