Dr Ben Goldacre 
 
By email only to [FOI #24031 email]
  
FOI 09 473 
 
30 December 2009 
 
Dear Dr Goldacre 
 
Thank you for your Freedom of Information Act (FOIA) request of 30 November 
about statins.  Your request has been passed to me as I coordinate FOIA 
requests for Vigilance and Risk Management of Medicines Division.  
 
You have asked about delays in updating statin product information referred to in 
the February 2008 Drug Safety Update (DSU) and specifically for: 
 
1.  all documents and correspondence relating to this delay; 
2.  the discussions between the MHRA, the EMEA, and the company 
about the addition of this new side effects information to the side 
effects listed on the label, and  
3.  the name of the company concerned. 
 
The MHRA has identified information we hold that falls within your request.  Much 
of this information relates to information that was written by third parties and we 
are still in the process of discussing release of this information with them.    I will 
not therefore be able to meet the 20 day deadline of 31 December but will 
respond to you by the end of January 2010. 
 
Please contact me if you wish to discuss your request. 
 
Yours sincerely 
 
 
Stephen Fawbert 
 
Mr Stephen Fawbert 
Freedom of Information Coordinator 
Vigilance and Risk Management of Medicines Division 
Tel: 020 7084 2788 

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