Dear Keith,

I am very concerned that fluoxetine (Prozac) is not to be made available in the UK in a low-dose solid formulation. Leaving aside the possibility of reducing the risk of dependence, the enclosed paper briefly explains why.

This doesn't seem safe, wise or ethical to me, and I'm writing to ask how it seems to the MCA/CSM. I believe the following questions would enable disclosure to be made in the performance of duty, within the meaning of s118 of the Medicines Act. But just in case, please treat these as formal requests under the Code, anyway.

1. Is the MCA/CSM already aware of the reasons why the US FDA approved the introduction of the 10mg (and 5mg) strength tablet? If so, will they publicly explain why the benefits of a lower dosage solid form of fluoxetine should not be available in the UK?

2. If the MCA/CSM are not yet aware of the reasons why low dose fluoxetine was approved in the US, will it undertake to find out, and then explain? Will the MCA/CSM also formally ask the license holder why they do not intend to introduce the low-dose form of fluoxetine in the UK - and will the MCA/CSM make its letter of enquiry disclosable, and also encourage the license holder to respond in kind?

3. Is the MCA/CSM satisfied that the need for low dose, solid formulations of fluoxetine was not evident years ago, if not at the time the product license was granted for the 20mg capsule? Given that the overwhelming majority of fluoxetine users either respond badly to the drug or would have responded as well to a placebo, was it ever appropriate to have made the drug available only in a single dosage solid form - and how can possibly it be ethical to continue to do so now?

Thank you for your attention and consideration. I look forward to hearing from you - sometime in the next century, I presume. 

Yours sincerely,

Charles Medawar

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