font size
Sign inprintPrint
LEGAL

Drug Companies Sue EMA over Trials Data

AbbVie and InteMune seek to head off release of proprietary data by regulator.

MICHAEL FITZHUGH

The Burrill Report

“We consider this information to be commercially confidential.”

AbbVie and InterMune are suing the European Medicines Agency to block it from releasing clinical trial data requested by competitors in freedom of information requests submitted to the regulator.

The lawsuits, first reported in the Financial Times, seek injunctions to prevent the release of detailed information about AbbVie’s rheumatoid arthritis therapy, Humira’s effect on individual patients, and InterMune’s Esbriet, a therapy for idiopathic pulmonary fibrosis. AbbVie is the U.S. pharmaceutical company recently spun off from Abbott Laboratories

In a statement provided to Bloomberg, AbbVie said that it is “seeking to protect AbbVie’s confidential and commercially-sensitive information.”

Jim Goff, a spokesman for InterMune, told Bloomberg that his company is challenging the EMA’s decision “to disclose to a competitor parts of documents” used in its marketing application for Ebriset. “We consider this information to be commercially confidential,” he said.

Improved communications and transparency are among the top priorities for the EMA in its 2013 work plan, a component of which will involve “opening the agency’s rich repository of data” and providing information “to benefit drug development and improve patient care,” it says. In addition, the agency says that following a November 2012 workshop, it is consulting with stakeholders in preparation for publishing its policy on the release of data from clinical trials in the latter part of 2013.

In November 2012, a Danish researcher suggested that European governments should sue Roche and that doctors and others should boycott the company’s products until it published additional clinical trial data on the effectiveness of the company’s flu treatment and prevention medicine, Tamiflu.

The effort was preceded in October 2012 by BMJ’s Editor-in-Chief, Fiona Godlee, asking Roche to make full clinical study reports available, part of the journal’s “open data campaign,” an effort under which the BMJ has committed to no longer publishing “any trial of drugs or devices where the authors do not commit to making the relevant anonymised patient level data available, upon reasonable request.”

Roche has said it is in support of greater transparency and has announced that it will expand access to its clinical trial data for third party researchers, but to date, it has not satisified the BMJ’s call for full public access to its data.



March 15, 2013
http://www.burrillreport.com/article-drug_companies_sue_ema_over_trials_data.html

[Please login to post comments]

Other recent stories

Sign Up to recevie the Burrill Weekly Brief


Follow burrillreport on Twitter