In the UK, the Department of Health is the “parent,” or sponsoring department, for the Medicines and Healthcare Products Regulatory Agency (MHRA). That seems reasonable. It would be surprising if the Department for Business, Innovation and Skills (BIS) were given the job, and yet something like this has just happened in the new European Commission […]
djfhdkfdkjfhakdjfhkadsfhldksjfajdfkdajfhkdlsfhkdlsfhkdsfhskldfhdkfhdsklCategory: Jim Murray
Jim Murray: Undermining the European Medicines Agency’s transparency policy
As previously mentioned, the European Medicines Agency pulled back on its transparency policy when it published a new draft for consultation in May this year. The European Ombudsman and Glenis Willmott MEP were among many who expressed concern or criticised the new draft policy. A final decision by the management board of the agency has been […]
djfhdkfdkjfhakdjfhkadsfhldksjfajdfkdajfhkdlsfhkdlsfhkdsfhskldfhdkfhdsklJim Murray: A surprising development in the case of InterMune vs the EMA
InterMune has withdrawn part of its legal challenge to stop the European Medicines Agency from disclosing certain documents, which relate to the medicine Esbriet (Pirfenidone). The company is still looking for a prohibition on disclosure, but has withdrawn its application for an interim order, which would prevent disclosure before the full hearing of the case. (InterMune […]
djfhdkfdkjfhakdjfhkadsfhldksjfajdfkdajfhkdlsfhkdlsfhkdsfhskldfhdkfhdsklJim Murray: Policy making behind closed doors
Campaigning for transparency on clinical trial results at EU level is getting to be like playing snakes and ladders, and I’ve just spotted three snakes. I’ve been trying to “deconstruct” the EMA’s reply by letter to the Ombudsman’s concerns about the agency’s volte-face on transparency. The results worry me—a lot. The EMA says that the […]
djfhdkfdkjfhakdjfhkadsfhldksjfajdfkdajfhkdlsfhkdlsfhkdsfhskldfhdkfhdsklJim Murray: Volte-face by the European Medicines Agency?
The European Medicines Agency (EMA) has recently published to a targeted audience final consultation draft papers on its new “proactive” transparency policy on clinical trial results. As reported, information published under the draft policy would be on a screen-read only basis, would not include commercially confidential information (CCI) as defined by the EMA, would be subject […]
djfhdkfdkjfhakdjfhkadsfhldksjfajdfkdajfhkdlsfhkdlsfhkdsfhskldfhdkfhdsklJim Murray: Who cares about the European Parliament?
Many people across Europe regard the European Parliament as irrelevant, or worse. Personally I find this sad but they are entitled to their view. I wrote a blog here a few months ago to illustrate the important work done by many MEPs, taking the example of clinical trials. You can find it here. I thought […]
djfhdkfdkjfhakdjfhkadsfhldksjfajdfkdajfhkdlsfhkdlsfhkdsfhskldfhdkfhdsklJim Murray: Abbvie withdraw case against European Medicines Agency
AbbVie have withdrawn their legal challenge against the release of certain company documents on Humira (adalimunab) by the EMA. This followed an offer by the agency to redact parts of the document originally intended for release. Is this good news? There are those who think it is, but we cannot be entirely sure at this […]
djfhdkfdkjfhakdjfhkadsfhldksjfajdfkdajfhkdlsfhkdlsfhkdsfhskldfhdkfhdsklJim Murray: Some MEPs work very hard
I sometimes feel sorry for MEPs, and not just at Christmas. I’m thinking of those who do a good job as rapporteur on important dossiers, such as the revision of the Clinical Trials Directive. They put this on their website and in their press releases, but in most cases their constituents have no idea what […]
djfhdkfdkjfhakdjfhkadsfhldksjfajdfkdajfhkdlsfhkdlsfhkdsfhskldfhdkfhdsklJim Murray: New fronts in the struggle for transparency
The European Court of Justice has struck down and ordered a rehearing of the cases for an interim injunction to stop the European Medicines Agency’s new transparency policy on clinical trial results. The two companies, AbbVie and Intermune, will have to give more specific arguments as to why the relevant data should not be disclosed, […]
djfhdkfdkjfhakdjfhkadsfhldksjfajdfkdajfhkdlsfhkdlsfhkdsfhskldfhdkfhdsklJim Murray: Transparency may help to reduce the misselling of medicines
Greater transparency on clinical trial results would help reduce off-label promotion—the promotion of medicines for uses for which they have not been approved. Looking at the US since 2004, I compiled a table of cases taken by the Department of Justice involving off-label promotion where the fines, penalties, and/or settlements came to more than $300 […]
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