EMA defends data black-out policy for AbbVie's Humira
- Transparency experts are fuming over the European Medicine Agency's (EMA) decision to omit certain data from a Humira (adalimumab) Clinical Study Report (CSR).
- The redaction was made as part of a 2013 settlement between the EMA and AbbVie, which wanted to keep certain parts of the CSR in question confidential.
- Humira is currently the best-selling drug in the world.
In October 2014, it was big news when the EMA decided to make CSRs available to the public at large, after a great deal of advocacy and politicking from the AllTrials group including phyisicans, policymakers, researchers, and patients demanding greater transparency.
But according to AbbVie, the publication of the data that they requested be omitted predated the transparency agreement—and the company reportedly had specific confidential reasons for not wanting it published. For now, the EMA's decision to redact the data stands.