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# Novo Nordisk Paying $58 Million in Whistleblower Cases
- URL: https://www.fdaweb.com/novo-nordisk-paying-58-million-in-whistleblower-cases/
- Published: 2017-09-06T12:00:00.000Z
- Updated: 2026-09-14T22:47:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139554

The Justice Department says Novo Nordisk will pay $58.65 million to resolve allegations brought by whistleblowers that the company failed to comply with an FDA-mandated REMS (risk evaluation and mitigation strategy) for its Type 2 diabetes drug Victoza (liraglutide). A department [statement](https://www.justice.gov/opa/pr/novo-nordisk-agrees-pay-58-million-failure-comply-fda-mandated-risk-program?ref=fdaweb.com) says the resolution includes disgorgement of $12.5 million for alleged violations of the Federal Food, Drug, and Cosmetic Act (FFDCA) from 2010 to 2012, and a payment of $46.5 million for alleged violations of the False Claims Act from 2010 to 2014.

The government says that at the time of Victoza’s 2010 approval, FDA required a REMS to mitigate the potential risk in humans of a rare form of cancer associated with the drug. The REMS required the company to provide information about Victoza’s potential risk of medullary thyroid carcinoma to doctors.

A federal complaint says that company sales representatives gave information to doctors creating the false or misleading impression that the REMS-required message was erroneous, irrelevant, or unimportant. The complaint also says the company failed to comply with the REMS by creating the false or misleading impression about the Victoza REMS-required message that violated provisions of the FFDCA and led some doctors to be unaware of the potential risks when prescribing the drug.

The government alleges that after a 2011 survey showed that half of primary care doctors polled were unaware of the potential cancer risk associated with Victoza, FDA required a REMS modification to increase awareness of the potential risk. However, it says, the company instructed its sales force to provide statements to doctors that obscured the information and failed to comply with the REMS modification.

The Justice Department says the settlement resolves seven lawsuits filed by False Claims Act whistleblowers. The whistleblowers will share in a portion of the government’s recovery; the exact amount each will receive has not been determined, the government says.