DOJ Launches Novartis Probe Into Gilenya Illegal Marketing

Novartis is warning investors about a new investigation that has been launched by the Justice Department, looking into the company’s marketing of the multiple sclerosis drug Gilenya.  

In a recent Securities and Exchange Commission (SEC) quarterly filing, Novartis disclosed that a request was issued this month by the U.S. Attorney’s office in New York, asking for documents and information relating to the company’s Gilenya marketing practices.

The Department of Justice (DOJ) is seeking information on payments the company made to doctors in connection to the drug, suggesting a potential probe into kickbacks or illegal promotion of the medication.

Under the federal anti-kickback statute (AKS), it is illegal for a company to pay kickbacks, bribes or rebates to get doctors to buy or recommend a drug that is covered by Medicare or Medicaid. Novartis is already the target of other Justice Department kickback lawsuits involving other medications.

In April, the DOJ filed a Myfortic kickback lawsuit against Novartis, accusing the company of convincing at least 20 pharmacies to switch thousands of kidney transplant patients to Myfortic by giving them a rebate bonus based on the pharmacy’s annual Myfortic sales. The DOJ claims the scheme cost tax payers tens of millions of dollars in unnecessary Medicare and Medicaid reimbursements.

The government also accused the company of using speaking engagements as a cover to pay off doctors with high sales of Lotrel and Valturna hypertension drugs. The engagements were allegedly just social events for doctors and an excuse for the company to reward them for selling the company’s products, the lawsuit claims.

Three years ago, Novartis entered into a corporate integrity agreement (CIA), promising not to engage in such practices. The agreement came following a case brought over the marketing of Trileptal, which resulted in an agreement that also included a guilty plea and $422.5 million in fines. The CIA was a five year agreement, suggesting that some of the more recent probes may involve actions that would violate the agreement.

Gilenya Side Effects

Gilenya (fingolimod) was approved by the FDA in 2010 as an oral treatment for relapsing forms of MS in adults. It is used to reduce how often flare-ups occur and to delay the onset of physical disability caused by MS.

Despite concerns over the safety of Gilenya when it was reviewed, the FDA agreed to fast-track the drug’s approval with minimal testing under a program aimed at getting crucial drugs to the market to address medication needs that have not been met by other drugs. It is the only oral MS drug on the market.

The known side effects of Gilenya include a decrease in heart rate and/or atrioventricular condition after the first dose. It is also known to increase the risks of vision loss and developing heart blocks or bradycardia when taken with some other drugs, including beta blockers and calcium channel blockers.

The FDA launched a safety investigation into Gilenya in 2011, after at least one patient died within 24 hours of taking the medication.

Although the agency was unable to determine whether Gilenya played a role in the death, they have contraindicated Gilenya for patients with pre-existing heart conditions or heart problems that have occurred within the last six months, such as heart attacks, unstable angina, heart failure or decompensated heart failure that required hospitalization, among others. The FDA also contraindicated Gilenya’s use by patients who have suffered a stroke or who take Class Ia or Class III anti-arrhythmic drugs.

The agency issued a drug safety communication on Gilenya heart risks last year.