Feds Suspect Novartis of Shady Marketing of Gilenya MS Pill – Exclusion a Possibility
July 18th, 2013 // 2:00 pm @ jmpickett
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The word is that the marketing arm of Novartis is being carefully probed by the US Attorney in New York. That office issued a demand for a civil investigation this week for documents and information regarding marketing for its multiple sclerosis treatment Gilenya. The feds also want to find out about how health care providers were compensated. This is another way of asking what types of goodies and cash were given to physicians.
This move is coming just as Novartis is dealing with a most protracted fight in the highly competitive market for multiple sclerosis drugs. Back in March, Biogen came out with the Tecidera pill. This is a drug that one analyst said was the holy grain of drug launches, as the drug got millions of prescriptions very fast. Novartis fought back by coming up with a new ad that targeted a younger population of patients.
This disclosure is three months after the DOJ filed two suits that accused Novartis of giving kickbacks to increase prescriptions of assorted drugs, and causing federal health care initiatives to pay for drugs based upon claims that were false.
In both of these cases, the feds have alleged that Novartis was reaping large profits illegally. In one of the cases, the government charged that the company gave kickbacks – rebates and discounts – to 20 pharmacies, in exchange for them switching patients who needed transplants from other firms’ medicines to the Myfortic immunosuppressant drug.
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In another case, the government alleged from 2001 to 2011, Novartis violated laws against kickbacks and also its own policies regarding speaker programs. These mandate that programs have an educational purpose and that slides about products from the company be shown. Instead of that, Novartis gave money to doctors to talk about several drugs, such as Lotrel and Valturna, which are for hypertension.
These new developments are making us wonder – Is Novartis violating its corporate integrity policy? The drugmaker in 2010 had to pay $400 million because it illegally marketed its Trileptal drug.
Because of that case, the company signed an CIA for five years, where the firm agreed to not engage in such shady practices. The alleged kickbacks in the current case happened before and after the CIA. This may mean that Novartis could be looking at exclusion – this means that the company could be excluded from contracts with federal government programs. This is a huge and devastating penalty for a pharmaceutical company.
The investigation over Gilenya is still just an investigation, but the feds are probing marketing practices of Novartis often. It appears that its payments and incentive programs for doctors are raising a good deal of suspicion.
