The letter from MHRA to Garnier typed out (easier to read) and saved as pdf

[Guest guest]

http://www.ssri-uksupport.com/files/MHRAtoGSK.pdf

" Safeguarding public

health

[MHRA LOGO]

6th March 2008

Dr Jean-Pierre Garnier

GlaxoKline

980 Great West Road

Brentford

Middlesex

TW8 9GS

Dear Dr Garnier

I am writing to advise you that the Medicines and Healthcare products

Regulatory Agency is today announcing the conclusion and outcome of

its investigation into a number of allegations regarding GSK, in

particular that the company withheld from the MHRA important clinical

trial data relating to the safety and efficacy of Seroxat in children

and adolescents, and promoted that product for use in this age group

despite safety and efficacy concerns.

In immediate practical terms, the outcome of the investigation is

that, having considered our investigation report, government lawyers

have decided not to pursue a prosecution of GSK. Their view is that

the law at the time these events took place did not require a

pharmaceutical company to inform the regulator of clinical trials

date in groups for whom the medicine was not licensed, and that there

is insufficient evidence of GSK promoting the product for " off-label "

use in under 18s. We will today be issuing a press release to

confirm that, and will be publishing on our website a short report

setting out the conduct and conclusions of the investigation. I am

attaching both the press release and the report for your records.

This is the immediate practical outcome but there are a number of

other issues arising from the process. There is obviously a need to

tighten the law to make it absolutely clear that pharmaceutical

companies have a legal responsibility to inform the regulator of any

information that changes the benefit risk profile of their products,

regardless of whether the information relates to a licensed

indication. We will be using the current European Commission

consultation on pharmacovigilance regulations and other opportunities

to press for changes to the law in this area.

Such a course of action should be unnecessary in an industry which

relies so heavily on public trust and aspires to high ethical

standards. I would have thought it self-evident that such

information should be made available promptly to the regulator in

order that action can be taken to protect public health. However,

that moral responsibility now needs to be insisted up by the

unambiguous force of law.

You will be aware that we have reviewed a large quantity of documents

from GSK. Legal provisions prevent us from releasing publicly any

information gained under our statutory powers in the course of a

criminal investigation. However, there has been a significant level

of quite legitimate public interest in this case, and I would there

like to release that information into the public domain. This of

course requires your consent. GSK has regularly asserted that it has

nothing to hide in this matter and so I should be grateful if you

could confirm in writing your consent to the release.

Finally, I have no doubt that the content of this letter will be the

subject of numerous Freedom of Information requests to the Agency in

the coming weeks. The MHRA takes the view that any considerations of

confidentiality are outweighed by the public interest in disclosure,

and we will therefore be publishing this letter today alongside our

investigation report.

If you have any queries about the contents of this letter, please do

not hesitate to contact me.

Yours sincerely

[signature]

Professor Kent Woods

CEO

Medicines and Healthcare products Regulatory Agency

Market Towers 1 Nine Elms Lane London SW8 5NQ

[Contact numbers, unreadable on

original] An Executive

Agency of the Department of Health "

[Guest guest]

http://www.ssri-uksupport.com/files/MHRAtoGSK.pdf

" Safeguarding public

health

[MHRA LOGO]

6th March 2008

Dr Jean-Pierre Garnier

GlaxoKline

980 Great West Road

Brentford

Middlesex

TW8 9GS

Dear Dr Garnier

I am writing to advise you that the Medicines and Healthcare products

Regulatory Agency is today announcing the conclusion and outcome of

its investigation into a number of allegations regarding GSK, in

particular that the company withheld from the MHRA important clinical

trial data relating to the safety and efficacy of Seroxat in children

and adolescents, and promoted that product for use in this age group

despite safety and efficacy concerns.

