One country is ahead of the curve in striking pay-for-performance deals on cancer drugs--and, more importantly, collecting the cash when treatments don't hit their goals.
While FDA regulatory action against Indian companies has drawn the media spotlight the last couple of years, European regulators also have been finding problems with some Indian plants. Both France and Italy took action against Indian drug manufacturers last month, finding them out of compliance and limiting product sales as a result.
Novartis' Fluad influenza vaccine has been declared safe by another regulator, this time the European Medicines Agency, after being called into question following the deaths of patients in Italy who had been given the jab.
After last week partially banning Novartis' Fluad, Italian officials now say tests on the flu vaccine show the product is safe.
Italy's drug regulator has a growing investigation on its hands, and Novartis is in the middle of it. The number of people who have died in the country after receiving one of the Swiss pharma giant's flu vaccines has risen by 10 just days after Italy issued a partial ban on the product.
Italy: the land of good food, rich history and pharma billionaires. The country boasts a number of pharma giants in its ranks thanks to recent deals and the continued success of decades-old businesses.
FDA inspections have uncovered a number of Indian companies that have manipulated data on their active pharmaceutical ingredients and deleted test results that didn't conform to specifications, an issue that has led to warning letters and contributed to import alerts. Many of those makers have been in India, but a warning letter posted today for an Italian company shows the problem is universal.
Novartis is in the process of trying to hive off its flu vaccines business after selling off the rest of its vax unit to GlaxoSmithKline. But first, it may have to deal with an Italian fraud investigation over pricing on a pair of those products.
In the U.S. pushing drugs for unapproved uses has gotten companies into big trouble. In Italy, the opposite is now true. To save money, the government will pay for patients to be treated for an eye disease with Roche's Avastin, a drug not approved for that use, and has taken legal action against the Swiss drugmaker and marketing partner Novartis for steering physicians toward the pricier Lucentis, which is.
Italian finance police searched the offices of the Italian Medicines Agency, looking for evidence in a criminal probe of potential fraud and market manipulation by the Swiss drugmakers Novartis and Roche. Officials have been investigating allegations that the two companies colluded to boost sales of Lucentis, their eye drug, by sidelining off-label use of the drug's close cousin, Avastin.