Oireachtas Joint and Select Committees

Wednesday, 8 November 2017

Joint Oireachtas Committee on Health

Evaluating Orphan Drugs: Discussion (Resumed)

9:00 am

Mr. Shaun Flanagan:

I think I would be pushing it to say that I was an authority on the FDA. We know what happened with Translarna because we always look at the evidence base to sense check any decisions the HSE has made to ensure they sustain challenges around whether or not we are outliers. We are always looking at how other authorities have looked at decisions, particularly when we have made a decision and their decision comes afterwards.

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