ARTICLE | Politics & Policy

EMA responds to EU Ombudsman on AbbVie redactions

February 11, 2015 1:21 AM UTC

EMA Humira adalimumab from AbbVie Inc. (NYSE:ABBV). Last October, O'Reilly asked EMA to explain numerous redactions from documents released after AbbVie settled a 2013 lawsuit against EMA challenging the agency's decision to release raw patient-level data for Humira as part of a broader data transparency effort (see BioCentury Extra, Nov. 12, 2014).

In a publicly released letter, EMA Deputy Executive Director Andreas Pott acknowledged the agency should not have redacted some information, but did so "in light of the massive amount of documents reviewed and the time pressure to release the documents." The agency said some errantly redacted information was not redacted in subsequent data requests. ...