Novartis back under microscope
pharmafile | June 23, 2014 | News story | Medical Communications, Sales and Marketing | Italy, Novartis, avastin, fraud, influenza, vaccines
Novartis is under the microscope yet again in Italy, with police visiting the company’s sites at Siena and Origgio in connection with a possible fraud involving two influenza vaccines which were bought by the country’s health ministry.
Bloomberg reports that the police believe the Basel-based firm boosted the cost of MF59 – an additive to the vaccines – to six times its normal price.
The result could be a claim by the ministry for as much as €16 million in damages, investigators said.
In a statement, the company insisted: “Novartis is committed to high standards of ethical business conduct and regulatory compliance in all aspects of its work.”
Despite this sanguine response, the Swiss company is already under pressure in Italy and the latest round of attention from the authorities will be less than welcome.
Last month the health ministry said it was looking for €1.2 billion in damages from Novartis and Roche over claims that the companies colluded to stop Roche’s cancer drug Avastin from being used by doctors to treat wet age-related macular degeneration (AMD).
Both firms have consistently said that there is no such agreement between them – but in March, Italy’s antitrust authority fined them €182.5 million nonetheless.
Off-label prescribing of Avastin (bevacizumab) for this eye condition has been relatively common even though the drug – unlike the more expensive Lucentis (ranibuzimab), which is co-marketed by Novartis and Roche – is not approved for this licence.
French competition authorities have already began their own investigation into the Avastin claims: the Authorite de la Concurrence said that unannounced visits were made in April to unnamed companies in France suspected of being involved in ‘anti-competitive activities’.
European Union regulators have also been considering whether they need to take any action over the allegations.
There has been no formal move by the European Commission, but Joaquin Almunia, vice president of the EC in charge of competition issues, was quoted as saying regulators were ‘gathering information’.
Adam Hill
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