EMA defends Humira redactions, says only commercial info was blacked out

By Gareth Macdonald contact

- Last updated on GMT

EMA defends Humira redactions
EMA defends Humira redactions

Related tags: Pharmaceutical industry, Food and drug administration

The EMA has defended its decision to redact three Humira clinical study reports, arguing that the information held back was ‘commercially confidential.’

The European Medicines Agency (EMA) set out its position today​, suggesting it only held back details of AbbVie’s commercial development plans for the monoclonal antibody (mAb).

The comments follow a letter sent​ by European Ombudsman Emily O'Reilly last October in which she questioned the omission of the names AbbVie’s contractors and details of the software the firm used from three CSRs requested by an unnamed third party.

O’reilly’s concerns – which were prompted by AbbVie’s efforts to prevent the EMA releasing the documents​ – also touched on the decision to black out details of sample sizes, protocols and information on assays used in the studies.

It is obvious, from a close reading of the documents, that certain redactions may be justified to protect the personal data of patients​,” or that relate to the confidential business relationships of AbbVie, O’Reilly wrote. “However, I have doubts and concerns as regards other redactions​”

In its defence, the EMA said while clinical reports are not confidential “some very limited information contained in a clinical report may be considered commercially confidential, and in these cases may be redacted​.”

Redaction unsatisfaction

The EMA comments come amid growing scrutiny​ of the EMA’s clinical study report publication policy after European politicians​ voted to force drugmakers and academics make CSR reports publically available.

UK-based campaigning group Alltrials​ – which wants all clinical trials, past and present to be registered and all data reported – has previously raised concerns about the EMS’s redaction policy.

Alltrials founder Dr Ben Goldacre even cited the EMA’s agreement with AbbVie that it would hold back details of protocol changes – which resulted in the US biotech withdrawing the case – in his concerns about the agency’s redaction policy.

Protocol changes in a trial are precisely the kind of information that researchers need to make an informed decision about whether that trial was a fair test of the treatment.

It is hard to see how it is justifiable to hide protocol changes, in a trial from eight years ago, on over-riding grounds of commercial confidentiality​” Goldacre said.

Related topics: Markets & Regulations, Bio-Outsourcing

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