The Pharmaceutical Journal
Vol 273 No 7320 p507
9 October 2004

This article
Reprint   Photocopy

  Acrobat Reader

News summary

MHRA meets its targets, but criticism continues

All the targets set for the time it takes the Medicines and Healthcare products Regulatory Agency to make medicines licensing decisions were exceeded last year. But questions continue to be asked about the quality of some of its decisions.

The MHRA annual report for 2003–04 says: “This year, the agency maintained excellent service levels in terms both of the speed with which it processed licensing applications and the quality of the decision-making process.”

But within days of the report’s publication, the BBC’s Panorama programme claimed that the MHRA could have been aware of serious side effects of paroxetine (Seroxat) before the drug was licensed.

Panorama said that clinical trial results contain evidence that Seroxat can leave a quarter of all users addicted, that it may increase the risk of suicide in young adults and that rapid increases in dosage can cause serious side effects. The programme claimed that the MHRA could have known this much earlier because it had some of the confidential clinical trial information before the drug was licensed 13 years ago.

In its defence, the MHRA said that the safety of paroxetine had been under continual review since it was first licensed. The agency had acted promptly as soon as new evidence had been made available. The report of an expert working group that has been reviewing the safety and efficacy of all SSRIs in adults is due to be published at the end of the year.

In addition, MHRA chief executive Kent Woods told Panorama that its claim that the regulation of drugs is a secretive business that does not put safety of patients first is inaccurate.

But the annual report admits that there is a perception that the agency is unduly uncommunicative and that this impacts on the tone in which its work is reported.

As a result, a specialist communications consultancy was asked to develop a strategy and action plan for the agency. One outcome is that the new post of communications director was advertised in August. An appointment is expected soon.

This is the first annual report since the MHRA was formed from the Medicines Control Agency and Medical Devices Agency. It says that the new agency must be greater than the sum of its two constituent parts in order to maximise its role in protecting public health.