Roaccutane use

Elisabeth made this Freedom of Information request to Medicines and Healthcare products Regulatory Agency

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

The request was partially successful.

Dear Medicines and Healthcare products Regulatory Agency,

As the UK government agency responsible for regulating medicines, I would like to request information on the drug Roaccutane. I understand that the MHRA has also published public assessment reports on the drug, most recently in November 2014.

I would appreciate as thorough responses as possible to the questions below:

1. According to the data, how many people are living in the UK are currently taking Roaccutane? And how many people in total have taken Roaccutane in the past 20 years?

2. What is the average revenue generated in pound sterling of Roaccutane sales in the UK each year? How much would a private patient pay for a six month supply of 20mg pills?

3.Why did Roche withdraw Roaccutane in the United States in 2009?

4. What has the MHRA done to combat the illegal sale of Roaccutane on the web?

5. Please take me through the changes that have taken place in terms of how Roaccutane has been regulated since it first came on the market in the 1980s.

6. How regularly must patients on Roaccutane have blood tests and pregnancy tests? If private consultant dermatologists do not require this, how are they held to account?
And how are NHS dermatologists monitored with reference to prescribing roaccutane?

7. How many individuals became pregnant whilst taking Roaccutane in 2014/2015?

8. What is the most common dosage given to people with severe acne and over what period? How is the right dosage determined?

Yours faithfully,

Elisabeth Perlman

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 15/186
       
Dear Ms Perlman,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
       
Thank you for your enquiry which we received on 16 April 2015.
       
I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt. Please note that we are unable to take forward questions 1 to 3 below as they fall outside of our remit.

With regards to your question "According to the data, how many people are living in the UK are currently taking Roaccutane? And how many people in total have taken Roaccutane in the past 20 years? ", please contact the Department of Health (DH) and NHS Business Services Authority (NHSBSA) for assistance. Their contact details are below:

DH
Tel: 020 7210 4850
Web: https://www.gov.uk/make-a-freedom-of-inf...

NHSBSA
Tel:
Email: [email address]

We would advise you to contact the manufacturer (Roche UK) for assistance with the following question "What is the average revenue generated in pound sterling of Roaccutane sales in the UK each year?". The Association of British Pharmaceutical Industry (ABPI) may also be able to assist or signpost you.

Roche UK
Web: www.roche.co.uk

ABPI
Email: [email address].

The Department of Health (DH) and NHS Business Services Authority (NHSBSA) can assist with "How much would a private patient pay for a six month supply of 20mg pills?".

The US Food and Drug Administration (FDA) can assist you with "Why did Roche withdraw Roaccutane in the United States in 2009?".

Web: www.fda.gov

If you need to contact us again about this request, please quote the reference number above.
       

Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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Pharmacovigilanceservice, Medicines and Healthcare products Regulatory Agency

1 Attachment

Dear Ms Perlman,

        

Thank you for your email.

 

Attached is the response to your FOI request.

       

 

Kind Regards,

 

FOI Team

 

Vigilance and Risk Management of Medicines Division

Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ

 

 

 

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