Sunday, March 10, 2013
AbbVie sues European regulator over data
A leading US pharmaceutical group has sued Europe’s medicines regulator, in a sharp intensification of the battle between advocates for greater transparency on drugs and companies who fear their competitive position will be undermined by more openness.
AbbVie has sought an injunction to block the European Medicines Agency from releasing detailed data on the effects in individual patients in clinical trials of its top-selling medicine Humira for rheumatoid arthritis.
The action, taken in the European Union’s general court, follows two Freedom of Information requests to the Agency in 2012 to release “raw data” on the drug’s safety and efficacy.