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EMA defends Humira redaction policy from transparency criticism

Regulator says spirit of trial transparency intact after its handling of AbbVie reports

EU FlagThe European Medicines Agency has defended its decision to black out some clinical trial report data relating to AbbVie's Humira (adalimumab) after concerns were raised this would jeopardise the transparency agenda.

The EMA was responding to the European Ombudsman Emily O'Reilly, who last October demanded that the Agency explain its reasoning behind the decision.

The redactions to the public data on arthritis drug Humira were made as part of a 2013 settlement between the regulator and AbbVie, which did not want all of its information for the medicine - currently the biggest-selling in the world - to be made viewable.

The US firm in fact took the Agency to court to stop it from publishing the information, but in a legal compromise AbbVie did allow its data to be published, though only after the EMA allowed 16 pieces of information to be redacted.

But some, such as lobby group AllTrials as well as O'Reilly, criticised the move, saying it violated the new transparency agenda by the EMA, which from January this year has seen it change its policy to allow more clinical trial data to be made public.

For O'Reilly, her specific concerns include the redaction of a section explaining the rationale for Humira's dose selection, because of an unspecified “ongoing development”, and she also asked whether the EMA is aware of this development or has simply relied on the company's “unsubstantiated assertion”.

In response to the Ombudsman, the EMA has said this week the redactions to the Humira data were minor and it only blacked out “limited information contained in a clinical report [that] may be considered commercially confidential”.

This, it says, includes information revealing, as yet undisclosed, commercial development plans, and in these cases the EMA says these data may be redacted.

In a statement the regulator said: “The redaction of information contained in a clinical study report is a dynamic process that evolves over time. Information that may have been considered confidential at a certain point in time may no longer fall under this category at a later time, depending on the development of the medicine and the availability of public information on those plans.

“EMA applies its technical and scientific competence in the assessment of claims of confidentiality made by pharmaceutical companies and in the redaction of clinical study reports.”

The Ombudsman will make her reply in the coming weeks.

Article by
Ben Adams

11th February 2015

From: Regulatory



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