On the 22nd October 2024, at the invite of Lord David Alton, I attended a meeting held in the House of Lords. This meeting was to consider safety warnings in relation to antidepressants.
At this meeting, was June Raine [CEO of MHRA] and Dr Alison Cave [MHRA Head Patient Safety Officer]. At the end of the meeting, I personally handed the following question to June Raine. I politely asked if the MHRA could provide a substantive reply to it:
“The recent adoption of the IRP fast-track process for licencing drugs approved by foreign regulators is going to require a higher level of fidelity from applicants than has been the case in the past, especially concerning US-based products. Given past compromises of the FDA approval system, how will a shorter time frame still allow the MHRA to “consider the applications against the same rigorous standards of safety, quality and efficacy as we would do for any non-IRP application?”
To date, I have received no reply and not even an acknowledgement.