21 December 2017Big Pharma

Janssen-Cilag fined €25m over ‘smear campaign’ against generic rivals

France’s competition regulator has fined Johnson & Johnson and its subsidiary Janssen-Cilag €25 million ($29.7 million) for delaying generic versions of the pain drug Durogesic.

In a strongly worded statement released yesterday, December 20, the Autorité de la Concurrence said Janssen had committed “grave practices” including a “vast smear campaign” denigrating rival drugs.

The authority said more than half of French pharmacies had been affected by the campaign, conducted between 2008 and 2009.

A Janssen-Cilag spokesperson said the company strongly contests the statements made in the press release as well as the underlying analysis of the authority in its decision.

“We will carefully review the decision and assess the legal options available.”

The case was brought by Ratiopharm, now called Teva Santé, after it was granted an EU marketing authorisation (MA) in 2007 for a generic version of the drug, which is often used to treat cancer patients.

According to the competition authority, Janssen then “interfered unduly” in the French MA procedure with the objective of delaying generics.

The authority said Janssen repeatedly made unjustified approaches to France’s medicines regulator—which has since been renamed the Agence Nationale de Sécurité du Médicament et des Produits de Santé—asking it to reject applications for generic versions.

Janssen questioned the quality of the generic products competing with Durogesic, “in particular questioning the bioequivalence, despite it having been established, and the existence of differences in the qualitative and quantitative composition of the active ingredient, fentanyl”, the authority said.

“It also put forward risks for public health that this substitution could cause in some patients,” the authority added.

As a result, the medicines regulator initially refused to accept applications for generic Durogesic.

The medicines regulator finally granted generic status to the competing products in late 2008, more than a year after the 2007 decision granting the MA in Europe.

When France’s regulator granted the generic status, it recommended that doctors carefully monitor certain patients, such as the elderly, in the event of changing between fentanyl-based medicinal products.

But Janssen then “distorted the content of the warning” by providing an inaccurate and incomplete presentation of the risks associated with substitution, the competition authority said.

Janssen initiated a mass communications campaign among healthcare professionals to discredit the rival drugs, emphasising the differences in the quantity of the active ingredient contained in the various patches, as well as their size difference, the authority said.

“The result was that doctors and pharmacists were reluctant to dispense the generic medicinal products, for fear that it would engage their liability.”

“These are grave practices. They have delayed the arrival to the market of generic medicines by several months and have discredited the generic versions of Durogesic, irrespective of any consideration of public health, by creating doubt in the minds of healthcare professionals regarding their effectiveness and safety.”

It is not the first time the authority has taken action over such practices.

In 2013, Sanofi-Aventis was fined €40.6 million for having implemented a strategy “discrediting” generic versions of Plavix (clopidogrel), a treatment for reducing the risk of heart disease and stroke.

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