EMA explains redaction of AbbVie’s data

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EMA explains redaction of AbbVie’s data

Home/Policies & Legislation | Posted 13/02/2015 0 Post your comment

The European Medicines Agency (EMA) has been criticized for the way it has implemented new European transparency rules for pharmaceuticals and in particular for its redaction of clinical study reports for AbbVie’s arthritis blockbuster Humira (adalimumab) [1]. In response to this criticism, EMA has published a ‘detailed response’ in which the agency ‘explains its redaction rules’.

The response comes after the European Ombudsman, Emily O’Reilly; expressed concern over the way EMA had redacted the clinical study reports for Humira, after she received a complaint about an access to documents request that was received by EMA in 2013. In a letter to EMA, dated 27 October 2014, she pointed out 16 cases where the rationale for redacting information from the clinical study reports was not clear and required explanation from EMA [1].

EMA states that the ‘access to documents’ request the Ombudsman refers to had led to a court case against EMA to prevent the agency from releasing any of the documents related to Humira. However, after agreeing ‘a limited number of redactions of the documents in line with the agency’s rules’ the court case was withdrawn.

EMA points out that it examined ‘extensively’ the set of redactions proposed by AbbVie and rejected some, but ‘accepted some redactions of information closely related to the ongoing and confidential commercial development of Humira’, and is in line with its Policy on Access to Documents of 2010.

The agency has, however, also been criticized for changes in its data transparency plans, which restrict access to data [2], which the Ombudsman has also expressed concern over [3].

Despite its ‘detailed response’, the agency did not reply to specific questions from the Ombudsman about why information on the rationale for dosage selection and determination of sample size had been redacted. It is somewhat worrying that the agency admits that the redactions were proposed by an originator company.

References
1.   GaBI Online - Generics and Biosimilars Initiative. EMA criticized for redaction of AbbVie’s data [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 13]. Available from: www.gabionline.net/Policies-Legislation/EMA-criticized-for-redaction-of-AbbVie-s-data
2.   GaBI Online - Generics and Biosimilars Initiative. EMA criticized for change in data transparency plans [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 13]. Available from: www.gabionline.net/Policies-Legislation/EMA-criticized-for-change-in-data-transparency-plans
3.   GaBI Online - Generics and Biosimilars Initiative. EMA changes transparency plans to increase access to data [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 13]. Available from: www.gabionline.net/Policies-Legislation/EMA-changes-transparency-plans-to-increase-access-to-data

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Source: EMA