http://blog.pharmtech.com/2009/04/27/which-way-forward-for-pharma/ The blog of Pharmaceutical Technology magazine Thu, 09 May 2013 23:30:55 -0400 http://wordpress.org/?v=2.8.4 hourly 1 http://blog.pharmtech.com/2009/04/27/which-way-forward-for-pharma/comment-page-1/#comment-13230 S C Burford Thu, 30 Apr 2009 09:05:15 +0000 http://blog.pharmtech.com/?p=1200#comment-13230 Lifecycle quality management has certainly been a stumbling block for pharma during the last decade or so; FDA has not backed off from pursuing the biggest companies when GXP inspections have shown quality systems at mega manufacturers to be deficient, as witnessed by the consent agreements and sometimes huge financial penalties that have been imposed. In recent years ICH and regional efforts to develop guidelines have put in place recommendations for Pharma Quality Management Systems. One problem is that these systems are time consuming and costly to implement for SMEs, who are consequently reluctant to make the necessary investments. This probably means that SMEs will tend to continue to focus on drug discovery and rely even more on partnering with big companies for the expensive, intensely regulated pharma development activities. Now that the economists have almost shut down basic research at big pharma by mistakenly trying to make it cost effective (whatever happened to 'skunk-works' in the pharma industry?), it looks as though big companies will increasingly have little choice except to compete with each other to pay ever higher prices to license in a decreasing number of innovative products. The question is, of course, how to break this cycle of self-destructive economic behavior by the pharma industry? Is it a parallel to the US automotive industry ostrich-like head-in-the-sand lose-lose attitude (do I sense an evil economist lurking here?) to the gas-guzzlers vs fuel-efficiency debate? (A bit of an apples vs oranges comparison, I admit; just the first one that came to mind). My [regulatory] kingdom for a......new paradigm! Lifecycle quality management has certainly been a stumbling block for pharma during the last decade or so; FDA has not backed off from pursuing the biggest companies when GXP inspections have shown quality systems at mega manufacturers to be deficient, as witnessed by the consent agreements and sometimes huge financial penalties that have been imposed.
In recent years ICH and regional efforts to develop guidelines have put in place recommendations for Pharma Quality Management Systems. One problem is that these systems are time consuming and costly to implement for SMEs, who are consequently reluctant to make the necessary investments. This probably means that SMEs will tend to continue to focus on drug discovery and rely even more on partnering with big companies for the expensive, intensely regulated pharma development activities.
Now that the economists have almost shut down basic research at big pharma by mistakenly trying to make it cost effective (whatever happened to ’skunk-works’ in the pharma industry?), it looks as though big companies will increasingly have little choice except to compete with each other to pay ever higher prices to license in a decreasing number of innovative products.
The question is, of course, how to break this cycle of self-destructive economic behavior by the pharma industry?
Is it a parallel to the US automotive industry ostrich-like head-in-the-sand lose-lose attitude (do I sense an evil economist lurking here?) to the gas-guzzlers vs fuel-efficiency debate?
(A bit of an apples vs oranges comparison, I admit; just the first one that came to mind).
My [regulatory] kingdom for a……new paradigm!

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