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
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