Summary
Amgen Inc. (AMGN) has announced a significant settlement with the U.S. government and 49 states, including the District of Columbia, to resolve previously disclosed investigations concerning the promotional practices of several key drugs. The total payment agreed upon is approximately $762 million. This includes $612 million to resolve civil liabilities related to promotional practices for drugs such as Aranesp®, EPOGEN®, NEUPOGEN®, Neulasta®, Enbrel®, and Sensipar®. Additionally, $150 million will be paid to resolve criminal liability specifically related to the marketing of Aranesp®. As part of the agreement, Amgen has pleaded guilty to a misdemeanor charge of misbranding Aranesp® for off-label promotion. The company also entered into a five-year corporate integrity agreement with the U.S. Department of Health and Human Services, which mandates continued maintenance and adherence to its corporate compliance program. Amgen had previously accrued $806 million for this settlement as of September 30, 2012, indicating the financial impact is largely accounted for.
Key Highlights
- 1Amgen reaches a settlement with the U.S. government and 49 states totaling approximately $762 million.
- 2The settlement resolves civil liabilities regarding promotional practices for multiple drugs, including Aranesp®, EPOGEN®, NEUPOGEN®, Neulasta®, Enbrel®, and Sensipar®.
- 3Amgen will pay $150 million to resolve criminal liability related to the marketing of Aranesp®.
- 4The company pleaded guilty to a single misdemeanor count of misbranding Aranesp® for promoting it differently than its label.
- 5A five-year corporate integrity agreement has been entered into with the U.S. Department of Health and Human Services.
- 6The settlement's financial impact is largely covered by the $806 million accrued as of September 30, 2012.