When the MHRA’s Dame June Raine said her organisation was shifting from being a watchdog to being an enabler, she meant it.

Dr. June Raine was appointed chief executive of the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) in August 2019. She has been integral to the agency’s work, particularly during the covid-19 pandemic. In 2022, she was awarded a Dame Commander of the Order of the British Empire (“DBE”) in recognition of her service to the public, more specifically for “services to healthcare and the covid-19 response.”  Earlier this year, it was announced she would step down as chief executive in the autumn of 2024, after five years in the role

Since 2020, the MHRA has developed a habit of providing assistance to well-connected US drug developers with friends in high places such as Dr. Robert Kadlec, the mastermind behind the US bio-defence project responsible for the covid-19 debacle. This assistance has taken the form of issuing questionable but critical pharmaceutical authorisations.

On 4 November 2021, following another of its ‘rigorous’ reviews, the MHRA became the first regulator in the world to authorise the oral antiviral molnupiravir, a drug in development for treating covid-19, which has a controversial history as detailed in a whistle-blower complaint filed in April 2020.

MHRA’s authorisation was granted after testing on only 775 people, despite concerns about the drug’s potential to cause birth defects. The MHRA declared the drug “safe and effective” without providing sufficient evidence to support this claim.

The MHRA issued a conditional marketing authorisation for molnupiravir, marketed in Great Britain by MSD (Merck) under the brand name Lagevrio. In Northern Ireland, where European Union law remains in effect, the MHRA issued a Regulation 174 authorisation for temporary supply, as a conditional marketing authorisation would have required approval from the European Medicines Agency.

Contrasting with the MHRA, the US Food and Drug Administration (“FDA”) delayed approving molnupiravir due to concerns shared by some reviewers about its potential to cause birth defects.  The FDA ultimately approved the drug on 23 December 2021, seven weeks after the MHRA’s authorisation – raising suspicions that some members of the FDA’s equivalent of the UK Commission on Human Medicines reviewing Merck’s application may have been swayed by the prior MHRA authorisation, which could have influenced their decision.

The MHRA’s authorisation of molnupiravir before adequate testing raises concerns about its priorities and standards. The drug’s conditional marketing authorisation remains in place, despite lack of efficacy being an insufficient reason for the MHRA to withdraw the authorisation. This suggests that commercial interests may have played a role in the decision-making process.

The MHRA’s review process and decision-making surrounding molnupiravir’s authorisation remain opaque. The agency’s assurances about the drug’s safety and efficacy lack transparency, and the public is left to question the true motivations behind the authorisation.

The above is a summary of the two-part series ‘Yet another MHRA drug scandal’ published by the Conservative Woman.  You can read the full articles HERE and HERE.