FDA Approvals... What We Can Learn

Not surprisingly, there's been a lot of commentary about the FDA's recent report touting a near-record 35 new drug approvals in 2011. As Paul Howard recognized, the FDA gladly taking credit for the increased rate of drug approvals in 2011 seems more than a bit disingenuous, especially after blaming drugmakers for the lower number of drugs approved over the last few years (21 in 2010, 24 in 2009, 23 in 2008, and 19 in 2007).

For years, the agency has claimed that the scarcity of new drugs approved was the result of lower quality applications, but now that approvals are up, they are singing their own praises. The FDA commissioner's statement about this apparent contradiction, "I think the point we're trying to make is that when high quality science, good applications come before us, we are able to act swiftly and surely," doesn't resolve this discrepancy. Nor does it address internal process delays that need to be addressed by the agency.

Even so, there are lessons to be learned from the types of drugs approved, rather than the total number:

Of the 35 approvals, two are theranostics -- personalized drugs approved for use in conjunction with a specific diagnostic test; seven are cancer drugs; 10 are for orphan diseases; and a total of 16 were approved under priority review. 2010, in contrast, only saw 21 approvals, and the outright rejection of two potential blockbuster weight-loss drugs. The argument I have been making in my last several posts now appears to be a reality. Increasing opportunities exist for drugmakers to pursue alternative research venues, particularly in the areas of theranostics and orphan drugs.

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