Euro Roundup: Politicians call for ‘substantial reform’ of MHRA

The UK Medicines and Healthcare products Regulatory Agency (MHRA) needs substantial reforms, with the patient safety concerns identified in 2020 “persisting and exacerbating” to this day, UK politicians say.

The Independent Medicines and Medical Devices Safety Review published in 2020 examined MHRA’s role in the Primodos, pelvic mesh, and sodium valproate safety scandals. The review said MHRA should undergo a “substantial revision, particularly in relation to adverse event reporting and medical device regulation.” The UK government accepted the recommendation and in 2021 said the work was ongoing.

Politicians met in the House of Commons last week to discuss the MHRA's current state. Esther McVey, the Conservative Party Member of Parliament for Tatton, put forward a statement that said the agency needs substantial reforms, described the yellow card adverse event system as “failing,” and raised concerns about the agency’s reliance on industry funding. McVey also said the agency had made a “delayed response” to COVID-19 vaccine safety signals.

She called on the government, which is no longer run by her political party, to acknowledge how MHRA’s “widespread regulatory failures” have harmed patients and put financial burdens on the healthcare system. Other politicians in the debate, who came from ruling and opposition parties, agreed with McVey's statement.

McVey and the other politicians reached an agreement after a debate that reiterated the issues raised in 2020 and cited developments since the review of UK drug and device safety. McVey quoted June Raine, CEO of MHRA, who said in 2022 that the COVID-19 pandemic “catalyzed the transformation of a regulator from a watchdog to enabler.”

MHRA gets 75% of its funding from the pharma industry, McVey noted. In that context, she said, “the agency’s transition from watchdog to enabler does little to quell suspicions of conflicts and the implications that has for patient safety.” McVey accused MHRA of reacting “slowly to strong signals that there was a serious problem with the AstraZeneca vaccine causing an autoimmune condition.”

Politicians from two other parties noted that “having a regulator funded by a drug company is genuinely a case of marking one’s own homework.” A Labour Party politician said, “I think we need a reform there.”

Another politician, Karin Smyth, the Labour Party member of parliament for South Bristol, put across the government’s position at the end of the debate. Smyth highlighted MHRA’s implementation of a new IT system that “will improve the efficiency of reporting and processing of yellow card reports ... supporting the prompt identification and assessment of new safety concerns” and the introduction of new medtech regulations.

“We plan to lay further reforms before Parliament this year, including unique device identifiers and implant cards to improve the traceability of implanted devices, as well as increasing the classification of devices to ensure that they receive the highest scrutiny throughout their lifetime,” Smyth said.

Debate Transcript

EMA’s pediatric committee puts anti-drug conjugate R&D on work plan for 2025

The European Medicines Agency’s Paediatric Committee (PDCO) has put an anti-drug conjugate (ADC) strategy forum on its work plan for 2025.

Drug developers are working to establish ADCs as part of the standard of care in multiple tumor types and there are potential opportunities in pediatric cancers. For example, HER2, the target of AstraZeneca and Daiichi Sanyko’s ADC Enhertu, is expressed in various childhood tumors and researchers at the MD Anderson Cancer Center have said clinical trials should be considered.

PDCO will discuss the powerful but potentially toxic modality at a multi-stakeholder oncology strategy forum in the first quarter of 2025. Other tasks on the roadmap include developing a focus group to explore how artificial intelligence can be used in the assessment of pediatric investigation plans (PIP) and in drug development programs for pediatric patients.

The committee also plans to update its guidance on stepwise PIP, an approach to managing a lack of crucial information that PDCO wants to establish as a permanent procedure. PDCO also plans to implement an International Council for Harmonisation guideline on pediatric extrapolation.

Work Plan

MHRA predicts increase in written feedback as it changes scientific advice process

Changes to how MHRA reviews new requests for scientific advice meetings could temporarily increase written-only responses.

On 21 January, MHRA began reviewing requests for meetings “against whether the requirements can be addressed with existing guidance, written advice or a scientific advice meeting.” The agency said that for “a temporary period,” applicants should expect that “an increased number of requests will progress as written-only advice from our experienced MHRA specialists.”

MHRA is planning to publish full guidance on the change on 31 January. The agency is enacting the new approach alongside the launch of a series of improvements to its service and guidance, starting with the introduction of a digital application form that MHRA has designed to be “simpler, clearer and faster to complete.”

The agency shared details of the changes in an update to its guidance on accessing scientific advice.

MHRA Guidance

EMA publishes guideline on specific adverse reaction follow-up questionnaires

EMA has shared guidance on when and how regulators should use specific adverse reaction follow-up questionnaires (AR FUQs) in routine pharmacovigilance activities.

Regulators use specific AR FUQs to collect additional information about adverse events when the initial information provided in an individual case safety report is incomplete. The guidance covers when and how to use specific AR FUQs, provides advice to marketing authorization holders on developing the questionnaires and thoughts on the discontinuation and removal of specific AR FUQs.

“The content of a specific AR FUQ should focus on collecting the missing data of main importance for assessing the safety concerns,” EMA said. “It should be prefilled with available information to avoid requesting the primary source to repeat information. A specific AR FUQ should not be overly extensive and its completion by the reporter should be easy to minimize the burden on reporters.”

EMA will bring the guidance into effect on 1 February.

EMA Guideline

Swissmedic clarifies rules on drug advertising amid claims it suppresses reporting

The Swiss Agency for Therapeutic Products (Swissmedic) has explained how its legal mandate to regulate the advertising of medicinal products applies to media reports on medicines.

Swissmedic said the Medicinal Products Advertising Ordinance applies to media representatives when reporting on medicines. Reporting may infringe the rules when “individual medicinal products are singled out and their advantages specifically highlighted,” Swissmedic said. The agency clarified the rules after facing accusations from the media.

“Various media have claimed that Swissmedic is suppressing ‘almost all reporting on weight-loss jabs’,” Swissmedic said. “This statement is incorrect, as the key words ‘weight-loss jabs’ alone find around 1,350 publications on this topic in the Swiss media database for 2024.”

There are four ongoing procedures between Swissmedic and media publishers, the agency said. The Federal Administrative Court upheld Swissmedic’s complaint in one case. The cases involving the media are part of a broader set of disputes over advertising. Swissmedic processed 80 advertising cases in 2023 and initiated legal proceedings in five cases.

Swissmedic Notice

Other news:

EMA published a report on the human medicines it approved in 2024. Press Release

Euro Roundup: Politicians call for ‘substantial reform’ of MHRA

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