FDA's new drug approval rate dropped in 2013 after '12 high

By MATTHEW PERRONE, Published: January 5, 2014
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The Food and Drug Administration approved 27 first-of-a-kind drugs in 2013, down from 39 new medications in 2012, which was a 15-year high.

Despite the decline, FDA officials say the tally of innovative medications approved last year is in line with the historical trend. On average, the FDA has approved 28 first-of-a-kind drugs annually over the past five years.

FDA drug approvals are watched closely by analysts as both a barometer of industry innovation and the federal government's efficiency in reviewing new therapies.

Experts say the number of drug approvals declined in 2013 mainly because there were fewer drugs submitted for review.

According to an FDA presentation given last month to industry executives, the agency received at least 32 applications for innovative medications in 2013, down from 41 in 2012. Generally the FDA takes between 6 and 10 months to review new drug applications.

“I don't think this reflects badly on the way FDA is working, rather on the number of applications they had to review,” said Ira Loss, for Washington Analysis. There are at least 25 new drug applications pending at FDA for 2014 with more expected this year, according to Washington Analysis.

More drug applications bode well for an industry that thrives on new products and has seen patents on some of its blockbuster sellers — including the cholesterol pill Lipitor and the blood thinner Plavix — expire in recent years.

FDA drug approvals peaked at 53 in 1996 before a series of high-profile drug safety incidents, culminating with the withdrawal of Merck's painkiller Vioxx in 2004 because of links to heart attack and stroke.

Drug approvals have been in the mid-twenties for the last decade or so, before jumping to 30 in 2011. The 39 drugs approved in 2012 was the highest annual tally since 1997.

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