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GlaxoSmithKline (MHRA Investigation)

The Medicines and Healthcare products Regulatory Agency (MHRA) is today announcing the outcome of its investigation into allegations that GlaxoSmithKline (GSK) withheld relevant information gathered in clinical trials on the use of Seroxat in children and adolescents. A report has been placed in the Library of the House and copies are available to hon. Members in the Vote Office. The decision taken by Government prosecutors is that there is no realistic prospect of obtaining a conviction in this case, and that the case will therefore not proceed to prosecution. The process of investigation has revealed weaknesses in EU legislation as it stood at the time, in terms of what safety information drugs companies were legally obliged to provide to the regulators. I have therefore asked that immediate steps are taken as follows:"to secure a strengthening of the law in this area; through changes to the EU Directive and, in the meantime, amending the law as it applies in the UK;""to make it clear to all pharmaceutical companies that, notwithstanding the limitations that may exist in the law, they ""should disclose any information they have that would have a bearing on the protection of health. The MHRA is writing today both to GSK and to pharmaceutical industry bodies to stress this point. Copies of those letters have been placed in the Library of the House; and""the MHRA will continue to monitor the risks and benefits of Seroxat and other Selective Serotonin Re-uptake Inhibitors (SSRIs) and provide advice to clinicians and patients. The outcome of this investigation does not affect existing advice on the safety of these medicines."