Approval Outlook for 2008

As I’ve noted in recent posts, the situation in 2007 was pretty rough for new drug approvals.  We saw an increase in approvable letters, and a decrease in the percentage of approval letters.  Will it get better in 2008?

I wouldn’t count on it.  Here’s why:

  • The Environment – There is still a huge appetite for risk aversion in this country.  The FDA recently formed a new advisory committee on risk communication in addition to the existing advisory committee it already had on risk.  The public focus is all on risk right now, even perhaps more than pricing.  When the public angst is so focused, policy makers respond – and that response is going to include further FDA reforms and much more oversight.
  • The Politics – Democrats in control of Congress are fully reacting to what I imagine they consider a lackluster job by the current Administration.  The FDA, and the industry by extension, are therefore the focus of a great deal of scrutiny.  In recent weeks, lawmakers have sent out letters that include inquiring into the conditions around an approvable letter for a specific drug and whether or not advisory committee members had a conflict of interest; a letter requesting information on the potential for a behind-the-counter (BTC) status for drugs; and a letter to examine whether or not Fast Track status has been given too freely to some products, meaning perhaps that safety has been sacrificed in the name of speed in the drug approval process.  Remember that in 2007 the concerns raised about Avandia safety were centered more in the halls of Congress than anywhere else.  The Avandia issue was more politics than science. 
  • The Election Cycle – The campaign, now fully underway, for new nominees and an eventual election provides a wealth of opportunities for public discourse over the public angst about drug safety – from debates to conventions to acceptance speeches to more debates, etc. etc.  It will also provide a showcase for new reforms, some of which may slow down the drug approval process further in the perceived interest of enforcing better safeguards.

In short, there is no reason to believe that the situation of 2007 is going to blossom into something better in 2008.  For better times, I’d look to 2009. 

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