Bioequivalence and Bioavailability Forum

Dear all,

I haven't really thought this fully through, but would in any case like to hear some views:

Here is a link to a draft document for which the consultation period ends in September 2011. It is about the type and extent of information national authorities could release upon request.

I do believe the community has some degree of interest in paving the way for cheaper alternatives to originator drugs and occasationally one hears stories about various tricks that can be made to prevent generic entry. Example of story here.
I do not intend to express sympathy with either side or any allegations; to clarify I think both originator drugs and generics are both justified and necessary.

The consultation document is rather soft in its wording - it mentions what type of info could be released. From a generics perspective I think there might be a point in suggesting that release of PK-variability (within and between) be absolutely mandatory. This info isn't always available by SPCs, Prescr. info., FOI sources etc. Release of this info, I think, this would help generic companies so that they don't need to conduct e.g. pilot studies (or two-stage studies). From a science perspective there is no reason to re-invent the wheel with e.g. a pilot study, and from an ethical perspective re-inventing the wheel with a pilot study would almost seem unimaginable if an alternative exists.

My point is, without siding with anyone here, I do see a point in suggesting in this consulation that release of specific info re. PK-variability be mandatory since it does not contain personal information and since there may be an ethical reason on top of that. What do you think?

Best regards,
EM.

PS: You might actually claim that such comments are borderline out of the scope of this consultation. I of course hafta agree
PPS: A better option would be if such info was mandatory on SPCs. But I am not aware of any consultation for that