FDAnews Drug Daily Bulletin

InterMune, Abbvie Case Against EMA Transparency Plan Sees New Setback

Dec. 9, 2013

A closely watched case over trial transparency in the EU has been sent back to the General Court of the European Union for re-examination, which will likely delay a final decision.

The European Court of Justice’s decision to set aside an injunction brought by Intermune and AbbVie, intended to prevent the European Medicines Agency (EMA) from disclosing clinical trial data, is an important development for industry, Alasdair Breckenridge, former chair of the UK’s Medicines and Healthcare products Regulatory Agency, said.

“The future actions of the EMA will be greatly influenced by the legal outcome, although the movement for greater transparency of clinical trial data has gained considerable momentum in the meantime,” he added.

While the case goes through the European legal system, the EMA has continued to push forward with its transparency plan. Recently, however, the agency also announced it may have to delay a Jan. 1, 2014, deadline to implement the plan in order to respond to an overwhelming amount of feedback from stakeholders in response to the initiative.

However, the two drugmakers and the trade associations that represent them argue the data disclosure could compromise patient privacy and commercially confidential information. — Ferdous Al-Faruque

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