Law change to force companies to report all ADRs
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Depressed young people should not be treated with Seroxat |
Legislative changes that will force pharmaceutical companies to report adverse drug events promptly, regardless of the source, will be introduced in the UK by the end of the year after a decision not to prosecute GlaxoSmithKline for allegedly withholding important safety data from its clinical trials on Seroxat (paroxetine) in children.
GSK rejects any suggestion that it withheld drug trial information since
results from its paediatric studies were documented and submitted to
regulators in accordance with regulatory requirements.
Alastair Benbow, medical director for GSK Europe, said: “We firmly
believe we acted properly and responsibly in first carrying out this
important clinical trials programme and then informing the regulatory
agencies when we identified a potential increased risk of suicidal thinking
and behaviour in patients under 18.”
However, the Medicines and Healthcare products Regulatory Agency has
made it clear that it believes GSK could and should have reported the
information earlier than it did and says the new rules will leave companies
in no doubt about their obligations to disclose information promptly.
The outcome of the MHRA’s four-year criminal investigation, the
largest of its kind in the UK, was published last week. After considering
the investigation, Government lawyers have decided that, because of a
gap in legislation, there is no realistic prospect of a conviction in
the case and it should not proceed to criminal prosecution.
Legislation in force at the time did not require companies to inform
the regulator of safety information when the drug was being used or tested
outside its licensed indications.
Writing to GSK, Kent Woods, chief executive of the MHRA, said that tightening
the law should be unnecessary in an industry that relies so heavily on
public trust and aspires to high ethical standards. “I would have
thought it self-evident that such information should be made available
promptly to the regulator in order that action can be taken to protect
public health. However, that moral responsibility now needs to be insisted
upon by the unambiguous force of the law.”
The MHRA advised prescribers that Seroxat should
not be prescribed for children under 18 years old (PJ, 14 June 2003, p813) after GSK submitted
information in 2003 showing that this population had a higher risk of
suicidal behaviour if taking Seroxat than if taking placebo and that
the drug was ineffective for treating depression in children.
The MHRA had two main concerns about GSK’s conduct, detailed in
the report
of its investigation: first, “… the length of time
between completion of some of the trials included in the analysis which
had raised the safety issue and the communication of this to the agency” and,
secondly, that this important safety concern was conveyed in a briefing
document about a proposal to extend Seroxat’s licence to include
children.
News feature p302
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The
Pharmaceutical Journal
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