Posted 04 April 2014 | By Alexander Gaffney, RAC, 

AbbVie Withdraws Legal Challenge Against EMA Regulatory Transparency Policy

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EU regulators have announced that one of two major legal challenges to a policy that would make public the results of many clinical trials used to support approval of already-approved drug products has been withdrawn.

Background

In recent years, a growing number of voices have been clamoring for greater transparency of clinical trials results, especially after some companies were found to have hidden unfavorable data regarding the safety of drugs which were later recalled.

In the EU, the European Medicines Agency (EMA) has responded to these calls by formulating an ambitious proposal that would require the results of clinical trials conducted in support of most drugs to be made public, regardless of the drug's eventual approval status.

That plan has won rave reviews from some transparency advocates, including those behind the AllTrials campaign, which is campaigning for the release of all clinical data. Industry, however, has been far less supportive, with at least two companies-AbbVie (formerly of Abbott Laboratories) and InterMune-suing the agency to stop it from releasing what they called "commercially confidential information."

Those arguments evidently held enough weight with the General Court of the EU to merit an interim order barring the agency from publishing its transparency plan. That order was kicked back to a lower court in December 2013, further delaying its resolution. "Until a new decision is taken by the courts, we will not release the documents relating to the AbbVie and InterMune products," EMA spokesman Martin Harvey told Reuters, leaving open the possibility of releasing information related to other products.

In December 2013, EMA reiterated its support for the data transparency plan, saying it would move forward with its plan after working with outside stakeholders

to "further clarify and fine-tune the proposed rules to achieve the broadest possible consensus."

AbbVie Drops Lawsuits

But on 4 April 2014, EMA announced that one of the two companies, AbbVie, had withdrawn two of its court cases against the agency regarding its clinical data transparency plan.

The company, EMA explained, had requested "very limited redactions" to the data, which regulators said were "consistent with the Agency's redaction practices, and also had no significant impact on the readability of the reports."

EMA then accepted AbbVie's redaction proposal, causing it to withdraw its legal challenge.

Still ongoing, however, its InterMune's legal challenge against EMA regarding its idiopathic pulmonary fibrosis drug Esbriet (perfenidone).

The news also comes just days after EU legislators passed a new clinical trial regulation which will eventually require the results of most clinical trials to be made public.