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InterMune drops EMA lawsuit over data release

Published on 10/06/14 at 02:12pm
Esbriet image
InterMune filed an injunction against the EMA for allowing third party access to Esbriet

InterMune has ended a year-long legal spat with the European Medicines Agency over the potential release of data for its lung drug Esbriet.

The specialist firm had last year filed an injunction against the EU drugs regulator from allowing third party access to its biggest earner. 

But legal documents released today show that the firm has now dropped the case, with both the EMA and InterMune saying they wished to “discontinue proceedings and requested that each party should bear its own [legal] costs”.

Neither group has yet made any public comment on why the legal proceedings have been stopped, and who initiated it.

InterMune said last year that making available “confidential information about InterMune’s only marketed product would be likely to cause the company serious and irreparable economic harm for various reasons, including because it could jeopardise InterMune’s ability to protect certain intellectual property for Esbriet (pirfenidone)”.

AbbVie had pursued a similar case against the regulator at around the same time last year as InterMune, but decided to drop its case in April.

AbbVie took exception to the EMA’s wish to release some data from its blockbuster drug Humira (adalimumab), currently the highest earning drug in the world.

The EMA was initially ruled not to release the data from both firms in April last year, but managed to successfully appeal against this decision.

But the regulator seemed to soften its stance earlier this year and came to a compromise with AbbVie by saying it would put the limits proposed by the US firm on what could be seen from the data – i.e., it would allow some redactions.

It was thought that InterMune would also drop its case at the same time after AbbVie, but it waited until now to do so – increasing the annoyance levels of AllTrials co-founder Dr Ben Goldacre who has criticised the lawsuits since they were made public.

Dr Goldacre says of this latest development: “This case was a scandal. Furthermore, InterMune did not act alone: both ABPI and EFPIA, the UK and EU industry bodies, gave these shameful anti-transparency cases full support, while publicly proclaiming their support for transparency around clinical trials.

“It is encouraging that the case has now been dropped, but at the same time, the EMA is suddenly rolling back its transparency plans, announcing greater restrictions on access to information.

He adds: “We cannot prescribe medicines safely and effectively for as long as this ludicrous situation persists: we need access to the full methods and results of all trials on all uses of all currently used treatments.”

New EU transparency agenda

This all comes several months after the European Parliament voted for greater clinical trial transparency to be imposed across Member States.

This new law will mean that from 2016 the EU will no longer see most study data as ‘commercially confidential’, thus removing many legal barriers for bodies like the EMA to publish trial information.

But there are concerns that the EMA, which is also looking to increase the level of transparency from pharma into its processes, may now be reneging on its promises on data disclosure.

Last month the regulator produced a further draft of its initial policy on this issue which could now introduce barriers for the access of clinical trial data – something not present in its first policy draft.

The transparency lobby group AllTrials say this would make the job of researchers who want to scrutinise it ‘almost impossible’.

This they argue, is because the policy introduces terms of use which say that researchers can access the data on screen only with printing, sharing or saving of the data forbidden.

It also allows the company who supplied the data to the EMA to decide which information to redact so researchers may never know what information is being kept hidden.

Ben Adams 

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