Impact of Approvable Letters 2007 – Part 2

Yesterday I posted about the impact of approvable letters and began by saying I have not yet been able to compare this year to other years, but my gut told me that it was a higher rate of approvables than ever.  Ask and ye shall receive. 

Today a release was issued by Sagient ResearchSagient Research is a publisher of independent research.  The release was about their research report which demonstrated a "significant decline" in FDA approvals during 2007 citing a 13% drop in 2007.  In addition, according to the company, the number of approvable letters increased by 40%:

Percentage Change in FDA Decisions: 2006 vs. 2007

Decision Type








Approvable Letter








Also according to the company, the average stock price change that was the result of an approvable letter dropped in 2007 to a 12.89% from 21.42% in 2006, which would mean that approvable letters are having less of an impact and that perhaps investors are adjusting to this new paradigm. 

This is not good news for the agency – especially one that is committed to bringing new drugs to market.  This, combined with a much lower rate of enforcement by the agency as expressed through a weak stream of warning letters indicates an agency, and hence and industry, that has much changed.   

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2 Responses to Impact of Approvable Letters 2007 – Part 2

  1. Anonymous says:

    Who said the Agency is really “…committed to bringing new drugs to market..”? Is there any mandate in the Agency’s authorizing legislation for that?

  2. Mark Senak says:

    The entire purpose of the establishment of the agency is to regulate drugs, including their approval. Each year the agency has to report on its track record in new approvals and PDUFA timelines. And the agency has developed a critical path initiative that, though never properly promoted, highlights the agency goals in bringing new molecules to the benefit of patients.

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