Intended for healthcare professionals


Drug firms take legal steps to prevent European regulator releasing data

BMJ 2013; 346 doi: (Published 12 March 2013) Cite this as: BMJ 2013;346:f1636
  1. Zosia Kmietowicz
  1. 1BMJ

A leading US pharmaceutical company, AbbVie, has taken legal action against Europe’s medicines regulator to try to prevent it from releasing data it holds on the safety and efficacy of one of its drugs.

If successful, the action could jeopardise the European agency’s plans to begin publishing from January 2014 all clinical trial data once it has decided whether to approve a drug for use across the European Union.1

AbbVie has sought an injunction to stop the European Medicines Agency (EMA) from releasing detailed information that it holds on its drug Humira (adalimumab) for rheumatoid arthritis. The move follows two freedom of information requests from Belgian pharmaceutical company UCB in late 2012 for patient level data on the drug’s side effects …

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