Health Warning

November, 28, 2021 | 3 Comments

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  1. Correspondence to: H Naci h.naci@lse.ac.uk
    MHRA’s new delivery plan strikes the wrong note

    On 4 July 2021, the Medicines and Healthcare Products Regulatory Agency (MHRA) published its delivery plan for 2021-2023: Putting Patients First: a New Era for our Agency.1 In this plan, the MHRA promises to make drug regulation in the UK more patient centred, while being “an agile and supportive regulator” to accommodate the interests of the United Kingdom’s life sciences industry.

    The MHRA’s latest commitment to put patients first follows last year’s landmark report by the Conservative peer Julia Cumberlege.2 The Independent Medicines and Medical Devices Safety Review (2020) chronicled the failure of regulators, alongside those of clinicians and other healthcare professionals, to tackle decades of patient reports of harm from medical treatments.3 The Cumberlege report characterised a healthcare system that is unfit for protecting patients and preventing harm, recommending that the MHRA engage more with patients and their outcomes.

    Going forward, the MHRA plans to include patients on all decision making committees.4 It will also support the development of patient reported outcome measures to make their use more widespread in clinical trials……
    the rest is behind a pay wall – which most ‘patients’ are exluded from unless they pay – how ridiculous

  2. With thanks to David here is the whole mess of a proposition

    On 4 July 2021, the Medicines and Healthcare
    Products Regulatory Agency (MHRA) published its
    delivery plan for 2021-2023: Putting Patients First: a
    New Era for our Agency.

    In this plan, the MHRA
    promises to make drug regulation in the UK more
    patient centred, while being “an agile and supportive
    regulator” to accommodate the interests of the United
    Kingdom’s life sciences industry.
    The MHRA’s latest commitment to put patients first
    follows last year’s landmark report by the
    Conservative peer Julia Cumberlege.2 The
    Independent Medicines and Medical Devices Safety
    Review (2020) chronicled the failure of regulators,
    alongside those of clinicians and other healthcare
    professionals, to tackle decades of patient reports of
    harm from medical treatments. The Cumberlege
    report characterised a healthcare system that is unfit
    for protecting patients and preventing harm,
    recommending that the MHRA engage more with
    patients and their outcomes.
    Going forward, the MHRA plans to include patients
    on all decision making committees.

    It will also support the development of patient reported outcome
    measures to make their use more widespread in
    clinical trials. The recent Patient Involvement
    Strategy further outlines how the MHRA will deliver
    on its vision to become a “patient focused regulator.”

    Including patients in regulatory decision making is
    a welcome development—and long overdue. But one
    lesson of the Cumberlege report is that regulatory
    agencies have a poor track record in prioritising
    patients, especially when patient interests are at odds
    with those of other stakeholders, including drug
    companies. So it is concerning that the MHRA fails
    to recognise the potential for conflict between its role
    as a public health agency and its promise to “reduce
    regulatory burden” to support “today’s brilliant life
    sciences industry” and “boost growth.”

    Fast track pathways
    Of additional concern is a growing body of research
    showing that initiatives similar to those proposed by
    the MHRA frequently fail to put patients first. One
    example is expedited regulatory pathways. Despite
    substantial evidence questioning the effectiveness
    of these pathways,
    the MHRA is launching a new one
    —the Innovative Licensing and Access
    Pathway—designed to accelerate the development
    and approval of new drugs.
    Expedited regulatory pathways are not new. They are
    modelled on initiatives first developed by the US Food
    and Drug Administration and continue a dominant
    trend in the European Union and UK medicines
    policy. Some programmes expedite regulatory
    review, while others reduce clinical trial
    requirements, thereby shortening the duration of
    clinical development.
    The Innovative Licensing and Access Pathway is just
    the latest example in a spate of government initiatives
    designed to make the UK a more attractive destination
    for drug companies following its departure from the
    European regulatory system. The Accelerated Access
    Collaborative was launched in 2018 to establish a
    faster route to market for “transformative” medicines,
    devices, diagnostics, and digital health
    technologies. In 2019, NHS England set up a
    Commercial Medicines Unit to develop tailor made
    confidential agreements with industry to support
    rapid uptake of new medicines in the NHS. With the
    launch of the new pathway, the MHRA now intends
    to “ensure that the UK becomes an even greater place
    to develop, manufacture, and supply products.”

