False Claims Act Lawsuits over REMS Safety Education

After a number of whistleblower lawsuits under the False Claims Act, Novo Nordisk will pay approximately $59 million to settle allegations that it minimized the cancer risk of Victoza, a diabetes medication, after the FDA required it to provide safety communications pursuant to a Risk Evaluation and Mitigation Strategies (REMS) program.

Congress gave the FDA the authority pursuant to the FDA Amendments Act of 2007 to require drug manufacturers to perform additional risk mitigation strategies to ensure that the benefits of certain prescription drugs outweigh the risks. They are typically required in a single drug or class of drugs when their is a serious risk that could be mitigated with education. Examples of REMS requirements include certification of the healthcare professional, patient education, or a negative pregnancy test prior to dispensing.

For Victoza, the FDA required distribution of a REMS safety notice concerning the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis. During premarket testing of the drug, some rodents exposed to Victoza developed thryoid C-cell tumors. The FDA required Novo Nordisk to communicate this unknown risk to healthcare providers. However, the Government’s complaint alleged that Novo Nordisk took various steps to mislead physicians about the cancer risk or create the false impression that the REMS message was unimportant or erroneous.

The FDA currently has 72 approved REMS programs agreed to by manufacturers. If other pharmaceutical manufacturers followed a similar path as Novo Nordisk and attempted to mislead or otherwise minimize the program, this will be a ripe area for False Claims Act litigation over the next few years.

If you are a pharmaceutical sales rep that has evidence of similar conduct at another pharmaceutical manager, you may be able to receive compensation for your information through a False Claims Act lawsuit. Please call 1-800-590-4116 for a confidential consultation with Eric Young or another whistleblower attorney at McEldrew Young.