AbbVie Sues EMA Over Clinical Trial Data

AbbVie Sues EMA Over Clinical Trial Data

March 11th, 2013 // 3:07 pm @

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In a direct challenge to the proponents of disclosing clinical trial data, AbbVie has filed a request for an injunction to prevent the European Medicines Agency from releasing detailed patient-level data from studies concerning its top-selling Humira rheumatoid arthritis treatment, The Financial Times writes.

Tomorrow – A Classic FDA Auditing Trick

The filing comes after two Freedom of Information requests were made to the EM last year to release “raw data” on the safety and efficacy of the medication, a multi-billion-dollar seller. One of those filings was made by UCB, which sells a rival treatment called Cimzia. A similar filing with the EMA was also lodged by InterMune and the US and European industry trade groups filed supporting pleas, the paper writes.

The move comes amid a heated controversy over data disclosure, which most drugmakers are fighting over concerns that confidential information could be unfairly obtained by rivals. On the other side of the debate are researchers who argue that results cannot be independently verified unless patient-level data and case-study reports are fully disclosed.

In a statement, the drugmaker says it is “seeking to protect AbbVie’s confidential and commercially-sensitive information,” according to the paper. Abbvie supports “transparency of clinical research and safety information for the benefit of patients and healthcare professionals, (but not) the disclosure of commercially confidential information that does not meaningfully contribute to the scientific review or evaluation of our products.”

There are, however, cracks showing in the stance taken by the pharmaceutical industry. Last year, GlaxoSmithKline (GSK) agreed to make patient-level data to independent researchers, a step that came after the drugmaker paid a $3 billion settlement to settle civil and criminal charges that included a failure to release trial data (see this). However, the drugmaker has not yet launched its effort.

Meanwhile, Roche (RHHBY) recently declared it will work with an “independent” group of “recognized experts” to evaluate and approve requests to access patient-level data and will also support the release of case study reports for all of its licensed medicines. This move, which came in response to a flap over Tamiflu data, has been met with skepticism, though (read more here and here).

The Tamiflu debate subsequently prompted the British Medical Journal, known as BMJ, to issue a policy in which studies will no longer be published unless patient level data is made available. BMJ is also one of several organizations sponsoring the AllTrial campaign, which is an online petition calling for drugmakers to make public all trial data (look here). PhRMA, in particular, blasted the effort (back story).

It is unclear what the AbbVie move will mean for the EMA, which last year agreed to publicly release by the start of 2014 all submitted data once a decision has been made either to approve or reject a medicine. The agency noted, by the way, that most Freedom of Information requests for data come from rivals, not independent researchers, the paper writes.

Last month, the lead legislator for the Environment, Public Health and Food Safety Committee in the European Parliament wants to toughen proposed legislation that is designed to bolster clinical trial practices and activities on the continent. One provision would require disclosure of full clinical studies – not summaries – to be submitted (read here).

Tomorrow – A Classic FDA Auditing Trick

This is not the first time that AbbVie has cited concerns over trade secrets to thwart competitors. Last year, Abbott Laboratories (ABT), which has since spun off AbbVie, (ABBV) filed a citizen’s petition with the FDA to ask that the agency not approve any biosimilar for its Humira treatment for rheumatoid arthritis. The drugmaker argued the FDA would have no choice but to use trade secrets submitted to the agency when approval for Humira was first sought.

H/T: Pharmalot


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