    Such pathways predictably deliver for drug
    companies by faciliating frequent interactions with
    regulators and securing early market access for
    medical products. But they may not ultimately benefit
    patients. Patients expect that medicines will improve
    either the quality or quantity of their lives, or
    both. Yet a growing proportion of drugs in
    expedited pathways are approved without robust
    studies and are supported by surrogate endpoints
    rather than patient relevant outcomes. Greater
    uncertainty may be an acceptable trade-off for some
    patients if fast-tracked drugs ultimately offer
    important therapeutic benefits. But research shows
    this is rarely the case. More than two thirds of
    expedited drugs do not perform better than existing
    alternatives. Some are later found to be ineffective

    Expedited pathways may also lead to major safety
    concerns. Previous studies from the United States,
    which has a long history of expedited drug approvals,
    show an association between products approved
    through expedited pathways and increased risk of
    postmarketing safety events similar to those identified
    by the Independent Medicines and Medical Devices
    Safety Review. The MHRA will need to take into
    account this evidence if it continues to pursue policies
    that prioritise ever faster drug development and
    regulatory review.
    As last year’s Independent Medicines and Medical
    Devices Safety Review concluded, the MHRA should
    take steps “to ensure that the patient perspective and
    the public interest always takes precedence over the
    interests of the industry.”

    In addition to including
    patients in decision making committees, regulators
    should more meaningfully engage patients and the
    public in setting the strategic direction of the agency.
    Consequential decisions like launching a new
    expedited pathway, for example, should take into
    account patient and public preferences for timely generation of
    good quality evidence on new drugs.
    In its latest attempt to strike a balance between health and industrial
    policy objectives, the MHRA’s delivery plan fails to put patients
    first. To realise its goal of improving the patient centredness of
    medicines regulation, the MHRA must be guided by the current best
    evidence on the benefits and harms of expedited regulatory
    pathways.

  3. 1 of 1
    Register to watch the Commission on Human Medicines (CHM) consideration of the isotretinoin review
    Inbox

    MHRA webmaster@subscriptions.mhra.gov.uk via service.govdelivery.com
    1:54 PM (1 hour ago)
    to me

    Isotretinoin review to the CHM
    View as a webpage / Share

    Medicines and Healthcare products Regulatory Agency bulletin
    Dear Colleague,

    As you may remember the Isotretinoin Expert Working Group (IEWG) has been reviewing the risk of psychiatric and sexual side effects with isotretinoin. This information is now going to be presented to the Commission on Human Medicines (CHM), where the next step of the isotretinoin review will be considered.

    Patients and other stakeholders have been involved throughout the isotretinoin review and we want to continue to involve patients and stakeholders in the next steps.

    Although the content and proceeding of CHM meetings are strictly confidential, we are offering patients and other stakeholders who have contributed or have an interest in the review an opportunity to watch CHM’s consideration of the information associated with the review.

    The CHM meeting will be held in two sessions, the first session will consider the information reviewed by the IEWG and the second session will consider the IEWG’s recommendations and the regulatory action needed. Patients and other stakeholders are invited to watch the first session.

    Please note that this CHM meeting is dedicated to the isotretinoin review, it is not a public meeting and only those who have registered will be able to attend.

    Date: Friday, 17 December 2021

    Time: 14:00-15:30

    Register now to confirm your place
    The deadline for registering to watch the CHM meeting is Monday, 13 December 2021 at 17.00 (GMT).

    Finally, please note that the CHM members must be independent, and we ask that individuals or campaign groups do not directly contact them regarding this review.

    We hope you will continue to be involved with this review and you’re able to join the CHM meeting, so please remember to register.

    If you have any further questions, please email us at MHRACustomerServices@mhra.gov.uk.

    Kind regards,

    Patient, Public and Stakeholder Engagement Team
    The Medicines and Healthcare products Regulatory Agency

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