Glaxo case prompts tighter drug trial laws

Posted on 6 Mar 2008 by The Manufacturer

GlaxoSmithKline has avoided criminal proceedings following claims it withheld potentially life threatening information on its antidepressant drug Seroxat.

Drugs regulators warned that the pharmaceutical giant failed to report quickly enough the risk of suicidal behaviour in young people that is linked with Seroxat. GSK, however, denied the claims.

In the light of the case, ministers have now agreed to tighten the laws surrounding drug trials so that firms are obliged to disclose trial results.

“I remain concerned that GSK could and should have reported this information earlier than they did,” said MHRA chief executive Professor Kent Woods. “All companies have a responsibility to patients, and should report any adverse data signals to us as soon as they discover them.

“This investigation has revealed important weaknesses in the drug safety legislation in force at the time,” he added.