The Burrill Report


AbbVie has dropped its challenge to the European Union court to block the European Medicines Agency from releasing clinical trial data from the company, reports Bloomberg. AbbVie’s decision comes amid European regulators efforts to push for more clinical trial transparency.

AbbVie told Bloomberg that it withdrew its lawsuits after the EMA accepted redacted documents from the company and also its reason for removing “certain commercially confidential information from clinical study reports that are at the center of the litigation.”

Spurred by drug safety concerns, European drug regulators vowed in 2010 to increase transparency by disclosing clinical trial data to the public when asked for every drug they review. AbbVie objected two EMA decisions for access to clinical trial data, one in 2012 and one in 2013. InterMune is also attempting to block the EMA in court from releasing its clinical trial data. It is hoped that it will also drop its lawsuit.

Meanwhile, the European Parliament has approved new rules that would require companies to publish all clinical trial data one year after the studies are completed. The rule is expected to go into effect in 2016 and will apply to all new trials going forward.

Some drugmakers have taken the lead to make trial data available to the public, including Johnson & Johnson and GlaxoSmithKline. While others, such as Pfizer, Sanofi, and Roche, have said they will begin to share their data to some extent.

April 04, 2014
http://www.burrillreport.com/article-abbvie_drops_attempt_to_block_eu_clinical_trial_transparency_effort.html