|Social Audit Ltd|
|P O Box 111 London NW1 8XG|
|Telephone/Fax 44 (0)20 7586 7771|
|[email protected] http://www.socialaudit.org.uk|
|Martin Bagwell, Senior Policy Manager|
|Medicines Control Agency|
|Market Towers, 1 Nine Elms Lane|
|London SW8 5NQ||
24 December 2002
Dear Mr Bagwell,
Thank you for your letter of 17 December: Ref OG/50. Even in the thick of this season of goodwill, I cannot accept ritual expressions of regret in place of a straightforward explanation for your inability to provide to provide any of the information I requested in my 28 November letter to Mr Alder.
Please point me to the provision of the Code of Practice that exempts you from its requirements. Please explain what the Agency means by "a series of connected requests" and why this entitles you to waive my rights to this information within 20 working days of your receipt of my request? Please treat these as formal requests under the Code, and this letter as a formal complaint: you have offered no meaningful explanation for exempting yourself from Code requirements, and undertake only to respond "some time." As the Guidance on Interpretation says: "Unexplained or undue delay is likely to attract criticism."
I did not ask the Agency "to consider" something; I asked for information I am entitled to get. Please treat the following as a new, discrete request for information under the Code.
1. Did there or did there not exist, at 28 November 2002, a database or some other collection of data from which it would have been possible to extrapolate, in less than four person hours, the core information I requested: [a] the number of occasions in the previous year on which the MCA had made representations about possible breaches of the medicines advertising regulations to licence holders, indicating in each case [b] the identity of manufacturer/ product and [c] the nature of complaint.
2. If not, what is the MCAs estimate of the amount of time it would take to respond to this request?
There was no question of connectedness with questions 12 to 18. Please could I have a response to these right away or at least some explanation and justification for delay?
12. Please provide a copy of any note or memorandum of understanding between the MCA and either of these bodies about the division of responsibilities for control of advertising and product promotional activity.
13. Does the MCA ever refer complaints relating to possible breaches of regulations relating to product advertising or promotion for investigation or adjudication to the ABPI/PMCOPA and, if so, how often does this happen and under what circumstances?
14. On what basis, did the Agency decide to take no unilateral action in the matters relating to GlaxoSmithKlines promotion of Seroxat (paroxetine) referred to in my letter of 12 October to Dr Raine until after the findings of the PMCOPA became known?
15. Does the MCA agree with the conclusion of the PMCOPA Appeal Board, that no statement in the GSK, "Reactive Key Messages and Issues Document" (19 December 2001) is incompatible with the Seroxat SPC? I asked this in my letter to Dr Raine of 12 October 2002 and a reply is overdue.
16. On how many occasions this century has the MCAs Independent Review Panel for Advertising assembled to consider matters relating to how many advertisements?
17. In what sense is this an "Independent Panel", when eight of the nine members who have disclosed interests have personal interests in pharmaceutical companies, including six who are shareholders?
18. What arrangements have been or would be made to consider regulatory matters involving products made by GlaxoSmithKline, when eight of the ten Panel members currently list personal interests in either GlaxoWellcome or SmithKline Beecham, including five who directly own shares?
Thank you for your attention. I look forward to hearing from you.
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