DoH is to tighten laws on drug trial disclosures

The DoH has promised to act after UK drug regulators called for tougher legislation on disclosure of adverse events by drug manufacturers.

The MHRA wants the European Commission to tighten rules over providing safety information about drugs on the market.

As part of current proposals, the MHRA wants companies to be legally obliged to disclose information on adverse effects even if noted outside of the EU or when used outside of marketing authorisations.

It also wants clear time scales within which information should be reported, along with sanctions for failing to comply.

Health minister Dawn Primarolo promised 'immediate steps' to secure a strengthening of the law 'to make it clear to all pharmaceutical companies that they should disclose any information they have that would have a bearing on the protection of health'.

The call follows a four-year investigation by the MHRA into handling of information on use of Seroxat (paroxetine) in under-18s by manufacturers GlaxoSmithKline (GSK).

GSK carried out nine clinical trials into the paediatric use of Seroxat between 1994 and 2002.

But the MHRA was only notified of the increased risk of suicidal behaviour in children taking the drug, in 2003, when GSK was applying for the drug licence to be extended to under-18s. This suicidal risk became evident after a meta-analysis of the nine trials.

The drug regulators say that GSK should have disclosed this information earlier.

However, government prosecutors saw no realistic prospect of a conviction.

GSK has defended its actions. Dr 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.'

MHRA Investigation

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