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European ombudsman questions European Medicines Agency over AbbVie redactions

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g6904 (Published 18 November 2014) Cite this as: BMJ 2014;349:g6904
  1. Rory Watson
  1. 1Brussels

The European ombudsman, Emily O’Reilly, has written to the European Medicines Agency asking it to explain by 31 January 2015 the redactions it made in the clinical trial data provided by AbbVie for its best selling drug adalimumab (Humira), used to treat rheumatoid arthritis.

The redactions were made as part of the settlement between the agency and the company after AbbVie had gone to court to try to prevent publication of certain clinical trial data.

In her letter O’Reilly acknowledged that “certain redactions may be justified to protect the personal data of patients.” She also accepted that “certain other …

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