BioCentury
ARTICLE | Politics & Policy

EU Ombudsman grills EMA on AbbVie settlement

November 13, 2014 2:45 AM UTC

EU Ombudsman Emily O'Reilly is scrutinizing EMA's settlement with AbbVie Inc. (NYSE:ABBV), in which the agency redacted information from clinical study reports about AbbVie's autoimmune drug Humira adalimumab.

According to O'Reilly's publicly released letter to EMA Director Guido Rasi, particular redactions could be justified to "protect the personal data of patients" or "relate to the confidential business relationships of AbbVie." However, she wrote, she had "doubts and concerns" regarding other redactions. ...