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 […]

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Jim 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InterMune has withdrawn part of its legal challenge to stop the European Medicines Agency from disclosing certain documents, which relate to the medicine Esbriet (Pirfenidone). The company is still looking for a prohibition on disclosure, but has withdrawn its application for an interim order, which would prevent disclosure before the full hearing of the case.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 […]

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Jim 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 […]

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Jim 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, […]

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Jim 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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