J&J struck by €25m fine over fentanyl pain patch

Johnson & Johnson has been fined by France’s competition authority, Autorité de la Concurrence, after it alleges the company had intentionally stifled generic competition to its painkiller patch.

The product in question is Durogesic, and the case was brought to the authority by Ratiopharm. The German company, which has since been taken over by Teva (in 2010), suggested that J&J had disparaged generic versions of its product to healthcare professionals.

As well as this, the pharma giant was accused of a "legally unjustified" approach to the French Health Authority suggesting that the generic and branded product were not equivalent.

The authority noted: "[Johnson & Johnson] proposed in a letter that Durogesic and its generic counterparts were not ‘exactly similar’. 

"In an account sent to the AFSSAPS, Janssen-Cilag even went as far as questioning the whole class of generic medicinal products by indicating that ‘the system in place does not offer all the necessary safety provisions’ and that reasons of cost led the laboratories to ‘look for sources of supply outside the European Union, involving countries that do not always offer the required guarantees of quality (e.g. Asia)’".

As a result of these findings, the authority has imposed a fine of €25 million against Janssen Cilag and its parent company, J&J.

Durogesic had not been without controversy prior to this case, with the active ingredient being fentanyl – a painkiller that is 50 times more powerful than heroin.

This led to a number of cases where patients, who were using the patch for the management of chronic pain, became addicted to the treatment and would experience severe withdrawal symptoms when trying to stop using the treatment.

Beyond this, there were numerous cases in different countries where the patch was incorrectly prescribed for the treatment of acute pain, when the treatment was given to children and when the patch was exposed to heat (increasing absorption of the drug).

The incidents led to deaths in certain patients and came despite the black box warning the drug carries.