GlaxoSmithKline will be breathing a sigh of relief this morning after UK regulators ruled that the company should not be prosecuted for a breach of drug safety regulation regarding its antidepressant Seroxat.

The ruling marks the end of a four-year investigation by the MHRA into whether the company delayed providing the Agency with clinical data showing that patients under the age of 18 taking Seroxat (paroxetine) were at a higher risk of suicidal behaviour than those given a ghost pill.

GSK submitted clinical data to the MHRA back in 2003 showing the higher risk of suicide and that the drug is ineffective in treating depressive illness in patients under 18, prompting the Agency to publish advice to all doctors that Seroxat should only be used in adults.

At the time, the BBC’s Panorama programme - which first raised concerns over Seroxat in 2002 - attacked the MHRA for failing to protect patients against the antidepressant, claiming that vital evidence regarding the risks could have been picked up when the drug first received a UK license.

But the MHRA insisted it had acted swiftly to prevent Seroxat’s use amongst the under-18s after GSK presented “new” data as part of a bid to win expanded labelling for the drug, which revealed a three-times greater risk of self-harm in this age group. GSK told Panorama that it had only seen an indication of a problem in May 2003, yet the last study was completed in 2001, raising concerns that the company had deliberately withheld this information and sparking the MHRA’s investigation into the two-year delay.

Weak legislation
While the Agency’s investigation has concluded that the information should indeed have been reported earlier, it believes that, because legislation at the time was not comprehensive enough as to require companies to submit safety data when the drug was being used or tested outside its licensed indications, there is no realistic prospect of a conviction and so the case should not proceed to criminal prosecution.

“I remain concerned that GSK could and should have reported this information earlier than they did [but] this investigation has revealed important weaknesses in the drug safety legislation in force at the time”, commented Professor Kent Woods, the MHRA’s chief executive. And he went on to say that, while subsequent legislation has partially addressed the problem, “we will take immediate steps to ensure the law is strengthened further, so that there can be no doubt as to companies’ obligations to report safety issues.”

Unfortunately, a spokesperson for GSK was unavailable for comment.