Original Message -----
From: Dr Gillis of NICE org
To: Janne
Cc: to previous NICE corespondent, MHRA, GSI GOV and Another
Sent: Thursday, May 11, 2006 7:10 PM
Subject: RE: Request for data and FOIA request about Strattera's effect on sexual maturation
Dear Ms Larsson,
Thank you for clarifying your request.
The assessment of drug safety comes within the remit of the MHRA, so investigation of any possible adverse effects of drugs would be their responsibility.
NICE‘s remit does not include assessing the safety of drugs, and so NICE cannot take action to investigate new data related to safety issues.
NICE produces guidance on the clinical and cost effectiveness of treatments only. Within the guidance production, NICE will consider all appropriate evidence which is available at the time the guidance is being produced, taking account of any specific advice available from the MHRA at that point. Health professionals are expected to refer to drug license indications and to any subsequent official safety information issued, when using NICE guidance.
With kind regards,
Dr Tonya Gillis
Communications Manager
National Institute for Health and Clinical Excellence (NICE)
MidCity Place
71 High Holborn
London WC1V 6NA
Tel: 020 7067 5937
Main switchboard : 020 7067 5800
Website: www.nice.org.uk
