The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Analyzing the FDA’s 2009 Approval Statistics

Two interesting Tweets appeared this morning:

Biotech drug approvals spiked in 2009. http://is.gd/5O2KD

followed shortly by

#FDA Drug Approvals Mostly Flat in 2009 http://bit.ly/5sAGF6

The actual numbers, which are based on analysis by investment research group Washington Analysis, are that 2009 saw 26 total approvals compared to 25 in 2008 and of those, seven were for biotech drugs compared to four in 2008. 

Is that a spike for biotech? Ira Loss (from Washington Analytics) tells FierceBiotech maybe, but wants to see if the increase holds in subsequent years.  Fisher’s exact test gives a p-value of 0.499, indicating that seven out of 26 is not a statistically significant increase over four out of 25; but as the Pharmaceutical Processing article says, “[t]he FDA can’t approve drugs that aren’t submitted.” 

So, we can’t really reach an answer without a real denominator — I’d suggest using the number of drugs with a PDUFA deadline during the calendar year; but even then it would be very hard to control for NDA quality or other possibly confounding factors.

Bottom line? Seven is better than four; and as FierceBiotech points out, fears that the Obama FDA would ratchet back approvals have not been substantiated.

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