In immediate practical terms, the outcome of the investigation is

that, having considered our investigation report, government lawyers

have decided not to pursue a prosecution of GSK. Their view is that

the law at the time these events took place did not require a

pharmaceutical company to inform the regulator of clinical trials

date in groups for whom the medicine was not licensed, and that there

is insufficient evidence of GSK promoting the product for " off-label "

use in under 18s. We will today be issuing a press release to

confirm that, and will be publishing on our website a short report

setting out the conduct and conclusions of the investigation. I am

attaching both the press release and the report for your records.

This is the immediate practical outcome but there are a number of

other issues arising from the process. There is obviously a need to

tighten the law to make it absolutely clear that pharmaceutical

companies have a legal responsibility to inform the regulator of any

information that changes the benefit risk profile of their products,

regardless of whether the information relates to a licensed

indication. We will be using the current European Commission

consultation on pharmacovigilance regulations and other opportunities

to press for changes to the law in this area.

Such a course of action should be unnecessary in an industry which

relies so heavily on public trust and aspires to high ethical

standards. I would have thought it self-evident that such

information should be made available promptly to the regulator in

order that action can be taken to protect public health. However,

that moral responsibility now needs to be insisted up by the

unambiguous force of law.

You will be aware that we have reviewed a large quantity of documents

from GSK. Legal provisions prevent us from releasing publicly any

information gained under our statutory powers in the course of a

criminal investigation. However, there has been a significant level

of quite legitimate public interest in this case, and I would there

like to release that information into the public domain. This of

course requires your consent. GSK has regularly asserted that it has

nothing to hide in this matter and so I should be grateful if you

could confirm in writing your consent to the release.

Finally, I have no doubt that the content of this letter will be the

subject of numerous Freedom of Information requests to the Agency in

the coming weeks. The MHRA takes the view that any considerations of

confidentiality are outweighed by the public interest in disclosure,

and we will therefore be publishing this letter today alongside our

investigation report.

If you have any queries about the contents of this letter, please do

not hesitate to contact me.

Yours sincerely

[signature]

Professor Kent Woods

CEO

Medicines and Healthcare products Regulatory Agency

Market Towers 1 Nine Elms Lane London SW8 5NQ

[Contact numbers, unreadable on

original] An Executive

Agency of the Department of Health "

[Guest guest]

http://www.ssri-uksupport.com/files/MHRAtoGSK.pdf

" Safeguarding public

health

[MHRA LOGO]

6th March 2008

Dr Jean-Pierre Garnier

GlaxoKline

980 Great West Road

Brentford

Middlesex

TW8 9GS

Dear Dr Garnier

I am writing to advise you that the Medicines and Healthcare products

Regulatory Agency is today announcing the conclusion and outcome of

its investigation into a number of allegations regarding GSK, in

particular that the company withheld from the MHRA important clinical

trial data relating to the safety and efficacy of Seroxat in children

and adolescents, and promoted that product for use in this age group

despite safety and efficacy concerns.

In immediate practical terms, the outcome of the investigation is

that, having considered our investigation report, government lawyers

have decided not to pursue a prosecution of GSK. Their view is that

the law at the time these events took place did not require a

pharmaceutical company to inform the regulator of clinical trials

date in groups for whom the medicine was not licensed, and that there

is insufficient evidence of GSK promoting the product for " off-label "

use in under 18s. We will today be issuing a press release to

confirm that, and will be publishing on our website a short report

setting out the conduct and conclusions of the investigation. I am

attaching both the press release and the report for your records.

This is the immediate practical outcome but there are a number of

other issues arising from the process. There is obviously a need to

tighten the law to make it absolutely clear that pharmaceutical

companies have a legal responsibility to inform the regulator of any

information that changes the benefit risk profile of their products,

regardless of whether the information relates to a licensed

indication. We will be using the current European Commission

consultation on pharmacovigilance regulations and other opportunities

to press for changes to the law in this area.

Such a course of action should be unnecessary in an industry which

relies so heavily on public trust and aspires to high ethical

standards. I would have thought it self-evident that such

information should be made available promptly to the regulator in

order that action can be taken to protect public health. However,

that moral responsibility now needs to be insisted up by the

unambiguous force of law.

