Blockbuster Drug Potential: Importance of Risk Management

Posted by cdavenport on Wednesday Oct 13, 2010 Under Drug Safety, FDA

Prior to drug approval, a potential new drug is usually subjected to the scrutiny of an expert advisory panel, selected by the FDA, who recommend whether or not the product should be marketed.   These recommendations are non-binding.  Industry analysts looked at product-specific decisions, a total of 120 votes, made by advisory committees to the FDA from 2007 through 2010.  The FDA followed its committees’ advice 74% of the time.  Significantly, only 3 times did the FDA overrule a “no” vote from the committee: Tarceva (lung cancer), Avastin (breast cancer), and Micardis (hypertension).  In other words, a “no” vote from an advisory panel is likely to meet acceptance, but a “yes” vote does not mean that the product will be approved.  All of the recent hype over obesity drugs aside, it is important to understand current events in light of historical precedence.  It also highlights the importance of risk management, particularly when dealing with drugs that have blockbuster potential.

Source: Forbes

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