Select Committee on Health Minutes of Evidence

Letter from the Chairman, Medicines and Healthcare Products Regulatory Agency, to the Clerk of the Committee (PI 124)

  I undertook to write to you about a small number of items after the appearance of officials from this Agency at the oral evidence session of the Health Select Committee. There are also one or two issues, which, on reading the minutes, I would like to clarify.

  Dr Ian Hudson's previous employment history was raised by Mr John Austin MP and I would be grateful for the opportunity to clarify the position here. Dr Hudson was the Director and Vice President, Worldwide Clinical Safety at Smith Kline Beecham (SKB) from January 1999 to January 2001. Prior to this he was involved in the clinical development of drugs in the inflammation, tissue repair and oncology therapeutic areas. As an employee of SKB, therefore, he was not involved in the original application for a licence for Seroxat in 1990 or in the action to contra-indicate the product for use in children taken by this Agency in June 2003. Since his employment with the MHRA began, he has taken no part in decisions relating regulatory action on this product in the UK or in Europe.

  The issue of fees was raised at the end of the MHRA evidence session and I undertook to let you have more information on this issue. Since 1992, the former MCA and, now the Medicines sector of the MHRA, has been fully funded from user-fees. The current fee-scale is attached for information at Annex A. It is worth noting that of MHRA (Medicines) income, 60% comes from capital fees (principally from various categories of applications and inspections), while 40% comes from an annual "service fee" payable by all marketing authorisation holders. This service fee income is devoted principally to pharmacovigilance and enforcement work.

  Turning finally to the issue of Seroxat I think it is important to return to the questions raised by John Austin MP and about the position adopted by the MHRA in relation to the frequency of withdrawal reactions. In fact, as was stated in our oral evidence, the MHRA has never indicated that withdrawal was rare. The clinical trials at the time of licensing for Seroxat did not systematically record symptoms occurring after treatment was stopped or reduced and therefore it was not possible to determine a valid estimate of the frequency. As can be seen from Annex B, warnings about withdrawal reactions were included in the Summary of Product Characteristics for Seroxat at the time of licensing. The available information did not allow an estimation of frequency at that time and CSM/MCA did not state that the frequency of withdrawal reactions with Seroxat could be described as rare.

  The Agency has kept this product under review and made announcements on specific issues related to this product as the sum of knowledge has increased. Some trials which were carried out after licensing in support of new indications for Seroxat did systematically measure symptoms on stopping treatment and allowed an estimate of frequency to be calculated. For example, an article in Current Problems in Pharmacovigilance in 1993 provided Yellow Card data on withdrawal reactions reported with Seroxat following experience in clinical use and stated that they had been reported more frequently with paroxetine than with other SSRIs. Warnings about withdrawal reactions (especially with paroxetine) are repeated in the British national formulary, supplied to all doctors.

  I hope that you find this additional information useful.

4 February 2005

previous page contents

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2005
Prepared 26 April 2005