You will be aware that we have reviewed a large quantity of documents

from GSK. Legal provisions prevent us from releasing publicly any

information gained under our statutory powers in the course of a

criminal investigation. However, there has been a significant level

of quite legitimate public interest in this case, and I would there

like to release that information into the public domain. This of

course requires your consent. GSK has regularly asserted that it has

nothing to hide in this matter and so I should be grateful if you

could confirm in writing your consent to the release.

Finally, I have no doubt that the content of this letter will be the

subject of numerous Freedom of Information requests to the Agency in

the coming weeks. The MHRA takes the view that any considerations of

confidentiality are outweighed by the public interest in disclosure,

and we will therefore be publishing this letter today alongside our

investigation report.

If you have any queries about the contents of this letter, please do

not hesitate to contact me.

Yours sincerely

[signature]

Professor Kent Woods

CEO

Medicines and Healthcare products Regulatory Agency

Market Towers 1 Nine Elms Lane London SW8 5NQ

[Contact numbers, unreadable on

original] An Executive

Agency of the Department of Health "

[Guest guest]

http://www.ssri-uksupport.com/files/MHRAtoGSK.pdf

" Safeguarding public

health

[MHRA LOGO]

6th March 2008

Dr Jean-Pierre Garnier

GlaxoKline

980 Great West Road

Brentford

Middlesex

TW8 9GS

Dear Dr Garnier

I am writing to advise you that the Medicines and Healthcare products

Regulatory Agency is today announcing the conclusion and outcome of

its investigation into a number of allegations regarding GSK, in

particular that the company withheld from the MHRA important clinical

trial data relating to the safety and efficacy of Seroxat in children

and adolescents, and promoted that product for use in this age group

despite safety and efficacy concerns.

In immediate practical terms, the outcome of the investigation is

that, having considered our investigation report, government lawyers

have decided not to pursue a prosecution of GSK. Their view is that

the law at the time these events took place did not require a

pharmaceutical company to inform the regulator of clinical trials

date in groups for whom the medicine was not licensed, and that there

is insufficient evidence of GSK promoting the product for " off-label "

use in under 18s. We will today be issuing a press release to

confirm that, and will be publishing on our website a short report

setting out the conduct and conclusions of the investigation. I am

attaching both the press release and the report for your records.

This is the immediate practical outcome but there are a number of

other issues arising from the process. There is obviously a need to

tighten the law to make it absolutely clear that pharmaceutical

companies have a legal responsibility to inform the regulator of any

information that changes the benefit risk profile of their products,

regardless of whether the information relates to a licensed

indication. We will be using the current European Commission

consultation on pharmacovigilance regulations and other opportunities

to press for changes to the law in this area.

Such a course of action should be unnecessary in an industry which

relies so heavily on public trust and aspires to high ethical

standards. I would have thought it self-evident that such

information should be made available promptly to the regulator in

order that action can be taken to protect public health. However,

that moral responsibility now needs to be insisted up by the

unambiguous force of law.

You will be aware that we have reviewed a large quantity of documents

from GSK. Legal provisions prevent us from releasing publicly any

information gained under our statutory powers in the course of a

criminal investigation. However, there has been a significant level

of quite legitimate public interest in this case, and I would there

like to release that information into the public domain. This of

course requires your consent. GSK has regularly asserted that it has

nothing to hide in this matter and so I should be grateful if you

could confirm in writing your consent to the release.

Finally, I have no doubt that the content of this letter will be the

subject of numerous Freedom of Information requests to the Agency in

the coming weeks. The MHRA takes the view that any considerations of

confidentiality are outweighed by the public interest in disclosure,

and we will therefore be publishing this letter today alongside our

investigation report.

If you have any queries about the contents of this letter, please do

not hesitate to contact me.

Yours sincerely

[signature]

Professor Kent Woods

CEO

Medicines and Healthcare products Regulatory Agency

Market Towers 1 Nine Elms Lane London SW8 5NQ

[Contact numbers, unreadable on

original] An Executive

Agency of the Department of Health "