Jacqui Wise states that a new ‘system allowing drugs to be approved in the UK by other “trusted” regulators such as the US Food and Drug Administration (FDA) is sparking concern among experts’ with the worry being that ‘the strategy risks lowering evidence standards, particularly in light of recent scandals in President Trump’s FDA, including conflicts of interest among panel members and a “revolving door” between the pharmaceutical industry and the regulator.’
I was invited by Lord David Alton to a meeting in the House of Lords with the MHRA on the 22nd October 2024. The meeting was in relation to safety warnings and prescribed antidepressants. I had intended to ask the following question at the meeting but there was not sufficient time. Therefore, at the end of the meeting I handed the following question to June Raine, CEO of MHRA. I asked her if she could provide a written answer:
‘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?”’
I have had no reply from the MHRA in relation to this question. Perhaps the MHRA could take the opportunity to reply here through the BMJ rapid response system?